signet selection guide to excipients 3

The information in this guide is to our best knowledge true and accurate but, all instructions, recommendations or suggestions are made without guarantee. Since the conditions of use are beyond their control, Signet Chemical Cor-poration Pvt. Ltd. disclaims any liability for loss or damage suffered for use of this data or suggestions. Furthermore, no liability is accepted if use of any product in accordance with this data orsuggestions infringes any patent.

Copyright 2011 Signet Chemical Corporation Pvt. Ltd. All rights reserved. The content in this publication is pro-tected by copyright. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher.

Signet Chemical Corporation Pvt. Ltd.

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For over twenty five years, Signet has aligned its key focus towards providing the world’s best pharmaceutical raw materials to Indian scientists and formulators. By steadily establishing brands, promoting advanced processes and encouraging a shift towards newer developments and innovative applications, today Signet occupies a stellar position as India’s largest excipients distributing company.

Setting Benchmarks through Market Understanding: We at Signet believe in providing the highest level of customer service, catering high quality products and providing a strong support infrastructure to ensure smooth delivery of customer expectations.

Global Connections for Global Giants: Staying informed about every international excipient producer in the market and bringing all new developments to our customer’s doorstep, is what we strive to achieve every day.

Everything Excipients: Signet, with its widely suitable, quality centred, robust and evolving range of excipients, today serves as a ‘One-Stop-Shop’ for formulators, with products manufactured in locations approved by international drug regulatory bodies.

The Entire Spectrum of Applications: Binders, fillers and disintegrants, sweeteners and coating agents - the company attempts at addressing every application need. From oral and dermal administration to intravenous delivery, our portfolio covers it all.

Evolved Systems and Processes: The pharmaceutical industry operates in a stringent regulatory environment and to comply with this need, we at Signet provide all requisite documents and support regarding the use and safety of products. Our customers can be assured of quality, transparency and reliability, at all times.

Team Signet. Our Power, Our Pride: At Signet, a fine blend of commercial and technical members have set a culture of proactivity, approachability and responsibility. The company’s greatest asset - its people - come together to give ‘Signet’ a distinctive edge in the market today.

FMC BioPolymer Roquette Frères

DFE Pharma

Shin-Etsu

Dead Sea Periclase

BASF

Pharm-A-Spheres

Kronos

Eastman

Cytec

Lakeshore Biomaterials NovaMatrix

Tereos Excipients Rockwood Pigments

Innophos

Scora

Asahi Kasei

Ferro Corporation

Ferro Pfanstiehl

CP Kelco

Imerys (Luzenac)

FreislandCampina Domo

AMCOL HBS Specialty Minerals GumBase

Glossary Contact

Company Products Page

AVICEL PH - Microcrystalline Cellulose 13 AVICEL DG - Microcrystalline Cellulose And Dibasic Calcium Phosphate

AVICEL HFE-102 - Microcrystalline Cellulose And Mannitol

AVICEL CE-15 - Microcrystalline Cellulose And Guar Gum

AVICEL RC / CL - Microcrystalline Cellulose And Carboxymethylcellulose Sodium

AC-DI-SOL - Croscarmellose Sodium

ALUBRA PG 100 - Sodium Stearyl Fumarate

AQUACOAT ECD-30 - Ethylcellulose Aqueous Dispersion

LUSTRECLEAR LC-103 - Microcrystalline Cellulose And Carrageenan Based Coating System

PROTANAL / MANUGEL / KELTONE / MANUCOL / KELCOSOL / KELSET / KELCOLOID - Alginates

PROTACID / KELACID - Alginic Acid

GELCARIN / VISCARIN / SEASPEN - Carrageenan

PEARLITOL - Mannitol 21 PEARLITOL FLASH - Compound Of Mannitol And Maize Starch

XYLISORB - Xylitol

NEOSORB - Sorbitol

SWEETPEARL - Maltitol

LYCASIN - Maltitol Solution

POLYSORB - Anhydrized Liquid Sorbitol

KLEPTOSE - Betadex

KLEPTOSE HPB - Hydroxypropyl Betadex

LYCADEX PF - Dextrose Monohydrate, Pyrogen-Free

DEXTROSE MONOHYDRATE GC - Dextrose Monohydrate, Agglomerated

DEXTROSE ANHYDROUS C - Dextrose Anhydrous, Crystalline

MAIZE / WHEAT / POTATO STARCH - Native Starch

LYCATAB PGS - Fully Pregelatinized Starch

LYCATAB C - Partially Pregelatinized Starch

LYCATAB DSH - Partially Hydrolyzed Starch

GLYCOLYS - Sodium Starch Glycolate

LYCOAT RS - Starch Based Coating System

READILYCOAT - Ready-To-Use Starch Based Coating Sytem

GLUCIDEX - Maltodextrin / Corn Syrup Solids

TACKIDEX - Dextrin

STARLAC - Compound Of Maize Starch And Lactose Monohydrate

NUTRIOSE - Soluble Fibre

HI-SWEET - High Fructose Corn Syrup

PHARMATOSE / LACTOCHEM / HMS LACTOSE - Lactose Monohydrate, 33 Sieved, Milled, Impalpable

SUPERTAB SD / LACTOPRESS SD - Spray-Dried, Directly Compressible Lactose

SUPERTAB AN / LACTOPRESS AN - Anhydrous, Directly Compressible Lactose

SUPERTAB GR / LACTOPRESS GR - Granulated, Directly Compressible Lactose

Product List

01


KOLLIDON - Povidone (PVP K) 37 KOLLIDON CL - Crospovidone

KOLLIDON VA 64 - Copovidone

KOLLIDON SR - Blend Of Polyvinyl Acetate And Povidone

KOLLICOAT SR 30 D - Polyvinyl Acetate Dispersion

KOLLICOAT IR - Macrogol Poly (Vinyl Alcohol) Grafted Copolymer

KOLLICOAT IR COATING SYSTEMS - Ready-To-Use Coating Systems

KOLLICOAT PROTECT - Macrogol Poly (Vinyl Alcohol) Grafted Copolymer And PVA

KOLLICOAT MAE - Methacrylic Acid Copolymer

KOLLICOAT SMARTSEAL 30 D - Methyl Methacrylate And Diethylaminoethyl Methacrylate Copolymer Dispersion

KOLLIPHOR (CREMOPHOR) - Polyoxyl-Hydrogenated Castor Oil

KOLLIPHOR CS (LANETTE PH) - Cetostearyl Alcohol, Emulsifying / Sodium Cetostearyl Sulfate

KOLLIPHOR HS 15 (SOLUTOL HS 15) - Polyoxyl-15-Hydroxystearate

KOLLIPHOR MCE (EUMULGIN B PH) - Polyoxyl Cetostearyl Ether

KOLLIPHOR P / KOLLISOLV P (LUTROL F / LUTROL L) - Poloxamer

KOLLIPHOR PS (POLYSORBATE PH) - Polysorbates

KOLLIPHOR SLS (TEXAPON) - Sodium Lauryl Sulfate

KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) - Vitamin E Polyethylene Glycol Succinate

KOLLISOLV G (SPEZIOL G PF) - Glycerin / Glycerol

KOLLISOLV PG - Propylene Glycol

KOLLISOLV GTA (SPEZIOL GTA) - Triacetin

KOLLISOLV PEG (LUTROL E) - Polyethylene Glycol (Macrogol)

KOLLISOLV MCT (MYRITOL PH) - Medium Chain Triglycerides

KOLLIWAX (SPEZIOL C PHARMA) - Myristyl / Cetyl / Stearyl / Cetostearyl Alcohol

KOLLIWAX GDB (SPEZIOL GDB PHARMA) - Glyceryl Behenate

KOLLIWAX GMS II (CUTINA GMS VPH) - Glyceryl Monostearate 40-55 (Type II)

KOLLIWAX HCO (CUTINA HR PH) - Hydrogenated Castor Oil

KOLLIWAX S (SPEZIOL L2SM) - Stearic Acid

KOLLICREAM CP 15 (CUTINA CP PH) - Cetyl Palmitate 15

KOLLICREAM DO (CETIOL V PH) - Decyl Oleate

KOLLICREAM IPM (ISOPROPYL MYRISTATE PH) - Isopropyl Myristate

KOLLICREAM OA (HD EUTANOL V PH) - Oleyl Alcohol

KOLLICREAM ODD (EUTANOL G PH) - Octyldodecanol

LUDIFLASH - Compound Of Mannitol, Crospovidone And Polyvinyl Acetate

LUDIPRESS - Compound Of Lactose Monohydrate And Povidone

SOLUPLUS - Polyvinyl Caprolactam-Polyvinyl Acetate-Polyethylene Glycol Graft Copolymer

NOVATA - Hard Fat

PHARMACOAT - Hypromellose (HPMC), Low Viscosity 55 METOLOSE SH - Hypromellose (HPMC), High Viscosity

METOLOSE SR - Hypromellose (HPMC), For Sustained-Release

METOLOSE SM - Methylcellulose

HPMCP - Hypromellose Phthalate

L-HPC - Low-Substituted Hydroxypropyl Cellulose

SHIN-ETSU AQOAT - Hypromellose Acetate Succinate

Product List

02


A-TAB - Dicalcium Phosphate Anhydrous, Granular 61 CALIPHARM A - Dicalcium Phosphate Anhydrous, Powder DI-TAB - Dicalcium Phosphate Dihydrate, Granular CALIPHARM D - Dicalcium Phosphate Dihydrate, Powder TRI-TAB - Tricalcium Phosphate Anhydrous, Granular TRI-CAL WG - Tricalcium Phosphate Anhydrous, Granular TCP-DC - Tricalcium Phospate, Granular CALIPHARM T - Tricalcium Phosphate Anhydrous, Powder VERSACAL MP - Tricalcium Phosphate Anhydrous, Micronized Powder

CELPHERE - Microcrystalline Cellulose Spheres 65 PC-10 - Partly Pregelatinised Starch SWELSTAR - Pregelatinised Starch TREHALOSE - Non-Reducing Di-Saccharide

XANTURAL - Xanthan Gum 69 KELCOGEL CG - Gellan Gum CEKOL - Carboxymethylcellulose Sodium

PHARM-A-SPHERES - Sugar Spheres 73

MAGNESIUM OXIDE - Heavy / Directly Compressible 75 MAGNESIUM CARBONATE - Heavy / Granulated MAGNESIUM HYDROXIDE - Directly Compressible

SCORALITE - Calcium Carbonate 79 SCORALITE DC - Directly Compressible Calcium Carbonate SCORABLEND - Compound Of Calcium Carbonate And Magnesium Oxide SCORAMAG DC - Directly Compressible Magnesium Carbonate LIGHT MAGNESIUM CARBONATE LIGHT MAGNESIUM OXIDE

SYNPRO MAGNESIUM STEARATE VG 83 SYNPRO ZINC STEARATE VG SYNPRO CALCIUM STEARATE VG SYNPRO ALUMINIUM STEARATE VG

LUZENAC PHARMA - Talc 85 LUZENAC PHARMA M - Talc, Micronized LUZENAC PHARMA UM - Talc, Ultra-Micronized

KRONOS 1171 - Titanium Dioxide, Super-White, Anatase Grade 87

POLYGLYCOLIDE 89 POLY(DL-LACTIDE) POLY(DL-LACTIDE-CO-GLYCOLIDE) POLYCAPROLACTONE

Product List

TM

03


PRONOVA - Sodium Alginate, Ultra-Pure 91 PROTASAN - Chitosan, Ultra-Pure SODIUM HYALURONATE PHARMA GRADE

SUCROSE, Low Endotoxin 95 D-GALACTOSE, Low Endotoxin MALTOSE, Low Endotoxin

PROYIELD / HYVITAL - Protein Hydrolysate 97 HIPROTAL - Whey Protein Concentrate REFIT - Milk Protein VIVINAL GOS - Galacto-Oligosaccharide COLOSTRUM VIVINAL LACTOFERRIN CASEINATE

CELLULOSE ACETATE (C-A) 101 CELLULOSE ACETATE PHTHALATE (C-A-P)

DSS - Docusate Sodium (100%) 103 DSS GRANULAR - Docusate Sodium (85%) With Sodium Benzoate DSS 50% - Docusate Sodium (50%) In PEG 400

COMPRESSUC - Directly Compressible Sucrose 105 ICING SUGAR - Milled Sucrose CASTER SUGAR / CRYSTAL SUGAR - Screened Sucrose

SICOVIT - Ferric (Iron) Oxide 109

MAGNABRITE HV - Magnesium Aluminium Silicate, High Viscosity 111 MAGNABRITE K - Magnesium Aluminium Silicate, Acid Stable MAGNABRITE S - Magnesium Aluminium Silicate, Regular MAGNABRITE F - Magnesium Aluminium Silicate, Micro-Fine MAGNABRITE HS - Purified Bentonite, High Stability

STURCAL - Precipitated Calcium Carbonate, Heavy 113 CALOPAKE - Precipitated Calcium Carbonate, Extra-Light

POWDER GUM - Directly Compressible Chewing Gum Base 115 MEDGUM BASE - Medicated Chewing Gum Base

Product List

04

Application Guide

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FILLERS / DILUENTS AND BINDERS A-TAB Dicalcium Phosphate Anhydrous, Granular 62AVICEL DG Microcrystalline Cellulose And Dibasic Calcium Phosphate 15AVICEL HFE-102 Microcrystalline Cellulose And Mannitol 15AVICEL PH Microcrystalline Cellulose 14CALIPHARM Dicalcium Phosphate, Powder 62CALOPAKE EXTRA LIGHT Precipitated Calcium Carbonate, Extra-Light 114CASTER SUGAR / CRYSTAL SUGAR Screened Sucrose 108COMPRESSUC Directly Compressible Sucrose 106DEXTROSE ANHYDROUS C Dextrose Anhydrous, Crystalline 27DEXTROSE MONOHYDRATE GC Dextrose Monohydrate, Agglomerated 27DI-TAB Dicalcium Phosphate Dihydrate, Granular 62GLUCIDEX Maltodextrin / Corn Syrup Solids 30HMS LACTOSE Lactose Monohydrate, Impalpable 36ICING SUGAR Milled Sucrose 107KOLLIDON Povidone (PVP K) 38KOLLIDON VA 64 Copovidone 39LACTOCHEM Lactose Monohydrate, Sieved / Milled 36LACTOPRESS Directly Compressible Lactose 36LUDIFLASH Compound Of Mannitol, Crospovidone And Polyvinyl Acetate 52LUDIPRESS Compound Of Lactose Monohydrate And Povidone 53LYCATAB DSH Partially Hydrolyzed Starch 28LYCATAB PGS Fully Pregelatinized Starch 28MAGNESIUM CARBONATE Magnesium Carbonate (Light / Heavy) 82, 78MAGNESIUM HYDROXIDE Magnesium Hydroxide 76MAGNESIUM OXIDE Magnesium Oxide (Light / Heavy) 81, 76MAIZE / WHEAT / POTATO STARCH Native Starch 28METOLOSE SH / SM Hypromellose (HPMC) / Methylcellulose 58NEOSORB P Sorbitol 24PEARLITOL Mannitol 22PHARMACOAT Hypromellose (HPMC), Low Viscosity 56PHARMATOSE Lactose Monohydrate, Sieved / Milled 34SCORALITE Calcium Carbonate 80SCORALITE DC Directly Compressible Calcium Carbonate 80STARLAC Compound Of Maize Starch And Lactose Monohydrate 31STURCAL Precipitated Calcium Carbonate, Heavy 114SUPERTAB Directly Compressible Lactose 34SWEETPEARL Maltitol 25SWELSTAR WB-1 Pregelatinized Starch 67TACKIDEX Dextrin 31TCP-DC Tricalcium Phospate, Granular 63TREHALOSE Non-Reducing Di-Saccharide 68TRI-CAL WG Tricalcium Phosphate Anhydrous, Granular 63TRI-TAB Tricalcium Phosphate Anhydrous, Granular 63VERSACAL MP Tricalcium Phosphate Anhydrous, Micronized Powder 63XYLISORB Xylitol 23

Products by Category Description Page

BINDER-DISINTEGRANT L-HPC Low-Substituted Hydroxypropyl Cellulose 59LYCATAB C Partially Pregelatinized Starch 28PC-10 Partly Pregelatinised Starch 66

DISINTEGRANTS AC-DI-SOL Croscarmellose Sodium 17GLYCOLYS Sodium Starch Glycolate 29KELACID Alginic Acid 19KOLLIDON CL Crospovidone 39L-HPC Low-Substituted Hydroxypropyl Cellulose 59PROTACID F120NM Alginic Acid 19SWELSTAR PD-1 Pregelatinized Starch 67

MODIFIED RELEASE AGENTS CEKOL Carboxymethylcellulose Sodium 72CELLULOSE ACETATE Cellulose Acetate 102GELCARIN / VISCARIN Carrageenan 20KELCOLOID / PROTANAL Propylene Glycol Alginate 19KELSET Sodium-Calcium Alginate 19KELTONE / MANUCOL / KELCOSOL Sodium Alginate 19KOLLIDON SR Blend Of Polyvinyl Acetate And Povidone 40KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) Vitamin E Polyethylene Glycol Succinate 46KOLLIWAX GDB (SPEZIOL GDB PHARMA) Glyceryl Behenate 49KOLLIWAX GMS II (CUTINA GMS VPH) Glyceryl Monostearate 40-55 (Type II) 49KOLLIWAX HCO (CUTINA HR PH) Hydrogenated Castor Oil 50KOLLIWAX S (SPEZIOL L2SM) Stearic Acid 50METOLOSE SH / SR Hypromellose (HPMC) 58SWELSTAR MX-1 Pregelatinized Starch 67XANTURAL Xanthan Gum 70

COATING AGENTS (FUNCTIONAL AND NON-FUNCTIONAL) AQUACOAT ECD-30 Ethylcellulose Aqueous Dispersion 18CASTER SUGAR / CRYSTAL SUGAR Screened Sucrose 108CELLULOSE ACETATE Cellulose Acetate 102CELLULOSE ACETATE PHTHALATE (C-A-P) Cellulose Acetate Phthalate 102HPMCP Hypromellose Phthalate 57KELTONE / MANUCOL Sodium Alginate 19KOLLICOAT IR Macrogol Poly (Vinyl Alcohol) Grafted Copolymer 41 KOLLICOAT IR COATING SYSTEMS Ready-To-Use Coating Systems 41KOLLICOAT MAE Methacrylic Acid Copolymer 42KOLLICOAT PROTECT Macrogol Poly (Vinyl Alcohol) Grafted Copolymer And PVA 41KOLLICOAT SR 30 D Polyvinyl Acetate Dispersion 40LUSTRECLEAR LC-103 Microcrystalline Cellulose And Carrageenan Based Coating System 18LYCOAT RS Starch Based Coating System 29PHARMACOAT Hypromellose (HPMC), Low Viscosity 56READILYCOAT Ready-To-Use Starch Based Coating System 29SHIN-ETSU AQOAT Hypromellose Acetate Succinate 60SWEETPEARL Maltitol 25XYLISORB Xylitol 23

Application Guide

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Application Guide

08

CHEWABLE AND ORODISPERSIBLE AIDS AVICEL CE-15 Microcrystalline Cellulose And Guar Gum 16AVICEL HFE-102 Microcrystalline Cellulose And Mannitol 15CASTER SUGAR / CRYSTAL SUGAR Screened Sucrose 108COMPRESSUC Directly Compressible Sucrose 106ICING SUGAR Milled Sucrose 107LUDIFLASH Compound Of Mannitol, Crospovidone And Polyvinyl Acetate 52LUDIPRESS Compound Of Lactose Monohydrate And Povidone 53LYCOAT RS Starch Based Coating System 29NEOSORB P Sorbitol 24PEARLITOL Mannitol 22PEARLITOL FLASH Compound Of Mannitol And Maize Starch 23STARLAC Compound Of Maize Starch And Lactose Monohydrate 31SWEETPEARL Maltitol 25XYLISORB Xylitol 23

BULK SWEETENERS CASTER SUGAR / CRYSTAL SUGAR Screened Sucrose 108COMPRESSUC Directly Compressible Sucrose 106DEXTROSE ANHYDROUS C Dextrose Anhydrous, Crystalline 27DEXTROSE MONOHYDRATE GC Dextrose Monohydrate, Agglomerated 27HI-SWEET High Fructose Corn Syrup 32ICING SUGAR Milled Sucrose 107LYCASIN Maltitol Solution 25NEOSORB P Sorbitol 24PEARLITOL Mannitol 22SWEETPEARL Maltitol 25TREHALOSE Non-Reducing Di-Saccharide 68XYLISORB Xylitol 23

ENCAPSULATING AGENTS KELTONE / MANUCOL Sodium Alginate 19KLEPTOSE Betadex 26KLEPTOSE HPB Hydroxypropyl Betadex 27POLY(DL-LACTIDE) Bioabsorbable Polymers 90POLY(DL-LACTIDE-CO-GLYCOLIDE) Bioabsorbable Polymers 90POLYCAPROLACTONE Bioabsorbable Polymers 90POLYGLYCOLIDE Bioabsorbable Polymers 90PRONOVA UP / SL Sodium Alginate, Ultra-Pure 92PROTASAN UP Chitosan, Ultra-Pure 93

TASTE MASKING AGENTS AQUACOAT ECD-30 Ethylcellulose Aqueous Dispersion 18KLEPTOSE Betadex 26KLEPTOSE HPB Hydroxypropyl Betadex 27KOLLICOAT IR Macrogol Poly (Vinyl Alcohol) Grafted Copolymer 41KOLLICOAT MAE Methacrylic Acid Copolymer 42KOLLICOAT SMARTSEAL 30 D Methyl Methacrylate And Diethylaminoethyl Methacrylate Copolymer Dispersion 42KOLLICOAT SR 30 D Polyvinyl Acetate Dispersion 40TREHALOSE Non-Reducing Di-Saccharide 68


Application Guide

SOLUBILIZERS DOCUSATE SODIUM Dioctyl Ester Of Sodium Sulfosuccinate 104KLEPTOSE Betadex 26KLEPTOSE HPB Hydroxypropyl Betadex 27KOLLICREAM DO (CETIOL V PH) Decyl Oleate 51KOLLICREAM IPM (ISOPROPYLMYRISTATE PH) Isopropyl Myristate 51KOLLICREAM OA (HD EUTANOL V PH) Oleyl Alcohol 51KOLLICREAM ODD (EUTANOL G PH) Octyldodecanol 52KOLLIPHOR (CREMOPHOR) Polyoxyl-Hydrogenated Castor Oil 43KOLLIPHOR HS 15 (SOLUTOL HS 15) Polyoxyl-15-Hydroxystearate 44KOLLIPHOR P (LUTROL F) Poloxamer 45KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) Vitamin E Polyethylene Glycol Succinate 46KOLLISOLV GTA (SPEZIOL GTA) Triacetin 47KOLLISOLV MCT (MYRITOL PH) Medium Chain Triglycerides 48KOLLISOLV P (LUTROL L) Poloxamer 45SOLUPLUS Polyvinyl Caprolactam-Polyvinyl Acetate-Polyethylene Glycol Graft Copolymer 53

EMULSIFIERS DOCUSATE SODIUM Dioctyl Ester Of Sodium Sulfosuccinate 104KELCOLOID / PROTANAL Propylene Glycol Alginate 19KOLLICREAM CP 15 (CUTINA CP PH) Cetyl Palmitate 15 50KOLLIPHOR CS (LANETTE PH) Cetostearyl Alcohol, Emulsifying / Sodium Cetostearyl Sulfate 44KOLLIPHOR MCE (EUMULGIN B PH) Polyoxyl Cetostearyl Ether 45KOLLIPHOR P (LUTROL F) Poloxamer 45KOLLIPHOR PS (POLYSORBATE) Polysorbates 46KOLLIPHOR SLS (TEXAPON) Sodium Lauryl Sulfate 46KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) Vitamin E Polyethylene Glycol Succinate 46KOLLISOLV P (LUTROL L) Poloxamer 45KOLLIWAX GMS II (CUTINA GMS VPH) Glyceryl Monostearate 40-55 (Type II) 49KOLLIWAX S (SPEZIOL L2SM) Stearic Acid 50MAGNABRITE Magnesium Aluminium Silicate 112

STABILIZERS KELCOGEL CG Gellan Gum 71KELCOLOID / PROTANAL Propylene Glycol Alginate 19KOLLIDON CL-M Crospovidone 39KOLLISOLV PG Propylene Glycol 47SYNPRO STEARATE (Al) Aluminium Stearate 84

SUSPENDING AGENTS AVICEL RC / CL Microcrystalline Cellulose And Carboxymethylcellulose Sodium 16CEKOL Carboxymethylcellulose Sodium 72GELCARIN / VISCARIN / SEASPEN Carrageenan 20KELCOGEL CG Gellan Gum 71MAGNABRITE Magnesium Aluminium Silicate 112METOLOSE SH / SM Hypromellose (HPMC) / Methylcellulose 58XANTURAL Xanthan Gum 70

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Application Guide

THICKENERS CEKOL Carboxymethylcellulose Sodium 72GELCARIN / VISCARIN / SEASPEN Carrageenan 20KELCOGEL CG Gellan Gum 71KOLLIDON Povidone (PVP K) 38KOLLIPHOR P (LUTROL F) Poloxamer 45KOLLISOLV P (LUTROL L) Poloxamer 45MAGNABRITE Magnesium Aluminium Silicate 112METOLOSE SH / SM Hypromellose (HPMC) / Methylcellulose 58SYNPRO STEARATE (Al) Aluminium Stearate 84XANTURAL Xanthan Gum 70

CONSISTENCY REGULATORS KOLLIWAX (SPEZIOL C PHARMA) Myristyl / Cetyl / Stearyl / Cetostearyl Alcohol 49KOLLIWAX GDB (SPEZIOL GDB PHARMA) Glyceryl Behenate 49KOLLIWAX GMS II (CUTINA GMS VPH) Glyceryl Monostearate 40-55 (Type II) 49KOLLIWAX S (SPEZIOL L2SM) Stearic Acid 50

HUMECTANTS KOLLISOLV G (SPEZIOL G) Glycerin / Glycerol 47NEOSORB LIQUID Sorbitol Solution 24

EMOLLIENTS KOLLICREAM DO (CETIOL V PH) Decyl Oleate 51KOLLICREAM IPM (ISOPROPYLMYRISTATE PH) Isopropyl Myristate 51KOLLICREAM OA (HD EUTANOL V PH) Oleyl Alcohol 51KOLLICREAM ODD (EUTANOL G PH) Octyldodecanol 52KOLLISOLV G (SPEZIOL G) Glycerin / Glycerol 47

PLASTICIZERS KOLLIPHOR (CREMOPHOR) Polyoxyl-Hydrogenated Castor Oil 43KOLLISOLV G (SPEZIOL G) Glycerin / Glycerol 47KOLLISOLV GTA (SPEZIOL GTA) Triacetin 47KOLLISOLV PEG (LUTROL E) Polyethylene Glycol (Macrogol) 48KOLLISOLV PG Propylene Glycol 47KOLLIWAX GMS II (CUTINA GMS VPH) Glyceryl Monostearate 40-55 (Type II) 49POLYSORB 85/70/00 Anhydrized Liquid Sorbitol 26

GELLING AGENTS CEKOL Carboxymethylcellulose Sodium 72GELCARIN Carrageenan 20KELCOGEL CG Gellan Gum 71KELTONE / MANUGEL Sodium Alginate 19KOLLIPHOR P (LUTROL F) Poloxamer 45XANTURAL Xanthan Gum 70

GLIDANTS LUZENAC PHARMA Talc 86

COLOURANTS KRONOS 1171 Titanium Dioxide, Super-White, Anatase Grade 88SICOVIT Ferric (Iron) Oxide 110

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Application Guide

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LUBRICANTS ALUBRA PG 100 Sodium Stearyl Fumarate 17KOLLIPHOR SLS (TEXAPON K) Sodium Lauryl Sulfate 46KOLLIWAX GDB (SPEZIOL GDB PHARMA) Glyceryl Behenate 49KOLLIWAX GMS II (CUTINA GMS VPH) Glyceryl Monostearate 40-55 (Type II) 49KOLLIWAX HCO (CUTINA HR PH) Hydrogenated Castor Oil 50KOLLIWAX S (SPEZIOL L2SM) Stearic Acid 50LUZENAC PHARMA Talc 86 SYNPRO STEARATES (Mg, Zn, Ca) Magnesium / Zinc / Calcium Stearate 84

MINERAL AND NUTRITIONAL SUPPLEMENTS A-TAB Dicalcium Phosphate Anhydrous, Granular 62CALIPHARM Dicalcium Phosphate, Powder 62CALOPAKE Precipitated Calcium Carbonate, Extra-Light 114CASEINATE Spray-Dried Milk Protein 100COLOSTRUM Colostral Whey Protein 100DI-TAB Dicalcium Phosphate Dihydrate, Granular 62HIPROTAL Whey Protein Concentrate 100HYVITAL Protein Hydrolysate 99KOLLISOLV MCT (MYRITOL PH) Medium Chain Triglycerides 48MAGNESIUM CARBONATE Magnesium Carbonate (Light / Heavy) 82, 78MAGNESIUM HYDROXIDE Magnesium Hydroxide 76MAGNESIUM OXIDE Magnesium Oxide (Light / Heavy) 81, 76NUTRIOSE Soluble Fibre 32REFIT Milk Protein 100SCORALITE Calcium Carbonate 80SCORALITE DC Directly Compressible Calcium Carbonate 80STURCAL Precipitated Calcium Carbonate, Heavy 114TCP-DC Tricalcium Phospate, Granular 63TRI-CAL WG Tricalcium Phosphate Anhydrous, Granular 63TRI-TAB Tricalcium Phosphate Anhydrous, Granular 63VERSACAL MP Tricalcium Phosphate Anhydrous, Micronized Powder 63VIVINAL GOS Galacto-Oligosaccharides 100VIVINAL LACTOFERRIN Lactoferrin 100

NEUTRAL CORES CELPHERE Microcrystalline Cellulose Spheres 66PEARLITOL Mannitol 22PHARM-A-SPHERES Sugar Spheres 74

PARENTERAL AND OPHTHALMIC AIDS D-GALACTOSE Galactose, Low Endotoxin 96KLEPTOSE HPB Hydroxypropyl Betadex 27KOLLIDON Povidone (PVP K) 38KOLLIPHOR HS 15 (SOLUTOL HS 15 ) Polyoxyl-15-Hydroxystearate 44KOLLIPHOR P (LUTROL F ) Poloxamer 45KOLLIPHOR ELP (CREMOPHOR ELP) Polyoxyl-35-Hydrogenated Castor Oil 43KOLLISOLV PEG (LUTROL E) Polyethylene Glycol (Macrogol) 48LYCADEX PF Dextrose Monohydrate, Pyrogen-Free 27MALTOSE Maltose, Low Endotoxin 96METOLOSE SH Hypromellose (HPMC), High Viscosity 58NEOSORB PF Sorbitol, Pyrogen-Free 24


Application Guide

12

PEARLITOL PF Mannitol, Pyrogen-Free 22 POLY(DL-LACTIDE) Bioabsorbable Polymers 90POLY(DL-LACTIDE-CO-GLYCOLIDE) Bioabsorbable Polymers 90POLYCAPTROLACTONE Bioabsorbable Polymers 90POLYGLYCOLIDE Bioabsorbable Polymers 90PRONOVA UP / SL Sodium Alginate, Ultra-Pure 92PROTASAN UP Chitosan, Ultra-Pure 93SUCROSE Sucrose, Low Endotoxin 96TREHALOSE Non-Reducing Di-Saccharide 68

BIOMATERIALS POLY(DL-LACTIDE) Bioabsorbable Polymers 90POLY(DL-LACTIDE-CO-GLYCOLIDE) Bioabsorbable Polymers 90POLYCAPTROLACTONE Bioabsorbable Polymers 90POLYGLYCOLIDE Bioabsorbable Polymers 90PRONOVA UP / SL Sodium Alginate, Ultra-Pure 92PROTASAN UP Chitosan, Ultra-Pure 93SODIUM HYALURONATE Ultra-Pure Sodium Hyaluronate 94

FERMENTATION AIDS D-GALACTOSE Galactose, Low Endotoxin 96MALTOSE Maltose, Low Endotoxin 96PROYIELD Plant Protein Hydrolysates 98SUCROSE Sucrose, Low Endotoxin 96

CHEWING GUM BASE POWDER GUM / MEDGUM BASE Chewing Gum Base 116

SUPPOSITORY BASE NOVATA PH Hard Fat 54

WOUND CARE AGENTS PROTANAL / MANUCOL Sodium Alginate 19


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FMC BioPolymer, with a legacy of over 60 years of innovation, is the market leader in cellulose based excipients. FMC’s ‘Avicel’, is the world’s largest selling brand of microcrystalline cellulose. The company’s other products ranging from alginates, carrageenans and gels to coating systems have been strategically harnessed from natural resources. They serve as raw materials to the world’s pharmaceutical, food and personal care industry.

FMC’s commitment to high standards of quality and care is reflected in their motto ‘quality begins with me’ and in their consistent efforts at protecting the environment, health and safety of its employees. Along with providing focused support to core markets, they also draw upon the expertise of a network of professionals involved in developing new technologies and applications. This enables them to have a wide partnering reach with their customers, including companies looking to increase efficiency and speed of their own research and development efforts.

FMC BioPolymer, a signatory to the ‘responsible care initiative’ of the International Coalition of Chemical Associations, is trusted to deliver the most consistent products, to the right place, at the right time and to assist customers in catering to the fast paced, challenging markets of today.

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AVICEL PHMicrocrystalline Cellulose USP/NF, EP, JP

Avicel PH, FMC’s innovator brand of microcrystalline cellulose, is a purified, partially depolymerized alpha-cellulose made by acid hydrolysis of specialty wood pulp. The process of polymerization involves high levels of quality and stringency.

Avicel PH’s unique properties - superior compactibility, drug carrying capacity and rapid disintegration - make it the excipient of choice in direct compression applications. When used in the wet granulation process, the risk of over-granulation is reduced, screen blockage is avoided and uniform, rapid drying is promoted. The distinct properties of this excipient also benefit the dry granulation processes of roller compaction and slugging. Avicel PH is an excellent extrusion-spheronization binder and its inclusion in capsule formulations improves flow, facilitates plug formation and aids capsule disintegration.

With the development of differentiated grades, Avicel PH remains an indispensible formulation tool, boosting productivity and meeting tough formulation challenges.

Conventional grade for wet and dry granulation

Improves flow in direct compression, dry phase of wet granulation and dry granulation

Well suited for moisture sensitive actives

Extra-fine particle size, used for direct compression of materials which are coarse or hard to compress

Lowest moisture content and is best suited for direct compression of moisture sensitive actives

Improves product stability, particularly of formulations using moisture sensitive actives

Largest particle size, enhances flow in direct compression and dry granulation whilst maintaining high levels of compressibility with minimum weight variation and content uniformity

Largest particle size with lowest moisture content, allowing for better flow rate than Avicel PH-112. Improvised grade for direct compression of moisture sensitive actives

High bulk density grade, for manufacturing of small tablets. Reduces powder stratification and tablet weight variation by allowing efficient mixing

High bulk density grade with larger particle size, used for production of thin tablets especially in high dose drug formulations. Avoids powder segregation and achieves good flow rates

3.0 - 5.0

3.0 - 5.0

NMT 3.0

NMT 5.0

NMT 1.5

NMT 2.0

2.0 - 5.0

NMT 1.5

3.0 - 5.0

3.0 - 5.0

50

100

50

20

100

50

180

180

50

100

Avicel PH-101

Avicel PH-102

Avicel PH-103

Avicel PH-105

Avicel PH-112

Avicel PH-113

Avicel PH-200

Avicel PH-200 LM

Avicel PH-301

Avicel PH-302

Grade Particle Size Moisture Content Applications (µm) (%)

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AVICEL DGMicrocrystalline Cellulose USP/NF, EP, JP and Dibasic Calcium Phosphate USP/NF, EP, JP

Avicel DG is a synergistic combination of 75 percent microcrystalline cellulose and 25 percent anhydrous dibasic calcium phosphate, produced using spray-dried, co-processing technology.

This product is a novel, high functionality excipient and is optimized for use in dry granulation. It has improved flow characteristics, high quality initial compactibility and excellent recompactability, which in turn minimizes the granulation process steps.

Avicel DG Produces robust ribbons,

lowers tablet rejection rates Dry granulation processes like roller and improves overall tableting compaction or slugging performance

Grade Advantages Applications

Compared with traditional microcrystalline cellulose grades it has improved flow, superior compactibility, low sensitivity to lubrication and better disintegration properties

Avicel HFE-102Direct compression of chewable, fast dissolving, M-U-P-S technology tablets and similar applications

AVICEL HFE-102Microcrystalline Cellulose USP/NF, EP, JP and Mannitol USP/NF, EP, JP

Avicel HFE-102, a high functionality excipient, is a spray dried blend of 90 percent microcrystalline cellulose and 10 percent mannitol. This novel, proprietary product exhibits synergistic functionality thereby providing superior benefits compared to individual or dry blended components.

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Provides smoother and creamier mouth feel, less grittiness, minimum chalkiness, low friability and reduced tooth packing

Designed for direct compression formulations to produce softer chewable tablets with low friability and rapid disintegration

AVICEL CE-15Microcrystalline Cellulose and Guar GumAvicel CE-15 is a patented combination of microcrystalline cellulose and guar gum, specially engineered to improve the organoleptic properties of chewable tablets. This free flowing, co-processed blend results in dramatic differences for end users, primarily in the areas of overall sensory experience and perceived taste when compared to other existing products.

AVICEL RC / CLMicrocrystalline Cellulose and Carboxymethylcellulose Sodium USP/NF, EP

Avicel RC / CL is a colloidal, water dispersible, spray-dried blend of microcrystalline cellulose and carboxymethylcellulose sodium.

Formulations which include this excipient have high thixotropy, low viscosity and display reduced settling or sedimentation effects. The range of thixotropies, viscosities, gel strengths and dispersion characteristics offered by this product line provide unparalleled suspension stability and functional versatility.

Viscosity regulator and modifier, eliminates lengthy hydration times, displays stability to heat and freeze / thaw over a wide pH range and has excellent emulsifying properties for oil-in-water systems

Oral suspensions, nasal / topical sprays, lotions, liquids, semi-solid dosage forms

Reconstitutables / dry and oral suspensions

39 - 91 (1.2% solids)

50 - 118 (2.6% solids)

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Avicel CE-15

Avicel RC-591

Avicel CL-611


Grade Viscosity Advantages Applications (cps)

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AC-DI-SOLCroscarmellose Sodium USP/NF, EP, JP

Ac-Di-Sol, the best known superdisintegrant, is crosslinked sodium carboxymethylcellulose or modified cellulose gum. This insoluble, hydrophilic polymer has dual-functionality of water wicking and rapid swelling, which results in its superior disintegration characteristics.

Effective at low use levels, has enhanced long term stability and facilitates quick disintegration and dissolution in tablets, capsules, granules and other dosage forms

Alubra PG 100 Enhanced dissolution, Water soluble lubricant for orodispersible

compatible with a wide range tablets, capsules, effervescent dosage of APIs, flexibility in blending forms and for formulations of poorly and improved compactibility soluble drugs

ALUBRA PG 100Sodium Stearyl Fumarate USP/NF, EP, JPE

Alubra PG 100 is a fine, white to off-white powder used as a water soluble lubricant in capsule and tablet formulations. The fumarate moiety of Alubra increases its melting temperature, which allows for greater functionality at high press speeds while the stearate chain maintains the lubricity of the compound, supporting low ejection forces.

Highly effective in direct compression, dry granulation and wet granulation independent of tablet hardness. Is used intra as well as extra-granularly

Ac-Di-Sol SD-711



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LustreClear LC-103

Provides a distinctive, clear, smooth, satin finish on solid dosage forms and makes their processing easier. The Aqueous film coating system used for a consequent advantages of variety of tablets and other solid taste masking and ease of dosage forms swallowing of the coated dosage form enhances patient compliance

Aquacoat ECD-30

Low viscosity, non-tacky and allows for various kinds of drug Variety of functional coating applications release patterns with the use such as sustained-release, taste masking of suitable plasticizers and and providing a moisture-barrier pore formers

AQUACOAT ECD-30Ethylcellulose Aqueous Dispersion USP/NF, JPE

This excipient is a 30 percent by weight aqueous dispersion of ethylcellulose polymer. It is a water based, pseudo latex system free of ammonia and used for solvent-free coating.

LUSTRECLEAR LC-103Microcrystalline Cellulose USP/NF, EP, JP and Carrageenan USP/NF Based Coating System

This product offers a unique, aqueous film coating technology that combines microcrystalline cellulose and carrageenan. It is an all-in-one, solvent-free, conventional, aesthetic coating system providing greater flexibility for processing a wide variety of products.

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ALGINATES and ALGINIC ACID USP/NF, EPAlginates are natural hydrocolloids of vegetable origin that occur as a structural component in marine brown algae and give strength and flexibility to the plant.

In contrast to most other polysaccharide gels, alginate gels can develop instantaneously into acid gels in the presence of divalent cations, low pH and constant temperature. The gelling gives rise to a three dimensional network which determines the gel strength. Alginates with a high content of G-blocks give stronger gels while M-rich alginates give softer and more fragile gels. The molecular weight determines the viscosity of alginate solutions while the ratio of mannuronic acid to guluronic acid (M / G) determines the relative strength of the gel.

FMC’s range of alginates and alginic acids, offer unique gel forming, film forming, thickening and stabilizing properties.

Grade Description Applications

Type Viscosity, mPa.s (% concentration)

Protacid F120NM -

Kelacid NF -

Protanal LFR 5/60

Manugel LBA

Alginic acid

Disintegrant in direct compression and wet granulation. Used in anti-reflux and effervescent tablets

300 - 700 (10%)

Sodium alginate

Sodium alginate Anti-reflux suspensions,

effervescent tablets and used as a gelling agent

100 - 300 (2%)

600 - 900 (1.25%)

60 - 170 (1%)

Keltone HVCR

Keltone LVCR

Manucol LKX

Kelcosol NF

Kelset NF

1000 - 1500 (1%)

500-1000 (0.5%)

Controlled-release formulations

Sodium-calcium alginate

700 - 1800 (2%)

30 - 60 (1%)

200 - 400 (1%)

1000 - 1500 (2%)

40 - 90 (1%)

600 - 800 (1%)

200 - 400 (1%)

200 - 400 (1%)

Kelcoloid K3B426

Manucol DH

Protanal HF 120RBS

Protanal KF 200RBS Potassium alginate

Protanal LF 200FTS

Protanal Ester SD-LB

Protanal LF 10/60FT

Protanal KF 200FTS

Propylene glycol alginate

Sodium alginate

Sodium alginate

Potassium alginate

Stabilizer, emulsifier and matrix former

Wound care

Dental impression material

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MARINE COLLOIDS Carrageenan USP/NF, EP

Carrageenan is a family of naturally occurring, high molecular weight polysaccharides extracted from red seaweed which yield kappa, iota and lambda types. They differ in properties mainly due to the number and position of ester sulfate groups on the galactose units. While kappa forms a brittle gel, iota forms an elastic gel and lambda does not form a gel. All carrageenans display protein and polyol reactivity.

Based on their properties, they are used as stabilizers, thickeners, suspending agents, gelling agents and flow regulators in pharmaceutical dosage forms.

Grade Description

Type Gel Type, Strength

Applications

Gelcarin PH-379 lota Elastic, medium

Gelcarin PH-812

Gelcarin PH-911 Brittle, firmKappa

Brittle, strong

Creams and suspensions. Promotes freeze thaw

Gives stronger gels than PH-911 with higher syneresis

Encapsulation / delivery systems

SeaSpen PF lota Elastic, weak

Viscarin PH-109

Viscarin PH-209Lambda Non-gelling

Suspensions, reconstitutables, topical lotions and creams

Creams and lotions. Also used for controlled-release formulations

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Founded in 1933, Roquette is today one of the world’s most advanced producers of starch and its derivatives. Along with this, it is an expert in the field of polyols and a leading producer of maltodextrins, pyrogen-free raw materials and cationic starches.

Roquette’s extensive line of products which cater to the pharma, food and cosmetics industries of the world are derived from renewable resources such as corn, wheat, potatoes and peas. Their commitment towards deliverance of high quality and environment friendly results can be seen in their superior production techniques.

With a sophisticated research centre, several production sites, a strong customer service base and a wide network of subsidiaries and agents, Roquette is looked upon as a reliable, responsible and innovative partner in the pharmaceutical industry.

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PEARLITOLMannitol USP/NF, EP, JP

Mannitol is a polyol manufactured by catalytic hydrogenation of starch, a natural raw material of vegetable origin. It occurs as a slightly sweet, white crystalline powder that gives a cooling sensation on dissolution in the mouth.

It has excellent stability, low hygroscopicity and good solubility in different solvents. It forms an ideal excipient for solid orals as well as injectable dosage forms and can be used for wet or dry granulation and direct compression. It also serves as a cryoprotective agent in freeze drying applications. Mannitol has low calorific values, is non-cariogenic and ideal for sugar-free formulations.

Grade Mean Type Applications

Diameter (µm)

Grade Mean Type Applications

Diameter (µm)

Diluent for tablets, capsules and sachets, excipient for chemically unstable or moisture sensitive actives and flash release forms, freeze-drying carrier and sweetener for pharmaceutical chewing gums

Pearlitol 25 C (Mannitol 25)



Pearlitol PF (Mannitol PFG) Diuretic-osmotic for injectable

solutions and also for freeze dried injectables

Diluent for direct compression especially for chewable, effervescent and orodispersible tablets, ideal excipient for chemically unstable or moisture sensitive actives and also diluent for capsules and sachets

DC types are also used as a neutral carrier base onto which actives are loaded

Pearlitol 100 SD 100

Pearlitol 200 SD 180

Pearlitol 300 DC 250



Spray-dried

Granulated

Crystalline Mannitol

Granular Mannitol

25 Extra-fine

50 Fine

160 Standard

- Pyrogen-free

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PEARLITOL FLASHCompound of Mannitol USP/NF, EP, JP and Maize Starch USP/NF, EP, JP

Pearlitol Flash is a novel excipient specifically designed for orodispersible tablets using the process of direct compression. This spray-dried compound of 80 percent mannitol and 20 percent maize starch allies robustness with rapid disintegration. It offers chemical inertness, requires a low level of lubricant usage and makes tablet formulation surprisingly simple. Pearlitol Flash results in end products with a very creamy mouth feel, smooth texture and a pleasant, sweet taste.


Ideal excipient for direct compression of orodispersible / fast-melt tablets

Pearlitol Flash

Excellent compressibility, high dilution potential, self-disintegrating properties, superior flowability and melt-in-mouth taste experience

XYLISORBXylitol USP/NF, EP, JP

Xylisorb is a five-carbon polyol with a characteristic crystalline shape. Of all polyols, it has the sweetest taste equaling that of sucrose. It induces a very pleasant sensation of cooling and freshness in the mouth resulting from its negative heat of solution. These qualities, coupled with its non-cariogenic nature and low calorific value, makes it an important alternative for use in a variety of pharmaceutical dosage forms.

Grade Mean Applications Diameter (µm)

Diluent for sachets, chewable and suckable tablets, excipient for coating as well as candying of lozenges, sweetener for pharmaceutical chewing gums, mouth rinses and tooth-pastes

Direct compression of smooth chewable tablets for nutraceuticals

Xylisorb 90 90

Xylisorb 300 300

Xylisorb 700 700

Xylisorb P 300 DC 300

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NEOSORB POWDERSorbitol USP/NF, EP, JP

Neosorb P grades are a range of crystalline sorbitol powders in the gamma stable form. These polyols have excellent tableting properties which readily form hard tablets. Neosorb powders have high chemical stability and do not undergo reducing or discolouration reactions with amino groups. They have a cool taste with a pleasant mouth feel and are used for non-cariogenic, non-acidogenic and sugar-free formulations in different types of tablets, as well as in sachets and dry syrups.

Grade Mean Type Applications Diameter (µm)

Excellent excipient for direct compression of suckable, effervescent and chewable tablets, diluent for sachets, sweetener in pharmaceutical chewing gums and in reconstitutable syrups

Parenteral nutrition - used in combination with amino acids

Neosorb P 100 T 110 Fine

Neosorb P 60 W 180 Standard

Neosorb P 30/60 480 Coarse

Neosorb P 20/60 650 Highly coarse

Neosorb P 300 DC 300 Spray-dried

Neosorb PF - Pyrogen-free

NEOSORB LIQUIDSorbitol Solution USP/NF, EP, JP

Neosorb liquid is a solution of sorbitol along with other hydrogenated long chain oligomers and polymers. It finds use as a substitute for sucrose and meets organoleptic (sweetening power) and dietetic requirements (sugar-free, low-calorie, non-cariogenic) and may be advised for diabetics.

Grade Type Sorbitol Applications (dry basis)

Bulk sweetener and humectant in syrups, suspensions, oral ampoules, lozenges, pastilles, paste and topical preparations. Also used as an excipient for pan-coating

Neosorb 70/70 B Non-crystallizing

74% min.

sorbitol solution

Neosorb 70/20

Crystallizing 93% min.

sorbitol solution

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SWEETPEARLMaltitol USP/NF, EP

SweetPearl is maltitol powder of high purity obtained by catalytic hydrogenation of D-maltose using a process which is patented by Roquette. It is a dimeric polyol providing a cool mouth feel and sweetness close to that of sucrose.

SweetPearl is a stable, polyhydric, non-cariogenic sugar alcohol with low glycemic index and calorific value. It is a robust and stable excipient with optimum flow, particle size and density, making it an ideal excipient for oral dosage forms.

Grade Mean Powder Type Applications Diameter (µm)

Diluent for tablets and sachets, excipient for hard coating as well as for candying of lozenges and sweetener for pharmaceutical chewing gums

Diluent for direct compression of crunchy chewable tablets

SweetPearl P 90 90 Fine, crystalline

SweetPearl P 200 200 Coarse, crystalline

SweetPearl P 300 DC 300 Granulated

LYCASINMaltitol Solution USP/NF, EP

Lycasin is obtained by the hydrogenation of maltose syrup and constitutes D-sorbitol, hydrogenated disaccharides and polysaccharides. It is supplied as a pure, odourless liquid and has a pleasant sweet taste. It is non-cariogenic, has low calorific value, is easily miscible with water and is chemically stable (absence of Maillard reaction).

Lycasin has high sweetening power (70 - 80 percent of sucrose) with good solubility and is used as a replacement for sugar in syrups, lozenges and jellies for specific patient groups.

Grade Maltitol Mean Viscosity Applications (dry basis) (mPa.s) at 20oC

Non-crystallizing bulk sweetener for sugarless syrups, suspensions, lozenges, oral ampoules and pharmaceutical chewing gums

A unique dry matter composition for hard boiled candies, pastilles and lozenges

Lycasin 75/75 72 - 76% 2400

Lycasin 80/55 50 - 55% 3000

Lycasin HBC 50 - 55% 13000

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POLYSORBAnhydrized Liquid Sorbitol USP/NF, EP

Polysorb 85/70/00 is a water solution containing a defined mixture of D-sorbitol and 1,4-sorbitan. This clear, colourless, syrupy liquid is perfectly miscible with water but practically insoluble in oils and has been developed particularly as an additive for the soft gelatin capsule application.

The advantage of this product in soft gels relates to its remarkable, balanced plasticizer properties without ‘surface’ crystallization i.e. graining, as is the case with standard crystallizing plasticizers and without the leaching phenomena in the filler media of the soft gels.

Grade Composition Applications

Optimal plasticizer for gelatin shell of soft capsules. Also enables good stability with the fillers used in the soft gels

High dry solid content of 83% constituting: Polysorb 85/70/00 1,4-sorbitan: 24 - 28% (on a dry basis) D-sorbitol: 35 - 45% (on a dry basis)

KLEPTOSEBetadex USP/NF, EP

Betacylcodextrins are cyclic oligosaccharides obtained from starch by enzymatic cyclization using enzymes called cycloglycosyl transferases. Their hydrophobic cavity of the truncated cone formed by the betacyclodextrin ring can accomodate suitable guest molecules and ‘complexes’ or inclusion compounds. An inclusion complex is a form of supramolecular complex in which one or part of a molecule, the ‘guest’ or substrate is enclosed, entrapped, encapsulated or embedded with another molecular structure. Kleptose allows the formation of complexes with actives in the solvent or dry phase.

Grade Type Properties Applications

Encapsulating agent for tablets, capsules, sachets, syrups, solutions and oral suspensions

Standard

Granular for direct compression

Micronized, suitable for aerosols

Low water content for moisture sensitive actives

Improves solubility thereby facilitating higher bioavailability, enhances flowability and compressibility, improves organoleptic properties, increases stability, reduces side effects and transforms liquid actives into easily manipulated solid complexes

Kleptose STD

Kleptose DC

Kleptose 10

Kleptose 7 PC

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KLEPTOSE HPB Hydroxypropyl Betadex USP/NF, EP

Kleptose HPB is a purified, polydisperse product resulting from controlled reaction of propylene oxide and native betadex under base catalysis. This product overcomes the low solubility and inadequate biological tolerance of the native betacyclodextrin molecule. Kleptose HPB is produced in a purpose built, state-of-the-art manufacturing plant following USFDA type GMP quality guidelines and is well supported by toxicology data.



Suitable for parenteral use, syrups, solutions and oral suspensions as well as for dry formulations (with possibility of in-situ encapsulation). Increases water solubility of poorly soluble drugs thereby improving bioavailability and enhances organoleptic properties of bitter or unpleasant actives

Osmotic agent in injectables and dialysis solutions, energy source for parenteral nutrition and treatment of hypoglycemia

Direct compression diluent with excellent compressibility and flowability for tablets, sachets and capsule formulations

Diluent for tablets, capsules and sachets

Parenteral grade, medium molecular substitution, endotoxin controlled

Kleptose HPB

DEXTROSE USP/NF, EP, JPGlucose or dextrose is a monomer of natural starch polymer. In its crystalline form, this natural sugar has long been used both as a sweetener and as a filler for oral dosage forms.

Lycadex PF

Dextrose Monohydrate GC

Dextrose Anhydrous C

Pyrogen-free dextrose monohydrate

Agglomerated dextrose monohydrate

Crystalline dextrose anhydrous

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Grade Type Applications

Robust wet granulation binder

Highly effective binder-disintegrant in direct compression and wet granulation, filler-disintegrant for hard gelatin capsules. Also used as a flow aid in powder blends

High wettability, low viscosity binder for wet granulation without impeding disintegration or dissolution. Ready-to-use, easily dispersible and quickly soluble with no maturation time. Also used as a diluent for direct compression of smooth tablets

Lycatab PGS

Lycatab C

Lycatab DSH


Diluent for tablets and capsules, powder for sachets and a disintegrant in solid orals

Low water content grade is for moisture sensitive actives

STARCH USP/NF, EP, JPNative Starches Starch is one of the most reliable excipients produced from different sources such as maize (corn), wheat, potato and peas. All grades are GMO free and microbiologically compliant.

MODIFIED STARCHESPregelatinized Starch USP/NF, EP

To overcome the drawbacks of native starch viz. cooking step, high viscosity, poor flow, agglomeration etc, the modified range of maize (corn) starch products were introduced.

The Lycatab range consists of pre-cooked, partially cooked and partially hydrolyzed starches made using special production processes. These products bring in reliability, flexibility and several advantages in wet granulation as well as direct compression tableting.

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Maize Starch B

Maize Starch Extra White

Maize Starch 5%

Wheat Starch TB

Potato Starch B

Conventional

Super-white

Low water content

Standard

Fully pregelatinized starch

Partially pregelatinized starch

Partially hydrolyzed, spray-dried starch

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LYCOATPregelatinized Hydroxypropyl StarchLycoat is a modified, pea starch based polymer specifically designed for aqueous film coatings of immediate release, solid oral dosage forms. This breakthrough polymer has low viscosity, allowing preparation of coating suspensions with high solid content. Coating time is thus drastically reduced when compared to traditional HPMC film coating systems. It is a new alternative for the formulator with benefits such as instant dispersion at room temperature, no foam formation, excellent mechanical properties, high gloss and smoothness with no logo bridging and a neutral taste.

Ready-mix products based on Lycoat are also available under the brand name of ReadiLycoat.


Aqueous, aesthetic film coating system for solid oral dosage forms

Novel excipient for orodispersible films

GLYCOLYSSodium Starch Glycolate USP/NF, EP, JP

Glycolys or sodium carboxymethyl starch, is a very well known and widely used superdisintegrant for all solid oral dosage forms. It has a potato starch base and the capacity to swell upto 280 - 320 times its original granule volume. Glycolys is sparingly soluble in ethanol and practically insoluble in water. It is a versatile excipient suitable for wet / dry granulation as well as direct compression and can be incorporated in intra and / or extra-granular modes.


Conventional disintegrant for solid oral dosage forms

Optimized to withstand high shear, wet granulation processes

Designed to resist acidic pH and maintain stability in strongly acidic drug formulations

Glycolys Standard, SSG - Type A

Glycolys LV Low viscosity, SSG - Type A

Glycolys Low pH Acid stable, SSG - Type B

Lycoat RS 780

ReadiLycoat

Lycoat RS 720

Low viscosity grade

Ready-to-use film coating system based on Lycoat

High viscosity grade

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GLUCIDEXMaltodextrin USP/NF, EPCorn Syrup Solids USP/NF, EP

Glucidex is a family of maltodextrins and dried glucose syrups obtained from starch by hydrolysis, followed by purification and spray-drying. These products exhibit good stability and display a varying range of sweetness depending on the degree of hydrolysis. Glucidex can help adjust and control the properties of viscosity and texture, anti-crystallizing power, browning reactions, fermentability and freezing point depression. These products are soluble in water and have a high standard of organic, mineral and bacteriological purity. Glucidex is also available in an ‘IT’ range which has a particular physical structure and provides superior free flowing properties with better solubilization effects.

Grade Dextrose Equivalent Applications (D.E.)

Diluent for tablets, capsules, sachets, carrier for spray-drying and as a carbohydrate source in infant and enteral foods. Can also be used for direct compression formulations

Glucidex 2 5 max.

Glucidex 6 5 - 8

Glucidex 9 8 - 10

Glucidex 12 11 - 14

Glucidex 17 15 - 18

Glucidex 19 18 - 20

Corn Syrup Solids (Dried Glucose Syrup) These are starch hydrolysis products with a dextrose equivalent (D.E.) greater than 20.

Diluent for tablets, capsules, sachets, carrier for spray-drying and as a carbohydrate source in infant and enteral foods. Can also be used for direct compression formulations

Glucidex 21 20 - 23

Glucidex 33 31 - 34

Glucidex 47 43 - 47

Grade Dextrose Equivalent Applications (D.E.)

Maltodextrin These are starch hydrolysis products with a dextrose equivalent (D.E.) of 20 and below.

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Filler-binder for direct compression and dry granulation processes. Also used for fast-dissolving tablets, capsule filling, cores for coating and low dosage formulations

STARLACCompound of Maize Starch USP/NF, EP and Lactose Monohydrate USP/NF, EP

StarLac is an innovative, spray-dried compound of 15 percent native maize starch and 85 percent alpha-lactose monohydrate available in a free flowing powder form designed for direct compression. This product shows technical improvements and adds value to the formulations due to its easier tableting development process and a combination of good binding performance with outstanding disintegration power.

StarLac

High compactibility, superior flowability, optimized disintegration, excellent tablet hardness, high shear force resistancy and good storage stability


Tablet and capsule filler, medium viscosity thickener in liquid formulations, fibre source and emulsion stabilizer

TACKIDEXDextrin USP/NF, EP

Tackidex is a starch polymer derived through solid-state heating from partially hydrolyzed starch. It is partially or completely soluble in cold water and has low viscosity.

Tackidex B 167 Potato starch based

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NUTRIOSESoluble FibreNutriose is an agglomerated soluble dextrin with high dietary fibre and very low sugar content. It is made by dextrinization of wheat or corn starch followed by refining, purification and drying. This free flowing powder has high digestive tolerance and exhibits good stability to pH and heat.

Grade Type Advantages Applications

For enteral nutrition, gut regulation and moderation of glucidic and lipid metabolism. Also used for low calorie formulations as well as for clinical nutrition and nutraceutical forms

Nutriose FB Wheat fibre

Nutriose FM Maize fibre

High fibre content (85%), low glycaemic and insulinaemic response, low calorific value, quick dissolution and dispersion, high stability, low osmolality, non-cariogenic and a neutral taste

HI-SWEETHigh Fructose Corn Syrup (HFCS)HFCS is a sweet, clear and odourless liquid manufactured by controlled hydrolysis of starch polymers, resulting in high fructose compositions with valuable bulk sweetening profiles. It exhibits less tendency to crystallize at low temperatures due to its lower dextrose and higher fructose level.


Used as a bulk sweetener and viscosity enhancer in syrups and suspensions. Provides high sweetness and a clean mouth feel, making it an ideal replacement for sucrose and invert sugar in various applications

Hi-Sweet 55 Solid content of minimum 55% fructose on dry basis

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DFE Pharma, a global leader in excipient solutions, develops, produces and markets products for oral solid dosage and dry powder inhalation formulations. The company’s new brand name, DFE Pharma, combines the former names DOMO-pharma and DMV-Fonterra Excipients into one new name, enabling them to further strengthen their knowledge base, sales network, sourcing and R&D capability.

The company continuously invests in cGMP standards and advanced excipient technologies teamed with high quality personnel, resulting in customers having great confidence in their overall capabilities. DFE Pharma, in its pursuit of achieving excipient excellence, offers strong co-operation, complete reliability and the shortest possible time-to-market during new product launches and is looked upon as a trustworthy partner in the pharmaceutical world.

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PHARMATOSELactose Monohydrate USP/NF, EP, JP

Pharmatose is crystalline alpha-cellulose monohydrate available in sieved and milled forms. The sieved type consists of regular shaped particles with good flowability while the milled type consists of small particles with a high surface area. Pharmatose displays extremely low moisture absorption even at high relative humidity.

* As determined by laser diffraction

SUPERTAB SD Lactose Monohydrate (Spray-Dried) USP/NF, EP, JP

SuperTab SD is spray-dried lactose with spherically shaped porous particles having a narrow size distribution. Particles consist of small alpha-lactose monohydrate crystals and some amorphous lactose to enhance compactibility.

Grade Mean Particle Size Advantages Applications µm (d50)*

SuperTab 11SD 125

Excellent flow properties, enhances compactibility, affords good blend and tablet content uniformity and has low lubricant sensitivity

Tablets made with SuperTab

SuperTab 14SD 130 14SD disintegrate more

readily than those with SuperTab 11SD

Used in direct compression formulations of drugs with poor flow properties. Has excellent mixing characteristics and prevents drug segregation in very low dose formulations. Also used in capsules and sachets

Mean Particle Size

µm (d50)*

Pharmatose 50M

Sieved

350

Pharmatose 60M 290

Pharmatose 70M 210

Pharmatose 80M 230

Pharmatose 90M 170

Pharmatose 100M 155

Pharmatose 110M 145

Pharmatose 125M 70

Pharmatose 130M

Milled

90

Pharmatose 150M 45

Pharmatose 200M 35

Pharmatose 350M 25

Pharmatose 450M 20

As a filler in wet or dry granulation, in extrusion spheronization, in capsules and as a diluent in sachets. Also used in direct compression formulations

Good flowability and mixing characteristics

Small particles and high surface area for excellent wettability and compressibility


Grade Type Advantages Applications

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SUPERTAB ANAnhydrous Lactose USP/NF, EP, JP

SuperTab AN is an anhydrous grade of directly compressible lactose with a very low moisture content obtained by physical modification. Particles are a build up of microcrystals, mainly consisting of beta-lactose and possess a high fragmentation propensity and high compactibility.


SuperTab 21AN 150

Has low moisture content and absorbs very little moisture even at higher relative humidities, has excellent compactibility and

SuperTab 22AN 210

low lubricant sensitivity

SuperTab 22AN is especially suitable for improvement of flow properties

Used in direct compression formulations of moisture sensitive actives. Used also in dry granulation processes, chewable tablets and for high dose drug formulations


SuperTab

30GR 140

Good flow properties, superior compactibility and shows consistent compaction over a wide range of humidities

Tablets produced with this grade disintegrate quickly compared to other directly compressible lactose grades

Used in direct compression formulations and for low dose actives. Also used in capsules and sachets

SUPERTAB GRLactose Monohydrate (Granulated) USP/NF, EP, JP

SuperTab GR is a standard grade of directly compressible lactose characterized by good flowability and good compactibility due to its special particle structure.



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HMS Lactose Filler in wet granulation, capsules and powder mixtures

LACTOCHEM and LACTOPRESS

Impalpable grade


Lactochem Fine Powder

Lactopress Spray-Dried 250

Lactopress Anhydrous 250

Lactopress Granulated

Filler in wet granulation, capsules and powder mixtures

Ideal for direct compression tableting with excellent flow, high compressibility and enables good content uniformity

In direct compression tableting of moisture sensitive actives. Is characterized by superior dissolution and binding properties

In direct compression tableting with an improved disintegration profile

Lactose monohydrate USP/NF, EP, JP (Milled type)

Lactose monohydrate USP/NF, EP, JP (Spray-dried, directly compressible)

Anhydrous lactose USP/NF, EP, JP

(Low-moisture, directly compressible)

Lactose monohydrate USP/NF, EP, JP (Granulated, directly compressible)

HMS LACTOSELactose Monohydrate USP/NF, EP

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BASF SE, headquartered in Ludwigshafen, Germany is the largest chemical company in the world. In 2008, this German company was converted into a European company (Societas Europaea SE) and was renamed ‘BASF SE’ from ‘BASF Aktiengesellschaft’. They have now also acquired Cognis, a German based leading supplier of innovative specialty chemicals.

BASF has been an expert partner to the pharmaceutical industry for decades, with its active ingredients, excipients and custom synthesis services manufactured by highly trained and experienced staff meeting the highest standards. They have been pioneers in the production of polyvinyl pyrrolidone range of products and their brands today are considered as quality benchmarks in the pharmaceutical industry. With their in-depth knowledge of science, research and technology, they have converted market trends and scientific ideas quickly into successful innovations. Through new technologies, they have launched several innovative, high functional excipients for various pharmaceutical applications, thus creating added value and opportunities for customers to achieve even greater business success.

Quality is BASF’s overriding priority and not just because pharmaceuticals are subject to strict legalization. All their production facilities are approved by international regulatory bodies and function within the strict framework of quality and safety. Decades of experience, knowledge, innovation, product consistency and unmatched quality has made BASF the partner of choice for manufacturers of pharmaceutical products in all four corners of the globe.

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KOLLIDONPovidone USP/NF, EP, JP

The soluble grades of Kollidon are polyvinylpyrrolidone (PVP K) obtained by free-radical polymerization of N-vinylpyrrolidone. By virtue of its solubility in water and many organic solvents as well as its high binding power and ability to form complexes, soluble PVP occupies a special position among the synthetic colloids.

Soluble Kollidon is available in a variety of grades based on their K-value and weight average molecular weight.

Kollidon 12 PF 10.2 - 13.8 2000 - 3000

Low molecular weight povidone of pyrogen-free quality for use as a solubilizer, crystallization inhibitor and suspension stabilizer in injections

Kollidon 17 PF 15.3 - 18.0 7000 - 11000

Same as Kollidon 12 PF. Additionally used as a lyophilization agent in injections and ophthalmic preparations

Kollidon 25 22.5 - 27.0 28000 - 34000

Medium molecular weight

Kollidon 30 27.0 - 32.4 44000 - 54000

povidone used as binders in tablets, capsules and granules, stabilizers in oral suspensions, as film formers, oral solubilizers, dispersants for pigments, enzyme stabilizers and as bioavailability enhancers

Kollidon 30 LP 27.0 - 32.4 44000 - 54000

Special low-peroxide and low-formaldehyde grade to prevent degradation of actives sensitive to oxidation. Other applications similar to Kollidon 30

Kollidon 90 F 81.0 - 96.3 1000000 - 1500000

High molecular weight povidone serving as a highly effective binder, stabilizer for oral and topical solutions, thickener, hydrophilizer and pore-former in surgical plastics

Grade Applications

K-value Weight Average Molecular Weight (Mw)

Description

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KOLLIDON CLCrospovidone USP/NF, EP, JPE

The insoluble grades of Kollidon are crosslinked polyvinylpyrrolidone manufactured by a polymerization process using an aqueous system, yielding crosslinked insoluble PVP in the form of a ‘popcorn’ polymer.

Kollidon CL grades are used as ‘superdisintegrants’ due to their property to swell very fast and predictably without forming a gel. These grades accelerate the dissolution and the bioavailability due to its power to form complexes with many insoluble actives.

KOLLIDON VA 64Copovidone USP/NF, EP, JPE

Kollidon VA 64 is a vinylpyrrolidone-vinyl acetate copolymer in a ratio of 6:4 (by mass) that is soluble in water and alcohol. This product strongly improves dry binding capacity. Due to its high plasticity, distinguishing it from povidone (Kollidon 30), it produces granules and mixtures that are less susceptible to capping and tablets that are less brittle.

Standard grade, for use as a tablet disintegrant and Kollidon CL 110 - 130 for improving the release of active substances from tablets, capsules and granules

Fine particle size grade, for use as a disintegrant Kollidon CL-F 20 - 40 in tablets, especially in formulations for small tablets and in wet granulation

Super-fine particle size grade for use as a Kollidon CL-SF 10 - 30 disintegrant in fast dispersible tablets due to its smooth mouth feel

Micronized particle size grade used as a

Kollidon CL-M 3 - 10 stabilizer for oral and topical suspensions and

for improving the release of active substances from tablets, capsules and granules

Grade Average Particle Applications Size Range (µm)

Grade Average Particle Size K-value Applications (µm)

Kollidon VA 64 55

25.2 - 30.8

Standard grade for use as a dry binder for direct compression and roller compaction, as a binder for wet granulation in tablets, capsules and granules, as a film forming agent in tablet coating / sub-coating as well as in topical sprays

Kollidon VA 64 Fine 17

Fine particle size grade resulting in higher binding efficiency. Displays increased tablet hardness, less friability and higher mechanical stability. Applications similar to Kollidon VA 64

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KOLLIDON SRBlend of Polyvinyl Acetate and Povidone USP/NF, EP, JP

Kollidon SR is a blend of 80 percent polyvinyl acetate and 19 percent povidone along with small quantities of sodium lauryl sulfate and silica, used as stabilizers.

Due to its combination of the very plastic polyvinyl acetate and strongly binding povidone, Kollidon SR has excellent compressibility and endows tablets with enormous hardness and low friability. When tablets formulated with this product are introduced into gastric or intestinal fluid, the water soluble povidone is leached out to form pores through which the active ingredient slowly diffuses out resulting in sustained action.

KOLLICOAT SR 30 DPolyvinyl Acetate Dispersion 30 Percent EP

Kollicoat SR 30 D is an aqueous dispersion consisting of 27 percent polyvinyl acetate stabilized with 2.7 percent povidone and 0.3 percent sodium lauryl sulfate. This product is miscible with water in any ratio whilst retaining its milky white appearance. It is however insoluble in dilute alkaline or acidic solutions.

Kollicoat SR 30 D


Kollidon SR 60.0 - 65.0

Grade K-value Advantages Applications

Non-ionic, pH-independent, allows drug release independent of compression force and tablet hardness

Matrix-forming agent in directly compressible sustained-release tablets. Can also be applied to roller compaction, wet granulation and extrusion

Low viscosity, pH-independent drug release, high binding capacity and excellent, flexible, film-forming properties

Used as a sustained-release coating on pellets, microspheres, granules and crystals, as a controlled-release matrix in tablets following wet granulation of the active substance. Also used for taste and odour masking and as a sub-coat for isolating active ingredients in order to prevent interactions

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KOLLICOAT IRMacrogol Poly (Vinyl Alcohol) Grafted Copolymer, EP

Kollicoat IR is a polyvinyl alcohol-polyethylene glycol graft copolymer with the addition of colloidal silica. It is a water soluble, film forming agent, ideal for manufacturing instant release coatings for solid dosage forms. The key features of this innovative excipient are low viscosity of the polymer solution, outstanding flexibility of the film coating without the addition of plasticizers and extremely rapid dissolution in the body. In terms of viscosity alone, this new technology offers significant advantages over cellulose derivatives.

KOLLICOAT IR COATING SYSTEMSReady-To-Use Coating Systems

Kollicoat IR Coating Systems are unique, innovative, ready-to-use coloured coating materials based on Kollicoat IR (polyvinyl alcohol-polyethylene glycol graft copolymer).

This novel system consists of seven globally approved base colour components which makes it possible to obtain a wide variety of shades simply by combining different numbers and concentrations of these individual components. The innovative, spray-agglomeration manufacturing process used, results in a raspberry-like structure, granular polymer with high surface area, enabling extremely rapid re-dispersibility in water. The coating suspensions can be easily prepared by weighing and dispersing the required individual components in water without additives.



Kollicoat IR White II

Kollicoat IR Black

Kollicoat IR Red

Kollicoat IR Yellow

Kollicoat IR Brilliant Blue

Kollicoat IR Sunset Yellow

Kollicoat IR Carmine

Easy re-dispersion, excellent flow properties without dust formation, low viscosity of coating suspension, high solid concentration, no lump formation and short process time

Ready-to-use colour film coating system for all solid oral dosage forms. Can even be applied at temperatures below 25ºC, making it ideal for coating formulations with thermo-sensitive ingredients

Kollicoat IR

Kollicoat Protect

Graft copolymer of PVA - PVP (75:25)

For instant release coatings of tablets, pellets and particulate matter, pore former in sustained-release coatings, as a binder for wet granulation and also film former in sprays and transdermal therapeutic systems

Co-processed product of Kollicoat IR (55-65%) and polyvinyl alcohol (35-45%)

Ready-to-use moisture barrier system for use in combination with pigments. Also acts as a pore former in sustained-release coatings and a taste masking agent

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KOLLICOAT MAEMethacrylic Acid Copolymer USP/NF, EP, JPE

Kollicoat MAE is an anionic polymer derived from methacrylic acid-ethyl acrylate in the molar ratio of 1:1. This product is a state-of-the-art, film-forming agent used for reliable and convenient enteric coating of solid oral dosage forms. Film coatings formed using Kollicoat MAE are insoluble below pH 5 and thus resistant to gastric fluid. Due to salt formation in the neutral to weakly alkaline medium of intestinal fluid, the films dissolve step-wise at pH values above 5.5.

KOLLICOAT SMARTSEAL 30 DMethyl Methacrylate and Diethylaminoethyl Methacrylate Copolymer Dispersion

Kollicoat Smartseal 30 D is the first water based dispersion for taste masking and moisture barrier applications. It is a 30 percent aqueous polymer dispersion of methyl methacrylate and diethylaminoethyl methacrylate stabilized with approx. 0.6 percent macrogol cetostearyl ether and 0.8 percent sodium lauryl sulfate.

Kollicoat Smartseal 30 D is stable in saliva (pH 6.8 - 7.2) and specifically soluble in gastric juices which insures effective protection from unpleasant taste and rapid release with onset of drug action, in the stomach. It is highly impermeable to water vapour, helping preserve the potency of sensitive actives.



Kollicoat MAE 30 DP

Kollicoat Smartseal 30 D

Kollicoat MAE 100 P

30% aqueous dispersion of low viscosity

Hides bitter taste with significantly reduced coating thickness. Has low viscosity and can be used at high spray rates

Enteric film coating of tablets, pellets, capsules and other solid dosage forms. Also used as a moisture barrier, for taste / odour masking and as a protective barrier between incompatible actives

Innovative taste masking agent and an effective sealant against moisture

Partially neutralized, re-dispersible powder

For production of an aqueous dispersion for coatings or a solution in organic solvents for enteric coatings of solid dosage forms. Other applications similar to Kollicoat MAE 30 DP

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KOLLIPHOR (CREMOPHOR)Solubilizers / Emulsifiers

Kolliphor (earlier known as Cremophor) is a family of non-ionic solubilizers and emulsifiers.

Kolliphor RH 40 is obtained by reacting one mole of hydrogenated castor oil with 45 moles of ethylene oxide, while Kolliphor EL and ELP are made by reacting castor oil with ethylene oxide in a molar ratio of 1:35.

Polyoxyl 35 castor oil USP/NF, EP

Pale yellow, oily liquid

Polyoxyl 40 hydrogenated castor oil USP/NF, EP



(Purified grade of Cremophor EL)

White to yellowish paste or cloudy liquid

White to yellowish paste

Pale yellow, oily liquid

To solubilize vitamins, hydrophobic actives and essential oil-in-water or hydroalcoholic mixtures, to improve bioavailability in solid dosage forms and as a solubilizer in oral / topical liquid and semi-liquid dosage forms

Extra-pure grade for special injection solutions. Also used as a solubilizer and emulsifier in liquid form for oral and topical preparations

Grade Pharmacopeial Name Appearance Applications

Kolliphor RH 40 (Cremophor RH 40)

Kolliphor EL (Cremophor EL)

Kolliphor ELP (Cremophor ELP)

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KOLLIPHOR CS (LANETTE PH)Kolliphor CS (earlier known as Lanette PH) is a family of self emulsifying cetostearyl alcohol and sodium cetostearyl sulfate.

Kolliphor CS A and Kolliphor CS B are anionic emulsifying waxes prepared by melting cetostearyl alcohol and heating to about 950C. Purified water and suitable anionic surfactants are added and this mixture is further heated upto 1150C with vigorous stirring until frothing ceases. The resulting wax is then rapidly cooled. Kolliphor CS A contains cetostearyl alcohol and sodium cetostearyl sulfate while Kolliphor CS B contains cetostearyl alcohol and sodium lauryl sulfate.

Kolliphor CS S on the other hand is an anionic emulsifier which is a mixture of fatty alcohol sulfates, especially sodium cetostearyl sulfate.

KOLLIPHOR HS 15 (SOLUTOL HS 15)Polyoxyl-15-Hydroxystearate USP/NF, EP

Kolliphor HS 15 (earlier known as Solutol HS 15) is a non-ionic solubilizer and emulsifying agent obtained by reacting 15 moles of ethylene oxide with 1 mole of 12-hydroxy stearic acid. It is soluble in water, ethanol and 2-propanol to form clear solutions. Its solubility in water decreases with increasing temperature and it is insoluble in liquid paraffin.

This product has high chemical stability and toxicology tests have shown that it is extremely well tolerated. Kolliphor HS 15 meets the requirements of a potent, modern, low toxicity solubilizer.

Kolliphor CS A Cetostearyl alcohol (Type A), (Lanette N PH) emulsifying EP

Kolliphor CS B Cetostearyl alcohol (Type B), (Lanette 20 PH) emulsifying EP

Kolliphor CS S (Lanette E PH)

Grade Pharmacopeial Name Applications

Kolliphor HS 15 (Solutol HS 15)


Non-ionic solubilizer for manufacturing aqueous parenteral preparations with vitamins and other lipophilic actives

Yellowish white paste at room temperature which transforms into a liquid at approx. 30°C

Anionic self-emulsifying base for topical emulsions

Anionic emulsifier used for topical emulsionsSodium cetostearyl sulfate EP

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KOLLIPHOR MCE (EUMULGIN PH)Polyoxyl Cetostearyl Ether USP/NF, EP

The Kolliphor MCE (earlier known as Eumulgin PH) range of products is polyoxyethylene alkyl ethers prepared by the condensation of linear fatty alcohols derived from vegetable sources with ethylene oxide. The reaction is a controlled one, so that the required ether is formed with the polyethylene glycol of desired molecular weight.

KOLLIPHOR P (LUTROL F / LUTROL L)Poloxamer USP/NF, EP, JPE

Poloxamers are synthetic block copolymer of ethylene oxide and propylene oxide. They are available in F types (Kolliphor P) which are white, coarse grained powders with a waxy consistency containing an appropriate quantity of the antioxidant BHT; while the L type (Kollisolv P) is a milky white paste or liquid containing DL-alpha tocopherol as an antioxidant.



Kolliphor MCE 12 (Eumulgin B1 PH)

Kolliphor MCE 20 (Eumulgin B2 PH)

Non-ionic surfactant for topical emulsions. Also used as a solubilizer and wetting agent

Macrogol cetostearyl ether 12 EP

Polyoxyl 20 cetostearyl ether USP/NF, EP

Kolliphor P 188 (Lutrol F 68)




Kolliphor P 188 Micro (Lµtrol Micro 68)

Kolliphor P 407 Micro (Lµtrol Micro 127)

Kollisolv P 124 (Lutrol L 44)

Poloxamer 188

Poloxamer 237

Poloxamer 338

Poloxamer 407

Microprilled poloxamer 188

Microprilled poloxamer 407

Poloxamer 124

Emulsifier, solubilizer and suspension stabilizer in liquid, oral, topical and parenteral dosage forms and as a plasticizer and bioavailability enhancer in solid formulations

Gel former, thickening agent and solubilizer in oral and topical solutions and as a stabilizer in topical suspensions

Solubilizing agent and dissolution enhancer for actives in solid oral dosage forms and a water soluble lubricant for actives incompatible with stearates

As a dispersion medium for APIs in liquid filled soft gel capsules. It is the only monographed poloxamer in liquid form at room temperature

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KOLLIPHOR PSPolysorbate USP/NF, EP, JP

Kolliphor PS is a range of polysorbate grades produced by partial esterification of sorbitan (a cyclic sorbitol anhydride) with a fatty acid derived from vegetable sources, to yield a hexitan ester. Finally, ethylene oxide is chemically added in the presence of a catalyst to yield the polysorbate. These products exist in liquid form and contain 20 units of oxyethylene.

KOLLIPHOR SLS (TEXAPON)Sodium Lauryl Sulfate USP/NF, EP, JP

Kolliphor SLS, (earlier known as Texapon) is manufactured by sulfation of the corresponding fatty alcohol of natural origin and subsequent neutralization with sodium hydroxide. The product is characterized by a very high active substance matter and a very low content of inorganic salts and unsulfated fatty alcohol. Kolliphor SLS is extremely efficient throughout the tableting process by assisting in drug dissolution and aiding water uptake during disintegration of the end formulation.

KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA)Vitamin E Polyethylene Glycol Succinate USP/NF

Kolliphor TPGS (earlier known as Speziol TPGS Pharma) is a mixture formed by the esterification of d-alpha tocopheryl acid succinate and polyethylene glycol for use in oral and topical dosage forms. It is a water soluble derivative of naturally sourced vitamin E that can directly enhance the bioavailability of poorly soluble drugs and also offers high solubilization effectiveness.

Kolliphor SLS Fine (Texapon K 12 P PH)

Kolliphor SLS (Texapon K 12 G PH)

Kolliphor TPGS (Speziol TPGS Pharma)

Kolliphor PS 20 Polyoxyethylene 20 sorbitan (Polysorbate 20 PH) monolaurate

Kolliphor PS 60 Polyoxyethylene 20 sorbitan (Polysorbate 60 PH) monostearate

Kolliphor PS 80 Polyoxyethylene 20 sorbitan (Polysorbate 80 PH) monooleate

This hydrophilic, non-ionic surfactant is widely used as an emulsifier for topical dosage forms. Also used as a wetting, dispersing and solubilizing agent


Grade Properties Applications

Grade Chemical Description Applications

Wetting agent in tableting, glidant, lubricant, anti-adherent, anionic surfactant, emulsifying agent and skin penetrant

Emulsifier and drug solubilizer for lipophilic actives, absorption enhancer, antioxidant, vehicle for lipid based drug delivery and a source of natural vitamin E

Low and defined particle size, free flowing powder

Granular powder

Waxy solid of white to light brown appearance with a melting range of 37 - 41ºC

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KOLLISOLV G (SPEZIOL G PF)Glycerin USP/NF, EP

Kollisolv G (earlier known as Speziol G PF) is a clear and colourless viscous liquid at temperatures of 20ºC. This product, derived from vegetable sources, is hygroscopic and has a sweet taste approximately 0.6 times that of sucrose. It is used in a wide variety of preparations such as oral, otic, ophthalmic, topical, rectal and parenteral. Depending on the glycerin content, it is available in two grades.

KOLLISOLV PG Propylene Glycol USP/NF, EP

Kollisolv PG is produced by converting propylene to chlorohydrin by chlorine water and hydrolyzing it to 1,2-propylene oxide. With further hydrolysis 1,2-propylene oxide is converted to propylene glycol.

KOLLISOLV GTA (SPEZIOL GTA)Triacetin USP/NF, EP

Kollisolv GTA (earlier known as Speziol GTA) is a triester of glycerol and acetic acid which is esterified at increased temperatures.

Kollisolv G 99 (Speziol G 99.8% PF)

Kollisolv G 85 (Speziol G 86% PF)

Glycerin USP/NF, EP, JP

Glycerol EP

Moisturizer, humectant, tonicity agent, solvent, co-solvent, sweetening agent and viscosifier. Also used as a plasticizer of gelatin in the production of soft gelatin capsules and gelatin suppositories




Used as a solvent and a water-miscible co-solvent. Also used as a humectant, plasticizer, anti-microbial preservative and a stabilizing agent in a variety of solid, liquid and semi-solid dosage forms

As a hydrophilic plasticizer in both, aqueous and solvent based polymeric coating of capsules, tablets, beads and granules. Also used as a solubilizer

Clear, colourless viscous liquid with a sweet, slightly acrid taste

Kollisolv PG

Kollisolv GTA (Speziol GTA)

Clear, colourless, slightly viscous liquid

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KOLLISOLV PEG (LUTROL E)Polyethylene Glycol (Macrogol) USP/NF, EP

These products (earlier known as Lutrol E) are liquid polyethylene glycols manufactured by alkali catalyzed polymerization of ethylene oxide with subsequent neutralization of the catalyst. They are readily soluble in water, ethanol, acetone, glycols and chloroform. Kollisolv PEG grades are available in different molecular weights. The higher the molecular weight of the product, the less hygroscopic it is and lower is its solubility in water.

KOLLISOLV MCT (MYRITOL PH)Medium Chain Triglyceride USP/NF, EP

Kollisolv MCT (earlier known as Myritol PH) is a triglyceride based on saturated fatty acids C8 and C10. It is produced by esterification of fatty acids or fatty acid methyl esters and glycerol at high temperatures.

Grade Molecular Weight Viscosity Applications (Mw) (mPa.s)

Solvents and solubilizing agents for actives in oral, parenteral, topical, ophthalmic and rectal preparations and carriers for dissolved or suspended actives in soft gelatin capsules. Also used widely as an ointment base

Solubilizer for oil soluble actives. Due to its polarity and spreadability, it is used for skin care preparations


Kollisolv PEG 400 380 - 420 105 - 130 (Lutrol E 400)

Clear, slightly yellowish, odourless oil Kollisolv MCT 70 (Myritol 318 PH)

80 - 105285 - 315Kollisolv PEG 300 (Lutrol E 300)

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KOLLIWAX GDB (SPEZIOL GDB PHARMA)Glycerin Behenate USP/NF, EP

Kolliwax GDB (earlier known as Speziol GDB Pharma) is a mixture of glycerol esters produced by esterification of fatty acids of vegetable origin with glycerol, at increased temperatures and with the use of a suitable catalyst.

KOLLIWAX GMS II (CUTINA GMS VPH)Glyceryl Monostearate 40-55 (Type II) USP/NF, EP

This product (earlier known as Cutina GMS VPH) is manufactured by the reaction of glycerin with triglycerides derived from vegetable sources, resulting in a mixture of monoglycerides and diglycerides.

Viscosity regulatory in oil-in-water emulsions. Also used as a non-ionic emulsifier, solubilizer, plasticizer, lubricant and stabilizer and to form sustained-release matrices for solid dosage forms



KOLLIWAX (SPEZIOL C PHARMA)Kolliwax (earlier known as Speziol C Pharma) grades are derived from vegetable sources using the fatty alcohol production process. They are available in the form of wax pellets while the other types exist in free flowing micro pearls form.

Myristyl alcohol USP/NF

Cetyl alcohol USP/NF, EP, JP

Stearyl alcohol USP/NF, EP

Cetostearyl alcohol USP/NF, EP, JPE

Viscosity regulator for oil-in-water emulsions. Also used as a pH-independent sustained-release agent


Kolliwax MA (Speziol C 14 Pharma)

Kolliwax CA (Speziol C 16 Pharma)

Kolliwax SA (Speziol C 18 Pharma)

Kolliwax CSA 50 (Speziol C 16 18 Pharma)

Kolliwax GDB (Speziol GDB Pharma)

Hydrophilic wax available in powder / pellets form

Viscosity increasing agent in emulsions, thickening agent, lubricant and binder in solid orals and a lipophilic matrix or a coating agent for sustained-release tablets or capsules

Kolliwax GMS II (Cutina GMS VPH)

White to slightly yellowish, hydrophilic wax powder

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KOLLIWAX S (SPEZIOL L2SM)Stearic Acid USP/NF, EP, JP

This product (earlier known as Speziol L2SM) is a mixture of stearic acid and palmitic acid, in neutralized saponified form, derived from raw materials of vegetable origin. Kolliwax S grades are available in a free flowing powder form of different particle sizes and display low variances in tablet characteristics due to material uniformity.

KOLLICREAM CP 15 (CUTINA CP PH)Cetyl Palmitate 15 EP

This product (earlier known as Cutina CP PH) is an ester which is manufactured by catalytic esterification of fatty acid and fatty alcohol.

Lubricant in oral dosage forms, matrix forming agent in sustained-release dosage forms, emulsifying and solubilizing agent in topical formulations and hardening agent in glycerin suppositories

Kollicream CP 15 White, coarse pellets

For emulsions, on account of its body (Cutina CP PH) giving characteristics

Grade Particle Size Applications


KOLLIWAX HCO (CUTINA HR PH)Hydrogenated Castor Oil USP/NF, EP, JP

Kolliwax HCO (earlier known as Cutina HR PH) is manufactured by hydrogenation of castor oil derived from vegetable sources. It is a hard wax with a high melting point.

Sustained-release agent, lubricant for solid orals and a consistency enhancer in topicals


Kolliwax HCO (Cutina HR PH)

White or pale yellow, free flowing powder

Kolliwax S Fine (Speziol L2SM GF)

Kolliwax S (Speziol L2SM GS)

Min. 40% <100 µm

Max. 10% <100 µm

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KOLLICREAM OA (HD EUTANOL V PH)Oleyl Alcohol USP/NF, EP

This product (earlier known as HD Eutanol V PH) is manufactured by the production process of fatty alcohols derived from vegetable sources. It is a mixture of unsaturated and saturated long chain fatty alcohols consisting mainly of oleyl alcohol and elaidyl alcohol. Mixed tocopherols are added to prevent autooxidation.

Emollient and emulsifying agent for semi-solid dosage forms. Also as a solubilizer for oil soluble actives


KOLLICREAM IPM Isopropyl Myristate USP/NF, EP, JP

This product (earlier known as Isopropylmyristat PH) is manufactured by transesterification of fatty acid methyl esters with isopropyl alcohol. It has low viscosity and congeals at about 5ºC.

Non-greasy emollient and skin penetrant in topical preparations Also used as a solubilizer for lipid soluble actives


KOLLICREAM DO (CETIOL V PH)Decyl Oleate EP

Kollicream DO (earlier known as Cetiol V PH) is a mixture of decyl esters of fatty acids, mainly oleic acid. Through the addition of mixed tocopherols, it is protected from autooxidation.

Kollicream DO Clear, slightly yellowish polar oil Emollient for topical delivery systems (Cetiol V PH)


Kollicream IPM (Isopropylmyristat PH)

Clear, colourless oil of medium polarity and high spreadability

Kollicream OA (HD Eutanol V PH)

Clear, slightly yellowish, weak polar oil

BASF

52

KOLLICREAM ODD (EUTANOL G PH) Octyldodecanol USP/NF, EP

Kollicream ODD (earlier known as Eutanol G PH) is produced by the condensation of two molecules of decyl alcohol using the Guerbet reaction. It is stable to hydrolysis and can be used in both the alkaline and acidic pH range.

Emollient and emulsifying agent for semi-solid dosage forms. Also as a solubilizer for oil soluble actives


LUDIFLASHCompound of Mannitol USP/NF, EP, Crospovidone USP/NF, EP and Polyvinyl Acetate EP

Ludiflash is an innovative, unique co-processed blend of 90 percent mannitol, 5 percent crospovidone and 5 percent polyvinyl acetate dispersion stabilized with povidone, specifically designed for orodispersible formulations. This sugar-free composition provides a pleasant, creamy mouth feel without a chalky or grainy sensation.

Tablets made with Ludiflash are compact but highly porous with exceptional hardness and low friability. They rapidly disintegrate or disperse within a few seconds when placed on the tongue and do not require external liquids to facilitate swallowing.


Direct compression of fast disintegrating, solid oral dosage forms (mouth-melts). Can also be used for wet granulation and roller compaction processes

Kollicream ODD (Eutanol G PH)

Clear, slightly yellowish oil of low polarity and good spreadability

LudiflashRapid disintegration, superior flow, low hygroscopicity and good compressibility

BASF

53

SOLUPLUSPolyvinyl Caprolactam-Polyvinyl Acetate-Polyethylene Glycol Graft CopolymerSoluplus is a polymeric solubilizer with an amphiphilic chemical structure which was particularly developed for solid solutions. Due to its bi-functional character, it acts as a matrix polymer for solid solutions on one hand and on the other hand, it is capable of solubilizing poorly soluble drugs in aqueous media.

The safety of this product is documented by a comprehensive range of toxicological data.


Innovative excipient for hot-melt extrusion, solubility and bioavailability enhancer. Also used as a binder in wet and dry granulation

LUDIPRESSCompound of Lactose Monohydrate USP/NF, EP, JP and Povidone USP/NF, EP, JP

Ludipress is an advanced, pre-granulated product based on lactose monohydrate (filler) and povidone (binder)-the functional components required for tablets in the necessary proportion. It is a ready-to-use, granular excipient for direct compression of solid oral dosage forms which reduces the tablet production process to a few steps. Excellent flowability, low water absorption, ideal particle size distribution, no segregation of active ingredients and binding capacity are the key features of this product.


Direct compression of solid orals (disintegrating tablets) and as a filler in hard gelatin capsules

Direct compression of lozenges, sublingual, chewable and effervescent tablets. Also used as a bulking agent for modified-release formulations

93% lactose monohydrate, 3.5% povidone and 3.5% crospovidone

96.5% lactose monohydrate and 3.5% povidone

Ludipress

Ludipress LCE

Soluplus

Effectively solubilizes poorly soluble actives, significantly improves bioavailability, has excellent capability to form solid solutions and displays high extrudability

BASF

54

NOVATAHard Fat EP

Novata is a range of hard fat suppository bases consisting mainly of mixtures of the triglyceride esters of higher saturated fatty acids along with varying proportions of mono and diglycerides. This product is manufactured by the esterification of fatty acid derived from vegetable sources with glycerin by using a suitable catalyst. Novata is available in pellet form and each type is characterized by its melting point, saponification value and hydroxyl value.

Novata 299 PH 33.3 - 34.5 235 - 250 Max. 5

Novata B PH 33.5 - 35.5 225 - 240 20 - 30

Novata BC PH 33.0 - 34.5 225 - 240 30 - 40

Novata BCF PH 35.0 - 37.0 225 - 240 20 - 30

Novata BD PH 33.5 - 35.5 225 - 245 5 - 15

Grade MeltingPointRange SaponificationValue HydroxylValue Applications (°C)

Suppository bases

Shin

-Ets

u C

hem

ical

Co.

, Ltd

.

55

Shin-Etsu, founded in Japan in 1926, has grown to become the world’s largest producer of methylcellulose and hypromellose. The company’s specialty products include film coating materials, binders, water soluble cellulose ethers and their derivatives, sustained-release agents and enteric coating materials. As part of their expansion strategy, they acquired the cellulose business unit of the Swiss based company, Clariant.

The company’s Naoetsu plant fully implements the Shin-Etsu ‘six sigma’ activities and pursues the principle of ‘total quality control’. Their speciality chemicals research centre proactively works on new applications for existing products and on development of innovative products to meet the customer’s ever growing needs. Shin-Etsu’s corporate symbol, ‘memorable glow’ is representative of their abidance to advanced technology, top quality, dynamism, high spirits and flexibility, all of which are activated by the light source at the centre, and today, this company has made themselves indispensible in the development of successful and new generation formulations.

Shin

-Ets

u

56

PHARMACOATHypromellose USP/NF, EP, JP

Pharmacoat is a low viscosity hydroxypropyl methylcellulose polymer which is easy to use as a film coating material and gives an excellent finish to the final product. It is versatile and suitable for many applications in the design of film coated tablet formulations.

This product is also effective as a binder since it does not interact with drugs, has superior stability and is non-ionic in character.

Pharmacoat 603 3.0 Binder in wet granulation

Pharmacoat 645 4.5 Regular film coating

Pharmacoat 606 6.0

Pharmacoat 615 15.0 Film coating of greater strength

Viscosity USP (mPa.s) Substitution Type


2910

Shin

-Ets

u

57

HPMCPHypromellose Phthalate USP/NF, EP, JP

This product is a monophthalic acid ester of hypromellose, widely used as a solvent based enteric coating agent to protect drugs from gastric degradation or to protect the gastric mucosa from irritant drugs. Its threshold pH value for rapid disintegration can be controlled by varying the phthalyl content.

HPMCP HP-55

≥ 5.5

40 Regular grade for enteric coating

HPMCP HP-55S 170

Due to its high molecular weight, this enteric film coat has greater strength and higher acid resistance

HPMCP HP-50 ≥ 5.0 55 Enteric coat soluble at lower pH

Dissolving pH Viscosity (cst)


Shin

-Ets

u

58

METOLOSEHypromellose USP/NF, EP, JP and Methylcellulose USP/NF, EP, JP

Metolose is a non-ionic, water soluble cellulose ether derived from highly purified natural pulp by initial treatment with caustic soda to obtain alkali-cellulose, followed by etherification with methyl chloride or with the combination of methyl chloride and propylene oxide.

It can be used as a binder for solid dosage forms and enjoys a variety of properties such as water retention, thickening, sustained-release and protective colloid.

Metolose consists of methylcellulose and three substitution types of hypromellose each available in several grades of differing viscosity. Shin-Etsu also manufactures Metolose SR grades specifically for use in hydrophilic sustained-release matrix systems.

Metolose 60SH-50 50

2910 Metolose 60SH-4000 4000

Metolose 60SH-10000 10000

Metolose 65SH-50 50 2906



2208 Metolose 90SH-15000 15000

Metolose 90SH-100000 100000

Metolose 90SH-100SR 100

2208 Metolose 90SH-4000SR 4000



Metolose SM-4 4 -

Metolose SM-15 15 -

Metolose SM-400 400 -

Metolose SM-4000 4000 -

HPMC polymer, used as a sustained-release agent, thickener, suspending agent and binder for tablets and granules. Also used for ophthalmic formulations

Special HPMC grade, used as hydrophilic matrix agents allowing for more controllable and reproducible drug release, along with good consistency in the final product

Methylcellulose polymer for granule coating

Methylcellulose polymer used as a granulating agent, emulsifying agent, thickener and bulk laxative

Viscosity USP (cps) Substitution Type


Shin

-Ets

u

59

L-HPCLow-Substituted Hydroxypropyl Cellulose USP/NF, JP

L-HPC is a low-substituted hydroxypropyl ether of cellulose. It is non-ionic, less reactive to active ingredients, insoluble in water and alcohol but swells in water by holding water molecules around hydroxypropyl groups that are distributed on the cellulose backbone. L-HPC is widely used as a dual-functionality excipient (binder-disintegrant) for tablets, granules or other pharmaceutical solid dosage forms depending on its particle size and substituent content. Tablets containing L-HPC disintegrate into very fine individual particles, thus resulting in rapid drug dissolution.

Shin-Etsu has also launched new ‘L-HPC NBD’ grades with different particle morphology that are designed to significantly improve binding capability.

Mean Hydroxypropoxy Particle Particle Size Content Appearance (μm) (%)

L-HPC LH-11

L-HPC LH-B1

L-HPC LH-31

L-HPC LH-32

L-HPC LH-21

L-HPC LH-22

55

55

45

Highly fibrous

Non-fibrous

Micronized 20

Moderately fibrous

Direct compression, anticapping

Pellet extrusion, layering

Fluidized-bed granulation, direct compression for high load formulations

Dry mixing, wet granulation

Allows for better disintegration due to lower hydroxypropoxy content

L-HPC NBD-020

L-HPC NBD-021

L-HPC NBD-022

45

11

11

11

11

8

8

14

11

8

Non-fibrous and smaller primary particles

Higher binding capability in wet granulation

Quick swelling, especially for orodispersible tablets

Direct compression


Shin

-Ets

u

60

SHIN-ETSU AQOAT Hypromellose Acetate Succinate USP/NF, JPE

This excipient is a novel, enteric coating polymer manufactured from highly purified pulp involving introduction of acetyl and succinoyl groups into the hydroxyl backbone of hypromellose.

The characteristics of ‘Shin-Etsu AQOAT’ allow its use in different coating techniques such as aqueous, solvent based, ammonia neutralization and dry / deposition coating. It is also recommended in solid dispersions to enhance the bioavailability of poorly soluble drugs as well as in the design of controlled-release dosage forms for targeting drug release to specific gastrointestinal sites.

Various grades of ‘Shin-Etsu AQOAT’ are available which differ in chemical substitution levels and particle sizes.

Mean Particle Dissolving Acetyl (%) / Size pH Succinoyl (%)

AQOAT AS-LF ≥ 5.5 8/15

AQOAT AS-MF 5 μm ≥ 6.0 9/11

AQOAT AS-HF ≥ 6.5 12/7

AQOAT AS-LG ≥ 5.5 8/15

AQOAT AS-MG 1 mm ≥ 6.0 9/11

AQOAT AS-HG ≥ 6.5 12/7

Micronized grade for aqueous and dry coating

Granular grade for solvent based coating


Inno

phos

, Inc

.

61

Innophos, established in 1902, is the culmination of over a century of advancement in phosphate technology. It is the leading manufacturer of high quality calcium phosphates, catering to the world’s pharmaceutical and food markets. Innophos and its predecessor company Rhodia, had pioneered the process of manufacturing extremely low lead content, superior quality, calcium phosphate excipients in both anhydrous and dihydrate forms. The company also holds a number of key patents governing the manufacture and use of phosphates.

Innophos’ quality management systems ensure a high level of performance in meeting customer needs and specifications. The company subscribes to the principals of sustainable development and continues to add to its product line, making constant improvements in products as well as enhancing capabilities at their manufacturing sites.

Today, as a result of their consistent efforts, Innophos has set high industry standards in purity, uniformity and formulation versatility.

Inno

phos

62

CALCIUM PHOSPHATESCalcium phosphates are manufactured by using a very pure grade of phosphoric acid which is reacted with calcium hydroxide derived from limestone. When calcium hydroxide is added to phosphoric acid in the appropriate ratio, dicalcium phosphate (DCP) is precipitated. On the other hand, when acid is added to calcium hydroxide, the precipitate is tricalcium phosphate (TCP) which contains the highest level of calcium content.

After drying, the resulting granular grades can be further milled to obtain a powder grade. The ‘milled’ or ‘powder’ grade is typically used in wet granulation processes while the ‘unmilled’ or ‘granular’ grade is used for direct compression.

Grade Type Calcium (%) / Applications Phosphorus (%)

A-Tab DCP, anhydrous granular 29.0 / 22.2

Calipharm A DCP, anhydrous powder 29.0 / 22.2

Di-Tab DCP, dihydrate granular 23.3 / 18.1

Calipharm D DCP, dihydrate powder 23.3 / 18.1

Tablet and capsule diluent for direct compression. Is non-hygroscopic and stable at room temperature resulting in better product stability

Filler in wet granulation, vitamin premixes and nutritional drinks

Tablet and capsule diluent for direct compression, flow agent, blend densifier, tablet punch polishing agent, time-release agent and a carrier of actives

Filler in wet granulation, vitamin premixes and nutritional drinks

Dicalcium Phosphate USP/NF, EP, JP

Inno

phos

63

Calipharm T TCP, anhydrous powder 38.0 / 17.3

Versacal MP TCP, anhydrous 38.0 / 17.3

micronized powder

Filler in wet granulation - particularly antacid formulations for its buffer action. Used in nutritional drinks and for formulations requiring calcium / phosphorous fortification

Provides fortification without grittiness due to its controlled particle size of less than 10 - 12 µm, especially in soft chews

Grade Description Calcium (%) / Applications Phosphorus (%)

Tri-Tab TCP, anhydrous granular 38.0 / 17.3

Tri-Cal WG TCP, anhydrous granular 37.6 / 17.3

TCP-DC TCP, granular 34.5 - 37.5 / 15.6 - 17.4

Tablet and capsule diluent for direct compression, glidant due to its high surface area and carrier of actives. Ideal for formulations requiring high calcium content

Special high density grade for use in wet granulation. Benefits similar to Tri-Tab

Spray-dried blend for improved compressibility relative to Tri-Tab. Exhibits enhanced taste profile and mouth feel in chewable tablets with the virtual elimination of grittiness and chalkiness

CALCIUM PHOSPHATES Tricalcium Phosphate USP/NF, EP

Inno

phos

64

Asa

hi K

asei

Che

mic

als

Cor

pora

tion

65

Asahi Kasei Chemicals Corporation is a core operating company of Asahi Kasei Group established in Japan in 1931. Process and product innovation have driven the expansion and growth of the company’s operations and they have a specialized line of excipients which include microcrystalline spheres and starch derivatives amongst their other products.

With a keen focus on domestic, global and new businesses, they hold true to their group’s vision of providing new value to society by enabling living in health, comfort and harmony with the natural environment. All their production facilities in Japan are compliant with various international, national and community standards.

By creating new value through unity and synergy and with sincerity towards everyone, Asahi Kasei continuously seeks change and boldly takes on new challenges.

Asah

i Kas

ei

66

CELPHEREMicrocrystalline Cellulose Spheres USP/NF, EP, JPE

Celphere is a 100 percent pure microcrystalline cellulose sphere which is highly spherical and uniform in its particle size distribution, enabling greater accuracy and consistency in drug layering and coating.

This product exhibits high mechanical strength and low friability, allowing it to withstand the rigors of fluidized-bed or wurster coating process. Celphere is insoluble, yet it absorbs water during processing, thereby reducing particle agglomeration even at high spray rates. During dissolution it avoids film deformation or rupturing under stress. It has low chemical reactivity and hence can be freely used to layer high dose, moisture sensitive and potent actives.

Grade Particle Size Range Applications (μm)

Used as a spherical seed core for drug layering, film coating and also for manufacturing sustained-release or taste masked granules

Celphere CP-102 106 - 212





PC-10 Pregelatinized Starch USP/NF, EP, JPE

PC-10 is a partly pregelatinized starch manufactured by controlled thermal gelation of raw corn starch. It is inert, high in water absorption and has pH-independent disintegrating properties. With a far lower soluble content, its particles swell in contact with water rather than dissolve, thereby serving as an excellent disintegrant to effect active ingredient release. PC-10 has high whiteness, good texture and excellent flow properties.

Grade Particle Size Applications (μm)

PC-10 70

Disintegrant and dissolution enhancer, granulation aid, stabilizer for moisture sensitive actives and a carrier for hygroscopic ingredients

Asah

i Kas

ei

SWELSTARPregelatinized Starch USP/NF, EP, JPE

Swelstar is a novel, pregelatinized starch produced by the modification of potato starch. This product is available in different grades which find broad application in the control of drug release, stability and disintegration.

Grade Average Particle Advantages Applications Diameter (μm)

For gel-matrix tablets, achieves pH-independent sustained-release under high ionic strength conditions

Superdisintegrant with high swelling properties. Reduces drug interaction and improves stability

Binder for high-shear granulation and fluidized-bed granulation

Non-ionic, strong gel structure, low reactivity, high swelling ability by rapid hydration, alpha-amylase resistant Excellent stability, non-ionic and low hygroscopic characteristics

Excellent binding and disintegration properties, low reactivity and allows for a fast drug dissolution profile

20 - 40

40 - 60

70 - 90

Swelstar MX-1

Swelstar PD-1

Swelstar WB-1

67

Asah

i Kas

ei

TREHALOSETrehalose is a non-reducing di-saccharide. It has moderate sweetness and displays distinctive characteristics such as low reactivity to basic drugs, high stability to moisture, heat and pH, high compactibility, effective taste masking and faster disintegration than sugar alcohols. It is digestible, has low laxative effect and is similar to sucrose in viscosity, osmotic pressure and water reactivity.


Trehalose P Powder

Trehalose G Crystalline granule

Trehalose SG

High purity, endotoxin-free powder

As a compactible sugar-type filler and a taste masking agent in solid as well as liquid dosage forms

Protein stabilizer and freeze-drying agent for parenteral dosage forms. Also used for ophthalmics

68

CP

Kel

co U

.S.,

Inc.

69

CP Kelco, a Huber company, is an innovation leader in the production of polysaccharides by microbial fermentation, extraction from land and sea plants and modification of cellulose based raw materials. With over 200 years of experience, they are experts in hydrocolloid manufacturing, modification and application. Through the use of nature based chemistry, CP Kelco strives to provide products such as xanthan gum, gellan gum and carboxymethylcellulose sodium with minimal modifications. These hydrocolloids in turn serve multiple functions such as viscosity modification, thickening, suspension stabilization and gelation.

With operations in several diverse global markets and a focus on responsible business practices, environmental stewardship and ethical conduct, the company has reached great heights. Based on their steadfast commitment to core values, CP Kelco is on the path of achieving continual success.

CP

Kelc

o

70

XANTURALXanthan Gum USP/NF, EP, JP

Xantural is an exocellular heteropolysaccharide produced by the process of fermentation. It has a unique polymeric structure where chains tend to associate forming a complex network, gel-like structure. When shear is applied, these hydrogen bonds are disrupted producing a flowable liquid. The process instantly reverses when the shear is removed. Hence, Xantural solutions exhibit extremely high viscosity at rest or under low shear conditions and very low viscosity under high shear conditions, demonstrating high degree of pseudoplastic behaviour.

Xantural gives clear and transparent gels / solutions and displays good stability and viscosity properties over a wide pH and temperature range. This enables it to function across a variety of applications as a suspending agent, stabilizer, viscosity enhancer, gelling and sustained-release agent.

Grade Particle Size Applications (μm)

Fine particle size grade for reconstitutable / oral suspensions, syrups and gels. Also used as a hydrophilic matrix former in sustained-release tablets

Standard grade for oral suspensions and syrups

Agglomerated grade which disperses easily and hydrates effectively under all mixing conditions

Xantural 75 75

Xantural 180 180

Xantural 11K 1100

CP

Kelc

o

71

KELCOGEL CG Gellan Gum USP/NF

Kelcogel CG is a water soluble, exocellular heteropolysaccharide produced by the process of fermentation. This novel gelling agent is extremely effective at low use levels in forming gels with cations, displays thermal stability and reversibility, is compatible with anionic, amphoteric as well as non-ionic surfactants and is stable over a wide pH range. These properties make it a multi-functional product for a variety of applications such as oral, ophthalmic, mucosal and transdermal drug delivery systems.

Ophthalmic solutions with gellan gum, on instillation, form in-situ gels in presence of ions of the lacrimal fluid. This gel may provide controlled or extended-release of actives. The pseudoplastic nature of the gel provides gelled solutions at rest but quickly flows under the shear of blinking, resulting in enhanced patient comfort.


Versatile polymer used as a gelling, texturizing, stabilizing, suspending and film forming agent for liquid, semi-solid and solid dosage forms

Kelcogel CG LA

Low acyl type, forms hard, non-elastic, brittle gels

Kelcogel CG HA

High acyl type, forms soft, very elastic, non-brittle gels

CP

Kelc

o

72

CEKOL Carboxymethylcellulose Sodium USP/NF, EP, JP

CEKOL or sodium CMC, is a water soluble polymer derived from wood and cotton cellulose by introducing carboxymethyl groups on the cellulose backbone. The formed anionic cellulose molecule hydrates and dissolves readily in water. Cekol is one of the most versatile water soluble colloids and has the ability to form viscous solutions in both cold and warm water.

Grade Viscosity Range, mPa.s Applications (% concentration)

Thickener, stabilizer, film former, suspending and gelling agent in liquid and semi-solid dosage forms. High strength tablet binder and matrix former in sustained-release tablet formulations. Also used as a bulk laxative

Cekol 150

Cekol LVD

Cekol 700

Cekol HVD

Cekol 2000

Cekol 4000

Cekol 10000

Cekol 20000

Cekol 30000

Cekol 40000

Cekol 50000

Cekol 100000

150 - 300 (2%)

350 - 700 (2%)

500 - 900 (2%)

1000 - 2000 (2%)

1500 - 2500 (2%)

300 - 700 (1%)

1000 - 1500 (1%)

1500 - 2500 (1%)

2500 - 3500 (1%)

3000 - 4500 (1%)

4500 - 7500 (1%)

7500 - 10000 (1%)

phar

m-a

-sph

eres

(Han

ns G

. Wer

ner G

mbH

+ C

o. K

G)

73

Founded in 1952, Hanns G. Werner is a leading manufacturer of exceptionally high quality neutral pellets (sugar spheres) and globuli sacchari (sugar globules) catering to the world’s pharmaceutical and food industries. Located in Germany, they are globally known for their in-house brand of sugar spheres called ‘pharm-a-spheres’. These products are of high sphericity and strength and find usage as drug-free cores for sustained-release formulations. They are also available in a wide range of particle sizes from 125 - 2000 µm.

Along with ‘pharm-a-spheres’, the company also produces little sugar spheres (globuli sacchari) which are used mainly by homeopathic manufacturers for loading actives in tincture form.

Werner’s long term, focused and consistent innovation in the field of manufacturing sugar spheres has helped them to meet and exceed the customer’s requirements in all aspects of formulating successful products.

TM

TM

74

phar

m-a

-sph

eres

PHARM-A-SPHERESSugar Spheres USP/NF, EP

Pharm-a-spheres are non-pareil seeds / neutral pellets of spherical form, composed of sucrose and corn starch. They are primarily used as inert cores in capsule and tablet formulations, particularly multi-particulate, sustained-release formulations. They form the base upon which a drug is coated, usually followed by a release-modifying polymer coating.

Pharm-a-spheres offer great mechanical strength, low friability and good flowability. Their high sphericity with a narrow particle size distribution allows for precise calculation of drug loading quantity. Pharm-a-spheres’ range covers the whole spectrum of diameters from 125 - 2000 µm. Customized sizes of this product, to meet specific formulation needs, are also possible.

Particle Size Range Particle Size Range Applications (mesh ASTM) (μm)

100 - 120 125 - 150

80 - 100 150 - 180

70 - 80 180 - 212

60 - 70 212 - 250

50 - 60 250 - 300

45 - 50 300 - 355

45 - 60 250 - 355

40 - 60 250 - 425

40 - 50 300 - 425

40 - 45 355 - 425

35 - 50 300 - 500

35 - 45 355 - 500

35 - 40 425 - 500

30 - 35 500 - 600

25 - 30 600 - 710

20 - 25 710 - 850

18 - 20 850 - 1000

16 - 20 850 - 1180

16 - 18 1000 - 1180

14 - 16 1180 - 1400

12 - 16 1180 - 1700

12 - 14 1400 - 1700

10 - 12 1700 - 2000

Used as drug-free cores for multi-particulate, sustained-release formulations

Dea

d Se

a Pe

ricla

se L

td.

Dead Sea Periclase, a division of the ICL Industrial Products, is a world leader in the production of high quality magnesium oxide, magnesium hydroxide and magnesium carbonate range of products. The waters of the Dead Sea, the most concentrated, naturally occurring solutions of dissolved salts in the world, are the brines which serve as raw materials to the company’s products.

Headquartered in Israel, the company has production plants in Israel and France and successfully manages the world’s largest magnesia supply chain. Two different processes for the production of their complimentary range of magnesia products are used. In the Israel plant, production is carried out using the ‘Aman Process’ while in France they follow the ‘Pattinson Process’. As leaders in their field, they have the technical competence to offer solutions in most areas of magnesia utilization and at the same time also welcome discussions with end users in designing ‘tailor made’ magnesia products for specific applications.

Stringent quality conditions ensure that the end products consistently meet purity standards and today, Dead Sea Periclase’s magnesium based products find usage across multiple pharmaceutical applications.

75

Dea

d Se

a Pe

ricla

se

76

MAGNESIUM OXIDE / HYDROXIDE / CARBONATEThis wide range of magnesium oxide, magnesium hydroxide and magnesium carbonate products are derived through a unique production process known as the ‘Aman Process’. These products are low in impurities such as lead and other metals present in magnesia derived from conventional precipitation processes. They also have exceptionally high purity and tightly controlled physical parameters.

Grade Description Typical Bulk Applications Density (g/cc)

PHRA 50 Heavy grade, 0.25 - 0.55 regular type

Magnesium Oxide HA Heavy grade, 0.48

sieved type

Heavy grade,

0.48

Magnesium Oxide HA5 micronized version of MgO HA

Magnesium Oxide HA4 Heavy grade, 0.25 - 0.55

fine particle size

Heavy grade,

0.95

Magnesium Oxide DC directly compressible, granular type

Used in antacid preparations and mineral supplements, as a pH modifier and in the production of magnesium derivatives

Magnesium Oxide USP/NF, EP

Dea

d Se

a Pe

ricla

se

77

Magnesium Hydroxide USP/NF, EP

Grade Tapped Bulk Density Applications (g/cc)

Magnesium Hydroxide HD5 0.40 - 0.60




Spray-dried, directly compressible powders for use in manufacture of antacid preparations and mineral supplements

Dea

d Se

a Pe

ricla

se

Magnesium Carbonate USP/NF, EP

Grade Description Bulk Density Applications (g/cc)

Basic magnesium

BMC carbonate, heavy 0.25 - 0.45

grade, free flowing powder

Granulated basic BMC - GR magnesium carbonate, 0.70 typical heavy grade

Used in antacid preparations and mineral supplements. Also used as a pH modifier, tablet and capsule diluent, adsorbent, anti-caking agent and free flowing agent

78

Scor

a S.

A.

79

Established in 1931, Scora is located in Caffiers, France and is the manufacturer of specialty performance products based on calcium & magnesium. In 1999, Scora was acquired by ICL Industrial Products, Israel and today it is an integral part of the ICL-IP Magnesia Division.

Scora’s expertise comes from a deep insight into the chemistry of calcium and magnesium, its proprietary processes and the use of specialized equipments. A unique process to manufacture synthetic calcium carbonates is used, while their magnesium carbonates and oxides are obtained through the ‘Pattinson Process’, ensuring results of highest purity and exceptional quality. Using advanced available technology and with the presence of expert application technicians in their laboratories, Scora is able to effectively and satisfactorily cater to growing customer needs.

Scor

a

80

SCORALITECalcium Carbonate USP/NF, EP, JP

Scoralite is a highly pure, free flowing, synthetic calcium carbonate manufactured using a unique synthesis and purification process. This results in a cubic crystalline structure which is tasteless contrary to other products that have a strong chalky taste. Another important parameter of Scoralite is its higher density as compared to other natural calcium carbonate types.

Scoralite Standard grade

Scoralite LL 250 Low lead content

(less than 250 ppb)

Scoralite LA Low aluminium content

(less than 2 ppm)

Scoralite LI Low iron content (less than 5 ppm)

Scoralite M Micronized grade



Tablet and capsule diluent. Also used in antacid preparations, osteoporosis treatment, mineral supplements and production of calcium derivatives

SCORALITE DCDirectly Compressible Calcium CarbonateScoralite DC range is a compound of 90 - 95 percent precipitated calcium carbonate granulated with different binders using the continuous fluid bed granulation process. This provides tableting advantages like excellent flowability, reduced dust formation and homogenous particle size distribution. Due to its high bulk density, production of tablets with lower thickness is easily achievable.

All these grades are also available with low lead (less than 250 ppb) or low aluminium (less than 2 ppm) contents.

Scoralite DC 90ST 90% CaCO3 and 10% starch

Scoralite DC 95ST 95% CaCO3 and 5% starch

Scoralite DC 90MD 90% CaCO3 and 10% maltodextrin

Scoralite DC 95MD 95% CaCO3 and 5% maltodextrin

Scoralite DC 85SO 85% CaCO3 and 15% sorbitol

Scoralite DC 97PVP 97% CaCO3 and 3% povidone

Scoralite DC 95AC 95% CaCO3 and 5% acacia gum

Scorablend DC MO 10ST Blend of CaCO3 and MgO (in 2:1 ratio) with 10% starch

Directly compressible diluent for solid oral dosage forms. Also used in antacid preparations, osteoporosis treatment and mineral supplements

Scor

a

81

LIGHT MAGNESIUM OXIDE USP/NF, EP, JPThis free flowing product of low bulk density is produced through a distinctive process known as the ‘Pattinson Process’. Amongst several other applications, this high purity product is also used as a precursor in the manufacture of magnesium hydroxide.

Grade Bulk Density Applications

Light Magnesium Oxide NMT 0.15 g/cc

Alkaline diluent in solid dosage forms, modifies pH, regulates viscosity and serves as a mineral supplement. Also used in antacid preparations

Scor

a

82

LIGHT MAGNESIUM CARBONATE USP/NF, EP, JP This light magnesium carbonate is a free flowing, high purity product manufactured through the ‘Pattinson Process’. It is used as a base to treat dyspepsia, rheumatism and gout as well as in the production of magnesium derivatives and high purity magnesium compounds as an acid acceptor.


Light Magnesium Carbonate

Bulk density: NMT 0.15 g/cc

ScoraMag DC 100 Granulated, directly

compressible powder

ScoraMag DC 90ST

Granulated, directly compressible powder of 90% MgCO3 and 10% starch

Tablet and capsule diluent, used in antacid preparations and laxatives. Also used as an adsorbent, viscosity regulator, anti-caking agent, free flowing agent and in mineral supplements

Ferr

o C

orpo

ratio

n

83

Ferro is a leading global producer of technology based performance materials used for a variety of applications across diversified markets. Established in 1919, the company supplies superior quality alkali stearates to the pharmaceutical industry.

These special grades of metallic stearates (of magnesium, zinc, calcium and aluminium) are specifically manufactured from vegetable derived stearic acid. To match manufacturing and process requirements of clients, Ferro, backed by strong technical capabilities, develops these materials to deliver specific product performance characteristics. The company’s objective is to increase the economic benefits for their customers through the use of advanced technology and service excellence.

84

Ferro

Cor

pora

tion

SYNPRO STEARATESSynpro stearates are a family of metallic stearates (of magnesium, zinc, calcium and aluminium) derived from non-genetically modified vegetable fatty acids. These hydrophobic products are offered in a fine, impalpable, white powder form with consistent particle size.

The validated and special process of manufacturing, guarantees a high degree of batch-to-batch consistency and specific surface area of the produced stearates. This results in a good speed of release during compression and constant performance of the tablets across parameters such as hardness and dissolution.

Synpro Magnesium Stearate VG Magnesium stearate

Lubricant for solid oral

USP/NF, EP, JP

dosage forms Synpro Zinc Stearate VG Zinc stearate

USP/NF, EP

Synpro Calcium Stearate VG Calcium stearate

USP/NF, EP

Synpro Aluminium Stearate VG Aluminium stearate

USP/NF

Viscosity enhancer in

non-aqueous formulations

and also as an emulsion stabilizer


Imer

ys S

.A.

(Luz

enac

)

85

Imerys mines rare minerals and turns them into specialties that improve the products and processes of all its customers. Their recent acquisition of the Luzenac Group, a world leader in talc processing, strongly complements their current range of products, extending and reinforcing Imerys’ position in key markets.

Active in 47 countries with more than 240 commercial and industrial sites, the company maintains high standards in areas such as innovation, technical assistance, product quality, health safety and the environment. Offering the widest talc product range an unsurpassed applications expertise, today Imerys is the only talc producer that can meet and exceed all end user requirements worldwide.

86

Imer

ys (L

uzen

ac)

LUZENAC PHARMATalc USP/NF, EP, JP

Talc or hydrated magnesium silicate, is the softest mineral in the world. This water repellant, inert, impalpable, platy mineral shows an affinity for organic substances. The speciality of Luzenac Pharma is its lamellar structure, extra-fine particle size and super-white colour. During manufacturing, these grades undergo a heat treatment process resulting in bacteriologically controlled products of exceptionally high purity.

Luzenac Pharma is an ideal excipient for use as a glidant, lubricant and diluent in various dosage forms. Imerys’ talc products are purified, bacteria controlled grades and are manufactured according to the IPEC GMP guide for bulk pharmaceutical excipients. They are heat-treated (sterilized) for decontamination before being packaged and form ideal excipients for use as glidants, lubricants and diluents.

Highly effective flow agent, reduces Luzenac Pharma Standard grade 10.0 fluctuations in tablet weight and enhances tablet homogeneity and quality

Anti-tacking agent for tablet coating,

Luzenac Pharma M Micronized grade 4.7 prevents agglomerations in the coater,

eliminates stickiness during drying and reduces coating time

High surface area lubricant for tablet Ultra-micronized presses, reduces friction, prevents Luzenac Pharma UM grade 1.1 binding during compression as well as ejection and guarantees smooth crack- free results

Grade Type Average Applications Diameter (µm)

Kro

nos

Wor

ldw

ide,

Inc

87

Kronos is a leading, global manufacturer of Titanium Dioxide. With several years of experience combined with highly reliable products, technical experience and customer service, the company today, has established a strong market position. Kronos owns mines in different parts of the world and all their facilities use environment friendly processes and integrated management systems compliant with international quality standards.

Kronos mines the titanium ore, refines it to produce pigments using either the sulfate process (with sulfuric acid) or the chloride process (with chlorine) and grinds it into a fine, uniform powder for optimum technical performance. Today, Kronos’ titanium dioxide is the world’s primary pigment for providing whiteness, brightness and opacity. Throughout the years the company has consistently delivered high product quality to all its customers and is in turn, poised on the path of continuous growth.

88

KRONOS 1171Titanium Dioxide USP/NF, EP, JP

KRONOS 1171 is a super-white, untreated, anatase powder manufactured by the sulfate process. Owing to its high refractive index, it has unique light scattering properties that may be exploited in its use as a white pigment and opacifier. Kronos 1171 is of exceptionally high purity, is chemically inert, insoluble in aqueous and organic solvents and yet disperses readily.


Super-white, amorphous, Kronos 1171 extra-fine particle size and bacteriologically controlled

Used as a white pigment and opacifier in film coating mixes for tablets, gelatin capsules and dermatological preparations

Lake

shor

e B

iom

ater

ials

, Inc

.

89

Lakeshore Biomaterials, a product focused leader in the area of drug delivery, provides a broad range of bioabsorbable polymers to pharmaceutical, biotech and medical device companies across the world. Their core focus is the development of extended-release parenteral products that systemically or locally deliver active pharmaceutical ingredients for days to months.

Lakeshore’s product range consists of customized polymers, developed to suit their client’s exact needs and standard grade polymers for commercial products and feasibility studies. The company is a responsive supplier with built-in flexibility in product development, specifications and packaging and just as required in chemistry, Lakeshore Biomaterials aims at forging bonds in working relationships to create substantial results.

90

Lake

shor

e Bi

omat

eria

ls

LAKESHORE BIOMATERIALSBioabsorbable PolymersLakeshore biomaterials are biodegradable polymers such as polylactides (PLA), polyglycolides (PGA), polycaprolactone (PCL) and their combinations, which have the benefit of being reabsorbed / biodegraded naturally by the body after a period of time. These polymers control drug delivery rates by either the molecular diffusion process and / or the biodegradation of the matrix, to provide sustained delivery (typically from weeks to months) for a wide range of compounds from small molecules to proteins. They enable site-specific and systemic delivery of drugs, employing durable and biodegradable polymer technologies.

This range of biodegradable polymers is available in different monomers along with differing monomer ratios (0:100 and 100:0), inherent viscosity (1.0 - 2.0 dL/g), end-group chemistry (acid or ester), molecular weight, solubility, degradation and PEG or mPEG chemistry, allowing for a broad range of polymer properties to suit the customer’s precise needs.

Using this extensive technology base, one can develop extended-release, injectable microparticles for systemic, local and cellular delivery of active pharmaceutical ingredients and vaccines. Examples of actives microencapsulated include small molecules, peptides, proteins (including antibodies) and nucleic acids.

Grade Composition Tg Melting Point Applications (°C) (°C)

100 PGA 100% polyglycolic acid 35 - 40 225 - 230

100 L 100% poly-l-lactide 56 - 60 173 - 178

9010G/L 90% glycolide / 10% l-lactide 35 - 45 180 - 200

100 DL 100% d,l-lactide 50 - 55 Amorphous*

8515 DL/G 85% d,l-lactide / 15% glycolide 50 - 55 Amorphous*




8515 DL/PCL 85% d,l-lactide / 15% 20 - 25 Amorphous* polycaprolactone

8515 L/PCL 85% l-lactide / 15% 20 - 25 Amorphous* polycaprolactone

7525 L/PCL 75% l-lactide / 25% 13 - 20 Amorphous* polycaprolactone

100 PCL 100% polycaprolactone (-60) - (-65) 60

Matrices for drug delivery systems such as microspheres, implants and in-situ gelling

Medical devices such as sutures, pins, anchors, stents and stent coating

Tissue engineering matrices

* Amorphous polymers process temperature range: 140 - 160 °C

Nov

aMat

rix

91

NovaMatrix is one of the world´s leading producers of highly purified and well characterized biopolymers and biomaterials for use in pharmaceutical, biotechnology and biomedical applications. It is a business unit of FMC Healthcare Ventures and is associated with FMC BioPolymer, a leading supplier of microcrystalline cellulose to the food, pharmaceutical and specialty products industries.

The ultra pure range of sodium alginates, chitosan and sodium hyaluronate offered by NovaMatrix are used in the development of novel drug delivery systems, in the formation of biostructures for tissue engineering, wound healing, for implants and advanced biotechnology applications amongst several other specialized uses. The company’s dedication and consistent focus in the sphere of innovation, allows them to meet the challenging application demands of all their customers.

Nov

aMat

rix

92

Pronova UP VLVG

Pronova UP LVG

Pronova UP MVG

Pronova UP VLVM

Pronova UP LVM

Pronova UP MVM

Pronova SLG20

Pronova SLG100

Pronova SLM20

Pronova SLM100

Ultra pure

Sterile

< 20

20 - 200

> 200

< 20

20 - 200

> 200

20 - 99

100 - 300

20 - 99

100 - 300

Guluronate: Min. 60%

Mannuronate: Min. 50%

Guluronate: Min. 60%

Mannuronate: Min. 50%

In the development of novel drug delivery systems in the form of alginate beads for immobilization / encapsulation of living cells or other biomaterials and in the form of alginate foams and gels in areas such as tissue engineering, wound management, anti-adhesion, in-vivo / in-vitro cell support, medical implants and in-situ controlled release applications

Grade Type Apparent Monomer Applications Viscosity Content (mPa.s)

PRONOVAUltra Pure Sodium Alginate USP/NF, EP

The Pronova product range is a family of highly purified, well characterized, biocompatible and biodegradable alginates, developed for use in biomedical and pharmaceutical applications. These products are available in two variants, Pronova UP (ultra pure) and Pronova SL (sterile), both having extremely low levels of endotoxins and proteins.

Alginates are linear copolymers with homopolymeric blocks of (1 >4)-linked beta-D-mannuronate (M) and its C-5 epimer alpha-L-guluronate (G) residues respectively, covalently linked together in different sequences or blocks. Alternating M and G blocks form the most flexible chains which exhibit excellent solubility at lower pH.

The process of sterilizing alginate solutions may often be an obstacle due to polymer degradation during autoclaving or irradiation procedures. On the other hand, sterile filtration of highly viscous solutions may also be difficult. To overcome these problems, Pronova SL grades are introduced which are available in a sterilized and lyophilized form. Sterile aqueous solutions of sodium alginates can now be made by simply adding sterile water or buffers to Pronova SL and shaking the vial to facilitate its dissolution.

Nov

aMat

rix

Grade Type Degree Of Apparent Applications Acetylation Viscosity (%) (mPa.s)

Protasan UP B 80 20

Protasan UP B 80 200


Protasan UP B 90 20



Protasan UP CL 113

Protasan UP CL 213

Protasan UP CL 214

Protasan UP G 113

Protasan UP G 213

Protasan UP G 214

80 - 89

≥ 90

75 - 90

≥ 90

20 - 199

200 - 499

500 - 999

500 - 999

< 20

20 - 200

20 - 200

1000 - 2000

20 - 199 Chitosan

base

Chitosan chloride

In biomedical applications such as wound healing, tissue re-engineering, tissue repair and local delivery of cells, drugs, proteins, genes and other therapeutics. Also used for nasal and mucoadhesive drug delivery systems

75 - 90

> 90

< 20 Chitosan

glutamate 20 - 200

93

20 - 200

PROTASAN Ultra Pure ChitosanThe Protasan product range is a series of ultra pure and well characterized chitosan bases and water soluble chloride and glutamate salts with low levels of endotoxins and proteins. Chitosan is a linear polysaccharide composed of randomly distributed beta-(1 >4)-linked D-glucosamine and N-acetyl-D-glucosamine. It is produced commercially by deacetylation of chitin, the structural element in the exoskeleton of crustaceans, with its viscosity primarily dependent on the average molecular weight of the polymer.

Chitosan is a biocompatible, biodegradable, bioadhesive, cationic, polyamine with a high charged density and readily binds to negatively charged surfaces such as mucosal membranes. It also enhances the transport of polar drugs across epithelial surfaces.

Nov

aMat

rix

SODIUM HYALURONATE PHARMA GRADEUltra Pure Sodium Hyaluronate EP

Sodium hyaluronate pharma grade consists of highly purified and well characterized sodium hyaluronate with controlled endotoxin content (max. 2.5 EU/g). It is a linear copolymer composed of (Beta-1,4)-linked D-glucuronate and (Beta-1,3)-N-acetyl-D-glucosamine. Sodium hyaluronate is a non-sulfated glycosaminoglycan found abundantly in the extracellular matrix of skin, joints, eyes and most tissues and organs of all higher animals. This product forms highly viscous aqueous solutions due to its random coil structure and can trap approx.1000 times its weight in water, resulting in the molecule's unique physiochemical properties as well as distinct biological functions.

An attractive building block for new biocompatible and biointeractive materials in drug delivery, tissue engineering and viscosupplementation

Grade Intrinsic Endotoxin Applications Viscosity Limits (m3/kg) (EU/g)

Sodium Hyaluronate 1.2 - 2.0 ≤ 2.5

Pharma Grade 80

Sodium Hyaluronate 2.1 - 2.8 ≤ 40 Pharma Grade 150

94

Ferr

o Pf

anst

iehl

Lab

orat

orie

s, In

c.

95

Ferro Pfanstiehl Laboratories, based in Waukegan, USA, is a wholly owned subsidiary of Ferro Corporation and specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin injectable formulation ingredients, pharmaceutical intermediates and active pharmaceutical ingredients, in gram to multi-ton commercial quantities.

With over four decades of experience, Ferro Pfanstiehl works closely with its clients in the pharmaceutical and biotechnology sectors and is conscious not only about product purity but also of the environment and their workers’ safety. Their production facilities are designed and equipped to comply with various international regulations and they successfully move new and innovative compounds from the laboratory to the commercial marketplace.

96

Ferro

Pfa

nstie

hl

ULTRA-PURE, LOW-ENDOTOXIN CARBOHYDRATES The properties of high purity and low endotoxin limits are needed when even the lowest level of contaminants, especially endotoxins (cell wall fragments of gram negative bacteria) and other high molecular weight impurities can compromise the final product’s purity, biological activity, shelf-life or patient safety.

This ultra-pure, low-endotoxin carbohydrate range of products from botanical sources is purified through a combination of various techniques including chromatography, de-ionization, ultrafiltration, nanofiltration, activated carbon treatment and dissolution re-crystallization. The key advantages of these products are its lot-to-lot and intra-lot consistency, low reducing sugar content, reduced sugar polymer content and its chemical and microbial purity, making it ideal for parenteral dosage forms and other specialized applications.

S-124-2-MC Sucrose, low endotoxin (<0.6 EU/g), USP/NF, EP, JP, Beet-derived

S-124-1 Sucrose, low endotoxin (<1.5 EU/g),

USP/NF, EP, Cane-derived

G-106-1 D-Galactose, low endotoxin USP/NF, EP, Plant-derived

M-131-2 Maltose, hydrate, low endotoxin USP/NF, EP, Bioburden tested

Grade Product Description Applications

As excipients and carrying agents in parenteral drug formulations, particularly intravenous and intramuscular injectables

For blood protein fractionation products

As nutrients in cell culture or fermentation media

Frei

slan

dCam

pina

Dom

o

97

Domo, an operating company of FrieslandCampina - the world’s largest dairy co-operative, discovers, develops and produces high quality ingredients and semi-finished products such as whey and milk products, hydrolysed proteins, galacto-oligosaccharides, bioactive products and various types of lactose. They cater to the medical nutrition, cell nutrition and sports nutrition industry on a global scale.

Domo is flexible, knowledgeable and result oriented and aims to provide ingredients that add value to end products and enrich peoples lives. The company, through its unique partnership process, focuses on the customer and their performance, markets and business processes. Over the years, Domo has built success through mutual trust with clients and is today sought after in the pharmaceutical world for the valuable partnership it offers.

Frei

sland

Cam

pina

Dom

o

98

PROTEIN HYDROLYSATESCell Culture and FermentationThis range of ultrafiltered protein hydrolysates is obtained due to the hydrolysis of plant proteins by enzymes. They are mainly composed of peptides and may also contain amino acids, carbohydrates and (essential) minerals.

Media formulated with protein hydrolysates typically give higher yields when compared with those using chemically defined media, due to their complex nature and high content of essential micronutrients

These hydrolysates of non-animal origin display excellent growth promotion as well as titer levels and display increased productivity. Additionally, they have reduced endotoxins, are light in colour, have no detectable Mycoplasma and no residual protease activity. This range is also a good source of iron and trace minerals, contains growth promoting factors, provides amino acids and peptides that are readily absorbed by the cells and can be autoclaved.

Grade Type Endotoxin Applications Limits (EU/ml)

Soy protein <5

Soy protein concentrate <10

Pea protein concentrate <10

Wheat gluten protein <16

Cotton seed <10

Proyield Soy SE50MAF-UF

Proyield Soy SE70M-UF

Proyield Pea PCE80B

Proyield Wheat WGE80M-UF

Proyield Cotton CNE50M-UF

For mammalian cell culture, bacterial cell culture, tissue culture media and sensitive cell culture applications where a reduced endotoxin level is required. Also used in fermentation nutrient systems

Frei

sland

Cam

pina

Dom

o

99

PROTEIN HYDROLYSATESInfant NutritionThis specialty range of hydrolysates, based on cow’s milk proteins, is ideal for use in formulae for infants with general, non-specific gastrointestinal problems due to their easy-to-digest property. Protein hydrolysates are also used to manage existing cow’s milk allergy and prevent its development, as well as the causes of and risk factors for developing the allergy. The CMA grades are used in formulae for infants with existing cow’s milk allergy while the HA grades prevent the development of cow’s milk allergy.

Grade Description Advantages

Hyvital Casein Easy-To-Digest Slightly hydrolysed casein Low lactose for use in (clinically) lactose-free products

Hyvital Whey Easy-To-Digest Slightly hydrolysed whey Delivers a source of readily protein concentrate absorbable peptides

Reduced allergenic properties by 106

Extensively hydrolysed times (ELISA), high concentration of

Hyvital Casein CMA casein di and tripeptides, low lactose for use in (clinically) lactose-free products and low in bitterness and off-flavours

Reduced allergenic properties by 105

Hyvital Whey CMA Extensively hydrolysed times (ELISA), high concentration of di whey protein concentrate and tripeptides and low in bitterness and off-flavours

Partially hydrolysed Reduced allergenic properties by 103

Hyvital Whey HA

whey protein concentrate times (ELISA) and low in bitterness and off-flavours

Frei

sland

Cam

pina

Dom

o

100



Pure whey protein concentrate (80%)

Instantized pure whey protein concentrate (80%) containing 1 ppm soy protein

Spray-dried milk protein. Variants include Na, K, Ca and Mg caseinates

Milk protein concentrate (80%)

Milk protein concentrate (80%) with reduced lactose content

Milk protein isolate (85%)

Hiprotal Casein Whey 80 Food

Hiprotal Casein Whey 80 Food Inst.

Caseinate

Refit MPC 80

Refit MPC 80 LR

Refit MPI 85

PROTEIN CONCENTRATESThese products contain a varying range of protein concentrates and are used as a protein base for infant nutrition. They are derived from whey or casein by acid hydrolysis.

A superior source of protein fortification for infant food

Excellent emulsifying properties and has an extremely low lactose content

Emulsifier / stabilizer in liquid nutritional formulae

Grade Description Advantages Applications

BIO ACTIVES

Closer to mother’s milk. Used in many standard and premium instant formulae, follow-on formulae and growing up milks

Vivinal Lactoferrin FD

Colostrum 2570

Vivinal GOS Syrup

Vivinal GOS Powder WPC

Vivinal GOS Powder Maltodextrin

Glycoprotein derived from milk

Colostral whey protein rich in immunoglobulin G (25%)

Galacto-oligosaccharides (GOS) syrup

GOS powder withwhey protein as a carrier

GOS powder withmaltodextrin as a carrier

Anti-bacterial and anti-viral properties, iron building and immune stimulation

Immune stimulation

Pre-biotic, supports growth of beneficial bacteria

101

Eastman, founded in 1920, is a pioneer in the production of the cellulose acetate series of products. Technology, quality, manufacturing excellence and customer service have been the pillars of their success globally. Accountability, empowerment, high performance culture, whatever you may call it, the company holds itself to high standards. Today, their products are extensively used in a variety of pharmaceutical dosage forms.

Eastman is a member of ‘Responsible Care’, a global voluntary initiative developed autonomously by the chemical industry to improve health, safety and environmental performance and has also been named one of the five best corporate citizens amongst chemical companies in the USA, by the ’Corporate Responsibility Officer’ magazine.

East

man

Che

mic

al C

ompa

ny

102

East

man

EASTMAN CELLULOSE ACETATE Cellulose Acetate USP/NF, EP

Cellulose acetate is cellulose in which a portion or all of the hydroxyl groups are acetylated. It is prepared from highly purified cellulose by treatment with acid catalysis and acetic anhydride and occurs as a white, odourless, tasteless, free flowing powder.

Cellulose acetate is used as a semi-permeable coating on tablets, especially on osmotic pump-type tablets and implants allowing for controlled-release of the actives. Cellulose acetate films, in conjunction with other materials, also offer sustained-release without the necessity of drilling a hole in the coating as is typical with osmotic pump systems. Cellulose acetate and other cellulose esters have also been used to form drug loaded micro-particles with controlled-release characteristics.

Grade Acetyl Hydroxyl Viscosity Applications (%) (%) (P)

CA-398-10 39.8 3.5 38.0

CA-320S 32.0 8.7 2.4

Semi-permeable coating for osmotic drug delivery systems. Also used for taste masking and as a directly compressible matrix former in extended-release tablets

C-A-P Pellets or 35.0 24.0 68.0 powder

Grade Types Phthalyl Acetyl Viscosity Applications (%) (%) (cP)

Enteric coating and matrix former in solid dosage forms

EASTMAN C-A-PCellacefate USP/NF

C-A-P or cellulose acetate phthalate is a pH sensitive cellulose derivative designed for enteric coating of solid dosage forms. C-A-P enteric coating material withstands prolonged contact with acidic gastric fluids, but dissolves readily in the mildly acidic to neutral environment of the small intestine. C-A-P is compatible with many plasticizers and also used in combination with other coating agents for drug controlled-release preparations.

Cyt

ec In

dus

trie

s In

c.

103

Cytec is a global, specialty chemicals company focused on developing, manufacturing and selling value-added products. They are a pioneer in the manufacture of Docusate Sodium (DSS), a versatile and highly effective anionic surfactant used across a variety of pharmaceutical applications.

Cytec uses its technology and application development expertise to formulate solutions catering to specific and critical requirements of the pharma industry. They are dedicated towards helping customers achieve business objectives by developing high quality products and improving the performance of manufacturing processes. A similar focus is seen in their commitment towards the health and safety of their employees and the overall natural environment.

Through innovation and operational excellence, Cytec adds and enhances product value and brings success to its employees, customers and shareholders.

DSS 100% DSS Rolls of wax-like

plastic sheets

DSS Granular 85% DSS with White, sodium benzoate crystalline powder

White to yellow, DSS 50% 50% DSS in PEG 400 clear viscous liquid

104

Cyt

ec

DOCUSATE SODIUM USP/NF, EPDocusate sodium (DSS), a dioctyl ester of sodium sulfosuccinate, is a versatile and effective anionic surfactant. This product aids the granulation process, improves tablet disintegration and dissolution, facilitates tablet coating and emulsifies gels and suspensions. DSS has a low order of toxicity coupled with good stability and compatibility with a wide range of actives.

An excellent solubilizing, wetting, dispersing and emulsifying agent in oral dosage forms.

Used in laxatives, stool softeners and enema / pre-operative colon cleansers. Also used as a tableting aid, in liquid or gel suspensions, topicals, iron preparations, effervescent tablets, ear wax removals, transdermal patches, transmucosal systems and sustained-release dosage forms

Grade Composition Description Applications

Tere

os E

xcip

ient

sTereos, one of the world’s leading producers of sugar, is a major player of pharmaceutical sucrose in global markets. With a solid understanding of technology and markets and its long term strategic vision, Tereos over the years has made continuous improvements in product quality, variety and the production process.

Its expertise extends right through the production chain, starting from beet or cane to the finished product. Its sucrose based excipients are available in different galenic forms that enable many pharmaceutical applications for dry as well as liquid formulations. With several modern, large-scale and quality focused manufacturing plants in France, Tereos offers a wide range of dry crystal sugars, liquid sugars and sugar specialities.

105

Tere

os E

xcip

ient

s

COMPRESSUCSucrose (Directly Compressible)Compressuc represents a new generation of sugars for direct compression, produced from an innovative and patented spray-drying process. It is made up of spherical, porous particles with a narrow particle size distribution which give remarkable free-flowing, mixing and compaction properties. Compressuc is anhydrous, fully soluble in water and has a sweet taste thereby masking the aftertaste of actives.

Spray-dried compound of Compressuc MS Compressible sugar sucrose (95 - 98%) with USP/NF maltodextrins / inverted sugar (2 - 5%)

Compressuc PS Sucrose Spray-dried sucrose

USP/NF, EP (100%) without additives

106

Excellent diluent, binder for direct compression of chewable, effervescent and orodispersible tablets. Also used in sachet fillings and dry syrups

Grade Pharmacopeial Composition Applications Name

Tere

os E

xcip

ient

s

107

Used for granulation, coating and sachet fillings

Icing Sugar with Starch

Pure Icing Sugar

ICING SUGARSucrose (Milled)Icing Sugar is obtained by continuous milling of sugar crystals. This high purity sugar range is available in an impalpable, easily compressible and very fine powder form which dissolves quickly in water compared to regular sugars.

Grade Pharmacopeial Composition Applications Name

Confectioner’s sugarUSP/NF, EP

Sucrose USP/NF, EP

Blend of milled sucrose and maize starch as an anti-caking agent

Milled sucrose (100%) without additives

Tere

os E

xcip

ient

s

CASTER SUGAR / CRYSTAL SUGARSucrose (Screened) USP/NF, EP

This range of sucrose is obtained by purification and crystallization of juice extracted from sugar beet followed by its continuous screening. It is an extremely pure, free flowing and dust-free crystalline powder which ensures production of quick dissolution, homogeneous dry mixes.

Grade Particle Size Applications Range (µm)

Caster Sugar 250 200 - 300

Caster Sugar 400 300 - 500

Crystal Sugar N°1 600 500 - 700

Crystal Sugar N°1 800 700 - 1000

Ideal for dry syrups / suspensions, powder sachets, granules and for sugar coatings

108

Roc

kwoo

d Pi

gmen

ts N

A, I

nc.

Rockwood Pigments, a unit of Rockwood Holdings Inc., has a proud history of manufacturing and supplying the world’s finest pigments since 1889. The company is a primary manufacturer and processor of liquid, powder and granulated forms of iron oxide colour pigments and supplies a wide range of natural and synthetic inorganic pigments and automated pigment handling systems. Their manufacturing facilities and quality management systems comply with the highest regulatory requirements.

Beyond the sale of their products, Rockwood is committed to solving its customer’s colour formulation and handling challenges. Their team of experienced chemists and technicians can help troubleshoot and modify existing formulations, develop new products, explore new applications, match colour shades or provide innovative product handling systems.

109

Roc

kwoo

d Pi

gmen

ts

SICOVITFerric OxideThe Sicovit product line comprises of highly pure, insoluble powders of iron oxide pigment which provide good opacity and protection to light sensitive actives. These inorganic compounds consist of any one or a combination of synthetically prepared iron oxides.


Sicovit Red 30 E172 Red pigment USP/NF

Sicovit Yellow 10 E172 Yellow pigment USP/NF

Sicovit Black 80 E172 Black pigment

Sicovit Brown 70 E172 Mixture of red, yellow and black pigments

As colourants and UV absorbers across a variety of dosage forms

110

AMCOLHea

lth&Bea

utySolutions

,Inc

.AMCOL Health & Beauty Solutions, Inc. is a wholly owned subsidiary of AMCOL International Corporation and caters to the fields of pharmaceutical, nutraceutical, cosmetics and personal care.

AMCOL’s micro-particle delivery systems along with their rheological products based on colloidal montmorillonite and saponite or smectite clays, provide solutions to improve the functional performance and aesthetic characteristics of final products. Their manufacturing facility in Los Angeles, USA manufactures a range of rheology modifiers under the brand name ‘Magnabrite’. These products, based on purified bentonite and / or magnesium aluminium silicate, are manufactured through a combination of advanced purification processes, mineral selection and surface modification. They are designed to enhance product stability, viscosity and efficacy. The breadth of AMCOL’s offerings and their dedication to providing rapid technical and new product development assistance significantly enhances their value proposition to pharmaceutical firms.

111

AMC

oL

HBS

MAGNABRITEMagnesium Aluminum Silicate USP/NF

Magnesium Aluminum Silicate products are natural smectite clays that are water washed to optimize purity and performance. Smectite clay, which is also known as bentonite, is valued for its ability to swell in water and to impart useful rheological properties to aqueous compositions. Due to its plate-like structure and colloidal nature, it functions as a unique thixotropic additive for emulsion stabilizing, suspending, binding, gelling, bodying and disintegrating activities.

Magnabrite is the brightest magnesium aluminium silicate and is stable over a wide pH range. Additionally it is non-toxic, non-irritating and rapidly reaches maximum viscosity.

Excellent suspension and emulsification properties, delivers high viscosity with good rheology in low solids formulations Stabilizing and suspending agent in liquid and semi-solid dosage forms, especially useful for acidic preparations. Has low acid demand and high acid compatibility

Excellent emulsification and thickening abilities, used in formulations requiring medium viscosity, high brightness and ease of dispersion

Used as an inert, low-bulk disintegrant. Excellent for large tablets where actives are the major weight and bulk of the tablet. Also used as a suspending and binding agent

Grade MAS Key Viscosity Applications Type Characteristics (cps, 5% solids)

Magnabrite HV Type IC High viscosity 800 - 2200 grade

Magnabrite K Type IIA Acid stable 100 - 300 type

Magnabrite S Type IA Regular 225 - 600 grade

Magnabrite F Type IB Microfine 150 - 450 particle size

MAGNABRITE HSPurified Bentonite USP/NF

Magnabrite HS is an absorbent aluminium phyllosilicate, highly refined, naturally occurring, complex colloidal white smectite clay. Chemically it is colloidal montmorillonite which has been processed to remove grit and non-swellable ores.

The properties of Magnabrite HS are similar to that of the other Magnabrite grades.

Grade Description Viscosity Applications (cps, 5% solids)

Used as a suspending, thickening and binding agent. Easily hydrates in warm or cold water producing high electrolyte stability. Typically used in antacids, oral suspensions, hydrocortisone and analgesic creams

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Magnabrite HS High stability 40 - 200 grade

Spec

ialty

Min

eral

s In

c.

Specialty Minerals, a U.K. based wholly owned subsidiary of Minerals Technologies Inc., is the world’s largest manufacturer of precipitated calcium carbonate and has a history dating back to 150 years of innovation in the manufacture and use of this widely used product.

The company has achieved great success due to their commitment to staying at par with advances in technology. Their research and technology centers are consistently developing new products for the fast growing market. Specialty Minerals’ production facilities are fully compliant with international quality standards. Additionally, precipitated calcium carbonate for pharmaceutical applications is covered by a specific certificate of suitability from the ‘European Directorate for the Quality of Medicines & Healthcare’.

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Spec

ialty

Min

eral

s

STURCAL and CALOPAKE Calcium Carbonate USP/NF, EP, JP

Sturcal and Calopake belong to the family of precipitated calcium carbonates (PCC) produced by the direct carbonation of hydrated lime, known as the ‘milk of lime’ process. These precipitated calcium carbonate grades are microcrystalline, white powders characterized by their high chemical purity, controlled particle shape and narrow particle size distribution. Although a number of different calcite crystal forms are possible, these products consist of agglomerates of scalenohedral calcite crystals.

Sturcal L Heavy grade 0.78 - 0.96

Calopake Extra Light Extra light grade 0.42 - 0.50

Tablet and capsule diluent, pH modulator and used in dentifrice products due to its flow and polishing properties. Also used in antacid preparations, mineral supplements and as a source of calcium

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Grade Type Apparent Density Applications

(g/ml)

Gum

Bas

e C

o.

GumBase Co., founded in 1967 as a privately held subsidiary of the Perfetti van Melle Group, is a world leader in the manufacture of gum base and compressed powder gum for the pharmaceutical, nutraceutical and confectionery industry.

Headquartered in Italy, the company delivers a range of more than 200 different gum base formulations in five different shapes i.e. slabs, sheets, pearls, pellets and drops. A founding member of the International Chewing Gum Association (ICGA), GumBase believes in constant research and innovation and their R&D personnel are trained to deliver the highest level of expertise in the manufacture of quality gum bases.

Based on uncompromising and unconditional integrity coupled with strong focus on customers, employees and the environment, GumBase, in its pursuit of excellence, has successfully overcome many challenges posed by the different industries it caters to.

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Gum

Base

GUM BASEChewing Gum BaseGum base is a non-nutritive, non-digestible, water-insoluble masticatory delivery system designed to carry sweeteners, flavours, minerals, vitamins, active pharmaceutical ingredients and other desired substances in chewing gum. The composition of gum bases differ but generally consist of elastomers, resins, waxes, fats, emulsifiers, fillers and antioxidants in varying proportions.

This new, alternative drug delivery system may contain one or more active substances, which are released on chewing, subsequent to which the gum base should be discarded and not swallowed. GumBase products provide fast onset of action with high bioavailability and pleasant taste. They can be taken anywhere, at any time, without the requirement of water, promoting high patient compliance.


Powder Gum (PG) Directly compressible chewing gum base powder

Specific gum base MedGum Base developed for medicated chewing gums

Chewing gum base in formulations for smoking cessation, weight management, xerostomia (dry mouth relief), stress reduction, motion sickness, pain relief and preventing dental caries amongst others

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Glossary

AC-DI-SOL Croscarmellose Sodium FMC BioPolymer 17

ALUBRA PG 100 Sodium Stearyl Fumarate FMC BioPolymer 17

AQUACOAT ECD-30 Ethylcellulose Aqueous Dispersion FMC BioPolymer 18

A-TAB Dicalcium Phosphate Anhydrous,

Granular Innophos 62

AVICEL CE-15 Microcrystalline Cellulose And

Guar Gum FMC BioPolymer 16

AVICEL DG Microcrystalline Cellulose And Dibasic

Calcium Phosphate FMC BioPolymer 15

AVICEL HFE-102 Microcrystalline Cellulose And Mannitol FMC BioPolymer 15

AVICEL PH Microcrystalline Cellulose FMC BioPolymer 14

AVICEL RC / CL Microcrystalline Cellulose And

Carboxymethylcellulose Sodium FMC BioPolymer 16

CALIPHARM A Dicalcium Phosphate Anhydrous, Powder Innophos 62

CALIPHARM D Dicalcium Phosphate Dihydrate, Powder Innophos 62

CALIPHARM T Tricalcium Phosphate Anhydrous, Powder Innophos 63

CALOPAKE Precipitated Calcium Carbonate,

Extra-Light Specialty Minerals 114

CASEINATE Spray-Dried Milk Protein FreislandCampina Domo 100

CASTER SUGAR /

CRYSTAL SUGAR Screened Sucrose Tereos Excipients 108

CEKOL Carboxymethylcellulose Sodium CP Kelco 72

CELLULOSE ACETATE (C-A) Cellulose Acetate Eastman 102

CELLULOSE ACETATE

PHTHALATE (C-A-P) Cellulose Acetate Phthalate Eastman 102

CELPHERE Microcrystalline Cellulose Spheres Asahi Kasei 66

COLOSTRUM Colostral Whey Protein FreislandCampina Domo 100

COMPRESSUC Directly Compressible Sucrose Tereos Excipients 106

DEXTROSE ANHYDROUS C Dextrose Anhydrous, Crystalline Roquette Frères 27

DEXTROSE

MONOHYDRATE GC Dextrose Monohydrate, Agglomerated Roquette Frères 27

D-GALACTOSE Galactose, Low Endotoxin Ferro Pfanstiehl 96

DI-TAB Dicalcium Phosphate Dihydrate, Granular Innophos 62

DSS Docusate Sodium (100%) Cytec 104

DSS 50% Docusate Sodium (50%) In PEG 400 Cytec 104

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Brand Name Product Description Company Page

Glossary

DSS GRANULAR Docusate Sodium (85%)

With Sodium Benzoate Cytec 104

GELCARIN / VISCARIN /

SEASPEN Carrageenan FMC BioPolymer 20

GLUCIDEX Maltodextrin / Corn Syrup Solids Roquette Frères 30

GLYCOLYS Sodium Starch Glycolate Roquette Frères 29

HIPROTAL Whey Protein Concentrate FreislandCampina Domo 100

HI-SWEET High Fructose Corn Syrup Roquette Frères 32

HPMCP Hypromellose Phthalate Shin-Etsu 57

ICING SUGAR Milled Sucrose Tereos Excipients 107

KELCOGEL CG Gellan Gum CP Kelco 71

KLEPTOSE Betadex Roquette Frères 26

KLEPTOSE HPB Hydroxypropyl Betadex Roquette Frères 27

KOLLICOAT IR Macrogol Poly (Vinyl Alcohol)

Grafted Copolymer BASF 41

KOLLICOAT IR COATING

SYSTEMS Ready-To-Use Coating Systems BASF 41

KOLLICOAT MAE Methacrylic Acid Copolymer BASF 42

KOLLICOAT SMARTSEAL 30 D Methyl Methacrylate And Diethylaminoethyl

Methacrylate Copolymer Dispersion BASF 42

KOLLICOAT SR 30 D Polyvinyl Acetate Dispersion BASF 40

KOLLICREAM CP 15

(CUTINA CP PH) Cetyl Palmitate 15 BASF 50

KOLLICREAM DO

(CETIOL V PH) Decyl Oleate BASF 51

KOLLICREAM IPM

(ISOPROPYL MYRISTATE PH) Isopropyl Myristate BASF 51

KOLLICREAM OA

(HD EUTANOL V PH) Oleyl Alcohol BASF 51

KOLLICREAM ODD

(EUTANOL G PH) Octyldodecanol BASF 52

KOLLIDON Povidone (PVP K) BASF 38

KOLLIDON CL Crospovidone BASF 39

KOLLIDON SR Blend Of Polyvinyl Acetate And Povidone BASF 40

KOLLIDON VA 64 Copovidone BASF 39

KOLLIPHOR (CREMOPHOR) Polyoxyl-Hydrogenated Castor Oil BASF 43

118


Glossary


KOLLIPHOR CS Cetostearyl Alcohol, Emulsifying /

(LANETTE PH) Sodium Cetostearyl Sulfate BASF 44

KOLLIPHOR HS 15

(SOLUTOL HS 15) Polyoxyl-15-Hydroxystearate BASF 44

KOLLIPHOR MCE

(EUMULGIN B PH) Polyoxyl Cetostearyl Ether BASF 45

KOLLIPHOR P / KOLLISOLV P

(LUTROL F / LUTROL L) Poloxamer BASF 45

KOLLIPHOR PS

(POLYSORBATE PH) Polysorbates BASF 46

KOLLIPHOR SLS (TEXAPON) Sodium Lauryl Sulfate BASF 46

KOLLIPHOR TPGS

(SPEZIOL TPGS PHARMA) Vitamin E Polyethylene Glycol Succinate BASF 46

KOLLISOLV G (SPEZIOL G PF) Glycerin / Glycerol BASF 47

KOLLISOLV GTA (SPEZIOL GTA) Triacetin BASF 47

KOLLISOLV MCT

(MYRITOL PH) Medium Chain Triglycerides BASF 48

KOLLISOLV PEG (LUTROL E) Polyethylene Glycol (Macrogol) BASF 48

KOLLISOLV PG Propylene Glycol BASF 47

KOLLIWAX Myristyl / Cetyl / Stearyl /

(SPEZIOL C PHARMA) Cetostearyl Alcohol BASF 49

KOLLIWAX GDB

(SPEZIOL GDB PHARMA) Glyceryl Behenate BASF 49

KOLLIWAX GMS II

(CUTINA GMS VPH) Glyceryl Monostearate 40-55 (Type II) BASF 49

KOLLIWAX HCO

(CUTINA HR PH) Hydrogenated Castor Oil BASF 49

KOLLIWAX S

(SPEZIOL L2SM) Stearic Acid BASF 50

KRONOS 1171 Titanium Dioxide, Super-White,

Anatase Grade Kronos 88

L-HPC Low-Substituted Hydroxypropyl Cellulose Shin-Etsu 59

LIGHT MAGNESIUM

CARBONATE Magnesium Carbonate, Light Grade Scora 82

LIGHT MAGNESIUM OXIDE Magnesium Oxide, Light Grade Scora 81

LUDIFLASH Compound Of Mannitol, Crospovidone

And Polyvinyl Acetate BASF 52

119

Glossary


LUDIPRESS Compound Of Lactose

Monohydrate And Povidone BASF 53

LUSTRECLEAR LC-103 Microcrystalline Cellulose And

Carrageenan Based Coating System FMC BioPolymer 18

LUZENAC PHARMA Talc Imerys (Luzenac) 86

LUZENAC PHARMA M Talc, Micronized Imerys (Luzenac) 86

LUZENAC PHARMA UM Talc, Ultra-Micronized Imerys (Luzenac) 86

LYCADEX PF Dextrose Monohydrate, Pyrogen-Free Roquette Frères 27

LYCASIN Maltitol Solution Roquette Frères 25

LYCATAB C Partially Pregelatinized Starch Roquette Frères 28

LYCATAB DSH Partially Hydrolyzed Starch Roquette Frères 28

LYCATAB PGS Fully Pregelatinized Starch Roquette Frères 28

LYCOAT RS Starch Based Coating System Roquette Frères 29

MAGNABRITE F Magnesium Aluminium Silicate,

Micro-Fine AMCOL HBS 112

MAGNABRITE HS Purified Bentonite, High Stability AMCOL HBS 112

MAGNABRITE HV Magnesium Aluminium Silicate,

High Viscosity AMCOL HBS 112

MAGNABRITE K Magnesium Aluminium Silicate,

Acid Stable AMCOL HBS 112

MAGNABRITE S Magnesium Aluminium Silicate, Regular AMCOL HBS 112

MAGNESIUM CARBONATE Magnesium Carbonate Dead Sea Periclase 78

MAGNESIUM HYDROXIDE Magnesium Hydroxide Dead Sea Periclase 77

MAGNESIUM OXIDE Magnesium Oxide Dead Sea Periclase 76

MAIZE / WHEAT /

POTATO STARCH Native Starch Roquette Frères 28

MALTOSE Maltose, Low Endotoxin Ferro Pfanstiehl 96

MEDGUM BASE Medicated Chewing Gum Base GumBase 116

METOLOSE SH Hypromellose (HPMC), High Viscosity Shin-Etsu 58

METOLOSE SM Methylcellulose Shin-Etsu 58

METOLOSE SR Hypromellose (HPMC), For

Sustained-Release Shin-Etsu 58

NEOSORB Sorbitol Roquette Frères 24

NOVATA Hard Fat BASF 54

NUTRIOSE Soluble Fibre Roquette Frères 32

PC-10 Partly Pregelatinised Starch Asahi Kasei 66

PEARLITOL Mannitol Roquette Frères 22

120

Glossary

121


PEARLITOL FLASH Compound Of Mannitol And Maize Starch Roquette Frères 23

PHARMACOAT Hypromellose (HPMC), Low Viscosity Shin-Etsu 56

PHARM-A-SPHERES Sugar Spheres Pharm-a-spheres 74

PHARMATOSE / Lactose Monohydrate, Sieved, Milled,

LACTOCHEM / HMS LACTOSE Impalpable DFE Pharma 34 / 36

POLY(DL-LACTIDE) Bioabsorbable Polymers Lakeshore Biomaterials 90

POLY(DL-LACTIDE-

CO-GLYCOLIDE) Bioabsorbable Polymers Lakeshore Biomaterials 90

POLYCAPROLACTONE Bioabsorbable Polymers Lakeshore Biomaterials 90

POLYGLYCOLIDE Bioabsorbable Polymers Lakeshore Biomaterials 90

POLYSORB Anhydrized Liquid Sorbitol Roquette Frères 26

POWDER GUM Directly Compressible Chewing Gum Base GumBase 116

PRONOVA Sodium Alginate, Ultra-Pure NovaMatrix 92

PROTACID / KELACID Alginic Acid FMC BioPolymer 19

PROTANAL / MANUGEL /

KELTONE / MANUCOL /

KELCOSOL / KELSET /

KELCOLOID Alginates FMC BioPolymer 19

PROTASAN Chitosan, Ultra-Pure NovaMatrix 93

PROYIELD / HYVITAL Protein Hydrolysate FreislandCampina Domo 98

READILYCOAT Ready-To-Use Starch Based

Coating System Roquette Frères 29

REFIT Milk Protein FreislandCampina Domo 100

SCORABLEND Compound Of Calcium

Carbonate And Magnesium Oxide Scora 80

SCORALITE Calcium Carbonate Scora 80

SCORALITE DC Directly Compressible Calcium Carbonate Scora 80

SCORAMAG DC Directly Compressible Magnesium

Carbonate Scora 82

SHIN-ETSU AQOAT Hypromellose Acetate Succinate Shin-Etsu 60

SICOVIT Ferric (Iron) Oxide Rockwood 110

SODIUM HYALURONATE

PHARMA GRADE Ultra-Pure Sodium Hyaluronate NovaMatrix 94

SOLUPLUS Polyvinyl Caprolactam-Polyvinyl Acetate-

Polyethylene Glycol Graft Copolymer BASF 53

STARLAC Compound Of Maize Starch And

Lactose Monohydrate Roquette Frères 31

STURCAL Precipitated Calcium Carbonate, Heavy Specialty Minerals 114

Glossary

122


SUCROSE Sucrose, Low Endotoxin Ferro Pfanstiehl 96

SUPERTAB AN / Anhydrous, Directly

LACTOPRESS AN Compressible Lactose DFE Pharma 35, 36

SUPERTAB GR / Granulated, Directly

LACTOPRESS GR Compressible Lactose DFE Pharma 35, 36

SUPERTAB SD / Spray-Dried, Directly

LACTOPRESS SD Compressible Lactose DFE Pharma 34, 36

SWEETPEARL Maltitol Roquette Frères 25

SWELSTAR Pregelatinised Starch Asahi Kasei 67

SYNPRO ALUMINIUM

STEARATE VG Aluminium Stearate Ferro Corporation 84

SYNPRO CALCIUM

STEARATE VG Calcium Stearate Ferro Corporation 84

SYNPRO MAGNESIUM

STEARATE VG Magnesium Stearate Ferro Corporation 84

SYNPRO ZINC STEARATE VG Zinc Stearate Ferro Corporation 84

TACKIDEX Dextrin Roquette Frères 31

TCP-DC Tricalcium Phospate, Granular Innophos 63

TREHALOSE Non-Reducing Di-Saccharide Asahi Kasei 68

TRI-CAL WG Tricalcium Phosphate

Anhydrous, Granular Innophos 63

TRI-TAB Tricalcium Phosphate

Anhydrous, Granular Innophos 63

VERSACAL MP Tricalcium Phosphate Anhydrous,

Micronized Powder Innophos 63

VIVINAL GOS Galacto-Oligosaccharide FreislandCampina Domo 100

VIVINAL LACTOFERRIN Lactoferrin FreislandCampina Domo 100

XANTURAL Xanthan Gum CP Kelco 70

XYLISORB Xylitol Roquette Frères 23

Signet Chemical Corporation Pvt. Ltd.

Corporate Office:A-801, Crescenzo C/38-39, G-BlockBandra Kurla ComplexMumbai - 400 051 India

Tel: +91 22 61462725Fax: +91 22 61462726Email: [email protected]

For any comments / suggestions on:‘The Selection Guide to Excipients 3’, please email us at [email protected] or fill in our feedback form available at www.signetchem.com

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