business unit performance materials innovative excipients

Innovative excipients for the pharmaceutical industry

Business Unit

Performance Materials

Think Asia. Think DKSH.

Business LinePharmaceutical IndustryIndia

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Ashland Inc., USA

Products Characteristics Applications

Crospovidone

Polyplasdone XL (Type A) Conventional particle size with 110-140 microns

Used as a disintegrant for IR tablets

Polyplasdone XL-10 (Type B) Fine particle size with 25-40 microns Used as disintegrant for ODT and provides smooth mouth feel

Polyplasdone INF-10 (Type B) Very fine particle size grade Used as suspending agent in oral suspension and also used as disintegrant for pellets and MUPS

Polyplasdone Ultra (Type A) Low peroxide content 30 ppm with conventional particle size of 110-140 microns

Used as a disintegrant for IR tablets containing oxidation sensitive API

Polyplasdone Ultra-10 (Type B)

Low peroxide content 50 ppm with fine particle size of 25-40 microns

Used as a disintegrant for ODT containing oxidation sensitive API

Povidone/PVP

Grade K value viscosity Weight average molecular weight

Applications

Plasdone K-12 10.2-13.8 4,000 Used as binder and vehicle for soft gelatin capsules and for drug solubilization

Plasdone K-17 16.0-17.5 10,000

Plasdone K-25 24.0-26.0 34,000 Used as a binder for wet/dry granulation in tablets, capsules, pellets and powders

Plasdone K-29/32 29.0-32.0 58,000

Plasdone K-90 85.0-95.0 1,300,000

Plasdone C 12 10.2-13.8 4,000 Pyrogen free grade used as solubliser and suspension stabiliser for parenteral products

Plasdone C17 16.0-17.5 10,000

Plasdone C 30 29.0-32.0 58,000

Copovidone

Grade K value viscosity Weight average molecular weight

Applications

Plasdone S-630 25.0-31.0 47,000 • Used as a dry binder aid in granulation and matrix polymer for solid dispersion formulations• It is used to enhance solubility of poorly water soluble drugs through melt extrusion or spray dried solid dispersions

2

Ashland Inc., USA


Hydroxypropyl Cellulose (HPC)

Grade Typical Brookfield Viscosity (mPa.s)

Weight average molecular weight

Applications

Klucel HF, HXF Pharm 1500-3000 1,150,000 Used as a release retardant in CR tablets and thickener for semisolids

Klucel MF, MXF Pharm 4000-6500 850,000 Used as a release retardant in CR tablets and binder for solid oral formulations

Klucel GF, GXF Pharm 150-400 370,000

Klucel JF, JXF Pharm 150-400 140,000

Klucel LF, LXF Pharm 75-150 95,000 • Conventional grades used as binder for wet granulation and fine particle grade is used for dry granulation and direct compression• Used in film coating system• Low molecular weight Klucel used in melt extrusion

Klucel EF, EXF Pharm 300-600 80,000

Klucel ELF Pharm 150-225 40,000

X: Stands for fine particles sizes

Hydroxypropyl Methylcellulose/Hypromellose (2208 substitution/K Type)

Grade Nominal Viscosity (mPa.s)ª


Applications

Benecel K 100 LV PH PRM ** 80-120 164,000 • These grades can be used in single or in combination intragranularly or extrgranularly as hydrophilic release retardant for CR tablets• DC grades are used as direct compressible release retardant agent

Benecel K250 PH PRM ** 200-300 200,000

Benecel K750 PH PRM ** 562-1050 250,000

Benecel K1500 PH PRM ** 1125-2100 300,000

Benecel K4M Pharm * 2700-5040 400,000

Benecel K4M PH DC 2700-5040 400,000

Benecel K15 M Pharm* 13500-25200 575,000

BenecelK15 M PH DC 13500-25200 575,000

Benecel K35M Pharm* 26250-49000 675,000

Benecel K100M Pharm* 75000-140000 1,000,000

Benecel K100M PH DC 75000-140000 1,000,000

Benecel K200M Pharm* 150000-280000 1,200,000

Benecel K100 M XR 75000-140000 1,000,000 Enhanced powder flow and tablet compaction at high speed tableting operations

*CR grades available, ** Only CR grades available, DC: Direct compressible grade, a: NF/EP/JP viscosity method

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Ashland Inc., USA


Methyl Cellulose

Grade Nominal Viscosity (mPa.s)ª Applications

Benecel A15 LV PH PRM 13-18 Used as granulating agent and thickener. Low viscosity Benecel A15-LV is commonly used in drug layeringBenecel A15C Pharm 1312-2450

Benecel A4 M Pharm 2700-5040

a: NF/EP/JP viscosity method

Methylhydroxyethyl Cellulose

Grade Nominal Viscosity (mPa.s)ª Applications

Benecel ME 233 P Pharm 3100-5700 Used as a binder in solid orals and as rheology modifier in liquid orals and topicals


Ready-Mix Coating System

Aesthetic

Aquarius Preferred HSC Cellulose polymers High-solids coatings

Aquarius Preferred HSP Copovidone with cellulosic polymers High-solids coatings for significant improvements in adhesion and sprayable solids

Aquarius Prime Cellulosic polymers (HPMC & HPC), sprayable at 10-15%w/w solids

Good film strength and moderate film adhesion

Aquarius Prime LS HPMC and lactose based film coating systems, sprayable at up to 20%w/w solids

Significant improvement in film adhesion

Functional

Aquarius Preferred MG A label friendly composition consists of natural wax, water based coating systems, sprayable up to 17.5%w/w solids, non tacky perforamce

The coating system reduces moisture uptake (moisture guard)

Aquarius Preferred TG Coating system masks the unpleasant taste of tablet

Aquarius Preferred OG Coating system masks the unpleasant odour of tablet

Aquarius Control ENA Methacrylic acid-ethyl acrylate copolymer Delayed-release (enteric) coatings, stable release profiles over a wide pH range

Aquarius Control SRX Solvent dispersible ethylcellulose coatings potentially modified with HPMC as a pore former

Sustained release coatings with no curing required

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Ashland Inc., USA


Sodium CMC/Carmellose Sodium

Grade Viscosity (mPa.s) Degree of substitution

Applications

Blanose 7H4XF PH 2500-4500 0.7 • Used as a thickener/ viscosity modifier in liquid orals/semi-solids• Also used as a binder and release retardant for CR tablets

Blanose 7HF PH 1500-2500

Blanose 7H3SF PH 1000-2800

Blanose 7HOF PH 1000-2800

Blanose 7M31F PH 1500-3100

Blanose 7M8SF PH 200-800

Blanose 7MF PH 400-600


Blnaose 7LP EP 25-50

Blanose 9H4XF PH 2500-4500 0.9



Blanose 12M31P 1500-3100 1.2

Blanose 12M8P 400-800

Sodium CMC/Carmellose Sodium


Applications

Aqualon 7HF PH 1500-3000 0.7 • Used as a thickener/ viscosity modifier in liquid orals/semi-solids• Also used as a binder and release retardant for CR tablets

Aqualon 7H3SF PH 1000-2800

Aqualon 7HOF PH 1000-2800

Aqualon 7MF PH 400-800

Aqualon 7M8SF PH 400-800

Aqualon 7LF PH 25-50

Aqualon 7L2P 50-200

Aqualon 9M31F PH 1500-3100 0.9

Aqualon 9M8F PH 400-800

Aqualon 12M31P 800-3100 1.2

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Ashland Inc., USA


Sodium CMC For parenteral and ophthalmic application


Applications

Aqualon 7MF PH BET 400-800 0.7 High purity grade of sodium CMC, produced and tested to meet low levels of bioburden and endotoxinAqualon 7LF PH BET 25-50

Aqualon 7L2P BET 50-200

Ethyl Cellulose

Grade Viscosity (mPa.s)ª Weight average molecular weight

Applications

Aqualon EC T10 Pharm 8-11 75,000 Used as binder in direct compression due to its good flow and compactibility

Aqualon EC N7 Pharm 6-8 65,000 Used for coating powder, granules and pellet to control drug release also used in seal coating

Aqualon EC N 10 Pharm 8-11 75,000

Aqualon EC N14 Pharm 12-16 120,000




a: Viscosity measured in 80:20 mixture of toluene/ethanol at 5% solution concentration

Hydroxyethyl Cellulose

Grade Typical Brookfield Viscosity (mPa.s)


Applications

Natrosol 250 HHX/HHW Pharm

3500-5500 1,300,000 • Used as a viscosity modifier in liquid orals and semi-solids• Also used as release retardant in CR tablet

Natrosol 250 HX Pharm, H Pharm

1500-2500 1,000,000

Natrosol 250 M Pharm 4500-6500 720,000

Natrosol 250 G Pharm 250-400 300,000

Natrosol 250 L Pharm 75-150 90,000

X: Fine particle size and W: Superfine particle size

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Ashland Inc., USA


Hypromellose Acetate Succinate/HPMCAS

Grade Nominal Viscosity (mPa.s)ª


Applications

Aquasolve L 2.4-3.6 114,700 Used as an enteric coating agent and as a solubliser for poorly soluble API in spray dried solid dispersions and hot melt extrusionAquasolve M 2.4-3.6 103,200

Aquasolve H 2.4-3.6 75,000


Native Cyclodextrin

Cavamax W6 Pharma a-cyclodextrin with molecular weight 973 • Grade for oral application • Used to enhance solubility of poorly soluble drugs in solid dispersions • Used to mask unpleasant odour/taste of API and its stabilization

Cavamax W7 Pharma b-cyclodextrin with molecular weight 1135

Cavamax W8 Pharma g-cyclodextrin with molecular weight 1297

Hydroxypropyl-b and Hydroxypropyl-g-Cyclodextrins

Cavasol W7 HP Pharma Hydroxypropyl b-cyclodextrin with molecular weight 1410 and typical degree of substitution 4.1-5.1

• Grade for oral application• Used to enhance solubility of poorly soluble drugs in solid dispersions • Used to mask unpleasant odour/taste of API and its stabilizationCavasol W8 HP Pharma Hydroxypropyl g-cyclodextrin with molecular

weight 1574 and typical degree of substitution 3.5-4.9

Cavitron W7 HP5 Pharma Hydroxypropyl b-cyclodextrin with molecular weight 1410 and typical degree of substitution 4.1-5.1

• Grade for Parenteral application• Used to increase solubility of drug in parenterals

Cavitron W7 HP7 Pharma Hydroxypropyl b-cyclodextrin with molecular weight 1520 and typical degree of substitution 6.0-8.0

N-Methyl-2 Pyrrolidone (NMP)

Pharmasolve Viscosity 1.7 Cp, crystal inhibitor Used as a solubility enhancer in parenteral applications and veterinary medicine

Macco, Canada


Organic mineral salts ofCalcium, potassium, ammonium, magnesium, sodium, zinc

Organic mineral salts Pharma, biopharma, infusion and dialysis solutions, chemical specialities

Glycerophosphates, glucohep-tonates, lactates, gluconates, citrates, citric acid

Organic mineral salts Pharma and nutrition

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Grace davison Chemicals, USA


Silicon Dioxide

Syloid G 156 FP Large internal surface area, intra particle porosity with a medium pore volume. Particle size 4.6-5.8 µm, pore volume 1.2 ml/g

Exclusively as a glidant in solid oral dosage forms, highly adsorptive as carrier for liquids

Syloid XDP 3150 Large internal surface area with a high pore volume. Particle size 120-170 µm, Pore

2volume 1.7.ml/g, BET 320 m /g, oil adsorption 300 g/100g

Superior adsorptive capacity as carrier for liquids and liquid pharmaceutical actives

Silsol 6035 Engineered advanced silica technologies generate high pore volume which facilitates voids for entrapment. Avg. particle size 37 µm with bulk density 420 g/l

Formulate a large class of poorly soluble acive ingredients and compounds (solubility enhancer)

Symega Flavours, India


Natural flavor, nature identical flavor, synthetic flavor

Flavor (Liquid Form) Equipped process capacity for generation of customized flavors

Flavoring agent for liquid orals

Spray Dried Flavor (Powder Form)

Flavoring agent for ODT, effervescent powder, granules and tablets

Bitter Taste Masker Unique combinations for bitter taste masking

Functional Flavor Delivery of nutraceutical actives for gut health

Stepan, USA


Sodium Lauryl Sulphate

Stepanol WA 100 Oral grade, Needle like crystals Used as a wetting agent in tablets, liquid orals and semisolids

Stepan Mild SL3-BA

Disodium Laureth Sulfosuccinate

Stepan Mild SL3-BA • Viscosity 200 CPS• pH 6.0

Cleansing agent used in manufacturing of creams and lotions

Stepl CS 270C

Sodium Lawveth Sulfate

Steol CS-270C pH 7.0-9.0 Foaming property, used in manufacturing of skin care formulations

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Solvay, (France and Thailand)


Sodium Carbonate IPH

Sodium Carbonate IPH Particle size less than 500 µm Alkalizing property, used in solid oral and liquid oral formulations

Sodium Bicarbonate

BICAR EXC-0/13 Particle size less than 200 µm Alkalizing property, used in solid oral and liquid oral formulations

BICAR EXC-27/50 Particle size less than 500 µm

Kimica Corporation, Japan


Alginic acid

Kimica Acid SN Complying NF Used as dis-integrants in anti-reflux and effervescent tablets

Kimica Acid SEB Complying EP and BP

Sodium Alginate Ultra low viscosity type

Grade Viscosity at 10% solution (mPa.s) Applications

Kimica Algin ULV-L3 20-50 • Used as gelling agent in anti-reflux suspensions and effervescent tablets• Gastric reflux preventionKimica Algin ULV-L5 30-60

Kimica Algin ULV-1 100-200



Sodium Alginate standard type


Kimica Algin IL-2 20-50 • Used in controlled release formulations• Gastric coating agent

Kimica Algin IL-6 40-80

Kimica Algin I-1 100-200




Kimica Algin I-S 900-1000

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Kimica Corporation, Japan


Sodium Alginate Ultra high viscosity type

Grade Viscosity (mPa.s) Applications

Kimica Algin LZ-2 1000-1500 Used in controlled release formulations

Sodium Alginate high stiffness gelation type


Kimica Algin ULV-1G 100-200 (10%) Used in controlled release formulations

Kimica Algin ULV-5G 300-700 (10%)

Kimica Algin IL-6G 30-60 (1%)

Kimica Algin I-1G 100-200 (1%)

Kimica Algin I-3G 300-400 (1%)

Propylene Glycol Alginate

Standard Type Propylene Glycol


Kimiloid LVC 70-170 Used as a suspending agent, emulsion stabilizer, plasticizer and binder

Kimiloid HVC 200-600

High Esterification Type Propylene Glycol Alginate


Kimiloid AB 13-40 Used as a suspending agent, emulsion stabilizer, plasticizer and binder

Kimiloid LLV 15-35

Kimiloid NLS-K 30-60

Kimiloid LV 60-100

Kimiloid MV 100-150

Kimiloid HV 150-250

Potassium Alginate

Kimica Algin K – Dental impression material

Calcium Alginate

Kimica Algin Ca – Wound dressing

Ammonium Alginate

Kimica Algin NH – Dental impression material

Magnesium Alginate

Kimica Algin Mag – Anti reflux suspensions for infants

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Precheza A.S., Czech Republic


Titanium Dioxide

Pretiox AV 01 PhG Gluten free, Melamine free, Genotoxic free, water soluble substances 0.25-0.50%

Used as an opacifier in capsul shell and Color coating System

Elementis, United Kingdom


Talc/Hydrated Magnesium Silicate

Microtalc Pharma 50 Standard particle size grade 12-50 µm Used as a anti-adherant for tablets

Microtalc Pharma 30 Fine particle size with 8-26 µm

Microtalc Pharma 8 Very fine particle with 2.2-9 µm Used for drug layering in pellets and also used as antitacking agent in film coating system

JMC Corporation, Korea


Sodium Saccharin

Sodium Saccharin, 15% moisture

Use of high purity raw material OTSA (Ortho-Toluene sulfonamide) facilitates for efficient control on generation of impurities

Used as a sweetner in powder, granules, ODT and liquid orals

Sodium Saccharin, 6% moisture

Daicel Corporation, Japan


Co-Processed Excipient

GNF D 211 • Co-processed excipient: D-Mannitol, Microcrystalline Cellulose, Crospovidone, Carboxymethyl Cellulose • Differentiation based on particle size 100 µm and 150 µm

• Co-processed excipient for ODT (direct compression) • Used in troubleshooting of content uniformity issue • Used in low dose API's formulations

GNF D 215

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NOF Corporation, Japan


Polysorbates, PEGs, Phospholipids

Polysorbate 20 Polyoxyethylene sorbitan monolaurate/ Polysorbate 20

Used as a solublizer in parenterals

Polysorbate 80 GS Polyoxyethylene Sorbitan mono-oleate/Polysorbate 80, low oxidation and degradation potential, low incidence of allergy

Used as a solublizer in parenterals

Polysorbate 80 HX2 High purity solubilizer for parenterals

PEGs

Activated PEGs Methoxy-polyethylene glycols (mPEGs), low diol contents, molecular weights ranging from 2kDa to 80kDa, PEG functional derivatives based on chemical conjugation

• Used for targeted drug delivery system• Gene and nucleic acid delivery • pH trigger release dependent drug delivery systems

Phospholipids Lipids

Phospholipids from natural sources

HSPC (Hydrogenated Soyabean Phosphatidylcholine)

• Used in liposomes • Use in lipid based drug delivery systems for onco (anti-cancer) molecules • pH responsive gene delivery and nucleic acid delivery systems • Tumor targeted gene delivery

EPC (Egg Phosphatidylcholine)

HEPC (Hydrogenated Egg Phosphatidylcholine)

Egg Sphingomyelin/Milk Sphingomyelin

Synthetic Phospholipids Different Derivatives of Phosphocholine

Different Derivatives of Phosphatidylglycerol

Different Derivatives of Phosphatidic acid, Sodium Salts

Different Derivatives of Phosphotidylethanolamine

Different Derivatives of Phosphatidylserine

Lipidure • Methacryloyloxyethyl Phosphoryl Choline• Ulta high hydrophilicity• Suppressing adhering proteins, suppressing adhering cells• Decreases the level of lactate dehydrogenase (LDH), Biocompatible material

• Dry eye score improvement • Protective effect against preservatives • Prevention of tear film breakup • Stabilization of tear film • Moisturizing effect

NOF CORPORATION

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Tata Chemicals Ltd, India


Mannitol

Mannitol DC (100 SD) Standard oral grade, spray dried powder, differentiation based on particle size

Used as a diluent in solid orals and also used in sugar free tablets

Mannitol DC (200 SD)

Fresenius Kabi, Germany


Purified Egg Phospholipids

Purified Egg Phospholipids PL 90

Parenteral grade Used as an emulsifier in injectables

Ingredion, USA


Aspartame

Dulcent Aspartame Artificial non-saccharide sweetener Used as a sweetener in powder, granules, ODT and liquid orals

Sucralose

Dulcent Sucralose Calorie free artificial sweetener Used as a sweetener in powder, granules, ODT and liquid orals

Diaonj Technologies, India


Dissolution media

Dissomed Biorelevant dissolution media (fasted and fed state)

Bioequivalence testing in-vivo and in-vitro correlation of formulation

We can source any product/s of your requirement, which may not be listed above

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Our core business

Disclaimer The information in this brochure 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, DKSH 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 or suggestions infringes any patent.

Fully compliant• Regulatory• Customs• FDA and audit complaint warehouses• Dedicated sample facility

Easy to work with• Market insights and intelligence• Warehousing/logistic support• Market development • Technical support/ troubleshooting• Sampling and regulatory documentation

Deliver value• High service level• Provide solution• Global company with local approach• Strong network and relationship in industry

DKSH – ideal partner for Pharmaceutical IndustryWe supply a wide range of innovative, high-performance excipients, interme-diates, solvents, key raw materials, actives for the pharmaceutical and nutraceutical industry. To ensure the long-term success of our business partners, we constantly deliver solutions that give them a compe-titive advantage. We provide, regulatory

support, technical assistance, logistics, warehousing, distribution and periodic market intelligence amongst a range of value added services.

Proven operational efficiencyWe continuously improve the efficiency of our processes. The quality of our services is based on best practices and standards throughout our organization. An efficient

supply chain coupled with synergies across all business units and countries allow us to fulfill the diverse requirements of the business we serve.

SourcingWe source ingredients for pharma and nutra industry from across the world.

Your preferred partner for sourcing• Comprehensive global sourcing

network • Highly dedicated team of sourcing specialists

Our key sourcing offices• China• Europe• India• Japan• Korea

DKSH Group• Leading provider of Market Expansion Services• Total Sales CHF 11.3 billion (2018)• 33,000 employees in 35 markets and 825 business locations• More than 150 years in Asia

Business Unit Performance Materials• We source, develop, market and distribute a wide range of specialty chemicals and ingredients• Focus on industries and applications• Over 1,080 specialized staff in 31 markets• 29 innovation centers• 100 business locations

Business Lines• Pharmaceutical Industry• Food & Beverage Industry• Personal Care Industry• Specialty Chemicals Industry

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Notes

DKSH India Private LimitedFantree Building, Sarla Park, Andheri East, Mumbai 400059, IndiaPhone +91 22 6157 7000, Fax +91 22 2920 0210 www.dksh.in

AhmedabadPhone +91 79 6543 9950

DelhiPhone +91 11 2691 6320/21

KolkataPhone +91 33 4060 5527

MumbaiPhone +91 22 6157 7000

SecunderabadPhone +91 40 6649 1011

[email protected]

Version: Pharmaceuticals; April, 2019

business unit performance materials innovative excipients

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