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AC-DI-SOL ® Croscarmellose Sodium USP/NF, EP, JP Ac-Di-Sol is a crosslinked sodium CMC that facilitates rapid disintegration and drug dissolution in tablets, capsules and other solid dosage forms. It performs dual functionality of water wicking and rapid swelling resulting in it's superior disintegration characteristics. Grade Description Application Ac-Di-Sol SD-711 Cross linked Sodium CMC or Modified Cellulose Gum Highly effective in wet granulation & direct compression products, independent of tablet hardness with low use level and excellent stability. Best known super disintegrant that is effective intra and extra-granularly. ALVEOSUCRE Agglomerated Sucrose USP/NF, EP, JP Alveosucre is obtained by wet granulation of pure icing sugar followed by subsequently drying in a fluidized air bed and then sieved. Grade Description Application Alveosucre fine Highly absorbent, allows for structured Fast dissolution instant sugar for homogenous dry mixes and sachet filling. Alveosucre Designed for dry mixes formulae and

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

Ac-Di-Sol is a crosslinked sodium CMC that facilitates rapid disintegration and drug dissolution in tablets, capsules and other solid dosage forms. It performs dual functionality of water wicking and rapid swelling resulting in it's superior disintegration characteristics.

GradeDescriptionApplication

Ac-Di-Sol SD-711Cross linked Sodium CMC or Modified Cellulose GumHighly effective in wet granulation & direct compression products, independent of tablet hardness with low use level and excellent stability. Best known super disintegrant that is effective intra and extra-granularly.

ALVEOSUCREAgglomerated Sucrose USP/NF, EP, JP

Alveosucre is obtained by wet granulation of pure icing sugar followed by subsequently drying in a fluidized air bed and then sieved.

GradeDescriptionApplication

Alveosucre fineHighly absorbent, allows for structured mixtures with homogenetic distribution of active ingredients while avoiding sedimentation or separation of ingredients. Instant cold dissolutionFast dissolution instant sugar for homogenous dry mixes and sachet filling.

Alveosucre with dextrinDesigned for dry mixes formulae and direct compression. Has high compaction rate.

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

AQOAT is an enteric coating material which was first approved in Japan in 1987. Subsequently the product was approved in Korea, Europe and USA.

Hypromellose acetate succinate is manufactured from highly purified pulp and involves introduction of acetyl and succinoyl groups into the hydroxyl backbone of Hypromellose. Various grades of AQOAT are available which differ in the particle size and chemical substitution levels.

The polymer, Hypromellose acetate succinate, lends itself to use in different coating techniques - aqueous, solvent based, ammonia neutralization and dry / deposition coating. It can also be 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.

GradeDescriptionMean particle sizeApplication

Dissolving pH*Acetyl (%) / Succinoyl (%)

Aqoat AS-LF 5.58 / 155 mMicronized grades or aqueous and dry coating.

Aqoat AS-MF 6.09 / 11

Aqoat AS-HF 6.512 / 7

Aqoat AS-LG 5.58 / 151 mmGranular grades for solvent-based coating.

Aqoat AS-MG 6.09 / 11

Aqoat AS-HG 6.512 / 7

* In Mcllvaine's buffer (citric acidNa2HPO4) and USP Phosphate Buffer (NaOHKH2PO4)

AQUACOAT CPD - 30Cellulose Acetate Phthalate aqueous dispersion USP/NF, EP, JP

Aquacoat CPD is a 30 percent solid polymer aqueous dispersion of cellulose acetate phthalate (CAP) for enteric coating. Enteric coatings allow acid sensitive drugs to pass through the stomach unaffected or to keep stomach upsetting drugs like aspirin from releasing in the stomach. Although CAP polymer is hydrophobic, the Aquacoat CPD process allows the product to be delivered in a totally aqueous pseudo-latex form that is easy to use and clean up, almost similar to that of solvent coating.

GradeDescriptionApplication

Aquacoat CPD-30A water based pseudo-latex system comprising of Cellulose Acetate PhthalateNo ammonia usedEnteric coating of tablets and capsules (hard and soft gelatin). Can also be coated onto beads for filling into hard gelatin capsules.

AQUACOAT ECD - 30Ethylcellulose aqueous dispersion USP/NF, EP, JPAquacoat ECD is a 30 percent solid polymer aqueous dispersion of ethylcellulose for film coating of pharmaceutical dosage forms. It is designed for a variety of coating applications to achieve sustained release, taste-masking and moisture-barrier/sealant coatings. As ethylcellulose is a hydrophobic polymer, various kinds of release patterns can be achieved by use of suitable plasticizers, pore formers, etc.

GradeDescriptionApplication

Aquacoat ECD-30A water based pseudo-latex system comprising of Ethylcellulose, Cetyl alcohol & sodium lauryl sulphate. Allows a wide choice of plasticizer. No ammonia usedSustained release beads for use in capsules / tablets, moisture barrier / sealant coating and for taste masking of powders, granules, tablets and capsules.

CALCIUM PHOSPHATES

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents. It has many positive characteristics as an excipient including good compressibility, excellent stability and white colour. Due to their inherent property of good compatibility, they find use in both direct compression and wet-granulation process. Two particle size grades of calcium phosphate are available. The Milled or Powder grade is typically used in wet granulation process or roller compaction while the Unmilled or Granular grade is used in direct compression process due to its good flow properties.

Granular grades USP/NF, EP, JP

GradeDescriptionApplication

A-TabDibasic calcium phosphate AnhydrousTablet and capsule diluent / filler, used in direct compression. Non-hygroscopic, stable at room temperature adding to better product stability. Source of calcium and phosphorous.

Di-TabDibasic calcium phosphate DihydrateTablet and capsule diluent / filler, used in direct compression. Flow agent, blend densifier, tablet punch polishing agent, time release agent and carrier of actives. Source of calcium and phosphorous.

Tri-TabTribasic calcium Phosphate Anhydrous Tablet and capsule diluent / filler, used in direct compression and as filler binder in vitamin mineral formulations. Also used as a glidant due to high surface area and carrier of actives. Higher calcium and phosphorous content.

Tri-Cal WGTribasic calcium phosphate Anhydrous Special high density grade for use in wet granulation. Benefits similar as Tri-Tab

CALCIUM PHOSPHATES

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents. It has many positive characteristics as an excipient including good compressibility, excellent stability and white colour. Due to their inherent property of good compatibility, they find use in both direct compression and wet-granulation process. Two particle size grades of calcium phosphate are available. The Milled or Powder grade is typically used in wet granulation process or roller compaction while the Unmilled or Granular grade is used in direct compression process due to its good flow properties.

Granular grades USP/NF, EP, JP

GradeDescriptionApplication

A-TabDibasic calcium phosphate AnhydrousTablet and capsule diluent / filler, used in direct compression. Non-hygroscopic, stable at room temperature adding to better product stability. Source of calcium and phosphorous.

Di-TabDibasic calcium phosphate DihydrateTablet and capsule diluent / filler, used in direct compression. Flow agent, blend densifier, tablet punch polishing agent, time release agent and carrier of actives. Source of calcium and phosphorous.

Tri-TabTribasic calcium Phosphate Anhydrous Tablet and capsule diluent / filler, used in direct compression and as filler binder in vitamin mineral formulations. Also used as a glidant due to high surface area and carrier of actives. Higher calcium and phosphorous content.

Tri-Cal WGTribasic calcium phosphate Anhydrous Special high density grade for use in wet granulation. Benefits similar as Tri-Tab.

AVICEL CE - 15Microcrystalline Cellulose and Guar Gum

Avicel CE-15 is a patented combination of Microcrystalline cellulose and Guar gum specially engineered to improve the organoleptic properties of chewable tablets by providing smoother and creamier mouthfeel, less grittiness, minimum chalkiness and reduced tooth packing. It can be used even in direct compression applications and yields softer tablets with reduced friability.

Avicel CE-15 in chewable tablets results in dramatic differences for end users, primarily in the areas of overall sensory experience and perceived taste, when compared to other tablet binders. It helps to improve overall patient compliance by improving the formulation palatability.

GradeDescriptionApplication

Avicel CE-15Free flowing powder, co-processed blendUsed for improved mouthfeel / superior sensory characteristics in chewable tablets.

AVICEL DGSpray dried compound of Microcrystalline Cellulose and Anhydrous Dibasic Calcium Phosphate

Avicel DG is a synergistic combination of 75% of Microcrystalline Cellulose and 25% of Anhydrous Dibasic Calcium Phosphate produced using spray dried, co-processing technology.Avicel DG offers good flow characteristics, a high quality initial compactability, required for the production of robust ribbons, and excellent recompactability, resulting in enhanced tabletting performance and fewer rejected tablets.GradeDescriptionApplication

Avicel DGWhite, odourless uniform particle size powderDry granulation binder for roller compaction process

AVICEL HFE - 102Spray dried compound of Microcrystalline cellulose and Mannitol

Avicel HFE-102 is a novel, proprietary, co-spray dried Microcrystalline cellulose (MCC) and Mannitol excipient for direct compression. The co-processing of MCC and Mannitol creates a synergistic functionality, providing superior benefits compared to the use of individual or dry-blended components.

Avicel HFE-102 is a highly compactible excipient and exhibits improved flow, superior compactibility and better disintegration properties compared to traditional MCC grades. The product also exhibits less sensitivity to lubrication.

GradeDescriptionApplication

Avicel HFE-102Medium particle size powderHigh functionality excipient for direct compression of tablets, chewable tablets, fast dissolving tablets, MUPS technology tablets etc. Helps accelerate tablet development, reduces sensitivity to lubricant thus enabling higher lubricant levels to reduce sticking problems in full-scale production.

Avicel PHMicrocrystalline Cellulose USP/NF, EP, JPAvicel PH is the innovators brand of microcrystalline cellulose. It is a purified, partially depolymerized alpha-cellulose made by acid hydrolysis of speciality wood pulp controlled to a stringent degree of polymerization than required by global pharmacopeia.

The unique properties of Avicel PH makes it an indispensable formulation tool and excipient of choice in direct compression applications on account of its superior compactibility, drug carrying capacity and rapid disintegration. These properties also benefit dry granulation process such as roller compaction or slugging. When used in wet granulation process, Avicel reduces the risk of over-granulation, avoids screen blockage and promotes uniform, rapid drying. Avicel PH is an excellent extrusion-spheronization binder. The inclusion of Avicel PH in capsule formulations improves flow, facilitates plug formation and aids capsule disintegration.

Avicel PH continues to set new standards with enhanced grades designed to boost productivity and meet any formulation challenge.GradeDescriptionApplication

Avicel PH 101Fine particle sizeFor conventional applications, specially in wet granulation and roller compaction.

Avicel PH 102Medium particle sizeFor improved flow in direct compression, dry phase of wet granulation and dry granulation.

Avicel PH 103Low moisture with fine particle sizeWell suited for moisture sensitive actives.

Avicel PH 105Extra fine particle sizeFor use in direct compression of coarse or hardtocompress materials.

Avicel PH 112Very low moisture with medium particle sizeBest for direct compression of moisture sensitive actives with increased flow.

Avicel PH 113Very low moisture with fine particle sizeImproves product stability by extending the shelf life, particularly of moisture sensitive actives.

Avicel PH 200Largest particle sizeFor best flow in direct compression and dry granulation applications while maintaining high levels of compressibility with minimum weight variation and content uniformity issues.

Avicel PH 200 LMVery low moisture with largest particle sizeBest for direct compression of moisture sensitive actives with superior flow rate than PH 112.

Avicel PH 301High bulk density with fine particle sizeFor manufacture of small tablets. reduces powder stratification and tablet weight variation by efficient mixing.

Avicel PH 302High bulk density with medium particle sizeFor manufacture of thin tablets despite high API content. Prevents powder segregation and gives good flow.

AVICEL RC/CLMicrocrystalline Cellulose and Carboxymethylcellulose Sodium USP/NF, BP, JPEAvicel RC/CL are water dispersible, colloidal, spray dried blends of microcrystalline cellulose and carboxymethylcellulose sodium used in pharmaceutical suspensions, emulsions, nasal sprays and creams. Avicel RC / CL products produce highly thixotropic, low viscosity, structured vehicles that yield desirable permanent suspensions without settling or sedimentation. It also eliminates lengthy hydration time while increasing formulation stability.

When used in reconstitutable suspensions, Avicel RC / CL facilitates hydration of the dry mix. Avicel dispersions are stable to heat and freeze/thaw over a wide pH range. Avicel thixotropy reduces the clearance of nasal spray formulations. It is an excellent stabilizer for oil-in-water emulsions, reducing oil droplet movement and coalescence. The wide range of thixotropies, viscosities, gel strengths, and dispersion characteristics of this product line provide unparalleled suspension stability and functional versatility.

GradeDescriptionApplication

Avicel RC-581Bulk dried powder requiring high shear mixing for dispersionConventional suspending agent and dispersion aid.

Avicel RC-591Spray dried powder requiring low shear mixing for dispersionUsed for oral suspensions, nasal sprays, topical sprays, lotions, liquid and semi-solid dosage forms. Provides a structured dispersion vehicle, acts as a protective colloid and facilitates dispersion.

Avicel CL-611Spray dried powder requiring low shear mixing for dispersion. Has more CMC contentRecommended for reconstitutable / dry suspensions. Also for oral suspensions.

BLANOSESodium Carboxymethylcellulose USP/NF, EP, JPBLANOSE, Carboxymethylcellulose Sodium is the sodium salt of carboxymethylcellulose (CMC) which is an anionic, water-soluble polymer derived from cellulose reacted with sodium monochloroacetate. BLANOSE is soluble in cold or hot water, insoluble in organic solvents, compatible with water / alcohol systems & imparts low water and oxygen transmission to coatings. BLANOSE grades find application as thickeners, binders, stabilizers, suspending agents and rheology modifiers. The grades designated P or PH are purified grades which meet pharmaceutical standards. A wide range of substitution types are also available, based on number of carboxymethyl groups present on the cellulose backbone. The low substitution grades (7 types) provide thixotropy whereas the higher substitution grades (9 and 12 types) provide smooth solutions without thixotropy.GradeViscosity in mPas (% w/w)*Application

Blanose 7H4F-PH2500 - 4500 (1%)Tablet coatings - Film former

Mucoadhesives - Absorbency

Syrups & Suspensions - Thickener & suspending agent

Sustained Release - Thickener, diffusion barrier

Bulk Laxative - Inert, high water binding agent

Ointments, Creams & Lotions - Stabilizer, thickener, film former

Blanose 7HF-PH1500 - 2500 (1%)

Blanose 7MF-PH400 - 600 (2%)

Blanose 7M1F-PH50 - 100 (2%)

Blanose 7LF-PH25 - 50 (2%)

Blanose 9M31F-PH1500 - 3100 (2%)

Blanose 9M8F-PH400 - 800 (2%)

Blanose 12M8P200 - 800 (2%)

Blanose 12M31P1500 - 3100 (2%)

*Also avaialbe in finely (X) ground grades.

*Viscosity in milli Pascal per second (mPas or cps) determined on aqueous solutions as per indicated weight %. at 250 C + 0.50 C using a Brookfield SyncroLectric LVF viscometer.DSTypeSubstitution rangeSodium content, %

70,65 to 0,90 **7,0 - 8,9

90,80 to 0,959,2 - 9,3

12 (for USP grades)1,15 to 1,4510,4 - 12,0

12 (for EP grades)1,12 to 1,2110,2 - 10,8

Cellulose Acetate Non-enteric celluose esterCellulose 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. It occurs as a white, odourless, tasteless, free-flowing powders. They are mainly used for sustained release applications and taste masking.

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

CA-320-SWater insoluble powder with viscosity of 170 280 cps in pyridine.Used in controlled-release applications as water permeable membrane in osmotic systems; direct compression matrix component; barrier component in taste masking.

CA-398-10Water insoluble powder of low viscosity solutionUsed for oral sustained release matrix drug delivery and in film coating applications.

CALCIUM PHOSPHATESCalcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents. It has many positive characteristics as an excipient including good compressibility, excellent stability and white colour. Due to their inherent property of good compatibility, they find use in both direct compression and wet-granulation process. Two particle size grades of calcium phosphate are available. The Milled or Powder grade is typically used in wet granulation processes or roller compaction while the Unmilled or Granular grade is used in direct compression processes due to its good flow properties.

Powder grades USP/NF, EP, JP

GradeDescriptionApplication

Calipharm ADibasic calcium phosphate AnhydrousFiller in wet granulation, multivitamin chewable tablets and nutritional drinks.

Calipharm DDibasic calcium phosphate Dihydrate.Filler in wet granulation, vitamin premixes and nutritional drinks.

Calipharm TTribasic calcium phosphate AnhydrousFiller in wet granulation, particularly antacid formulations for its buffer action. Also used in nutritional drinks and calcium / phosphorous fortifications.

STURCAL L & CALOPAKE Extra Light(Precipitated) Calcium Carbonate USP/NF, EP, JP

Precipitated Calcium Carbonate (PCC), alternatively known as purified, refined or synthetic calcium carbonate is produced by direct carbonation of hydrated lime by a simple process called Milk of lime process. The process involves combining lime (CaO) with water to form slaked lime, addition of carbon dioxide and precipitation of calcium carbonate in a very fine, white form. The precipitated calcium carbonate is then washed, purified, dried and packaged.

Specialty Minerals Inc. uses high quality limestone sources for its PCC products, including some from the 150 year old SMI limestone mine in Adams, Massachusetts. Although a number of different calcite crystal forms are possible, Sturcal L & Calopake Extra Light consist of agglomerates of scalenohedral calcite crystals. The two grades differ in particle size and apparent densities and are compliant as per USP/NF, EP & JP.

GradeDescriptionMedian Particle size (m)Application

Sturcal LHeavy grade, apparent density: 0.78 0.9675 Used mainly in antacid tablets and liquids, in dentifrices &therapeutically as calcium supplement in pharmaceuticals & fortified foods.

Calopake Extra LightExtra light grade, apparent density: 0.42 0.5045 Used as abrasive in dentifrice products, for calciumsupplementation in nutritional and pharma products, also as antacid, pH modulator and flocculent.

CASTER SUGARScreened Sucrose USP/NF, EP, JPSieved sucrose or screened sucrose is obtained by purification and crystallization of juice extracted from sugar beet and subsequently screening it continuously. It is a highly pure crystalline powder recommended for applications requiring high quality clear solutions or for coatings.GradeDescriptionApplication

Caster Sugar 250Extremely pure, crystalline powder with low dispersion particle size. Dust free and free flowingIdeal for dry syrups, suspensions, granulation and coating. Facilitates dissolution and ensures homogenous mixture.

Caster Sugar 400Highly pure, fine grain crystalline powder. Dust free and free flowingFacilitates preparation of dry syrups, liquid syrups due to higher dissolution rate than crystal sugar. Also used for coating.

CELLULOSE ACETATE PHTHALATE (C-A-P)Cellacefate USP / NF, EP, JP

C-A-P is a cellulose in which about half the hydroxyl groups are acetylated, and about a quarter are esterified with one of two acid groups being phthalic acid, where the remaining acid group is free. It is a pH-sensitive cellulose derivative designed for enteric coating of pharmaceutical dosage forms like tablets or granules. It can also be used for matrix drug delivery.

C-A-P can withstand prolonged contact with acidic gastric fluids while being able to dissolve readily in the mildly acidic to neutral environment of the small intestine. C-A-P is commonly applied to solid-dosage forms either by coating from organic or aqueous solvent systems or by direct compression. C-A-P is compatible with many plasticizers and the addition of plasticizers improves the water resistance of this coating material thus making the formulations more effective.GradeFormApplication

C-A-P PelletsWhite pelletsUsed as enteric film coating material for solid dosage forms like tablets, pellets and capsules. Also used as a matrix binder.

C-A-P PowderWhite powder

CELPHEREMicrocrystalline Cellulose USP/NF, EP, JP, JPE

Celphere represents 100% pure microcrystalline cellulose (MCC) spheres or seed cores and is a product of cellulose particle research, development and process technology at Asahi Kasei. It is used in manufacturing of granules for sustained / controlled release, taste masked and other special properties.

Celphere enables greater accuracy and consistency in drug layering and coating as it is highly spherical, has narrow particle size distribution and exhibits optimum water absorption. It has low chemical reactivity and hence can be freely used to layer high dose, moisture sensitive & potent actives. Its high mechanical strength and low friability allows it to withstand the rigors of fluidized bed or wurster coating process. It is conveniently available in various particle size grades ranging from 75 to 850 m.

GradeParticle size range (m)Application

Celphere SCP-10075 - 212Used as spherical seed cores for drug layering & film coating. Also used in manufacture of granules / beads with sustained / controlled release, taste masking & other special properties.

Celphere CP-102106 - 212

Celphere CP-203150 - 300

Celphere CP-305300 - 500

Celphere CP-507500 - 710

Celphere CP-708710 - 850

CEOLUS KG / UFMicrocrystalline Cellulose USP/NF, EP, JP

Ceolus KG / UF are super-compactibility Microcrystalline Cellulose (MCC) powder grades. The unparalleled compactibility is attributed to its distinctive rod-form particle configuration. Ceolus KG / UF grades thus enable lowest friability, reduced compression force, low addition rate and reduced tablet size. Even at 5% addition, they are very effective.

Ceolus KG / UF finds use in direct compression, wet granulation, roller compaction as well as for adsorption of oily actives for direct compression. They occupy a unique position among dry binders in its combination of three salient performance characteristics far higher compactibility, together with an optimum balance of powder flowability and tablet disintegration.

GradeParticle size (m)Application

CEOLUS KG 80250Effective in tableting of high dose actives, poorly compressible actives, pressure -sensitive actives, coated granules / pellets and orally disintegrating tablets. It is ideal in formulations based on MUPS (Multiple unit particulate systems) technology.

CEOLUS KG 1000Similar applications like KG grades. However, flow is more superior compared to KG types.

CEOLUS UF 711

COMPRESSUCSpray Dried Sugars USP/NF, EP, JP

Compressuc represents a new generation of sugar for direct compression, produced from an innovative and patented spray drying process. Anhydrous, fully soluble in water with a sweet taste; Compressuc is probably one of the most efficient excipient available on the market for direct compression tabletting.

GradeDescriptionApplication

Compressuc MSDirectly compressible sucrose with maltodextrins / inverted sugar.Excellent diluents, binder for direct compression of chewable, effervescent and orodispersible tablets. Has remarkable free-flow, mixing, compaction properties.Also used in sachet fillings and dry syrups.

Compressuc PSDirectly compressible pure sucrose (without additives)

CREMOPHORNon-ionic solubilizers / Emulsifiers

Cremophor RH 40 is a non-ionic solubilizer and emulsifying agent obtained by reacting 45 moles of ethylene oxide with one mole of hydrogenated castor oil.

Cremophor EL is a non ionic solubiliser and emulsifier made by reacting castor oil with ethylene oxide in a molar ratio of 1:35. Cremophor ELP is a purified grade of Cremophor EL specially developed to give stable formulations of sensitive APIs, especially in injectable form.

The Cremophor A types are prepared by reacting higher saturated fatty alcohols with ethylene oxide, with the degree of ethoxylation being indicated by the numeral in the name.

GradePharmacopoeial NameAppearanceApplication

Cremophor RH 40Polyoxyl-40Hydrogenated Castor OilWhite to yellowish, nearly odourless, tasteless, pasteUsed to solubilize vitamins, hydrophobic actives, and essential oil-in-water or hydroalcoholicmixtures, to improve bioavailability in soliddosage forms and as solubilizer in oral / topical liquid and semi-liquid dosage forms.

Cremophor ELPolyoxyl-35 Castor Oil(Standard grade)Pale yellow oily liquid

Cremophor ELPPolyoxyl-35 Castor Oil(Extra pure grade of EL).White to yellowish paste or cloudy liquidUsed as solubilizer and emulsifier inliquid formulation for oral, topical and parenteral use.

Cremophor A 6Macrogol-6-cetostearyletherWhitish waxy substanceNon-ionic emulsifiers used for production of ointments, creams, gels based on oil-in wateremulsions / water-in-oil emulsions. Also usedfor emulsification of hydrophobic APIs toform very stable oilinwater emulsions.

Cremophor A 25Macrogol-25-cetostearyletherFree flowing, nondusting micro beads

CRYSMEBMethyl Betacyclodextrin

Kleptose Crysmeb is a new generation, low metylated betacyclodextrin which is a purified polydisperse product resulting from the controlled reaction of a methylation agent and native betacyclodextrin. This unique patented product of Roquette has good water solubility, enhanced stability to form inclusion compounds and a good potential for biological tolerance.

GradeDescriptionApplication

CrysmebMethyl Betacyclodextrin with low molar substitutionSuitable for encapsulation of low solubility, volatile or unstable active ingredients. Used for injectables, syrups, solutions and oral suspensions.

GLUCOSEDextrose USP/NF, EP, JPGlucose or Dextrose is the monomer of natural starch polymer. It is white, odourless, sweet, in crystalline or granular powder form and freely soluble in water. This monomer is also the natural physiological sugar in the human body. In its crystalline form this doubly natural sugar has long been used both as a filler for oral dosage forms and as a sweetener. It also helps in improving the stability of API sensitive to oxidation due to its slight reducing properties. Therapeutically it is used as a preferred source of carbohydrate in parenteral nutrition. Roquette has a range of dextrose products wide enough to meet any of manufacturers different requirements.GradeDescriptionApplication

Lycadex PFPyrogen free dextrose monohydrateOsmotic agent in injectables and dialysis solutions, for parenteral nutrition and treatment of hypoglycemia.

Dextrose Anhydrous PFPyrogen free dextrose anhydrous

Dextrose GCAgglomerated dextrose monohydrateDirect compression diluent with excellent compressibility and flowability for use in tablets, sachets and capsule formulations.

RoferoseDextrose MonohydrateDiluent for tablets, capsules and sachets.

Dextrose Anhydrous CCrystalline dextrose anhydrous

RoclysDextrose syrup without extensive hydrolysisFor inhibiting sucrose crystallization as texturizer and bulk sweetener in syrups, lozenges, pastilles and pharmaceutical chewing gums.

FlolysDextrose syrup with extensive hydrolysis

CALCIUM PHOSPHATES

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents. It has many positive characteristics as an excipient including good compressibility, excellent stability and white colour. Due to their inherent property of good compatibility, they find use in both direct compression and wet-granulation process. Two particle size grades of calcium phosphate are available. The Milled or Powder grade is typically used in wet granulation process or roller compaction while the Unmilled or Granular grade is used in direct compression process due to its good flow properties.

Granular grades USP/NF, EP, JP

GradeDescriptionApplication

A-TabDibasic calcium phosphate AnhydrousTablet and capsule diluent / filler, used in direct compression. Non-hygroscopic, stable at room temperature adding to better product stability. Source of calcium and phosphorous.

Di-TabDibasic calcium phosphate DihydrateTablet and capsule diluent / filler, used in direct compression. Flow agent, blend densifier, tablet punch polishing agent, time release agent and carrier of actives. Source of calcium and phosphorous.

Tri-TabTribasic calcium Phosphate Anhydrous Tablet and capsule diluent / filler, used in direct compression and as filler binder in vitamin mineral formulations. Also used as a glidant due to high surface area and carrier of actives. Higher calcium and phosphorous content.

Tri-Cal WGTribasic calcium phosphate Anhydrous Special high density grade for use in wet granulation. Benefits similar as Tri-Tab.

DOCUSATE SODIUM USP/NF, EPDioctyl Ester of Sodium Sulfosuccinate (DSS)Docusate Sodium (DSS) enjoys the reputation of being one of the most versatile and effective anionic surfactants (surface active agents) used by the Industry. It has excellent wetting, solubilizing, dispersing and emulsifying properties allowing it to be used in a multiplicity of applications in pharmaceutical formulations especially in oral dosage forms. Cytecs DSS is of exceptionally high purity and has a valid Drug Master File no. with the USFDA.

DSS is virtually free from adverse reactions, non habit-forming and causes the least possible disturbance of normal body physiology. It is effective alone or in combination with peristaltic stimulants and bulking agents in the treatment of constipation. It is also an effective wetting agent in topically applied medical preparations like creams, lotions and ointments.GradeDescriptionApplication

Docusate Sodium (100 %)Rolls of white wax-like plastic sheetsAids the granulation process, improves tablet disintegration and dissolution, facilitates tablet coating, emulsifies gels & suspensions.

Also used in laxatives and stool softeners, prenatal and geriatric vitamin preparations, colon cleansing aids (used before Xray or surgery) and in ear wax removal formulations.

Docusate Sodium (85%)with Sodium Benzoate (15%)White crystalline powder

Docusate Sodium (50%) in Polyethylene glycol (50 %)White to yellow, clear viscous liquid

DUB DBHGGlyceryl Dibehenate EPGlyceryl Behenate is prepared by the esterification of glycerin by behenic acid without the use of catalysts. It is a mixture of diacylglycerols, mainly dibehenoylglycerol, together with variable quantities of mono and triacylglycerols. It is generally regarded as a relatively non-irritant and non-toxic material.

GradeDescriptionApplication

DUB DBHGFine, micronized powder with a faint odourUsed as lubricant for tablets. Also can be used as lipidic matrix for sustained release.

DUB DBSDibutyl Sebacate USP/NFDibutyl Sebacate is manufactured by the esterification of n-butanol and sebacic acid in the presence of a suitable catalyst, and by the distillation of sebacic acid with n-butanol in the presence of concentrated acid. DUB DBS is stable and is not reactive with water and thus hazardous polymerization does not occur. However it is incompatible with strong oxidizing materials and strong alkalis.

GradeDescriptionApplication

DUB DBSClear, colorless, oily liquid with a bland to slight butyl odour.Used in oral pharmaceutical formulations as a plasticizer for film coatings on tablets, beads and granules, in controlled-release tablets and microcapsule preparations.

DUB MCTMedium Chain Triglycerides USP/NF, EPMedium chain triglycerides are a class of fatty acids obtained by esterification of glycerol with mixtures of caprylic and capric fatty acids which are fractionated from coconut or palm kernel oils. They are specially processed to achieve superior oxidative stability and low colour and then are further refined to remove residual fatty acids resulting in a product with no odour or flavor.

Their chemical composition is of a shorter length than the long-chain fatty acids present in most other fats and oils. They are also different from other fats as they have a slightly lower calorie content and are more rapidly absorbed and metabolized as energy resembling a carbohydrate more than fat. The unique metabolic and functional properties, a consequence of their chemical structure make them versatile ingredients in a number of pharmaceutical and food formulations.GradeDescriptionApplication

DUB MCT 5545Oily liquidEnergy source for patients with fat malabsorption syndrome. Used as plasticizer, tablet lubricant and as a liquid base for parenterals. Also used as low calorie fats in diet preparations and in capsule filling.

DUB MCT 7030

DUB MCT 6535

DUB MICROLUBStearic Acid USP/NF, EPStearin or Stearic acid is a mixture of stearic acid and palmitic acid derived from an edible source. The content of stearic acid is not less than 40% while that of palmitic acid is also not less than 40% and the sum of the two not less than 90%. It occurs as a hard, white or faintly yellowish, somewhat glossy, crystalline solid or as white or yellowish white powder, with a faint odor and taste, suggesting tallow.GradeDescriptionApplication

DUB MICROLUB 70Stearic Acid 70% - Micronised powderUsed as a tablet lubricant. Micronized grade imparts a smooth, shiny surface to film coated tablets. Also used as emulsifying and solubilizing agent in topical formulations like ointments and creams.

DUB MICROLUB 50Stearic Acid 50% - Micronised powder

Also available is STEARIC ACID 95% (in flakes form) and STEARIC ACID 50% (in pellets or powder form)

DUB PPHemi-synthetic Glycerides USP/NF, EPDUB PP are hard fat suppository bases and are a mixture of triglycerides, diglycerides and monodiglycerides which may be obtained either by esterification of natural fatty acids with glycerol or by inter-esterification of natural fats. Each type of hard fat is characterised by its melting point, its saponification value and its hydroxyl value. These suppository bases, DUB PP, are made from vegetable fatty acids. They are presented in non-toxic, neutral pellet form allowing for easier use. Moreover, they do not contain any oxidizing or stabilizing agent.GradeSaponificationValueMelting Point(C)Hydroxyl ValueApplication

DUB PP C 3230 24033 3520 30Multipurpose Suppository Bases

DUB PP CDL 1225 24533.5 35.5 15

DUB PP D 1234 24734 36 10

DUB PP E 1235 24535 36.5 10

DUB PP E 3235 24535 36.520 30

DUB PP F 1235 24536 37.5 10

DUB PP H 1230 24038 40 10

DUB PP M 1223 23342 44 10Specific Suppository Bases

DUB PP KC 3225 24033.5 35.520 30

DUB PP KCD 1235 24533.5 35.5 15

DUB PP KD 3225 24034 3620 30

DUB PP KE 3215 236Ac-Di-Sol SD-71120 30

DUB PP KF 1235 250 35.5 37.5 15

DUB SESucrose Esters USP/NF, EPSucrose esters are natural surfactant materials obtained by the esterification of one or more of the hydroxyl groups of the sucrose molecule with vegetable fatty acids. These compounds are non-ionic and have excellent emulsifying, wetting and dispersing properties. By modifying the esterfication degree of the sucrose, it is possible to obtain a range of different emulsifiers with HLB from 3 to 16.

Sucrose esters are tasteless, odorless and non-toxic. They are non-irritant, mild to the skin and find use in pharmaceuticals, cosmetics and foods.

GradeDescriptionApplication

DUB SE 3SSucrose TristearateLow HLB grades used as tablet / capsule lubricant while high HLB grades are used to make easy dispersible tablets. Also used as a solubilizer, foam enhancer and as an emulsifier - stabilizer in oil-in-water emulsions. Their nonionic nature makes them co-emulsifiers as well.

DUB SE 5SSucrose Distearate

DUB SE 11SSucrose Stearate

DUB SE 15PSucrose Palmitate

DUB SE 16PSucrose Palmitate

AQUALON ETHYL CELLULOSE PHARMEthylcellulose USP/NF, EP, JPAQUALON EC is a non-ionic ethyl ether of cellulose, soluble in a wide range of organic solvents. Typically, ethylcellulose is used as a non-swellable, insoluble component in matrix or coating systems. When water soluble binders cannot be used in dosage processing because of water sensitivity of the active ingredient, ethylcellulose is often chosen.

Ethylcellulose can be used to coat one or more active ingredients of a tablet to prevent them from reacting with other materials or with one another. It can prevent discoloration of easily oxidizable substances such as ascorbic acid, allowing granulations for easily compressed tablets and other dosage forms. Ethylcellulose can be used on its own or in combination with water-soluble polymers to prepare sustained release film coatings that are frequently used for the coating of micro-particles, pellets and tablets.

GradeViscosity in mPas (% w/w)*Application

EC N 7 Pharm6 to 8Microencapsulation - Stabilizes against active interactions, hydrolysis and oxidation.

Tablet coating Film coating for sustained release.

Tablet Binder - Plastic flow, suitable for direct compression, injection molding and melt extrusion.

Taste Masking - improved taste through suppression of bitter taste & strong odours of actives.

EC N 10 Pharm8 to 11

EC N 14 Pharm12 to 16

EC N 22 Pharm18 to 24

EC N 50 Pharm18 to 24

EC N 100 Pharm80 to 105

EC T 10 Pharm8 to 11Directly compressible, micronized grade with high ethoxyl content and low viscosity for optimum compactibility and good powder flow. Eliminates the need for solvents in direct compression controlled release matrices.

* Determined using 5% ethyl cellulose solution (by weight) in 80 parts toluene & 20 parts ethanol

GLUCOSEDextrose USP/NF, EP, JPGlucose or Dextrose is the monomer of natural starch polymer. It is white, odourless, sweet, in crystalline or granular powder form and freely soluble in water. This monomer is also the natural physiological sugar in the human body. In its crystalline form this doubly natural sugar has long been used both as a filler for oral dosage forms and as a sweetener. It also helps in improving the stability of API sensitive to oxidation due to its slight reducing properties. Therapeutically it is used as a preferred source of carbohydrate in parenteral nutrition. Roquette has a range of dextrose products wide enough to meet any of manufacturers different requirements.

GradeDescriptionApplication

Lycadex PFPyrogen free dextrose monohydrateOsmotic agent in injectables and dialysis solutions, for parenteral nutrition and treatment of hypoglycemia.

Dextrose Anhydrous PFPyrogen free dextrose anhydrous

Dextrose GCAgglomerated dextrose monohydrateDirect compression diluent with excellent compressibility and flowability for use in tablets, sachets and capsule formulations.

RoferoseDextrose MonohydrateDiluent for tablets, capsules and sachets.

Dextrose Anhydrous CCrystalline dextrose anhydrous

RoclysDextrose syrup without extensive hydrolysisFor inhibiting sucrose crystallization as texturizer and bulk sweetener in syrups, lozenges, pastilles and pharmaceutical chewing gums.

FlolysDextrose syrup with extensive hydrolysis

Marine Colloids CarrageenanCarrageenan USP/NFCarrageenan is a family of naturally-occurring high molecular weight polysaccharides extracted from red seaweed. The main seaweed types include Eucheuma, Chondrus and Gigartina which yields kappa, iota and lambda carrageenan.

The carrageenan structure is made up of repeating galactose and 3,6 anhydrogalactose units, both sulfated and non-sulfated joined by alternating alpha 1-3 and beta 1-4 glycosidic linkages. The kappa, iota and lambda carrageenans differ in properties mainly due to the number and position of ester sulphate groups on the galactose units. While kappa forms a brittle gel, iota forms an elastic gel and lambda does not form a gel. Based on their properties, they find use as stabilizers, thickeners, suspending agents, gelling agents and flow regulators in pharmaceutical dosage forms.GradeDescriptionApplication

Carrageenan TypeViscosityGel Type

Gelcarin GP-379IotaHigh thixotropicElastic, Medium strengthCreams and suspensions. Is polyol and protein reactive. Promotes freeze thaw.

Gelcarin GP-812KappaLowBrittle, StrongGives stronger gels than GP 911 with higher syneresis.

Gelcarin GP-911KappaLowBrittle, FirmUsed in encapsulation / delivery systems. Is polyol and protein reactive.

Viscarin GP-109LambdaMediumNongellingUsed in creams and lotions. Is polyol and protein reactive.

Viscarin GP-209LambdaHighNongellingUsed in creams and lotions. Is polyol and protein reactive.

SeaSpen PFIotaMediumthixotropicElastic, WeakUsed in suspensions, reconstitutables, topical lotions and creams.

GLUCIDEXGLUCIDEX is a large family of maltodextrins and dried glucose syrups, obtained from starch by hydrolysis, followed by purification and spray drying. Glucidex grades exhibit good stability and range from slightly sweet-to-sweet products. Depending on the grade used, GLUCIDEX products can help adjust and control the properties of viscosity and texture, sweetness, anti-crystallizing power, browning reactions, fermentability and freezing point depression.GLUCIDEX MaltodextrinsMaltodextrin USP/NF, EPMaltodextrins are dried starch hydrolysis products with a dextrose equivalent (D.E.) lower than 20. These are fine white, neutral or slightly sweet tasting powders, soluble in water and with a high standard of organic, mineral and bacteriological purity.GradeDescriptionApplication

Glucidex 2 DMaltodextrin with dextroseequivalent of maximum 5Diluent for tablets, capsules, sachets, carrier for spraydrying, carbohydrate source in infant and enteral foods. Can also be used for DC formulations of vitamins ormineral supplements.

Glucidex 6 DMaltodextrin with dextroseequivalent of 5 to 8

Glucidex 9 DMaltodextrin with dextroseequivalent of 8 to 10

Glucidex 12 DMaltodextrin with dextroseequivalent of 11 to 14

Glucidex 17 DMaltodextrin with dextroseequivalent of 15 to 18

Glucidex 19 DMaltodextrin with dextroseequivalent of 18 to 20

Note: Also available in IT grades with free flow properties and better solubilization due to its particular physical structure.GLUCIDEX Dried glucose syrupsCorn syrup solids USP/NF, EPCorn syrup solids (earlier known as dried glucose syrups) are dried starch hydrolysis products with a Dextrose equivalent (DE) greater than 20. They have greater sweetness as compared to maltodextrins. These are fine white, neutral or slightly sweet tasting powders, soluble in water and with a high standard of organic, mineral and bacteriological purity.GradeDescriptionApplication

Glucidex 21 DDried glucose syrup with dextroseequivalent of 20 to 23Diluent for tablets, capsules, sachets, carrier in spraydrying, carbohydrate source in infant and enteral foods.

Glucidex 33 DDried glucose syrup with dextroseequivalent of 31 to 34

Glucidex 47 DDried glucose syrup with dextroseequivalent of 43 to 47

Note: Also available in IT grades with free flow properties and better solubilization due to its particular physical structure.

GLYCOLYSSodium Starch Glycolate USP/NF, EP, JPESodium Starch Glycolate is the sodium salt of cross-linked carboxymethyl ether of starch. It is a white-to-off-white, odourless, tasteless, free flowing powder which is sparingly soluble in 95% ethanol and practically insoluble in water. GLYCOLYS is potato starch based and has the capacity to swell upto 300 times its original volume in water, a property that attributes to its use as a superdisintegrant.

Roquette has been producing SSG for more than 20 years now and has developed different grades of GLYCOLYS to meet the specific needs of viscosity, moisture, pH or solvent-free properties.

GradeDescriptionApplication

GlycolysStandard grade SSG - Type ASuper disintegrant for solid dosage forms. Used in both wet granulation and directcompression processes.

Glycolys LVLow viscosity grade SSG - Type ADesigned to withstand high shear in wet granulation processes.

Glycolys LMLow moisture grade SSG - Type AFor moisture sensitive actives.

Glycolys Low pHAcid stable grade SSG - Type BDesigned to resist acidic pH and stabilize products containing strongly acidic drugs.

HI-SWEETHigh Fructose Corn Syrup (HFCS)High Fructose Corn Syrups (HFCS) products are sweet, clear, clean-tasting, odorless liquids manufactured by controlled hydrolysis of starch polymers thus resulting in high fructose compositions with valuable bulk sweetening profiles. Roquette offers two grades of HFCS differing in sweetness and viscosity.

GradeDescriptionApplication

Hi-Sweet 55Solid content of minimum 55% fructose on dry basis.Used as a bulk sweetener and viscosity enhancer in medicated syrups and suspensions. Provides high sweetness and clean mouth feel compared to sucrose and invert sugar.

Hi-Sweet 42Solid content of minimum 42% fructose on dry basis.

HPMCPHypromellose Phthalate USP/NF, EP, JPHypromellose Phthalate (Hydroxypropyl Methylcellulose Phthalate) is a phthalic half ester of Hypromellose and the threshold pH value for rapid disintegration of HPMCP can be controlled by varying the phthalyl content.

HPMCP is a solvent based enteric coating agent used to protect drugs from gastric degradation or to protect the gastric mucosa from irritant drugs.

Two types of HPMCP are available based on the pH solubility, HP-50 and HP-55. Additionally, there is a special type viz, HP-55S which has a higher molecular weight and gives films of greater strength and gastric resistance.

GradeDescriptionApplication

Dissolving pH*Viscosity (cst)

HPMCP HP55 5.540Regular grade

HPMCP HP55S170Greater film strength

HPMCP HP50 5.055Soluble at low pH

* In Mcllvaine's buffer solution (citric acidNa2HPO4) and Clark-Lubs buffer solutionICING SUGARMilled Sucrose USP/NF, EP, JPIcing Sugar is obtained by continuous grinding of sugar crystals. The range of icing sugar is particularly adapted to any use requiring a finely milled and high purity sugar.

GradeDescriptionApplication

Icing Sugar PureVery fine powder, impalpable (100% sucrose)Used for granulation, coating and in sachets. Easily compressible and dissolves quickly in water than regular sugar.

Icing Sugar with StarchVery fine powder, impalpable (with maize starch added as an anti-caking agent)

ALGINATES and ALGINIC ACIDS USP/NF, EP, JPAlginates are natural hydrocolloids of vegetable origin that occur as a structural component in marine brown algae, where they give strength and flexibility to the plant. In contrast to most other polysaccharide gels, alginate gels can develop instantaneously in the presence of divalent cations into acid gels at low pH and constant temperature. The gelling gives rise to a three dimensional network which determines the gel strength. Alginates with high content of G-blocks give stronger gels & M-rich alginates give softer and more fragile gels. The molecular weight determines the viscosity of alginate solutions while the ratio of mannuronic acid guluronic acid (M/G) determines the relative strength of the gel.

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

GradeDescriptionApplication

Alginate TypeViscosity (mPas)

Protacid F 120 NMAlginic Acid-Used in antireflux and effervescent tablets. Also as a natural disintegrant in wet and direct compression granulation.

KelacidAlginic Acid-

Alginic Acid DCAlginic Acid,Directly Compressible-

Protanal LFR 5/60Sodium300 700 (10%)AntiReflux Suspensions (Raft formation).

Protanal LF Mg 5/60*Magnesium1000 - 1800 (7.5%)

Manugel LBASodium300-700 (10%)

Manugel LBBSodium8000 (10%)

Protanal LF 240 DSodium70 200 (1%)Controlled release.

Protanal LF 120 MSodium70 150 (1%)

Keltone LVCRSodium35 (1%)

Keltone HVCRSodium400 (1%)

Manucol LKXSodium60-170 (1%)

KelcosolSodium1000-1500 (1%)Gelling.

Manugel LBASodium500 (10%)

Manucol LBSodium4 (1%)Viscosity enhancer.

Kelcoloid SPropylene Glycol25 (1%)

Manucol DHSodium40-90 (5%)Thickener and stabilizer for syrups, emulsions.

Manucol DMFSodium300 (1%)

Kelvis *Sodium760 (1%)

Protanal Ester SD-LBPropylene Glycol700 - 1800 (2%)

Kelcoloid K3B426Propylene Glycol120 (1%)

Kelcoloid HVF *Propylene Glycol400 (1%)

Kelcoloid LVF *Propylene Glycol120 (1%)

Manucol Ester E/RK *Propylene Glycol125 (1%)

Manucol Ester M *Propylene Glycol200 (1%)

Protanal KF 200 *Potassium200 400 (1%)Dental Impression materials.

Protanal TA 250 *Triethanolamine200 400 (1%)

Kelmar *Potassium400 (1%)

Manucol SS / LLSodium200 (1%)Dental Fixtures.

KelsetSodium-Calcium500 1000 (0.5%)Selfgelling polymers for controlled release.

Keltose *Ammonium-CalciumSemi-gel (1%)

Protanal LF 200 MSodium200 400 (1%)Wound Healing.

Protanal LF 10/60Sodium20 - 70 (1%)

Manucol LFSodium25 (1%)

* Non-pharmacopeial gradesKLEPTOSEBetadex USP/NF, EP, JPEThe complexes formed with betacyclodextrin are of monomolecular type leading to the concept of molecular encapsulation. Betacyclodextrins can improve the solubility of poorly soluble compounds and finds use as encapsulating agents, solubility and stability enhancers for tablets, capsules, sachets and oral suspensions. They are also used for taste masking of bitter or unpleasant active ingredients.

GradeDescriptionApplication

Kleptose STDStandard gradeFor inclusion in liquid phase.

Kleptose DCGranular gradeFor direct compression.

Kleptose 10Micronized gradeFor aerosols.

Kleptose 7PCLow moisture gradeFor inclusion in dry phase.

KLEPTOSE HPB / HPHydroxypropyl Betadex (HPBCD) USP/NF, EP, JPEHydroxypropyl Betadex (HPBCD) are purified polydisperse products resulting from controlled reaction of propylene oxide and native betadex under base catalysis. By virtue of its amorphous polydisperse composition, it overcomes the low solubility and inadequate biological tolerance of the native betacyclodextrin. Kleptose HPB is produced in a purpose built, state-of-the-art manufacturing plant following USFDA type GMP quality guidelines for API and is perhaps the only brand supported by toxicology data.

GradeDescriptionApplication

Kleptose HPBHPBCD with medium molar substitution (Endotoxin controlled)Increases water solubility of poorly soluble drugs by encapsulation. Suitable for parenteral solutions, syrups, oral suspensions and dry formulation. Increases bioavailability and improves organoleptic properties of bitter and unpleasant actives.

Kleptose HPHPBCD with high molar substitution (Oral grade)

KLUCELHydroxypropyl Cellulose USP/NF, EP, JPKLUCEL HPC is non-ionic water-soluble cellulose ether, formed by reaction of cellulose with propylene oxide. KLUCEL provides a remarkable set of physical properties for tablet binding, modified release and film coating. It combines organic solvent or aqueous solubility, thermoplasticity and surface activity with aqueous thickening and stabilizing properties.

GradeViscosity in mPas (% w/w)*Application

Klucel LF Pharm75 - 150 (5%)Tablet binding for immediate release - Yields unmatched tablet hardness and friability in wet granulation and direct compression or dry granulation.

Modified release - Provides effective diffusion limiting matrix systems.

Tablet coating - Imparts good flexibility and adhesion to films while providing a good barrier to water and oxygen transmission.

Klucel LXF Pharm (extra fine)

Klucel GF Pharm150 - 400 (2%)

Klucel GXF Pharm (extra fine)

Klucel JF Pharm150 - 400 (5%)

Klucel JXF Pharm (extra fine)

Klucel EF Pharm300 - 600 (10%)

Klucel EXF Pharm (extra fine)

Klucel HF Pharm1500 - 3000 (1%)

Klucel HXF Pharm (extra Fine)

Klucel MF Pharm4000 - 6500 (2%)

Klucel MXF Pharm (extra fine)

*Viscosity in milli Pascal per second (mPas or cps) determined on aqueous solutions as per indicated weight %. at 250 C + 0.50 C using a Brookfield - Syncro-Lectric LVF viscometer.

KOLLICOAT IRPVA-PEG graft copolymerA breakthrough in instant release film coating, Kollicoat IR is an innovative new coating polymer derived from BASFs extensive polymer research. They are basically polyvinyl alcohol-polyethylene glycol graft copolymers slightly modified to render different application values. All the grades are in powder form and give an extremely flexible film without addition of any plasticizer and offer pH independent release. Kollicoat IR grades are white to faintly yellow free-flowing powder that is very rapidly soluble in acidic, neutral and alkaline aqueous media. Such aqueous solutions have low viscosity.

GradeDescriptionApplication

Kollicoat IRGraft copolymer of 75% polyvinyl alcohol units and 25% polyethylene glycol unitsUsed for instant release coating of tablets, pellets and particulate matter, as a pore former in sustained-release coatings, as a binder using a binding solution for wet granulation.

Kollicoat IR WhiteGraft copolymer of 75% polyvinyl alcohol units and 25% polyethylene glycol units with white pigmentsReady-to-use, white colour coating system. Instantaneous dispersion due to a patented manufacturing process.

Kollicoat ProtectCo-processed product of Kollicoat IR and Polyvinyl alcoholReady-to-use moisture barrier system for use in combination with pigments.

KOLLICOAT MAEMethacrylic acid / Ethyl acrylate copolymer USP/NF, EP, JPEKollicoat MAE 30 DP and Kollicoat MAE 100P are anionic polymers based on methacrylic acid and methacrylic acid esters and are used as film-formers for the production of enteric coatings for solid dosage forms. The ratio of carboxyl groups to ester units is about 1:1. The films are insoluble below pH 5 and thus resistant to gastric fluid. By salt formation in the neutral to weakly alkaline medium of intestinal fluid, the films dissolve step-wise at pH values above 5.5.

GradeDescriptionApplication

Kollicoat MAE 30 DPAqueous, milky white, low viscosity dispersion with solid content of 30% and a faint characteristic odourFor enteric film coating of tablets, pellets, capsules, crystals, soft gelatin capsules and other solid dosage forms. . Also used as a moisture barrier, taste odour masking and as a barrier between incompatible actives.

Kollicoat MAE 100 PWhite, partially neutralized, redispersible powder with a faint characteristic odourFor the production of an aqueous dispersion for coating or a solution in organic solvents for enteric coatings on tablets, pellets, capsules, crystals, soft gelatin capsules and other solid dosage forms.

KOLLICOAT SR 30 DPolyvinyl acetate dispersion EPKollicoat SR 30 D is a an aqueous dispersion consisting of 27% polyvinyl acetate stabilized with 2.7% povidone and 0.3% sodum lauryl sulfate. This dispersion is suitable for the manufacture of pH independent sustained release formulations. Very effective control of drug release is achieved by coating pellets, granules and crystals. This dispersion can also be used for taste masking.

GradeDescriptionApplication

Kollicoat SR 30 DLow viscosity, milky white or slightly yellowish dispersion with solid content of 30% and a weak characteristic odourUsed for sustained release coating of pellets, granules, etc; for sustained release matrix tablets; for taste and odour masking and protective coatings of interacting ingredients.

KOLLIDONPovidone USP/NF, EP, JPThe Kollidon range consists of soluble polyvinyl pyrrolidone which is obtained by radical polymerization of N-vinylpyrrolidone in water or isopropanol under cGMP conditions to yield the chain structure constituting polyvinylpyrrolidone (PVP). By virtue of its solubility in water and many organic solvents, its high binding power and ability to form complexes, soluble PVP occupies a special position among the synthetic colloids.

Kollidon is available in different grades on the basis of their K-value and molecular weight. All grades are supplied as almost white, free flowing, tasteless powders with a slight characteristic odour in pharmaceutically pure form.

GradeDescriptionApplication

KvalueMolecular weight (Mw)

Kollidon 12 PF10.2 - 13.8Low (2000-3000)Pyrogen free grade, used as solubilizing, stabilizing agents, dispersants and crystallization inhibitors particularly for injectables; especially antibiotics in solution or lyophylisate form.

Kollidon 17 PF15.3 - 18.0Low (7000-11000)Same as Kollidon 12 PF. Can be additionally used as solubilizer, film former or thickener in ophthalmic preparations.

Kollidon 2522.5 - 27.0Medium (28000 - 34000)Versatile and widely used as binders in tablets, capsules and granules, stabilizers in oral suspensions, film formers, dispersants for pigments, thickeners and bioavailability enhancers

Kollidon 3027.0 - 32.4Medium (44000 - 54000)

Kollidon 90 F81.0 - 96.3High (1000000 - 1500000)Highly effective binder for wet and dry granulation; stabilizer and thickener for oral and topical solutions including ophthalmic preparations.

KOLLIDON CLCrospovidone USP/NF, EP, JPECrospovidone grades are the insoluble grades of Povidone manufactured by a polymerization process that yields crosslinked insoluble polyvinylpyrrolidone in the form of a popcorn polymer. The polymerisation is performed using an aqueous system.

Crospovidones are Super Disintegrants completely insoluble in solvents. In contrast to many other disintegrants they are also non-water soluble. As a consequence, there is no influence on the disintegration of a tablet and the dissolution of the active due to the increased viscosity. The crosspovidones act as disintegrants by absorbing water and subsequently swelling. This gain in volume is responsible for the subsequent disintegration of the tablet. The different Kollidon CL are distinguished by their different particle sizes.

GradeDescriptionApplication

Kollidon CLStandard gradeUsed as a tablet disintegrant and for improving the release of active substances from tablets, capsules and granules.

Kollidon CL-FFine particle size gradeUsed as disintegrant in tablets, especially in formulations for small tablets and in wet granulation (less content uniformity problems).

Kollidon CL-SFSuperfine particle size gradeUsed as disintegrant in fast dispersible tablets for a smooth mouth-feel.

Kollidon CL-MMicronized gradeUsed as a stabilizer for oral and topical suspensions and for improving the release of active substances from tablets, capsules and granules.

KOLLIDON SRBlend of Polyvinyl Acetate and PovidoneKollidon SR is a blend of polyvinyl acetate and povidone for use as a matrix-forming agent in directly compressible sustained release tablets. It consists of 80% polyvinyl acetate and 19% povidone alongwith small quantities of sodium lauryl sulfate and silica as stabilizers.

Polyvinyl acetate is a very plastic material that produces a coherent matrix under low compression forces. When the tablets formulated using Kollidon SR 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 through these pores to give sustained action. Kollidon SR contains no ionic groups and is therefore inert to drug substances. The sustained-release properties are unaffected by ions or salts.

GradeDescriptionApplication

KvalueCharacteristics

Kollidon SR60.0 - 65.0White or slightly yellowish, free-flowing powder, insoluble in water (only povidone part is soluble) and very soluble in NMPUsed in formulation of pH independent sustained release matrix dosage forms tablets, pellets and granules by either direct compression, roller compaction, wet granulation or extrusion.

KOLLIDON VA 64Copovidone USP/NF, EP, JPEKollidon VA 64 grades are excellent dry binders. Basically they are vinylpyrrolidone - vinyl acetate copolymers which are soluble in both water and alcohols. It is white or slightly yellowish powder with a faint characteristic odour and practically no taste. An important property of Kollidon VA 64 is its plasticity which distinguishes it from Povidone (eg. Kollidon). This property often gives granules and mixtures that are less susceptible to capping during tabletting and results in tablets that are less brittle.

GradeDescriptionApplication

KvalueCharacteristics

Kollidon VA 6425.2 - 30.8Copolymer of vinylpyrrolidone and vinyl acetate in a ratio of 6:4 by massDry 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 and in topical sprays.

Kollidon VA 64 FineFine particle size grade for increased tablet hardness resulting in less friability and better mechanical stability.

KRONOS 1171Titanium Dioxide USP/NF, EP, JPKRONOS 1171 Titanium dioxide is an amorphous, fine, superwhite powder produced by the sulphate process. It is a special anatase grade of exceptionally high purity specifically manufactured for the pharmaceutical industry. Due to its high refractive index, Kronos 1171 Titanium Dioxide has unique light scattering properties and thus widely used as a white pigment and opacifier.

Kronos 1171 Titanium Dioxide complies to the latest monographs of USP/NF, EP, JP etc as well as to several purity regulations of the EU and USFDA.GradeDescriptionApplication

Kronos 1171Anatase grade, super white, fine particle size and bacteria controlledUsed as a white pigment and opacifier in film coating mixes for tablets, gelatin capsules, sugar coated tablets, films and dermatological preparations. Can also be admixed with other pigments to lend different colour tones to tablets and coatings.

LACTOCHEMLactose Monohydrate USP/NF, EP, JPLactochem is a white, crystalline powder. It is the alpha-isomer of lactose and in crystalline form it is present as alpha monohydrate lactose. The water of crystallization is tightly bound and shows no chemical activity while bound. Moisture sorption is extremely low even at high relative humidity. Lactochem is available in sieved and milled forms of different particle size distributions, ranging from coarse to very fine material.Milled Lactochem products are all characterized by small particles and high specific surface area, resulting in good binding properties. Therefore these products are especially useful in wet granulation tabletting, pelletization as well as spheronization.

GradeDescriptionApplication

Lactochem PowderMilled LactoseWidely used as fillers in wet granulation processes. Also used for capsule filling and in powder mixtures filled into sachets.

Lactochem Coarse Powder

Lactochem Regular Powder

Lactochem Fine Powder

Lactochem Extra Fine Powder

Lactochem Super Fine Powder

Sieved Lactochem products are all characterized by a low Carrs index, implying good flowability and are therefore ideal for filling of capsules and sachets where excellent flowability is needed. These products are also successfully applied as diluents for direct compression. The finer crystal types are suitable for pelletization as well.

GradeDescriptionApplication

Lactochem CrystalsSieved LactosePrevents segregation in capsule based formulations and sachets. Used as filler - binder in directly compressible formulations.

Lactochem Coarse Crystals

Lactochem Fine Crystals

Lactochem Extra Fine Crystals

LACTOPRESSDirectly Compressible Lactose USP/NF, EP, JPLactopress is a white, free flowing directly compressible Lactose powder. It is available in two forms; spray dried and anhydrous with different particle sizes distributions. The good flowability of these powders in combination with excellent compactibility characteristics make them ideal for direct compression tabletting. These products are also suitable for applications that require only excellent flowability.

Lactopress Anhydrous is characterized by superior dissolution and excellent binding properties. It consists mainly of the beta-isomer of lactose, which contains no water of crystallization and the free moisture content is low. Lactopress anhydrous does not absorb water even at high relative humidity which makes it the best choice for use in direct compression of moisture sensitive actives.GradeDescriptionApplication

Lactopress Anhydrous 250Roller dried DC Lactose, Coarse particle sizeAs low moisture DC binder and filler in tablets and capsules. Improves stability ofmoisture sensitive actives as well as their dissolution due to its high intrinsic solubility.

Lactopress Anhydrous Fine PowderRoller dried DC Lactose, Fine particle size

Lactopress spray-dried is produced by spray-drying a suspension of small crystals of lactose monohydrate. It consists mainly of spherical particles resulting in excellent flowability and binding. Lactopress spray-dried contains up to 15% amorphous lactose, which ensures low friction with the die wall, preventing capping behavior. It is therefore highly effective in modern, high-speed tabletting machines.GradeDescriptionApplication

Lactopress Spray Dried 250DC Lactose, Fine particle sizeAs binder, fillerbinder, and flow aid in direct compression due to its excellent flow and high compressibility. Ensures good content uniformity.

Lactopress Spray Dried 260DC Lactose, Coarse particle size

Lactopress Spray DriedDC Lactose, Coarse particle size

LACTOPRESS GRANULATEDLactose monohydrate, modified USP/NF, EP, JP Lactopress granulated is a highly stable excipient having excellent flow, low density, low hygroscopicity and good compaction properties. It has low lubricant sensitivity and offers short disintegration time on use in formulations. The short disintegration time together with the sweet taste, makes it and ideal excipient for use in orodispersible tablets.GradeDescriptionApplication

Lactochem GranulatedGranulated Lactose monohydrate Direct compression formulations Orodispersible tablets Low dose applications Capsules and sachets filling

Directly Compressible Lactose USP/NF, EP, JPLactopress is a white, free flowing directly compressible Lactose powder. It is available in two forms; spray dried and anhydrous with different particle sizes distributions. The good flowability of these powders in combination with excellent compactibility characteristics make them ideal for direct compression tabletting. These products are also suitable for applications that require only excellent flowability.

Lactopress Anhydrous is characterized by superior dissolution and excellent binding properties. It consists mainly of the beta-isomer of lactose, which contains no water of crystallization and the free moisture content is low. Lactopress anhydrous does not absorb water even at high relative humidity which makes it the best choice for use in direct compression of moisture sensitive actives.GradeDescriptionApplication

Lactopress Anhydrous 250Roller dried DC Lactose, Coarse particle sizeAs low moisture DC binder and filler in tablets and capsules. Improves stability ofmoisture sensitive actives as well as their dissolution due to its high intrinsic solubility.

Lactopress Anhydrous Fine PowderRoller dried DC Lactose, Fine particle size

Lactopress spray-dried is produced by spray-drying a suspension of small crystals of lactose monohydrate. It consists mainly of spherical particles resulting in excellent flowability and binding. Lactopress spray-dried contains up to 15% amorphous lactose, which ensures low friction with the die wall, preventing capping behavior. It is therefore highly effective in modern, high-speed tabletting machines.GradeDescriptionApplication

Lactopress Spray Dried 250DC Lactose, Fine particle sizeAs binder, fillerbinder, and flow aid in direct compression due to its excellent flow and high compressibility. Ensures good content uniformity.

Lactopress Spray Dried 260DC Lactose, Coarse particle size

Lactopress Spray DriedDC Lactose, Coarse particle size

LACTOPRESS GRANULATEDLactose monohydrate, modified USP/NF, EP, JP Lactopress granulated is a highly stable excipient having excellent flow, low density, low hygroscopicity and good compaction properties. It has low lubricant sensitivity and offers short disintegration time on use in formulations. The short disintegration time together with the sweet taste, makes it and ideal excipient for use in orodispersible tablets.GradeDescriptionApplication

Lactochem GranulatedGranulated Lactose monohydrate Direct compression formulations Orodispersible tablets Low dose applications Capsules and sachets filling

LACTOPRESSDirectly Compressible Lactose USP/NF, EP, JPLactopress is a white, free flowing directly compressible Lactose powder. It is available in two forms; spray dried and anhydrous with different particle sizes distributions. The good flowability of these powders in combination with excellent compactibility characteristics make them ideal for direct compression tabletting. These products are also suitable for applications that require only excellent flowability.

Lactopress Anhydrous is characterized by superior dissolution and excellent binding properties. It consists mainly of the beta-isomer of lactose, which contains no water of crystallization and the free moisture content is low. Lactopress anhydrous does not absorb water even at high relative humidity which makes it the best choice for use in direct compression of moisture sensitive actives.GradeDescriptionApplication

Lactopress Anhydrous 250Roller dried DC Lactose, Coarse particle sizeAs low moisture DC binder and filler in tablets and capsules. Improves stability ofmoisture sensitive actives as well as their dissolution due to its high intrinsic solubility.

Lactopress Anhydrous Fine PowderRoller dried DC Lactose, Fine particle size

Lactopress spray-dried is produced by spray-drying a suspension of small crystals of lactose monohydrate. It consists mainly of spherical particles resulting in excellent flowability and binding. Lactopress spray-dried contains up to 15% amorphous lactose, which ensures low friction with the die wall, preventing capping behavior. It is therefore highly effective in modern, high-speed tabletting machines.

GradeDescriptionApplication

Lactopress Spray Dried 250DC Lactose, Fine particle sizeAs binder, fillerbinder, and flow aid in direct compression due to its excellent flow and high compressibility. Ensures good content uniformity.

Lactopress Spray Dried 260DC Lactose, Coarse particle size

Lactopress Spray DriedDC Lactose, Coarse particle size

L-HPCLow substituted Hydroxypropyl Cellulose USP/NF, JPL-HPC is a low-substituted hydroxypropyl ether of cellulose. It is non-ionic and less reactive to active ingredients. It is insoluble in water and alcohols but swells in water. It causes changes in the binding and disintegrating characteristics as a result of subtle changes in its physical properties like particle size and substituent content. Hence, it is widely used as a dual-functional excipient (disintegrant / binder) for tablets, granules or other pharmaceutical solid dosage forms.GradeDescriptionApplication

Mean particle size (m)Particle type

LHPC LH-1150 Highly fibrousDirect Compression (anticapping).

LHPC LH-2140Moderately fibrousRegular grade (dry mixing, wet granulation).

LHPC LH-2240Moderately fibrousLower hydroxypropoxy content (sometimes betterdisintegration).

LHPC LH-3120MicronizedMicronized grade (Pellet extrusion, layering).

LHPC LH-3220Micronized grade with lower hydroxypropoxy content (Pellet extrusion, layering).

LHPC LH-B150Non fibrousHigh density grade suitable for direct compression with good flowability and high loading capability.

* Laser diffraction methodLUDIFLASHCompound of Mannitol, Crospovidone and Polyvinyl AcetateLudiflash is an innovative, unique co-processed blend of mannitol (95%), crospovidone (5%) and polyvinyl acetate (5%) manufactured in a validated patented process. Ludiflash is practically in a league of its own when it comes to excipients for direct compression tablets that rapidly disintegrate in the mouth to form a smooth and creamy texture.

Thanks to its unique composition, Ludiflash produces tablets with an excellent compression / hardness curve, very low friability and very high content uniformity even at high tabletting speed. The oro-dispersible tablets made with Ludiflash can be taken without water, anytime, anywhere and have extremely rapid disintegration (within seconds) and fast release rates.GradeDescriptionApplication

LudiflashAll-in-one system with a mild sweet taste and cooling effect in the mouth. White to off-white powder with superior flowability and low hygroscopicity. Does not dissolve completely in water or organic solventsExcellent excipient for direct compression of fast-disintegrating solid oral dosage forms (mouth-melts) for rapid release.

LUDIPRESSCompoud of Lactose Monohydrate and PovidoneLudipress is the result of an intensive research and development effort by BASF to produce an advanced excipient for the manufacture of tablets by the direct compression process. Ludipress is white, free-flowing, tasteless and odourless granules of lactose monohydrate (93%), povidone (3.5%) and crospovidone (3.5%) and combines the three functionalities of a filler, binder and disintegrant into a single, ready-to-use excipient for direct compression. The versatility of Ludipress allows very simple formulations resulting in rapidly disintegrating tablets of excellent hardness and low friability

Ludipress LCE, on the other hand, is a directly compressible compound of lactose monohydrate (96.5%) and povidone (3.5%). Due to the absence of a disintegrant, Ludipress LCE is completely soluble in water and particularly suitable for cost saving production of lozenges, chewables, effervescent tablets etc.

GradeDescriptionApplication

LudipressGranules of lactose monohydrate, povidone and crospovidoneDirect compression tabletting (disintegrating tablets) and as a filler in hard gelatin capsules.

Ludipress LCEGranular compound of lactose monohydrate and povidoneDirectly compressible production of lozenges, sublingual, chewable tablets particularly, in effervescent tablets. Also used as a bulking agent for modified release formulations.

LUSTRECLEAR LC - 103Microcrystalline Cellulose and Carrageenan based film coating systemLustreClear LC-103 is a highly effective, proprietary all-in-one aqueous film coating system. This unique film coating technology combines microcrystalline cellulose (MCC) and carrageenan to provide a distinctive, smooth, satin finish on solid dosage forms. It is clearly an innovative, cost-effective, aesthetic coating system opening new possibilities in aqueous film coating for a wide variety of tablets and other solid dosage forms. This advanced technology platform, makes processing easier and offers distinctive sensory attributes. Its added advantages of taste masking and ease of swallowing of the coated dosage forms add to the patients appeal and compliance.

GradeDescriptionApplication

LustreClear LC-103All-in-one, aqueous, clear, conventional film coating system comprising of microcrystalline cellulose, carrageenan and polyethylene glycolUsed for film coating of tablets and other solid dosage forms into elegant, easy to swallow and taste masked products.

LUTROL EPolyethylene Glycol (Macrogol) USP/NF, EPLutrol E types are liquid polyethylene glycols manufactured by alkali-catalysed polymerisation of ethylene oxide with subsequent neutralisation of the catalyst. Lutrol E grades are readily soluble in water, ethanol, acetone, glycols and chloroform. The number in the name of the product is indicative of the average molecular weight. The higher the molecular weight of the product; the less hygroscopic it is and lower its solubility in water.

Lutrol E 300 and Lutrol E 400 are colourless, almost odourless and tasteless liquids at room temperature; while Lutrol E 600 can be either liquid or pasty at room temperature.

GradeDescriptionApplication

Lutrol E 300Molecular weight : 285 - 315Viscosity : 5.4 - 6.4 mPa.sUsed as solvents and solubilizing agents for oral, parenteral, topical, ophthalmic and rectal preparations. Carriers for dissolved or suspended drug in soft gelatin capsules. Widely used as an ointment base.

Lutrol E 400Molecular weight : 380 - 420Viscosity : 6.8 - 8.0 mPa.s

Lutrol E 600Molecular weight : 570 - 630Viscosity : 9.9 11.3 mPa.s

LUTROL FPoloxamer USP/NF, EP, JPEThe Lutrol F grades or Poloxamers are block copolymer of polyoxyethylene polyoxypropylene (Pluronics). While Lutrol F 68 (Poloxamer 188) is a white to slightly yellowish, waxy substance in the form of microbeads with a faint odour, Lutrol F 127 (Poloxamer 407) is a white, coarse-grained powder with a waxy consistency. Both grades are soluble in ethanol and water.

The Ltrol micro grades - Ltrol F micro 68 and Ltrol F micro 127 are white, micronized Poloxamer powders of average particle size of ~50 m. with a weak odour.

GradeDescriptionApplication

Lutrol F 68Poloxamer 188 (Block polymer of 81% polyethylene glycol and 19% polypropylene glycol) with an average molecular weight of 8600 Emulsifier, solubilizer and suspension stabilizer in liquid, oral, topical and parenteral dosage forms, as a plasticizer and bioavailability enhancer in solid preparations. Also as coemulsifier in creams and emulsions and as a tablet lubricant.

Ltrol Micro 68Micronized Poloxamer 188 with a mean particle size of 50 m for homogenous mixingDissolution enhancer for actives in solid oral dosage forms; water soluble lubricant for effervescent tablets and for actives incompatible with stearates.

Lutrol F 127Poloxamer 407 (Block polymer of 73% polyethylene glycol and 27% polypropylene glycol with an average molecular weight of 12,000Gel former, thickening agent and solubilizer in oral and topical solutions and as a stabilizer in topical suspensions.

Ltrol Micro 127Micronized Poloxamer 407 with a mean particle size of 50 m for homogenous mixingDissolution enhancer for actives in solid oral dosage forms; water soluble lubricant for effervescent tablets and for actives incompatible with stearates.

MAGNABRITEMagnesium Aluminum Silicate USP/NF, BP

Magnabrite product range are highly refined, naturally occurring, complex colloidal white smectite clays i.e. Magnesium Aluminum Silicates manufactured to meet the specifications of the USP/NF and BP. Chemically Magnesium Aluminum Silicate is a blend of colloidal montmorillonite and saponite that has been processed to remove grit and non- swellable ore components. The plate-like structure and colloidal nature of Magnabrite contributes to a wide range of applications for stabilization of emulsions, as a suspending agent, thickener, rheology modifier, binder, and as a tablet disintegrant. Magnabrite is available in different particle sizes and varying viscosity to suit the end-user.

GradeDescriptionApplication

TypeViscosity at 5% solids (cPs)

Magnabrite HVHigh viscosity grade, Small flakes, 800 - 2200Excellent suspension and emulsification properties, delivers high viscosity with excellent rheology in low solid formulations.

Magnabrite KAcid stable grade, Small flakes,100 - 300Low acid demand and high acid compatibility, used to reduce thickening and flocculation in acidic preparations / suspensions.

Magnabrite SStandard grade, Small flakes,225 - 600Excellent emulsification and thickening abilities, used in formulations requiring medium viscosity, high brightness and ease of dispersion.

Magnabrite FMicro fine powder grade, Free flowing150 - 450Used as an inert low-bulk disintegrant in large tablets. Also used as a suspending agent.

MAGNABRITE HSPurified Bentonite USP/NF, BPMagnabrite 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.

GradeDescriptionApplication

TypeViscosity at 5% solids (cPs)

Magnabrite HSHigh electrolyte stability grade, Small flakes 40 - 200Easily hydrates in hot or cold water, used as suspending, thickening agent and binder.

MAGNESIUM CARBONATE USP/NF, EP, BP Magnesium carbonate is a basic hydrated magnesium carbonate or a normal hydrated magnesium carbonate. DSPs magnesium carbonates are manufactured by an unique process which ensures freedom from the impurities generated by the commonly used precipitation processes grades. Their product is thus of exceptionally high purity and characterized by particularly low levels of impurities such as lead and other minerals. They are offered in two grades Basic and Heavy.

GradeDescriptionApplication

Basic Magnesium CarbonateLight grade (Tapped BD: 0.35-0.55 g/cc)For use in the manufacture of antacid preparations and mineral supplements, Also used in microsphere formulations for the purpose of stabilizing encapsulated proteins or to absorb flavors, in tableting processes.

Heavy Magnesium Carbonate Heavy grade (Tapped BD : NLT 0.50 g/cc)To produce tablets with high crushing strength, low friability, and good disintegration properties.

MAGNESIUM CARBONATE LIGHT USP/NF, EP, BP Magnesium carbonate is a basic hydrated magnesium carbonate or a normal hydrated magnesium carbonate. Scoras magnesium carbonate is manufactured by the Pattinson process which ensures freedom from the impurities generated by the commonly used precipitation processes grades. The product is thus of high purity and exceptional quality.

GradeDescriptionApplication

Basic Magnesium CarbonateHeavy grade, free flowingViscosity regulator, anti-caking and free flow aid. Used in antacid preparations / tablets, laxatives and in production of pharmaceutical magnesium derivatives. Also used in mineral supplements & food additives.

MAGNESIUM HYDROXIDE USP/NF, EP, BPMagnesium hydroxide is an inorganic compound, not very soluble in water. While the solubility of magnesium hydroxide is low, all of the magnesium hydroxide that does dissolve in the water does dissociate. DSPs magnesium hydroxides are manufactured by an unique process which ensures freedom from the impurities generated by the commonly used precipitation processes grades. Their product is thus of exceptionally high purity and characterized by particularly low levels of impurities such as lead and other minerals. They are available as spray dried powders with different bulk densities thus offering a wide choice of compounding possibilities for tablet and powder dosage systems.

GradeDescriptionApplication

Magnesium Hydroxide HD5Lowest bulk density gradeSpray dried, directly compressible powders for use in the manufacture of antacid preparations and mineral supplements.

Magnesium Hydroxide HD7Low bulk density grade

Magnesium Hydroxide HD9Medium bulk density grade

Magnesium Hydroxide HD12High bulk density grade

MAGNESIUM OXIDE USP/NF, EP, BPMagnesium oxide is a free flowing white powder, insoluble in alcohol and almost insoluble in water. It is a source of magnesium and formed by an ionic bond between one magnesium and one oxygen atom. DSPs magnesium oxides are manufactured by an unique process which ensures freedom from the impurities generated by the commonly used precipitation processes grades. Their product is thus of exceptionally high purity and characterized by particularly low levels of impurities such as lead and other minerals. They are available in a variety of grades to meet the requirements of the formulator.

GradeDescriptionApplication

Magnesium Oxide LightLow bulk density gradeFor use in the manufacture of tablet-form antacid preparations, pH modifier, mineral supplements and in the production of pharmaceutical grade magnesium derivatives.

Magnesium Oxide PHRA 50Heavy grade

Magnesium Oxide DCDirectly compressible grade, Granular

MAGNESIUM OXIDE LIGHT USP/NF, EP, BPMagnesium oxide is a free flowing white powder, insoluble in alcohol and almost insoluble in water. It is a source of magnesium and formed by an ionic bond between one magnesium and one oxygen atom. Scoras magnesium oxides are manufactured by the Pattinson process which ensures freedom from the impurities generated by the commonly used precipitation processes grades. The product is thus of high purity and exceptional quality.

GradeDescriptionApplication

Magnesium Oxide LightLow bulk density gradeUsed as precursor of magnesium hydroxide, pH modifier and viscosity regulator in antacid preparations. Also used in mineral supplements, food additives and in production of pharmaceutical grade magnesium stearates.

MALIC ACIDD, L Malic Acid USP/NF, EPMalic Acid is widely found in nature and is the predominant organic acid in many fruits and berries. Commercially, Malic Acid is manufactured by hydration of Maleic Anhydride, at high temperature and pressure. The Malic Acid crystallizes out from aqueous solutions as white, translucent, anhydrous, non-hygroscopic and non-volatile crystals. It's properties allow it to be stored under normal conditions for a very long time without any caking & contribute to its long shelf life.

Malic Acid works by blending with flavours and essences. Its acid taste building up slowly at the beginning, but persists for a long period. The final effect gives a stronger taste and a pronounced flavor note. It works synergistically with most sweetners and has the ability to enhance the effect of the aromas used to mask the undesirable tastes and smell of medicinals. Polynt offers malic acid in both powder & granule forms.

GradeDescriptionApplication

Malic acid granularWhite crystalline powder or granules with a distinct acidic taste. Extremely soluble in waterUsed in throat lozenges, cough syrups, effervescent powders and tablets. Masks undesired taste and odour of medicinals. Also used in health / sports drinks and anti-wrinkle creams.

Malic acid fine granular

Malic acid special fine granular

Malic acid powder

MALTISORB & LYCASINMaltitol USP/NF, EPMaltitol is a white crystalline powder of high purity obtained by the catalytical hydrogenation of D-maltose using a process patented by Roquette. It is a dimeric polyol with a cool mouthfeel and sweetness close to that of Sucrose. Maltitol is a stable polyhy