SIGNET Selection Guide to Excipients 3

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The information in this guide is to our best knowledge true and accurate but, all instructions, recommendations or suggestions are made without guarantee. Since the conditions of use are beyond their control, Signet Chemical Corporation Pvt. Ltd. disclaims any liability for loss or damage suffered for use of this data or suggestions. Furthermore, no liability is accepted if use of any product in accordance with this data or suggestions infringes any patent. Copyright 2011 Signet Chemical Corporation Pvt. Ltd. All rights reserved. The content in this publication is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher.

Signet Chemical Corporation Pvt. Ltd.

towards success & growth For over twenty five years, Signet has aligned its key focus towards providing the world’s best pharmaceutical raw materials to Indian scientists and formulators. By steadily establishing brands, promoting advanced processes and encouraging a shift towards newer developments and innovative applications, today Signet occupies a stellar position as India’s largest excipients distributing company. Setting Benchmarks through Market Understanding: We at Signet believe in providing the highest level of customer service, catering high quality products and providing a strong support infrastructure to ensure smooth delivery of customer expectations. Global Connections for Global Giants: Staying informed about every international excipient producer in the market and bringing all new developments to our customer’s doorstep, is what we strive to achieve every day. Everything Excipients: Signet, with its widely suitable, quality centred, robust and evolving range of excipients, today serves as a ‘One-Stop-Shop’ for formulators, with products manufactured in locations approved by international drug regulatory bodies. The Entire Spectrum of Applications: Binders, fillers and disintegrants, sweeteners and coating agents - the company attempts at addressing every application need. From oral and dermal administration to intravenous delivery, our portfolio covers it all. Evolved Systems and Processes: The pharmaceutical industry operates in a stringent regulatory environment and to comply with this need, we at Signet provide all requisite documents and support regarding the use and safety of products. Our customers can be assured of quality, transparency and reliability, at all times. Team Signet. Our Power, Our Pride: At Signet, a fine blend of commercial and technical members have set a culture of proactivity, approachability and responsibility. The company’s greatest asset - its people - come together to give ‘Signet’ a distinctive edge in the market today.

Product List

Application Guide

FMC BioPolymer

Roquette Frères

DFE Pharma

BASF

Shin-Etsu

Innophos

Asahi Kasei

CP Kelco

Pharm-A-Spheres

Dead Sea Periclase

Scora

Ferro Corporation

Imerys (Luzenac)

Kronos

Lakeshore Biomaterials

NovaMatrix

Ferro Pfanstiehl

FreislandCampina Domo

Eastman

Cytec

Tereos Excipients

Rockwood Pigments

Amcol HBS

Specialty Minerals

GumBase

Glossary

Contact

Product List Company Products

Page 13



AVICEL PH - Microcrystalline Cellulose



AVICEL DG - Microcrystalline Cellulose And Dibasic Calcium Phosphate



AVICEL HFE-102 - Microcrystalline Cellulose And Mannitol



AVICEL CE-15 - Microcrystalline Cellulose And Guar Gum



AVICEL RC / CL - Microcrystalline Cellulose And Carboxymethylcellulose Sodium



AC-DI-SOL - Croscarmellose Sodium



ALUBRA PG 100 - Sodium Stearyl Fumarate



AQUACOAT ECD-30 - Ethylcellulose Aqueous Dispersion



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



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



PROTACID / KELACID - Alginic Acid



GELCARIN / VISCARIN / SEASPEN - Carrageenan



PEARLITOL - Mannitol



PEARLITOL FLASH - Compound Of Mannitol And Maize Starch



XYLISORB - Xylitol



NEOSORB - Sorbitol



SWEETPEARL - Maltitol



LYCASIN - Maltitol Solution



POLYSORB - Anhydrized Liquid Sorbitol



KLEPTOSE - Betadex



KLEPTOSE HPB - Hydroxypropyl Betadex



LYCADEX PF - Dextrose Monohydrate, Pyrogen-Free



DEXTROSE MONOHYDRATE GC - Dextrose Monohydrate, Agglomerated



DEXTROSE ANHYDROUS C - Dextrose Anhydrous, Crystalline



MAIZE / WHEAT / POTATO STARCH - Native Starch



LYCATAB PGS - Fully Pregelatinized Starch



LYCATAB C - Partially Pregelatinized Starch



LYCATAB DSH - Partially Hydrolyzed Starch



GLYCOLYS - Sodium Starch Glycolate



LYCOAT RS - Starch Based Coating System



READILYCOAT - Ready-To-Use Starch Based Coating Sytem



GLUCIDEX - Maltodextrin / Corn Syrup Solids



TACKIDEX - Dextrin



STARLAC - Compound Of Maize Starch And Lactose Monohydrate



NUTRIOSE - Soluble Fibre



HI-SWEET - High Fructose Corn Syrup



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



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



SUPERTAB AN / LACTOPRESS AN - Anhydrous, Directly Compressible Lactose



SUPERTAB GR / LACTOPRESS GR - Granulated, Directly Compressible Lactose

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Product List Company Products

Page 37



KOLLIDON - Povidone (PVP K)



KOLLIDON CL - Crospovidone



KOLLIDON VA 64 - Copovidone



KOLLIDON SR - Blend Of Polyvinyl Acetate And Povidone



KOLLICOAT SR 30 D - Polyvinyl Acetate Dispersion



KOLLICOAT IR - Macrogol Poly (Vinyl Alcohol) Grafted Copolymer



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



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



KOLLICOAT MAE - Methacrylic Acid Copolymer

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

KOLLIPHOR (CREMOPHOR) - Polyoxyl-Hydrogenated Castor Oil

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

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



KOLLIPHOR MCE (EUMULGIN B PH) - Polyoxyl Cetostearyl Ether



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



KOLLIPHOR PS (POLYSORBATE PH) - Polysorbates



KOLLIPHOR SLS (TEXAPON) - Sodium Lauryl Sulfate



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



KOLLISOLV G (SPEZIOL G PF) - Glycerin / Glycerol



KOLLISOLV PG - Propylene Glycol



KOLLISOLV GTA (SPEZIOL GTA) - Triacetin



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



KOLLISOLV MCT (MYRITOL PH) - Medium Chain Triglycerides



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



KOLLIWAX GDB (SPEZIOL GDB PHARMA) - Glyceryl Behenate



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



KOLLIWAX HCO (CUTINA HR PH) - Hydrogenated Castor Oil



KOLLIWAX S (SPEZIOL L2SM) - Stearic Acid



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



KOLLICREAM DO (CETIOL V PH) - Decyl Oleate



KOLLICREAM IPM (ISOPROPYL MYRISTATE PH) - Isopropyl Myristate



KOLLICREAM OA (HD EUTANOL V PH) - Oleyl Alcohol



KOLLICREAM ODD (EUTANOL G PH) - Octyldodecanol



LUDIFLASH - Compound Of Mannitol, Crospovidone And Polyvinyl Acetate



LUDIPRESS - Compound Of Lactose Monohydrate And Povidone



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



NOVATA - Hard Fat



PHARMACOAT - Hypromellose (HPMC), Low Viscosity



METOLOSE SH - Hypromellose (HPMC), High Viscosity



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



METOLOSE SM - Methylcellulose



HPMCP - Hypromellose Phthalate



L-HPC - Low-Substituted Hydroxypropyl Cellulose



SHIN-ETSU AQOAT - Hypromellose Acetate Succinate

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Product List Company Products

Page 61



A-TAB - Dicalcium Phosphate Anhydrous, Granular



CALIPHARM A - Dicalcium Phosphate Anhydrous, Powder



DI-TAB - Dicalcium Phosphate Dihydrate, Granular



CALIPHARM D - Dicalcium Phosphate Dihydrate, Powder



TRI-TAB - Tricalcium Phosphate Anhydrous, Granular



TRI-CAL WG - Tricalcium Phosphate Anhydrous, Granular



TCP-DC - Tricalcium Phospate, Granular



CALIPHARM T - Tricalcium Phosphate Anhydrous, Powder



VERSACAL MP - Tricalcium Phosphate Anhydrous, Micronized Powder



CELPHERE - Microcrystalline Cellulose Spheres



PC-10 - Partly Pregelatinised Starch



SWELSTAR - Pregelatinised Starch



TREHALOSE - Non-Reducing Di-Saccharide



XANTURAL - Xanthan Gum



KELCOGEL CG - Gellan Gum



CEKOL - Carboxymethylcellulose Sodium

65

69

Pharm-A-Spheres - Sugar Spheres

73



MAGNESIUM OXIDE - Heavy / Directly Compressible

75



MAGNESIUM CARBONATE - Heavy / Granulated



MAGNESIUM HYDROXIDE - Directly Compressible



SCORALITE - Calcium Carbonate



SCORALITE DC - Directly Compressible Calcium Carbonate



SCORABLEND - Compound Of Calcium Carbonate And Magnesium Oxide



SCORAMAG DC - Directly Compressible Magnesium Carbonate



LIGHT MAGNESIUM CARBONATE



LIGHT MAGNESIUM OXIDE



SYNPRO MAGNESIUM STEARATE VG



SYNPRO ZINC STEARATE VG



SYNPRO CALCIUM STEARATE VG



SYNPRO ALUMINIUM STEARATE VG



LUZENAC PHARMA - Talc



LUZENAC PHARMA M - Talc, Micronized



LUZENAC PHARMA UM - Talc, Ultra-Micronized



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



TM

POLYGLYCOLIDE

79

83

85

87 89

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

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Product List Company Products

PRONOVA - Sodium Alginate, Ultra-Pure



PROTASAN - Chitosan, Ultra-Pure



SODIUM HYALURONATE PHARMA GRADE



SUCROSE, Low Endotoxin



D-GALACTOSE, Low Endotoxin



MALTOSE, Low Endotoxin



PROYIELD / HYVITAL - Protein Hydrolysate



HIPROTAL - Whey Protein Concentrate



REFIT - Milk Protein



VIVINAL GOS - Galacto-Oligosaccharide

Page 91

95

97

COLOSTRUM

VIVINAL LACTOFERRIN

CASEINATE

CELLULOSE ACETATE (C-A)

101



CELLULOSE ACETATE PHTHALATE (C-A-P)



DSS - Docusate Sodium (100%)



DSS GRANULAR - Docusate Sodium (85%) With Sodium Benzoate



DSS 50% - Docusate Sodium (50%) In PEG 400



COMPRESSUC - Directly Compressible Sucrose ICING SUGAR - Milled Sucrose



CASTER SUGAR / CRYSTAL SUGAR - Screened Sucrose



SICOVIT - Ferric (Iron) Oxide

109



MAGNABRITE HV - Magnesium Aluminium Silicate, High Viscosity

111



MAGNABRITE K - Magnesium Aluminium Silicate, Acid Stable



MAGNABRITE S - Magnesium Aluminium Silicate, Regular



MAGNABRITE F - Magnesium Aluminium Silicate, Micro-Fine



MAGNABRITE HS - Purified Bentonite, High Stability



STURCAL - Precipitated Calcium Carbonate, Heavy



CALOPAKE - Precipitated Calcium Carbonate, Extra-Light



POWDER GUM - Directly Compressible Chewing Gum Base



MEDGUM BASE - Medicated Chewing Gum Base

103

105

113

115

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Application Guide Products by Category

Description

Page

FILLERS / DILUENTS AND BINDERS

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

62 15 15 14 62 114 108 106 27 27 62 30 36 107 38 39 36 36 52 53 28 28 82, 78 76 81, 76 28 58 24 22 56 34 80 80 31 114 34 25 67 31 63 68 63 63 63 23

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Application Guide Products by Category

Description

BINDER-DISINTEGRANT L-HPC LYCATAB C PC-10

Low-Substituted Hydroxypropyl Cellulose Partially Pregelatinized Starch Partly Pregelatinised Starch

DISINTEGRANTS

AC-DI-SOL GLYCOLYS KELACID KOLLIDON CL L-HPC PROTACID F120NM SWELSTAR PD-1

Croscarmellose Sodium Sodium Starch Glycolate Alginic Acid Crospovidone Low-Substituted Hydroxypropyl Cellulose Alginic Acid Pregelatinized Starch

MODIFIED RELEASE AGENTS

CEKOL CELLULOSE ACETATE GELCARIN / VISCARIN KELCOLOID / PROTANAL KELSET KELTONE / MANUCOL / KELCOSOL KOLLIDON SR KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) KOLLIWAX GDB (SPEZIOL GDB PHARMA) KOLLIWAX GMS II (CUTINA GMS VPH) KOLLIWAX HCO (CUTINA HR PH) KOLLIWAX S (SPEZIOL L2SM) METOLOSE SH / SR SWELSTAR MX-1 XANTURAL

Carboxymethylcellulose Sodium Cellulose Acetate Carrageenan Propylene Glycol Alginate Sodium-Calcium Alginate Sodium Alginate Blend Of Polyvinyl Acetate And Povidone

Page 59 28 66 17 29 19 39 59 19 67 72 102 20 19 19 19 40

Vitamin E Polyethylene Glycol Succinate 46 Glyceryl Behenate 49 Glyceryl Monostearate 40-55 (Type II) 49 Hydrogenated Castor Oil 50 Stearic Acid 50 Hypromellose (HPMC) 58 Pregelatinized Starch 67 Xanthan Gum 70

COATING AGENTS (FUNCTIONAL AND NON-FUNCTIONAL) AQUACOAT ECD-30 CASTER SUGAR / CRYSTAL SUGAR CELLULOSE ACETATE CELLULOSE ACETATE PHTHALATE (C-A-P) HPMCP KELTONE / MANUCOL KOLLICOAT IR KOLLICOAT IR COATING SYSTEMS KOLLICOAT MAE KOLLICOAT PROTECT KOLLICOAT SR 30 D LUSTRECLEAR LC-103 LYCOAT RS PHARMACOAT READILYCOAT SHIN-ETSU AQOAT SWEETPEARL XYLISORB

Ethylcellulose Aqueous Dispersion 18 Screened Sucrose 108 Cellulose Acetate 102 Cellulose Acetate Phthalate 102 Hypromellose Phthalate 57 Sodium Alginate 19 Macrogol Poly (Vinyl Alcohol) Grafted Copolymer 41 Ready-To-Use Coating Systems 41 Methacrylic Acid Copolymer 42 Macrogol Poly (Vinyl Alcohol) Grafted Copolymer And PVA 41 Polyvinyl Acetate Dispersion 40 Microcrystalline Cellulose And Carrageenan Based Coating System 18 Starch Based Coating System 29 Hypromellose (HPMC), Low Viscosity 56 Ready-To-Use Starch Based Coating System 29 Hypromellose Acetate Succinate 60 Maltitol 25 Xylitol 23

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Application Guide Products by Category

Description

CHEWABLE AND ORODISPERSIBLE AIDS

AVICEL CE-15 AVICEL HFE-102 CASTER SUGAR / CRYSTAL SUGAR COMPRESSUC ICING SUGAR LUDIFLASH LUDIPRESS LYCOAT RS NEOSORB P PEARLITOL PEARLITOL FLASH STARLAC SWEETPEARL XYLISORB

Microcrystalline Cellulose And Guar Gum Microcrystalline Cellulose And Mannitol Screened Sucrose Directly Compressible Sucrose Milled Sucrose Compound Of Mannitol, Crospovidone And Polyvinyl Acetate Compound Of Lactose Monohydrate And Povidone Starch Based Coating System Sorbitol Mannitol Compound Of Mannitol And Maize Starch Compound Of Maize Starch And Lactose Monohydrate Maltitol Xylitol

BULK SWEETENERS CASTER SUGAR / CRYSTAL SUGAR Screened Sucrose COMPRESSUC Directly Compressible Sucrose DEXTROSE ANHYDROUS C Dextrose Anhydrous, Crystalline DEXTROSE MONOHYDRATE GC Dextrose Monohydrate, Agglomerated HI-SWEET High Fructose Corn Syrup ICING SUGAR Milled Sucrose LYCASIN Maltitol Solution NEOSORB P Sorbitol PEARLITOL Mannitol SWEETPEARL Maltitol TREHALOSE Non-Reducing Di-Saccharide XYLISORB Xylitol ENCAPSULATING AGENTS KELTONE / MANUCOL Sodium Alginate KLEPTOSE Betadex KLEPTOSE HPB Hydroxypropyl Betadex POLY(DL-LACTIDE) Bioabsorbable Polymers POLY(DL-LACTIDE-CO-GLYCOLIDE) Bioabsorbable Polymers POLYCAPROLACTONE Bioabsorbable Polymers POLYGLYCOLIDE Bioabsorbable Polymers PRONOVA UP / SL Sodium Alginate, Ultra-Pure PROTASAN UP Chitosan, Ultra-Pure TASTE MASKING AGENTS AQUACOAT ECD-30 KLEPTOSE KLEPTOSE HPB KOLLICOAT IR KOLLICOAT MAE KOLLICOAT SMARTSEAL 30 D KOLLICOAT SR 30 D TREHALOSE

Ethylcellulose Aqueous Dispersion Betadex Hydroxypropyl Betadex Macrogol Poly (Vinyl Alcohol) Grafted Copolymer Methacrylic Acid Copolymer Methyl Methacrylate And Diethylaminoethyl Methacrylate Copolymer Dispersion Polyvinyl Acetate Dispersion Non-Reducing Di-Saccharide

Page 16 15 108 106 107 52 53 29 24 22 23 31 25 23 108 106 27 27 32 107 25 24 22 25 68 23 19 26 27 90 90 90 90 92 93 18 26 27 41 42 42 40 68 Back to Index

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Application Guide Products by Category

Description

SOLUBILIZERS DOCUSATE SODIUM KLEPTOSE KLEPTOSE HPB KOLLICREAM DO (CETIOL V PH) KOLLICREAM IPM (ISOPROPYLMYRISTATE PH) KOLLICREAM OA (HD EUTANOL V PH) KOLLICREAM ODD (EUTANOL G PH) KOLLIPHOR (CREMOPHOR) KOLLIPHOR HS 15 (SOLUTOL HS 15) KOLLIPHOR P (LUTROL F) KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) KOLLISOLV GTA (SPEZIOL GTA) KOLLISOLV MCT (MYRITOL PH) KOLLISOLV P (LUTROL L) SOLUPLUS

Dioctyl Ester Of Sodium Sulfosuccinate Betadex Hydroxypropyl Betadex Decyl Oleate

104 26 27 51

Isopropyl Myristate Oleyl Alcohol Octyldodecanol Polyoxyl-Hydrogenated Castor Oil Polyoxyl-15-Hydroxystearate Poloxamer

51 51 52 43 44 45

Vitamin E Polyethylene Glycol Succinate Triacetin Medium Chain Triglycerides Poloxamer Polyvinyl Caprolactam-Polyvinyl Acetate-Polyethylene Glycol Graft Copolymer

46 47 48 45

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

Gellan Gum Propylene Glycol Alginate Crospovidone Propylene Glycol Aluminium Stearate

SUSPENDING AGENTS

Microcrystalline Cellulose And Carboxymethylcellulose Sodium Carboxymethylcellulose Sodium Carrageenan Gellan Gum Magnesium Aluminium Silicate Hypromellose (HPMC) / Methylcellulose Xanthan Gum

AVICEL RC / CL CEKOL GELCARIN / VISCARIN / SEASPEN KELCOGEL CG MAGNABRITE METOLOSE SH / SM XANTURAL

Page

53 104 19 50 44 45 45 46 46 46 45 49 50 112 71 19 39 47 84 16 72 20 71 112 58 70

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09

Application Guide Products by Category

Description

THICKENERS CEKOL GELCARIN / VISCARIN / SEASPEN KELCOGEL CG KOLLIDON KOLLIPHOR P (LUTROL F) KOLLISOLV P (LUTROL L) MAGNABRITE METOLOSE SH / SM SYNPRO STEARATE (Al) XANTURAL

Carboxymethylcellulose Sodium Carrageenan Gellan Gum Povidone (PVP K) Poloxamer Poloxamer Magnesium Aluminium Silicate Hypromellose (HPMC) / Methylcellulose Aluminium Stearate Xanthan Gum

CONSISTENCY REGULATORS KOLLIWAX (SPEZIOL C PHARMA) KOLLIWAX GDB (SPEZIOL GDB PHARMA) KOLLIWAX GMS II (CUTINA GMS VPH) KOLLIWAX S (SPEZIOL L2SM)

Myristyl / Cetyl / Stearyl / Cetostearyl Alcohol Glyceryl Behenate Glyceryl Monostearate 40-55 (Type II) Stearic Acid

HUMECTANTS KOLLISOLV G (SPEZIOL G) Glycerin / Glycerol NEOSORB LIQUID Sorbitol Solution EMOLLIENTS KOLLICREAM DO (CETIOL V PH) KOLLICREAM IPM (ISOPROPYLMYRISTATE PH) KOLLICREAM OA (HD EUTANOL V PH) KOLLICREAM ODD (EUTANOL G PH) KOLLISOLV G (SPEZIOL G)

Page 72 20 71 38 45 45 112 58 84 70 49 49 49 50 47 24

Decyl Oleate

51

Isopropyl Myristate Oleyl Alcohol Octyldodecanol Glycerin / Glycerol

51 51 52 47

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

43 47 47 48 47 49 26

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

72 20 71 19 45 70

GLIDANTS LUZENAC PHARMA

Talc

COLOURANTS

KRONOS 1171 SICOVIT

Titanium Dioxide, Super-White, Anatase Grade Ferric (Iron) Oxide

86 88 110

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Application Guide Products by Category

Description

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

A-TAB CALIPHARM CALOPAKE CASEINATE COLOSTRUM DI-TAB HIPROTAL HYVITAL KOLLISOLV MCT (MYRITOL PH) MAGNESIUM CARBONATE MAGNESIUM HYDROXIDE MAGNESIUM OXIDE NUTRIOSE REFIT SCORALITE SCORALITE DC STURCAL TCP-DC TRI-CAL WG TRI-TAB VERSACAL MP VIVINAL GOS VIVINAL LACTOFERRIN

Dicalcium Phosphate Anhydrous, Granular Dicalcium Phosphate, Powder Precipitated Calcium Carbonate, Extra-Light Spray-Dried Milk Protein Colostral Whey Protein Dicalcium Phosphate Dihydrate, Granular Whey Protein Concentrate Protein Hydrolysate Medium Chain Triglycerides Magnesium Carbonate (Light / Heavy) Magnesium Hydroxide Magnesium Oxide (Light / Heavy) Soluble Fibre Milk Protein Calcium Carbonate Directly Compressible Calcium Carbonate Precipitated Calcium Carbonate, Heavy Tricalcium Phospate, Granular Tricalcium Phosphate Anhydrous, Granular Tricalcium Phosphate Anhydrous, Granular Tricalcium Phosphate Anhydrous, Micronized Powder Galacto-Oligosaccharides Lactoferrin

NEUTRAL CORES CELPHERE PEARLITOL PHARM-A-SPHERES

Microcrystalline Cellulose Spheres Mannitol Sugar Spheres

Page 17 46 49 49 50 50 86 84 62 62 114 100 100 62 100 99 48 82, 78 76 81, 76 32 100 80 80 114 63 63 63 63 100 100 66 22 74

PARENTERAL AND OPHTHALMIC AIDS

D-GALACTOSE KLEPTOSE HPB KOLLIDON KOLLIPHOR HS 15 (SOLUTOL HS 15 ) KOLLIPHOR P (LUTROL F ) KOLLIPHOR ELP (CREMOPHOR ELP) KOLLISOLV PEG (LUTROL E) LYCADEX PF MALTOSE METOLOSE SH NEOSORB PF

Galactose, Low Endotoxin Hydroxypropyl Betadex Povidone (PVP K) Polyoxyl-15-Hydroxystearate Poloxamer Polyoxyl-35-Hydrogenated Castor Oil Polyethylene Glycol (Macrogol) Dextrose Monohydrate, Pyrogen-Free Maltose, Low Endotoxin Hypromellose (HPMC), High Viscosity Sorbitol, Pyrogen-Free

96 27 38 44 45 43 48 27 96 58 24 Back to Index

11

Application Guide Products by Category PEARLITOL PF POLY(DL-LACTIDE) POLY(DL-LACTIDE-CO-GLYCOLIDE) POLYCAPTROLACTONE POLYGLYCOLIDE PRONOVA UP / SL PROTASAN UP SUCROSE TREHALOSE

Description Mannitol, Pyrogen-Free Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Sodium Alginate, Ultra-Pure Chitosan, Ultra-Pure Sucrose, Low Endotoxin Non-Reducing Di-Saccharide

BIOMATERIALS POLY(DL-LACTIDE) POLY(DL-LACTIDE-CO-GLYCOLIDE) POLYCAPTROLACTONE POLYGLYCOLIDE PRONOVA UP / SL PROTASAN UP SODIUM HYALURONATE

Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Sodium Alginate, Ultra-Pure Chitosan, Ultra-Pure Ultra-Pure Sodium Hyaluronate

FERMENTATION AIDS

D-GALACTOSE MALTOSE PROYIELD SUCROSE

Galactose, Low Endotoxin Maltose, Low Endotoxin Plant Protein Hydrolysates Sucrose, Low Endotoxin

CHEWING GUM BASE POWDER GUM / MEDGUM BASE

Chewing Gum Base

SUPPOSITORY BASE NOVATA PH

Hard Fat

WOUND CARE AGENTS

PROTANAL / MANUCOL

Sodium Alginate

Page 22 90 90 90 90 92 93 96 68 90 90 90 90 92 93 94 96 96 98 96 116 54 19

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12

FMC BioPolymer

FMC BioPolymer, with a legacy of over 60 years of innovation, is the market leader in cellulose based excipients. FMC’s ‘Avicel’, is the world’s largest selling brand of microcrystalline cellulose. The company’s other products ranging from alginates, carrageenans and gels to coating systems have been strategically harnessed from natural resources. They serve as raw materials to the world’s pharmaceutical, food and personal care industry. FMC’s commitment to high standards of quality and care is reflected in their motto ‘quality begins with me’ and in their consistent efforts at protecting the environment, health and safety of its employees. Along with providing focused support to core markets, they also draw upon the expertise of a network of professionals involved in developing new technologies and applications. This enables them to have a wide partnering reach with their customers, including companies looking to increase efficiency and speed of their own research and development efforts. FMC BioPolymer, a signatory to the ‘responsible care initiative’ of the International Coalition of Chemical Associations, is trusted to deliver the most consistent products, to the right place, at the right time and to assist customers in catering to the fast paced, challenging markets of today.

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AVICEL PH Microcrystalline Cellulose USP/NF, EP, JP Avicel PH, FMC’s innovator brand of microcrystalline cellulose, is a purified, partially depolymerized alpha-cellulose made by acid hydrolysis of specialty wood pulp. The process of polymerization involves high levels of quality and stringency. Avicel PH’s unique properties - superior compactibility, drug carrying capacity and rapid disintegration - make it the excipient of choice in direct compression applications. When used in the wet granulation process, the risk of over-granulation is reduced, screen blockage is avoided and uniform, rapid drying is promoted. The distinct properties of this excipient also benefit the dry granulation processes of roller compaction and slugging. Avicel PH is an excellent extrusion-spheronization binder and its inclusion in capsule formulations improves flow, facilitates plug formation and aids capsule disintegration. With the development of differentiated grades, Avicel PH remains an indispensible formulation tool, boosting productivity and meeting tough formulation challenges.

Particle Size Moisture Content (µm) (%)

Applications

Avicel PH-101

50

3.0 - 5.0

Conventional grade for wet and dry granulation

Avicel PH-102

100

3.0 - 5.0

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

Avicel PH-103

50

NMT 3.0

Well suited for moisture sensitive actives

Avicel PH-105

20

NMT 5.0

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

Avicel PH-112

100

NMT 1.5

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

Avicel PH-113

50

NMT 2.0

Improves product stability, particularly of formulations using moisture sensitive actives

2.0 - 5.0

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

NMT 1.5

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

3.0 - 5.0

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

3.0 - 5.0

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

Avicel PH-200

Avicel PH-200 LM

Avicel PH-301

Avicel PH-302

180

180

50

100

FMC BioPolymer

Grade

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14

AVICEL DG Microcrystalline Cellulose USP/NF, EP, JP and Dibasic Calcium Phosphate USP/NF, EP, JP Avicel DG is a synergistic combination of 75 percent microcrystalline cellulose and 25 percent anhydrous dibasic calcium phosphate, produced using spray-dried, co-processing technology. This product is a novel, high functionality excipient and is optimized for use in dry granulation. It has improved flow characteristics, high quality initial compactibility and excellent recompactability, which in turn minimizes the granulation process steps.



Grade

Avicel DG

Advantages

Produces robust ribbons, lowers tablet rejection rates and improves overall tableting performance

Applications

Dry granulation processes like roller compaction or slugging

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

Grade

Avicel HFE-102

Advantages

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

Applications

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

FMC BioPolymer



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AVICEL CE-15 Microcrystalline 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. This free flowing, co-processed blend results in dramatic differences for end users, primarily in the areas of overall sensory experience and perceived taste when compared to other existing products.



Grade

Avicel CE-15

Advantages

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

Applications

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

AVICEL RC / CL Microcrystalline Cellulose and Carboxymethylcellulose Sodium USP/NF, EP Avicel RC / CL is a colloidal, water dispersible, spray-dried blend of microcrystalline cellulose and carboxymethylcellulose sodium. Formulations which include this excipient have high thixotropy, low viscosity and display reduced settling or sedimentation effects. The range of thixotropies, viscosities, gel strengths and dispersion characteristics offered by this product line provide unparalleled suspension stability and functional versatility.

Viscosity (cps)

Avicel RC-591

39 - 91 (1.2% solids)

Avicel CL-611

50 - 118 (2.6% solids)

Advantages

Applications

Oral suspensions, Viscosity regulator and modifier, nasal / topical sprays, eliminates lengthy hydration lotions, liquids, semi-solid times, displays stability to heat dosage forms and freeze / thaw over a wide pH range and has excellent emulsifying properties for Reconstitutables / dry oil-in-water systems and oral suspensions

FMC BioPolymer

Grade

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16

AC-DI-SOL Croscarmellose Sodium USP/NF, EP, JP Ac-Di-Sol, the best known superdisintegrant, is crosslinked sodium carboxymethylcellulose or modified cellulose gum. This insoluble, hydrophilic polymer has dual-functionality of water wicking and rapid swelling, which results in its superior disintegration characteristics.



Grade

Ac-Di-Sol SD-711

Advantages

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

Applications

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

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

Grade

Alubra PG 100

Advantages

Enhanced dissolution, compatible with a wide range of APIs, flexibility in blending and improved compactibility

Applications

Water soluble lubricant for orodispersible tablets, capsules, effervescent dosage forms and for formulations of poorly soluble drugs

FMC BioPolymer



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AQUACOAT ECD-30 Ethylcellulose Aqueous Dispersion USP/NF, JPE This excipient is a 30 percent by weight aqueous dispersion of ethylcellulose polymer. It is a water based, pseudo latex system free of ammonia and used for solvent-free coating.



Grade

ECD-30 Aquacoat



Advantages

Low viscosity, non-tacky and allows for various kinds of drug release patterns with the use of suitable plasticizers and pore formers

Applications

Variety of functional coating applications such as sustained-release, taste masking and providing a moisture-barrier

LUSTRECLEAR LC-103 Microcrystalline Cellulose USP/NF, EP, JP and Carrageenan USP/NF Based Coating System This product offers a unique, aqueous film coating technology that combines microcrystalline cellulose and carrageenan. It is an all-in-one, solvent-free, conventional, aesthetic coating system providing greater flexibility for processing a wide variety of products.

Grade

LustreClear LC-103

Advantages

Provides a distinctive, clear, smooth, satin finish on solid dosage forms and makes their processing easier. The consequent advantages of taste masking and ease of swallowing of the coated dosage form enhances patient compliance

Applications

Aqueous film coating system used for a variety of tablets and other solid dosage forms

FMC BioPolymer



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18

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



Grade Description

Applications

Type Viscosity, mPa.s (% concentration)

Kelacid NF Protanal LFR 5/60 Manugel LBA

Alginic acid

-

Sodium alginate

300 - 700 (10%)

Keltone LVCR

100 - 300 (2%)

Keltone HVCR

600 - 900 (1.25%)

Manucol LKX

Sodium alginate

Protanal Ester SD-LB

Sodium-calcium alginate

Propylene glycol alginate

Kelcoloid K3B426 Protanal LF 10/60FT

Sodium alginate

Manucol DH Protanal KF 200FTS Protanal LF 200FTS

Potassium alginate Sodium alginate

Protanal HF 120RBS Protanal KF 200RBS

Anti-reflux suspensions, effervescent tablets and used as a gelling agent

Controlled-release formulations

1000 - 1500 (1%)

Kelcosol NF Kelset NF

60 - 170 (1%)

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

Potassium alginate

500-1000 (0.5%) 700 - 1800 (2%) 1000 - 1500 (2%) 30 - 60 (1%) 40 - 90 (1%)

Stabilizer, emulsifier and matrix former

Wound care

200 - 400 (1%) 200 - 400 (1%) 600 - 800 (1%)

Dental impression material

200 - 400 (1%)

FMC BioPolymer

Protacid F120NM

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MARINE COLLOIDS Carrageenan USP/NF, EP Carrageenan is a family of naturally occurring, high molecular weight polysaccharides extracted from red seaweed which yield kappa, iota and lambda types. They differ in properties mainly due to the number and position of ester sulfate groups on the galactose units. While kappa forms a brittle gel, iota forms an elastic gel and lambda does not form a gel. All carrageenans display protein and polyol reactivity. Based on their properties, they are used as stabilizers, thickeners, suspending agents, gelling agents and flow regulators in pharmaceutical dosage forms.

Grade

Description Type

Elastic, medium

Creams and suspensions. Promotes freeze thaw

Brittle, strong

Gives stronger gels than PH-911 with higher syneresis

Brittle, firm

Encapsulation / delivery systems

Lambda

Non-gelling

Creams and lotions. Also used for controlled-release formulations

lota

Elastic, weak

Suspensions, reconstitutables, topical lotions and creams

lota

Gelcarin PH-812 Gelcarin PH-911 Viscarin PH-109 Viscarin PH-209 SeaSpen PF

Gel Type, Strength

Kappa

FMC BioPolymer

Gelcarin PH-379

Applications

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20

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

Roquette Frères

Roquette’s extensive line of products which cater to the pharma, food and cosmetics industries of the world are derived from renewable resources such as corn, wheat, potatoes and peas. Their commitment towards deliverance of high quality and environment friendly results can be seen in their superior production techniques. With a sophisticated research centre, several production sites, a strong customer service base and a wide network of subsidiaries and agents, Roquette is looked upon as a reliable, responsible and innovative partner in the pharmaceutical industry.

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21

PEARLITOL Mannitol USP/NF, EP, JP Mannitol is a polyol manufactured by catalytic hydrogenation of starch, a natural raw material of vegetable origin. It occurs as a slightly sweet, white crystalline powder that gives a cooling sensation on dissolution in the mouth. It has excellent stability, low hygroscopicity and good solubility in different solvents. It forms an ideal excipient for solid orals as well as injectable dosage forms and can be used for wet or dry granulation and direct compression. It also serves as a cryoprotective agent in freeze drying applications. Mannitol has low calorific values, is non-cariogenic and ideal for sugar-free formulations. Crystalline Mannitol Grade Pearlitol 25 C (Mannitol 25)

Mean Diameter (µm) 25

Type Applications

Extra-fine

Pearlitol 50 C (Mannitol 35) 50 Fine Pearlitol 160 C (Mannitol 60) 160 Pearlitol PF (Mannitol PFG) -

Standard

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

Pyrogen-free

solutions and also for freeze dried injectables

Granular Mannitol Mean Diameter (µm)

Pearlitol 100 SD

100

Pearlitol 200 SD

180

Pearlitol 300 DC

250

Pearlitol 400 DC

360

Pearlitol 500 DC

520

Type Applications

Spray-dried

Granulated

Diluent for direct compression especially for chewable, effervescent and orodispersible tablets, ideal excipient for chemically unstable or moisture sensitive actives and also diluent for capsules and sachets DC types are also used as a neutral carrier base onto which actives are loaded

Roquette Frères

Grade

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

Grade



Pearlitol Flash

Advantages Applications Excellent compressibility, high dilution Ideal excipient for direct potential, self-disintegrating properties, compression of superior flowability and melt-in-mouth orodispersible / fast-melt tablets taste experience

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

Mean Diameter (µm)

Xylisorb 90

90

Xylisorb 300

300

Xylisorb 700

700

Xylisorb P 300 DC

300

Applications

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

Roquette Frères

Grade

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23

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

Grade

Mean Type Diameter (µm)

Neosorb P 100 T

110 Fine

Neosorb P 60 W

180 Standard

Applications

Neosorb P 20/60

Excellent excipient for direct compression of suckable, effervescent and chewable tablets, diluent for sachets, sweetener 480 Coarse in pharmaceutical chewing gums and in 650 Highly coarse reconstitutable syrups

Neosorb P 300 DC

300 Spray-dried

Neosorb P 30/60



Neosorb PF

- Pyrogen-free

Parenteral nutrition - used in combination with amino acids

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

Grade Type Sorbitol (dry basis)



Neosorb 70/20



Non-crystallizing sorbitol solution

74% min.

Crystallizing sorbitol solution

93% min.

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

Roquette Frères

Neosorb 70/70 B

Applications

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SWEETPEARL Maltitol USP/NF, EP SweetPearl is maltitol powder of high purity obtained by catalytic hydrogenation of D-maltose using a process which is patented by Roquette. It is a dimeric polyol providing a cool mouth feel and sweetness close to that of sucrose. SweetPearl is a stable, polyhydric, non-cariogenic sugar alcohol with low glycemic index and calorific value. It is a robust and stable excipient with optimum flow, particle size and density, making it an ideal excipient for oral dosage forms.

Grade

Mean Powder Type Diameter (µm)

SweetPearl P 90

90

Fine, crystalline

SweetPearl P 200

200

Coarse, crystalline

SweetPearl P 300 DC 300 Granulated

Applications

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

LYCASIN Maltitol Solution USP/NF, EP Lycasin is obtained by the hydrogenation of maltose syrup and constitutes D-sorbitol, hydrogenated disaccharides and polysaccharides. It is supplied as a pure, odourless liquid and has a pleasant sweet taste. It is non-cariogenic, has low calorific value, is easily miscible with water and is chemically stable (absence of Maillard reaction). Lycasin has high sweetening power (70 - 80 percent of sucrose) with good solubility and is used as a replacement for sugar in syrups, lozenges and jellies for specific patient groups.

Mean Viscosity (mPa.s) at 20oC

Lycasin 75/75

72 - 76%

2400

Lycasin 80/55

50 - 55%

3000

Lycasin HBC

50 - 55%

13000

Applications Non-crystallizing bulk sweetener for sugarless syrups, suspensions, lozenges, oral ampoules and pharmaceutical chewing gums A unique dry matter composition for hard boiled candies, pastilles and lozenges

Roquette Frères

Grade Maltitol (dry basis)

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POLYSORB Anhydrized Liquid Sorbitol USP/NF, EP Polysorb 85/70/00 is a water solution containing a defined mixture of D-sorbitol and 1,4-sorbitan. This clear, colourless, syrupy liquid is perfectly miscible with water but practically insoluble in oils and has been developed particularly as an additive for the soft gelatin capsule application. The advantage of this product in soft gels relates to its remarkable, balanced plasticizer properties without ‘surface’ crystallization i.e. graining, as is the case with standard crystallizing plasticizers and without the leaching phenomena in the filler media of the soft gels.



Grade



Polysorb 85/70/00

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

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

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

Kleptose STD Kleptose DC Kleptose 10

Kleptose 7 PC

Type

Properties

Applications

Improves solubility thereby facilitating Granular for direct higher bioavailability, compression enhances flowability Encapsulating agent for and compressibility, tablets, capsules, sachets, Micronized, improves organoleptic syrups, solutions and oral suitable for aerosols properties, increases suspensions stability, reduces side effects and Low water content transforms liquid actives for moisture into easily manipulated sensitive actives solid complexes Standard

Roquette Frères

Grade

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

Grade

Kleptose HPB

Description

Parenteral grade, medium molecular substitution, endotoxin controlled

Applications

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

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

Grade

Description

Applications

Lycadex PF

Pyrogen-free dextrose monohydrate

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

Dextrose Monohydrate GC

Agglomerated dextrose monohydrate

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

Dextrose Anhydrous C

Crystalline dextrose anhydrous

Diluent for tablets, capsules and sachets

Roquette Frères



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27

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



Grade

Description

Maize Starch B

Conventional

Maize Starch Extra White

Super-white

Maize Starch 5%

Low water content

Wheat Starch TB Potato Starch B

Applications Diluent for tablets and capsules, powder for sachets and a disintegrant in solid orals Low water content grade is for moisture sensitive actives

Standard

MODIFIED STARCHES Pregelatinized Starch USP/NF, EP To overcome the drawbacks of native starch viz. cooking step, high viscosity, poor flow, agglomeration etc, the modified range of maize (corn) starch products were introduced. The Lycatab range consists of pre-cooked, partially cooked and partially hydrolyzed starches made using special production processes. These products bring in reliability, flexibility and several advantages in wet granulation as well as direct compression tableting.

Grade Lycatab PGS

Type

Applications

Fully pregelatinized starch

Robust wet granulation binder

Lycatab C

Partially pregelatinized starch

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

Lycatab DSH

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

Roquette Frères



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28

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

Grade

Description

Applications

Glycolys

Standard, SSG - Type A

Conventional disintegrant for solid oral dosage forms

Glycolys LV

Low viscosity, SSG - Type A

Optimized to withstand high shear, wet granulation processes

Glycolys Low pH

Acid stable, SSG - Type B

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

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

Description

Lycoat RS 780

Low viscosity grade

ReadiLycoat

Ready-to-use film coating system based on Lycoat

Lycoat RS 720

High viscosity grade

Applications Aqueous, aesthetic film coating system for solid oral dosage forms Novel excipient for orodispersible films

Roquette Frères

Grade

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29

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

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

Dextrose Equivalent (D.E.)

Glucidex 2

5 max.

Glucidex 6

5-8

Glucidex 9

8 - 10

Glucidex 12

11 - 14

Glucidex 17

15 - 18

Glucidex 19

18 - 20

Applications

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

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

Dextrose Equivalent (D.E.)

Glucidex 21

20 - 23

Glucidex 33

31 - 34

Glucidex 47

43 - 47

Applications

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

Roquette Frères

Grade

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30

TACKIDEX Dextrin USP/NF, EP Tackidex is a starch polymer derived through solid-state heating from partially hydrolyzed starch. It is partially or completely soluble in cold water and has low viscosity.

Grade Tackidex B 167

Description

Potato starch based

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

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



StarLac



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

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

Roquette Frères

Grade

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31

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

Grade

Type

Nutriose FB

Wheat fibre

Nutriose FM

Maize fibre

Advantages

Applications

High fibre content (85%), For enteral nutrition, gut low glycaemic and regulation and moderation insulinaemic response, low of glucidic and lipid calorific value, quick metabolism. Also used for dissolution and dispersion, high stability, low osmolality, low calorie formulations as well as for clinical nutrition non-cariogenic and a and nutraceutical forms neutral taste

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

Hi-Sweet 55

Description

Solid content of minimum 55% fructose on dry basis

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

Roquette Frères

Grade

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32

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

DFE Pharma

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

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33

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

Type

Pharmatose 50M

Mean Particle Size µm (d50)*



290

Pharmatose 70M

210

Pharmatose 80M Sieved Pharmatose 90M

230

Pharmatose 100M

155

Pharmatose 110M

145

Pharmatose 125M

70

Applications

350

Pharmatose 60M

Pharmatose 130M

Advantages

170

90

Pharmatose 150M

45

Pharmatose 200M Milled

35

Pharmatose 350M

25

Pharmatose 450M

20

Good flowability and As a filler in wet or mixing characteristics dry granulation, in extrusion spheronization, in capsules and as a diluent in sachets. Also used in direct compression formulations Small particles and high surface area for excellent wettability and compressibility

* As determined by laser diffraction

SUPERTAB SD Lactose Monohydrate (Spray-Dried) USP/NF, EP, JP SuperTab SD is spray-dried lactose with spherically shaped porous particles having a narrow size distribution. Particles consist of small alpha-lactose monohydrate crystals and some amorphous lactose to enhance compactibility.

SuperTab 11SD 125 SuperTab 14SD

130

* As determined by laser diffraction

Excellent flow properties, enhances compactibility, affords good blend and tablet content uniformity and has low lubricant sensitivity Tablets made with SuperTab 14SD disintegrate more readily than those with SuperTab 11SD

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

DFE Pharma

Grade Mean Particle Size Advantages Applications µm (d50)*

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34

SUPERTAB AN Anhydrous Lactose USP/NF, EP, JP SuperTab AN is an anhydrous grade of directly compressible lactose with a very low moisture content obtained by physical modification. Particles are a build up of microcrystals, mainly consisting of betalactose and possess a high fragmentation propensity and high compactibility.



Grade





Mean Particle Size µm (d50)*

Advantages

Applications



Has low moisture content and absorbs very little moisture even at higher Used in direct compression relative humidities, has excellent compactibility and formulations of moisture sensitive actives. Used also low lubricant sensitivity in dry granulation processes, chewable tablets and for high SuperTab 22AN is dose drug formulations especially suitable for SuperTab 22AN 210 improvement of flow properties SuperTab 21AN 150

* As determined by laser diffraction

SUPERTAB GR Lactose Monohydrate (Granulated) USP/NF, EP, JP SuperTab GR is a standard grade of directly compressible lactose characterized by good flowability and good compactibility due to its special particle structure.

Grade



Mean Particle Size µm (d50)*

Advantages

Good flow properties, superior compactibility and shows consistent compaction over a wide range of humidities SuperTab 30GR 140 Tablets produced with this grade disintegrate quickly compared to other directly compressible lactose grades

Applications

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

DFE Pharma



* As determined by laser diffraction

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35

LACTOCHEM and LACTOPRESS Grade Lactochem Fine Powder

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

Applications

Filler in wet granulation, capsules and powder mixtures

Lactose monohydrate USP/NF, EP, JP Lactopress Spray-Dried 250 (Spray-dried, directly compressible)

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

Anhydrous lactose USP/NF, EP, JP Lactopress Anhydrous 250 (Low-moisture, directly compressible)

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



Lactopress Granulated

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



In direct compression tableting with an improved disintegration profile

HMS LACTOSE Lactose Monohydrate USP/NF, EP

Grade

HMS Lactose

Description Impalpable grade

Applications Filler in wet granulation, capsules and powder mixtures

DFE Pharma



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36

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

BASF SE

BASF has been an expert partner to the pharmaceutical industry for decades, with its active ingredients, excipients and custom synthesis services manufactured by highly trained and experienced staff meeting the highest standards. They have been pioneers in the production of polyvinyl pyrrolidone range of products and their brands today are considered as quality benchmarks in the pharmaceutical industry. With their in-depth knowledge of science, research and technology, they have converted market trends and scientific ideas quickly into successful innovations. Through new technologies, they have launched several innovative, high functional excipients for various pharmaceutical applications, thus creating added value and opportunities for customers to achieve even greater business success. Quality is BASF’s overriding priority and not just because pharmaceuticals are subject to strict legalization. All their production facilities are approved by international regulatory bodies and function within the strict framework of quality and safety. Decades of experience, knowledge, innovation, product consistency and unmatched quality has made BASF the partner of choice for manufacturers of pharmaceutical products in all four corners of the globe.

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KOLLIDON Povidone USP/NF, EP, JP The soluble grades of Kollidon are polyvinylpyrrolidone (PVP K) obtained by free-radical polymerization of N-vinylpyrrolidone. By virtue of its solubility in water and many organic solvents as well as its high binding power and ability to form complexes, soluble PVP occupies a special position among the synthetic colloids. Soluble Kollidon is available in a variety of grades based on their K-value and weight average molecular weight.



Grade

Description

Applications

K-value Weight Average Molecular Weight (Mw) Kollidon 12 PF

10.2 - 13.8

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

2000 - 3000

15.3 - 18.0

7000 - 11000

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

Kollidon 25

22.5 - 27.0

28000 - 34000

Kollidon 30

27.0 - 32.4

44000 - 54000

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

Kollidon 30 LP

27.0 - 32.4

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

44000 - 54000

Kollidon 90 F

81.0 - 96.3

1000000 - 1500000

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

BASF

Kollidon 17 PF

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38

KOLLIDON CL Crospovidone USP/NF, EP, JPE The insoluble grades of Kollidon are crosslinked polyvinylpyrrolidone manufactured by a polymerization process using an aqueous system, yielding crosslinked insoluble PVP in the form of a ‘popcorn’ polymer. Kollidon CL grades are used as ‘superdisintegrants’ due to their property to swell very fast and predictably without forming a gel. These grades accelerate the dissolution and the bioavailability due to its power to form complexes with many insoluble actives.

Grade

Average Particle Size Range (µm)

Applications

Kollidon CL 110 - 130

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

Kollidon CL-F 20 - 40

Fine particle size grade, for use as a disintegrant in tablets, especially in formulations for small tablets and in wet granulation

Kollidon CL-SF 10 - 30

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



Micronized particle size grade used as a stabilizer for oral and topical suspensions and for improving the release of active substances from tablets, capsules and granules

Kollidon CL-M 3 - 10

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

K-value

Kollidon VA 64 55

Applications

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

25.2 - 30.8 Fine particle size grade resulting in higher binding efficiency. Displays Kollidon VA 64 Fine 17 increased tablet hardness, less friability and higher mechanical stability. Applications similar to Kollidon VA 64

BASF

Grade Average Particle Size (µm)

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KOLLIDON SR Blend of Polyvinyl Acetate and Povidone USP/NF, EP, JP Kollidon SR is a blend of 80 percent polyvinyl acetate and 19 percent povidone along with small quantities of sodium lauryl sulfate and silica, used as stabilizers. Due to its combination of the very plastic polyvinyl acetate and strongly binding povidone, Kollidon SR has excellent compressibility and endows tablets with enormous hardness and low friability. When tablets formulated with this product are introduced into gastric or intestinal fluid, the water soluble povidone is leached out to form pores through which the active ingredient slowly diffuses out resulting in sustained action.

Grade

Kollidon SR

K-value

60.0 - 65.0

Advantages

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

Applications

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

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

Grade

Kollicoat SR 30 D

Advantages

Applications

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

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

BASF



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



Grade

Composition

Applications

Kollicoat IR

Graft copolymer of PVA - PVP (75:25)

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

Kollicoat Protect

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

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

KOLLICOAT IR COATING SYSTEMS Ready-To-Use Coating Systems Kollicoat IR Coating Systems are unique, innovative, ready-to-use coloured coating materials based on Kollicoat IR (polyvinyl alcohol-polyethylene glycol graft copolymer). This novel system consists of seven globally approved base colour components which makes it possible to obtain a wide variety of shades simply by combining different numbers and concentrations of these individual components. The innovative, spray-agglomeration manufacturing process used, results in a raspberry-like structure, granular polymer with high surface area, enabling extremely rapid re-dispersibility in water. The coating suspensions can be easily prepared by weighing and dispersing the required individual components in water without additives.



Grade

Advantages

Applications

Kollicoat IR Black Kollicoat IR Red Kollicoat IR Yellow Kollicoat IR Brilliant Blue Kollicoat IR Sunset Yellow

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

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

BASF

Kollicoat IR White II

Kollicoat IR Carmine Back to Index

41

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



Grade

Kollicoat MAE 30 DP

Kollicoat MAE 100 P

Description

Applications

30% aqueous dispersion of low viscosity

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

Partially neutralized, re-dispersible powder

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

KOLLICOAT SMARTSEAL 30 D Methyl Methacrylate and Diethylaminoethyl Methacrylate Copolymer Dispersion Kollicoat Smartseal 30 D is the first water based dispersion for taste masking and moisture barrier applications. It is a 30 percent aqueous polymer dispersion of methyl methacrylate and diethylaminoethyl methacrylate stabilized with approx. 0.6 percent macrogol cetostearyl ether and 0.8 percent sodium lauryl sulfate. Kollicoat Smartseal 30 D is stable in saliva (pH 6.8 - 7.2) and specifically soluble in gastric juices which insures effective protection from unpleasant taste and rapid release with onset of drug action, in the stomach. It is highly impermeable to water vapour, helping preserve the potency of sensitive actives.

Grade

Kollicoat Smartseal 30 D

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

Applications

Innovative taste masking agent and an effective sealant against moisture

BASF



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42

KOLLIPHOR (CREMOPHOR) Solubilizers / Emulsifiers Kolliphor (earlier known as Cremophor) is a family of non-ionic solubilizers and emulsifiers. Kolliphor RH 40 is obtained by reacting one mole of hydrogenated castor oil with 45 moles of ethylene oxide, while Kolliphor EL and ELP are made by reacting castor oil with ethylene oxide in a molar ratio of 1:35.

Grade

Kolliphor RH 40 (Cremophor RH 40)

Kolliphor EL (Cremophor EL)

Kolliphor ELP (Cremophor ELP)

Pharmacopeial Name

Appearance

Applications

To solubilize vitamins, hydrophobic actives and essential oil-in-water or hydroalcoholic mixtures, to improve bioavailability in solid dosage forms and as a solubilizer in Polyoxyl 35 Polyoxyl castor oil35 Pale yellow, oily oral / topical liquid and Pale yellow, USP/NF, EPcastor oil USP/ liquid semi-liquid dosage forms oily liquid NF, EP Extra-pure grade for special injection solutions. Polyoxyl 35 castor oil White to Also used as a solubilizer USP/NF, EP yellowish paste and emulsifier in liquid (Purified grade of or cloudy liquid form for oral and topical Cremophor EL) preparations Polyoxyl 40 hydrogenated castor oil USP/NF, EP

White to yellowish paste

BASF



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43

KOLLIPHOR CS (LANETTE PH) Kolliphor CS (earlier known as Lanette PH) is a family of self emulsifying cetostearyl alcohol and sodium cetostearyl sulfate. Kolliphor CS A and Kolliphor CS B are anionic emulsifying waxes prepared by melting cetostearyl alcohol and heating to about 950C. Purified water and suitable anionic surfactants are added and this mixture is further heated upto 1150C with vigorous stirring until frothing ceases. The resulting wax is then rapidly cooled. Kolliphor CS A contains cetostearyl alcohol and sodium cetostearyl sulfate while Kolliphor CS B contains cetostearyl alcohol and sodium lauryl sulfate. Kolliphor CS S on the other hand is an anionic emulsifier which is a mixture of fatty alcohol sulfates, especially sodium cetostearyl sulfate.



Grade

Pharmacopeial Name

Kolliphor CS A (Lanette N PH)

Cetostearyl alcohol (Type A), emulsifying EP

Kolliphor CS B (Lanette 20 PH)

Cetostearyl alcohol (Type B), emulsifying EP

Kolliphor CS S (Lanette E PH)

Sodium cetostearyl sulfate EP

Applications

Anionic self-emulsifying base for topical emulsions Anionic emulsifier used for topical emulsions

KOLLIPHOR HS 15 (SOLUTOL HS 15) Polyoxyl-15-Hydroxystearate USP/NF, EP Kolliphor HS 15 (earlier known as Solutol HS 15) is a non-ionic solubilizer and emulsifying agent obtained by reacting 15 moles of ethylene oxide with 1 mole of 12-hydroxy stearic acid. It is soluble in water, ethanol and 2-propanol to form clear solutions. Its solubility in water decreases with increasing temperature and it is insoluble in liquid paraffin. This product has high chemical stability and toxicology tests have shown that it is extremely well tolerated. Kolliphor HS 15 meets the requirements of a potent, modern, low toxicity solubilizer.

Grade

Kolliphor HS 15 (Solutol HS 15)

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

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

BASF



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44

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



Grade

Pharmacopeial Name

Kolliphor MCE 12 (Eumulgin B1 PH)

Macrogol cetostearyl ether 12 EP

Kolliphor MCE 20 (Eumulgin B2 PH)

Polyoxyl 20 cetostearyl ether USP/NF, EP

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

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

Grade

Type

Kolliphor P 188 (Lutrol F 68)

Poloxamer 188

Kolliphor P 237 (Lutrol F 87)

Poloxamer 237

Kolliphor P 338 (Lutrol F 108)

Poloxamer 338

Kolliphor P 407 (Lutrol F 127)

Poloxamer 407

Kolliphor P 188 Micro (Lµtrol Micro 68)

Microprilled poloxamer 188

Kolliphor P 407 Micro (Lµtrol Micro 127)

Microprilled poloxamer 407

Kollisolv P 124 (Lutrol L 44)

Poloxamer 124

Applications Emulsifier, solubilizer and suspension stabilizer in liquid, oral, topical and parenteral dosage forms and as a plasticizer and bioavailability enhancer in solid formulations Gel former, thickening agent and solubilizer in oral and topical solutions and as a stabilizer in topical suspensions Solubilizing agent and dissolution enhancer for actives in solid oral dosage forms and a water soluble lubricant for actives incompatible with stearates As a dispersion medium for APIs in liquid filled soft gel capsules. It is the only monographed poloxamer in liquid form at room temperature

BASF



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45

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



Grade

Chemical Description

Kolliphor PS 20 (Polysorbate 20 PH)

Polyoxyethylene 20 sorbitan monolaurate

Kolliphor PS 60 (Polysorbate 60 PH)

Polyoxyethylene 20 sorbitan monostearate

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

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

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

Grade

Type

Kolliphor SLS Fine (Texapon K 12 P PH)

Low and defined particle size, free flowing powder

Kolliphor SLS (Texapon K 12 G PH)

Granular powder

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

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

Kolliphor TPGS (Speziol TPGS Pharma)

Properties Applications

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

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

BASF

Grade

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46

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



Grade

Pharmacopeial Name

Kollisolv G 99 (Speziol G 99.8% PF)

Glycerin USP/NF, EP, JP

Kollisolv G 85 (Speziol G 86% PF)

Glycerol EP

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

KOLLISOLV PG Propylene Glycol USP/NF, EP Kollisolv PG is produced by converting propylene to chlorohydrin by chlorine water and hydrolyzing it to 1,2-propylene oxide. With further hydrolysis 1,2-propylene oxide is converted to propylene glycol.

Grade

Kollisolv PG

Advantages

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

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

KOLLISOLV GTA (SPEZIOL GTA) Triacetin USP/NF, EP Kollisolv GTA (earlier known as Speziol GTA) is a triester of glycerol and acetic acid which is esterified at increased temperatures.

Grade

Kollisolv GTA (Speziol GTA)

Description

Clear, colourless, slightly viscous liquid

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

BASF



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47

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

Grade

Molecular Weight Viscosity (Mw) (mPa.s)

Kollisolv PEG 300 285 - 315 80 - 105 (Lutrol E 300) Kollisolv PEG 400 380 - 420 105 - 130 (Lutrol E 400)

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

KOLLISOLV MCT (MYRITOL PH) Medium Chain Triglyceride USP/NF, EP Kollisolv MCT (earlier known as Myritol PH) is a triglyceride based on saturated fatty acids C8 and C10. It is produced by esterification of fatty acids or fatty acid methyl esters and glycerol at high temperatures.

Kollisolv MCT 70 (Myritol 318 PH)

Description

Clear, slightly yellowish, odourless oil

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

BASF

Grade

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48

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



Grade

Pharmacopeial Name

Kolliwax MA (Speziol C 14 Pharma)

Myristyl alcohol USP/NF

Kolliwax CA (Speziol C 16 Pharma)

Cetyl alcohol USP/NF, EP, JP

Kolliwax SA (Speziol C 18 Pharma)

Stearyl alcohol USP/NF, EP

Kolliwax CSA 50 (Speziol C 16 18 Pharma)

Cetostearyl alcohol USP/NF, EP, JPE

Applications

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

KOLLIWAX GDB (SPEZIOL GDB PHARMA) Glycerin Behenate USP/NF, EP Kolliwax GDB (earlier known as Speziol GDB Pharma) is a mixture of glycerol esters produced by esterification of fatty acids of vegetable origin with glycerol, at increased temperatures and with the use of a suitable catalyst.

Grade Kolliwax GDB (Speziol GDB Pharma)

Description Hydrophilic wax available in powder / pellets form

Applications

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

KOLLIWAX GMS II (CUTINA GMS VPH) Glyceryl Monostearate 40-55 (Type II) USP/NF, EP This product (earlier known as Cutina GMS VPH) is manufactured by the reaction of glycerin with triglycerides derived from vegetable sources, resulting in a mixture of monoglycerides and diglycerides.

Grade Kolliwax GMS II (Cutina GMS VPH)

Description White to slightly yellowish, hydrophilic wax powder

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

BASF



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49

KOLLIWAX HCO (CUTINA HR PH) Hydrogenated Castor Oil USP/NF, EP, JP Kolliwax HCO (earlier known as Cutina HR PH) is manufactured by hydrogenation of castor oil derived from vegetable sources. It is a hard wax with a high melting point.



Grade

Description

Kolliwax HCO (Cutina HR PH)

White or pale yellow, free flowing powder

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

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



Grade

Particle Size

Kolliwax S Fine (Speziol L2SM GF)

Min. 40% 200

Pronova UP VLVM



< 20

Pronova UP LVM



20 - 200

Pronova UP MVM



Pronova SLG20



Pronova SLG100

100 - 300

Monomer Content

Applications

< 20 Guluronate: Min. 60%

Ultra pure

Mannuronate: Min. 50%

> 200 20 - 99

Guluronate:

Min. 60%

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

Sterile

Pronova SLM100

100 - 300

20 - 99

Mannuronate: Min. 50%

NovaMatrix

Pronova SLM20

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92

PROTASAN Ultra Pure Chitosan The Protasan product range is a series of ultra pure and well characterized chitosan bases and water soluble chloride and glutamate salts with low levels of endotoxins and proteins. Chitosan is a linear polysaccharide composed of randomly distributed beta-(1 >4)-linked D-glucosamine and N-acetylD-glucosamine. It is produced commercially by deacetylation of chitin, the structural element in the exoskeleton of crustaceans, with its viscosity primarily dependent on the average molecular weight of the polymer. Chitosan is a biocompatible, biodegradable, bioadhesive, cationic, polyamine with a high charged density and readily binds to negatively charged surfaces such as mucosal membranes. It also enhances the transport of polar drugs across epithelial surfaces.

Grade Type Degree Of Apparent Applications Acetylation Viscosity (%) (mPa.s) Protasan UP B 80 20

20 - 199

Protasan UP B 80 500 Protasan UP B 90 20

80 - 89

500 - 999

Chitosan base

Protasan UP B 90 500

20 - 199 ≥ 90

Protasan UP B 90 1000 Protasan UP CL 113 Protasan UP CL 213

Protasan UP G 213 Protasan UP G 214

500 - 999 1000 - 2000

Chitosan chloride

Protasan UP CL 214 Protasan UP G 113

200 - 499

75 - 90 ≥ 90

Chitosan glutamate

75 - 90 > 90

< 20 20 - 200 20 - 200 < 20

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

20 - 200 20 - 200

NovaMatrix

Protasan UP B 80 200

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93

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

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

Sodium Hyaluronate Pharma Grade 80

1.2 - 2.0

≤ 2.5

Sodium Hyaluronate Pharma Grade 150

2.1 - 2.8

≤ 40

Applications

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

NovaMatrix

Grade

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94

Ferro Pfanstiehl Laboratories, Inc.

Ferro Pfanstiehl Laboratories, based in Waukegan, USA, is a wholly owned subsidiary of Ferro Corporation and specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin injectable formulation ingredients, pharmaceutical intermediates and active pharmaceutical ingredients, in gram to multi-ton commercial quantities. With over four decades of experience, Ferro Pfanstiehl works closely with its clients in the pharmaceutical and biotechnology sectors and is conscious not only about product purity but also of the environment and their workers’ safety. Their production facilities are designed and equipped to comply with various international regulations and they successfully move new and innovative compounds from the laboratory to the commercial marketplace.

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95

ULTRA-PURE, LOW-ENDOTOXIN CARBOHYDRATES The properties of high purity and low endotoxin limits are needed when even the lowest level of contaminants, especially endotoxins (cell wall fragments of gram negative bacteria) and other high molecular weight impurities can compromise the final product’s purity, biological activity, shelf-life or patient safety. This ultra-pure, low-endotoxin carbohydrate range of products from botanical sources is purified through a combination of various techniques including chromatography, de-ionization, ultrafiltration, nanofiltration, activated carbon treatment and dissolution re-crystallization. The key advantages of these products are its lot-to-lot and intra-lot consistency, low reducing sugar content, reduced sugar polymer content and its chemical and microbial purity, making it ideal for parenteral dosage forms and other specialized applications.

Grade

Product Description Sucrose, low endotoxin (