Excipients Guide

April 3, 2017 | Author: eshwar_org | Category: N/A
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Partnership Towards Success & Growth For over twenty years, we have built partnerships with our customers and with foreign manufacturers whose products we promote and distribute. From inception, Signet aligned it’s key focus to reflect a global perspective. Our goal was for Indian scientists and formulators to have access to raw materials and excipients available elsewhere in the world. With this in mind, we tied up with several major producers in USA, France, Germany, Japan and other countries. All are global leaders in their respective fields and today Signet proudly occupies a stellar position as India’s largest excipients distributing company. The following fundamentals have contributed to our success and steady growth. Customer Service: Close customer contact backed by well-trained and experienced team dedicated to every aspect pertinent to sales and personal service. Needs of timing, pricing, specifications and delivery are met in the best possible manner. Logistics Support: A management system that assures the right products in the right place at the right time. Careful strategic analysis of lead times, stock levels and pertinent costs that builds maximum efficiency into the supply chain. Technical Support: A team of qualified pharmaceutical personnel collaborating at all levels, whether it is introducing a new product, sampling, assistance in formulating or more complex issues involving our principals; Signet goes with you. Regulatory Support: Pharma industry operates in a regulatory environment. Whether it is for domestic markets or export areas, documents governing use, safety, etc. are a part of the process. GMP, DMF, TSE/BSE, GMO, OVI are just a few of them. Signet is committed to provide all that is available and required. We enjoy our legacy and reputation and continually look forward to deliver better and higher standards of service.

Contents Index

FMC BioPolymer

Application Guide

1 Innophos

4

Tereos

43

57

77

79

47

63

81

(A division of Hercules Inc.)

29 Kronos International

49 Cytec Industries

65

BASF Aktiengesellschaft

Aqualon

25 Ferro Industrias Quimicas

Scora

Glossary

Musashino Chemical Laboratory

17

45

61

Shin-Etsu Chemical Co.

Rio Tinto Minerals (Luzenac)

Dead Sea Periclase

Hanns G. Werner

Lonza

9 CP Kelco

Domo

41

Roquette Freres

51

67

33 Health & Beauty Solutions (Amcol)

69

39 Specialty Minerals

53 GumBase Co.

Stepan Co.

Asahi Kasei Chemicals Coporation

71

55 Stearinerie Dubois

73

Index Company

Products

FMC BioPolymer

Avicel PH - Microcrystalline Cellulose (MCC) Avicel RC / CL - Microcrystalline Cellulose & Sodium CMC (Hydrocolloid) Avicel CE - Microcrystalline Cellulose & Guar Gum Ac-Di-Sol - Croscarmellose Sodium LustreClear LC 103 - Aqueous Film Coating System Aquacoat - Aqueous Dispersion for modified release Protanal - Alginate Protacid - Alginic Acid Marine Colloids - Carrageenan

Novamatrix

Protosan UP - Ultrapure Chitosan Salt Pronova UP / SL - Ultrapure / Sterile Sodium Alginate Sodium Hyaluronate

15

Roquette Freres

Pearlitol C - Mannitol Crystalline Pearlitol SD / DC - Mannitol, Directly Compressible Kleptose - Betacyclodextrin Kleptose HPB - Hydroxy Propyl Betacyclodextrin Glycolys - Sodium Starch Glycolate Neosorb - Sorbitol Xylisorb - Xylitol Maltisorb - Maltitol Glucidex - Maltodextrin Lycoat - Peas Starch based aqueous film coating system ReadiLYCOAT - Ready-to-use, Aqueous film coating system Lycatab - Modified Starch Lycatab Mineral CC - Compound of Calcium Carbonate & Maize Starch G-D-L - Glucono Delta Lactone Lycadex PF - Injectable Dextrose Monohydrate Lycasin - Maltitol Solution Polysorb - Aqueous Solution of D-Sorbitol & Sorbitan Hi-Sweet - High Fructose Corn Syrup (HFCS) Starlac - Directly compressible Starch & Lactose compound Starch - Maize (Corn) / Potato / Wheat Nutriose - Soluble Fibre Roferose - Dextrose Monohydrate Tackidex - Dextrin Solulys AST - Corn-steep powder

17

Shin-Etsu Chemical Co.

Pharmacoat - HPMC, Low viscosity Metolose SH - HPMC, High viscosity Metolose SM - Methyl Cellulose L-HPC - Low Substituted Hydroxy Propyl Cellulose HPMCP - HPMC Phthalate Aqoat - HPMC Acetate Succinate

25

Aqualon (A division of Hercules, Inc.)

Ethyl Cellulose Pharm Klucel - Hydroxy Propyl Cellulose Natrosol - Hydroxy Ethyl Cellulose Blanose – Sodium Carboxymethylcellulose (Na CMC)

29

BASF Aktiengesellschaft

Kollidon - Povidone (PVPK 12PF, 17PF, 25, 30, 90F) Kollidon SR - Matrix Sustained Release Excipient Kollidon VA 64 - Copolyvidone (Vinyl Acetate Copolymer) Kollidon CL - Crosspovidone (Crosslinked PVP) Kollicoat - Aqueous Coating Systems for modified release Cremophor - Non-ionic surfactants Lutrol - PEG (Macrogol) / Poloxamer Solutol HS 15 - Macrogol-15-Hydroxystearate Ludipress - Advanced Excipient for direct compression Sicovit - Iron Oxide Soluphor P - 2-Pyrrolidone PVP Iodine - Povidone Iodine

33

1

Page 9

Company

Products

Page

Asahi Kasei Chemicals Corporation

Celphere - Microcrystalline Cellulose Spheres Ceolus KG - Highly Compactible MCC PCS PC 10 - Partly Pregelatinised Starch Trehalose - Non-reducing Di-Saccharide

39

Innophos

Di-Tab - Dicalcium Phosphate Dihydrate, Granular A-Tab - Dicalcium Phosphate Anhydrous, Granular Tri-Tab - Tricalcium Phosphate Anhydrous, Granular Calipharm - Calcium Phosphate, Powder

41

Domo

Lactochem - Lactose Monohydrate Lactopress - DC Lactose

43

CP Kelco

Xantural - Xanthan Gum

45

Rio Tinto Minerals (Luzenac)

Talc Luzenac Pharma

47

Ferro Industrias Quimicas

Synpro Stearates - Magnesium Stearate / Calcium Stearate / Zinc Stearate 49

Kronos International

Kronos 1171 Titanium Dioxide - Anatase & Superwhite Grade

51

Health & Beauty Solutions (Amcol)

Magnabrite - Magnesium Aluminium Silicate

53

Specialty Minerals

Sturcal L - Heavy, Precipitated Calcium Carbonate Calopake - Extra Light, Precipitated Calcium Carbonate

55

Tereos

Compressuc - DC Sucrose Icing Sugar - Milled Sucrose

57

Hanns G. Werner

Pharm-a-spheres - Sugar Spheres (Non-Pareil Seeds)

61

Dead Sea Periclase

Magnesium Oxide Magnesium Carbonate Magnesium Hydroxide

63

Scora

Scoralite - Calcium Carbonate Magnesium Carbonate Magnesium Oxide

65

Cytec Industries

Docusate Sodium (DSS)

67

Stepan Co.

Stepanol - Sodium Lauryl Sulfate

69

GumBase Co.

Medicated Chewing Gum Base / DC Chewing Gum Base

71

Stearinerie Dubois

DUB DUB DUB DUB DUB DUB DUB

73

Lonza

D-L Malic Acid

77

Musashino Chemical Laboratory

D-L Lactic Acid

79

Microlub - Stearic Acid SE - Sucrose Esters MCT - Medium Chain Triglycerides GMS - Glyceryl Stearate DBS - Dibutyl Sebacate DBHG - Glyceryl Dibehenate PP - Hemi-synthetic Glycerides

2

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Application Guide Category

Product

Page

Agglomerated Sucrose Dicalcium Phosphate Anhydrous, Granular Microcrystalline Cellulose (MCC) Calcium Phosphate Powder Extra Light, Precipitated Calcium Carbonate Screened Sucrose Highly Compactible MCC Directly Compressible Sucrose Directly Compressible Glucose Monohydrate Dicalcium Phosphate Dihydrate, Granular Maltodextrin Milled Sucrose Lactose Monohydrate DC Lactose Advanced Excipient for direct compression Modified Starch Magnesium Oxide / Magnesium Carbonate / Magnesium Hydroxide Maltitol Sorbitol Partly Pregelatinised Starch Mannitol Dextrose Monohydrate Calcium Carbonate of high purity Maize (Corn) / Potato / Wheat based Directly compressible Starch & Lactose compound Heavy, Precipitated Calcium Carbonate Dextrin Non-reducing Di-Saccharide Tricalcium Phosphate Anhydrous, Granular Xylitol

59 42 10 42 56 60 40 58 23 42 24 58 44 44 37 21 64 20 19 40 18 23 66 21 22 56 24 40 42 20

Hydroxy Propyl Cellulose Povidone (PVPK 25, 30, 90F) Copolyvidone (Vinyl Acetate Copolymer) Modified Starch Partially Hydrolyzed Maize Starch Hydroxypropyl Methyl Cellulose (HPMC - High Viscosity) Methyl Cellulose Hydroxypropyl Methyl Cellulose (HPMC - Low viscosity) Maize (Corn) / Potato / Wheat based

31 34 34 21 21 27 27 26 21

Low Substituted Hydroxypropyl Cellulose Partially Pregelatinised Maize Starch Partly Pregelatinised Starch

28 21 40

Talc

48

Fillers and General Binders Alveosucre A-Tab Avicel PH Calipharm Calopake Caster Sugar / Crystal Sugar Ceolus KG Compressuc Dextrose GC Di-Tab Glucidex Icing Sugar Lactochem Lactopress Ludipress Lycatab Magnesium Salts Maltisorb Neosorb PCS PC-10 Pearlitol Roferose Scoralite Starch Starlac Sturcal L Tackidex Trehalose Tri-tab Xylisorb

Granulating Binders Klucel Kollidon Kollidon VA 64 Lycatab Lycatab DSH Metolose SH Metolose SM Pharmacoat Starch

Binders cum Disintegrating agents L-HPC Lycatab C PCS PC-10

Glidants Talc Luzenac Pharma

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Application Guide Category

Product

Page

Croscarmellose Sodium Sodium Starch Glycolate Crosspovidone (Crosslinked PVP) Low Substituted Hydroxypropyl Cellulose Alginic Acid

11 22 35 28 13

Disintegrants Ac-Di-Sol Glycolys Kollidon CL L-HPC Protacid

Coating agents (Functional & Non - Functional) Aqoat Aquacoat CPD 30 Aquacoat ECD 30 Ethyl Cellulose HPMC P Klucel Kollicoat IR Kollicoat MAE Kollicoat SR 30D Kollidon SR LustreClear LC 103 Lycoat Maltisorb Metolose SH Metolose SR Natrosol 250 Pharm Pharmacoat Protanal Protanal Ester ReadiLYCOAT Xylisorb

Hydroxy Propyl Methyl Cellulose Acetate Succinate (HPMCAS) Aqueous dispersion of Cellulose Acetate Phthalate Aqueous dispersion of Ethyl Cellulose Ethyl Cellulose Pharm Hydroxy Propyl Methyl Cellulose Phthalate Hydroxypropyl Cellulose Polyvinyl Alcohol-PEG Graft Copolymer Methacrylic Acid Copolymer Aqueous Dispersion of PVA and PVP Matrix Sustained Release Excipient MCC & Carrageenan based Aqueous Film Coating System Peas Starch Based Aqueous Film Coating System Maltitol Hydroxypropyl Methyl Cellulose (HPMC - High Viscosity) Hydroxypropyl Methyl Cellulose (HPMC - Sustained Release grade) Hydroxy Ethyl Cellulose (HEC) Hydroxypropyl Methyl Cellulose (HPMC - Low viscosity) Alginate Propylene Glycol Alginate Ready-to-use, Aqueous film coating system Xylitol

28 12 12 30 26 31 35 36 36 35 12 20 20 27 27 30 26 13 13 20 20

Anatase & Superwhite Grade Iron Oxide

52 38

Microcrystalline Cellulose and Guar Gum Highly Compactible MCC Malic Acid Crosspovidone (Crosslinked PVP) Lactose Monohydrate and povidone (PVPK) compound Compound of Calcium Carbonate & Maize Starch Peas Starch Based Aqueous Film Coating System Maltitol Sorbitol Mannitol Directly compressible Starch & Lactose compound Xylitol

11 40 78 35 37 21 20 20 19 18 22 20

Corn-steep powder Cellulose free, high vegetable protein

19 19

Colourants Kronos 1171 Titanium Dioxide Sicovit

Chewable and Orodispersible aids Avicel CE15 Ceolus KG D-L Malic Acid Kollidon CL Ludipress Lycatab Mineral CC Lycoat Maltisorb Neosorb Pearlitol Starlac Xylisorb

Fermentation aids Solulys AST Soluten 50

5

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Application Guide Category

Product

Page

Glyceryl Dibehenate Medium Chain Triglycerides Stearic Acid Sucrose Esters Sodium Lauryl Sulfate Magnesium Stearate / Calcium Stearate / Zinc Stearate Talc

75 75 74 74 70 50 48

Medicated Chewing Gum Base / DC Chewing Gum Base

72

Potassium Alginate / Triethanolamine Alginate

13

Dicalcium Phospate Anhydrous, Granular Calcium Phospate Powder Extra Light, Precipitated Calcium Carbonate Dicalcium Phospate Dihydrate, Granular Compound of Calcium Carbonate & Maize Starch Magnesium Oxide / Magnesium Carbonate / Magnesium Hydroxide Calcium Carbonate Heavy, Precipitated Calcium Carbonate Tricalcium Phospate Anhydrous, Granular

42 42 56 42 21 64 66 56 42

Soluble Fibre Medium Chain Triglycerides

22 75

Polyoxyl - 35 - Castor Oil (Extra pure grade) Low MS Methyl Betacyclodextrin Injectable Glucose Anhydrous Synthetic Grade Lactic Acid Medium Chain Triglycerides Hydroxypropyl Betacyclodextrin Polyvinyl Pyrrolidone (PVPK - 12PF, 17PF) Polyethylene Glycol (PEG) / Macrogol Poloxamer Injectable Dextrose Monohydrate Hydroxypropyl Methyl Cellulose (HPMC - High Viscosity) Hydroxy Ethyl Cellulose Sorbitol Pyrogen Free Grade Mannitol Pyrogen Free Grade 2 - Pyrrolidone Macrogol - 15 - Hydroxystearate Xylitol Pyrogen Free Grade

38 23 23 80 75 23 34 37 37 23 27 30 19 18 36 38 20

Lubricating agents DUB DBHG DUB MCT DUB Microlub DUB SE Stepanol Synpro Stearates Talc Luzenac Pharma

Chewing gum base MedGumBase / CPG

Dental Impression Materials Protanal

Mineral supplements A-Tab Calipharm Calopake Di-Tab Lycatab Mineral CC Magnesium Salts Scoralite Sturcal L Tri-tab

Nutritional supplements Nutriose DUB MCT

Parenteral & Opthalmic aids Cremophor ELP Crysmeb Dextrose Anhydrous PF D-L Lactic Acid DUB MCT Kleptose HPB Kollidon Lutrol E Lutrol F Lycadex PF Metolose SH Natrosol 250 Pharm Neosorb PF Pearlitol PF Soluphor P Solutol HS-15 Xylisorb PF

6

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Application Guide Category

Product

Page

Aqueous dispersion of Ethyl Cellulose Low MS Methyl Betacyclodextrin Ethyl Cellulose Pharm Betacyclodextrin Hydroxy Propyl Betacyclodextrin Alginate

12 23 30 23 23 13

Hydrogenated Castor Oil Dibutyl Sebacate Medium Chain Triglycerides Polyethylene Glycol (PEG) / Macrogol Aqueous Solution of D-Sorbitol & Sorbitan Propylene Glycol Alginate

38 75 75 37 19 13

Hydrogenated Castor Oil Low MS Methyl Betacyclodextrin Dioctyl Ester of Sodium Sulfosuccinate Stearic Acid Sucrose Esters Betacyclodextrin Hydroxypropyl Betacyclodextrin Poloxamer 2 - Pyrrolidone Macrogol - 15 - Hydroxystearate

38 23 68 74 74 23 23 37 36 38

Microcrystalline Cellulose Spheres Sugar Spheres (Non-Pareil Seeds)

60 62

Macrogol - Cetostaryl Ether Dioctyl Ester of Sodium Sulfosuccinate Glyceryl Stearate Stearic Acid Sucrose Esters Poloxamer Magnesium Aluminum Silicate Sodium Lauryl Sulfate Sodium Stearate

38 68 75 74 74 37 54 70 50

Microcrystalline Cellulose and Sodium CMC (Hydrocolloid) Sodium Carboxymethylcellulose (Na CMC) Magnesium Aluminum Silicate Carrageenan Hydroxypropyl Methyl Cellulose (HPMC - High Viscosity) Methyl Cellulose Hydroxy Ethyl Cellulose (HEC) Alginate Xanthan Gum

11 32 54 14 27 27 30 13 46

Encapsulating agents Aquacoat ECD 30 Crysmeb Ethyl Cellulose Kleptose Kleptose HPB Protanal

Plasticizing agents Cremophor DUB DBS DUB MCT Lutrol E Polysorb 85/70/00 Protanal Ester

Solubilizing aids Cremophor Crysmeb Docusate Sodium (DSS) DUB Microlub DUB SE Kleptose Kleptose HPB Lutrol F Soluphor P Solutol HS-15

Spherical Seed Core Celphere Pharm-a-spheres

Emulsifying agents Cremophor A Docusate Sodium (DSS) DUB GMS DUB Microlub DUB SE Lutrol F Magnabrite Stepanol Synpro Stearate

Suspending agents Avicel RC/CL Blanose Magnabrite Marine Colloids Metolose SH Metolose SM Natrosol 250 Pharm Protanal Xantural

7

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Application Guide Category

Product

Page

Malic Acid Propylene Glycol Alginate Crosspovidone (Crosslinked PVP)

78 13 35

Agglomerated Sucrose Screened Sucrose Directly Compressible Sucrose Dextrose syrup with extensive hydrolysis High Fructose Corn Syrup (HFCS) Milled Sucrose Maltitol Syrup Maltitol Sorbitol Mannitol Dextrose Syrup without extensive hydrolysis Liquid sucrose Xylitol

59 60 58 23 21 58 20 20 19 18 23 59 20

Aqueous dispersion of Ethyl Cellulose Low MS Methyl Betacyclodextrin Ethyl Cellulose Pharm Betacyclodextrin Hydroxypropyl Betacyclodextrin Polyvinyl Alcohol-PEG Graft Copolymer Methacrylic Acid Copolymer Non-reducing Di-Saccharide

12 23 30 23 23 35 36 40

Sodium Carboxymethylcellulose (Na CMC) Glyceryl Stearate Hydroxy Propyl Cellulose Povidone (PVPK 25, 30, 90F) Poloxamer Magnesium Aluminum Silicate Carrageenan Hydroxypropyl Methyl Cellulose (HPMC - High Viscosity) Methyl Cellulose Hydroxy Ethyl Cellulose Alginate Dextrin Xanthan Gum

32 75 31 34 37 54 14 27 27 30 13 24 46

Hemi-synthetic Glycerides Sodium Stearate

76 50

Povidone Iodine

36

Stabilizing agents D-L Malic Acid Protanal Ester Kollidon CL

Sweetening agents Alveosucre Caster Sugar / Crystal Sugar Compressuc Flolys Hi-Sweet Icing Sugar Lycasin Maltisorb Neosorb Pearlitol Roclys Sucrose Solution Xylisorb

Taste Masking agents Aquacoat ECD 30 Crysmeb Ethyl Cellulose Kleptose Kleptose HPB Kollicoat IR Kollicoat MAE Trehalose

Thickening agents Blanose DUB GMS Klucel Kollidon Lutrol F Magnabrite Marine Colloids Metolose SH Metolose SM Natrosol 250 Pharm Protanal Tackidex Xantural

Suppository bases DUB PP Synpro Stearate

Disinfectants PVP Iodine

8

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FMC BioPolymer Microcrystalline Cellulose, Alginate, Carrageenan, Cellulose Gel and Coating Systems. For more than half a century, manufacturers around the world have turned to FMC BIOPOLYMER for the uncompromising performance and quality of these distinctive products. The very name FMC BioPolymer reflects the natural and renewable raw materials from which their products are derived and the polymer chains within the products that create strong and stable applications in the pharmaceutical industry. Apart from a very focussed customer service network, FMC BioPolymer offers partnerships to companies in developing new technologies, applications and other technical support. It has ISO certified manufacturing facilities in Europe, North America and Asia. Their commitment to product quality and functionality exists at every level - from raw material sourcing to manufacturing, process control, storage and shipping. It is one global producer that is different from all others.

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AVICEL® PH Microcrystalline Cellulose USP/NF, EP, JP Avicel PH is purified, partially depolymerized alpha cellulose derived from purified speciality grades of wood pulp. The unique properties of Avicel PH makes it an indispensable formulation tool. It is the excipient of choice for direct compression formulations, lending superior compactibility, drug carrying capacity and rapid disintegration. These properties also benefit dry granulation processes such as roller compaction or slugging. When used in wet granulation processes, Avicel reduces the risk of overgranulation, avoids screen blockage and promotes uniform, rapid drying. Avicel PH is an excellent extrusion-spheronization binder. The inclusion of Avicel PH in capsule formulations improves flow, facilitates plug formation and aids capsule disintegration. Grade

Description

Application

Avicel PH - 101

Standard grade with medium particle size

For conventional applications, especially in wet granulation and roller compaction

Avicel PH - 102

Standard grade with large particle size

For improved flow in direct compression, the dry phase of wet granulation and dry granulation

Avicel PH - 103

Low moisture content with fine particle size

Well suited to moisture-sensitive drugs

Avicel PH - 105

Extra fine particle size

For use in direct compression of coarse or hard-tocompress materials

Avicel PH - 112

Very low moisture content with large particle size

For increased flow in direct compression with moisture-sensitive ingredients

Avicel PH - 113

Very low moisture content with fine particle size

Helps extend shelf life and improve final product stability especially with moisture-sensitive drugs

Avicel PH - 200

Largest particle size

For best flow rate in direct compression and dry granulation maintaining high levels of compressibility and minimizing problems of weight-variation and content uniformity

Avicel PH - 200 LM

Largest particle size with very low moisture content

For best flow rate in direct compression with moisture-sensitive ingredients

Avicel PH - 301

High bulk density with fine Reduces powder stratification, helps mixing of fine particle size actives and facilitates making smaller tablets

Avicel PH - 302

High bulk density with large particle size

Avoids powder segregation, achieves good flow rates and can be used for high dose formulations to produce thin tablets

10

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AVICEL® RC/CL Microcrystalline Cellulose and Carboxymethylcellulose Sodium USP/NF, BP, JPE Avicel RC/CL are water dispersible, spray-dried blends of microcrystalline cellulose and sodium carboxymethylcellulose used in preparation of pharmaceutical suspensions and emulsions. Usage of these products eliminate lengthy hydration time and provides long shelf-life stability. They act as viscosity regulators and modifiers thus preventing caking or sedimentation in suspensions. Grade

Description

Application

Avicel RC-591

Spray dried, requiring low shear for dispersion

Provides a structured dispersion vehicle, acts as a protective colloid and facilitates dispersion

Avicel RC-581

Bulk dried, requiring high shear for dispersion

Conventional suspending agent and dispersion aid

Avicel CL-611

Spray dried, requiring low shear for dispersion

Excellent for reconstitutable / dry suspensions

AVICEL® CE Microcrystalline Cellulose and Guar Gum Avicel CE 15 is a speciality proprietary combination product specially engineered to improve the organoleptic properties of chewable tablets. Grade

Description

Application

Avicel CE-15

Co-processed MCC and Guar Gum

Improved mouth feel, less grittiness, chalkiness, softer tablets with reduced friability and in general superior sensory characteristics in chewable tablets

AC-DI-SOL® Croscarmellose Sodium USP/NF, EP, JP Ac-Di-Sol is a crosslinked sodium CMC that facilitates rapid disintegration and drug dissolution in tablets, capsules and other solid dosage forms. It performs dual functionality of water wicking and rapid swelling resulting in it's superior disintegration characteristics. Grade

Description

Ac-Di-Sol SD-711

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

11

Application

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LUSTRECLEAR™ Microcrystalline Cellulose and Carrageenan based Coating System LustreClear LC-103 is a new product line based on proprietary FMC technology - aesthetic coatings with exciting sensory properties that enhance the patient’s experience and create unique product design opportunities. Grade

Description

Application

LustreClear LC-103

An aqueous clear film coating All-in-one solvent free, clear conventional coating for tablets and other solid providing formulators with flexibility and resulting dosage forms in elegant, easy to swallow and taste masked finished forms

AQUACOAT® ECD Aqueous dispersion of Ethyl Cellulose USP/NF, EP, JP Aquacoat Ethyl Cellulose is a 30% solid polymer aqueous dispersion of submicron Ethyl Cellulose spheres for pharmaceutical film coating. Grade

Description

Application

Aquacoat ECD-30

A water based pseudo-latex system allowing solvent free coating. Also allows a wide choice of plasticizer

Sustained released beads for capsules / tablets, moisture barrier / sealant and taste masking for powders, granules, tablets and capsules

AQUACOAT® CPD Aqueous dispersion of Cellulose Acetate Phthalate USP/NF, EP, JP Aquacoat Cellulose Acetate Phthalate is a 30% solid polymer aqueous dispersion for enteric coated formulations. Grade

Description

Application

Aquacoat CPD-30

A water based pseudo-latex system allowing solvent free enteric coating

Enteric coating of tablets and capsules. Provides an elegant appearance for even embossed tablets and facilitates formation of stable films with 6 - 10% coating level by weight. Can also be coated onto beads for hard gelatin capsules

12

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PROTANAL® & PROTACID™ Alginates and Alginic acid USP/NF, EP, JP Alginates are natural hydrocolloids of vegetable origin that occur as a structural component in marine brown algae, where they give strength and flexibility to the plant. FMC Protanal alginates and Protacid alginic acids offer unique gel-forming, film-forming, thickening and stabilizing properties. Grade

Description

Protacid F 120 NM

Acid

Protanal LFR 5/60

Na Salt

300 - 700 (10%)

Protanal LFMg 5/60

Mg Salt

1000 - 1800 (7.5%)

Protanal LF 240 D

Na Salt

70 - 200

Protanal LF 120 M

Na Salt

70 - 150

Protanal LF 200 M

Na Salt

200 - 400

Protanal LF 10/60 D

Na Salt

20 - 70

Protanal LF 10/60 LS

Na Salt

20 - 70

Protanal LF 10/60

Na Salt

20 - 70

Protanal Ester SD-LB

Propylene Glycol

700 - 1800 (2%)

Stabilizer, Binder, Plasticizer & Emulsifier

Protanal HF 12 RBS

Na Salt

600 - 1000

Dental Impression Materials

Protanal LF 200 DL

Na Salt

200 - 400

Protanal LF 200 M

Na Salt

200 - 400

Protanal LF 200 S

Na Salt

200 - 400

Protanal KF 200 RBS

K Salt

200 - 400

Protanal KF 200

K Salt

200 - 400

Protanal KF 200 S

K Salt

200 - 400

Protanal TA 250

Triethanolamine

200 - 400

13

Viscosity (mPas) (1%) Application –

Anti-Reflux Tablets Anti-Reflux Suspensions

Sustained Release

Wound Healing

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MARINE COLLOIDS™ CARRAGEENAN Carrageenan USP/NF Marine Colloids Carrageenan is a naturally-occurring family of polysaccharides extracted from red seaweeds. FMC develops blends for specific gelling, thickening and stabilizing properties desired for pharmaceutical applications. Grade

Description CGN Type Viscosity

Application Gel Type

Gelcarin GP-379 Iota

High Thixotropic

Elastic, medium strength

Creams, Suspensions Polyol and Protein reactive Promotes freeze thaw

Gelcarin GP-812 Kappa

Low

Brittle, strong

Stronger gels than GP 911 Syneresis higher than GP 911

Gelcarin GP-911 Kappa

Low

Brittle, firm

Encapsulation / Delivery systems Polyol and Protein reactive

Viscarin GP-109

Lambda

Medium

Non-gelling

Creams, Lotions Polyol and Protein reactive

Viscarin GP-209

Lambda

High

Non-gelling

Creams, Lotions Polyol and Protein reactive

SeaSpen PF

Iota

Medium Thixotropic Elastic, weak

Suspensions / Reconstitutables Topical lotions / creams

14

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A business unit of FMC BioPolymer NovaMatrix is a newly created business unit of FMC BioPolymer. Their current products are special ultra pure grades of sodium alginates, chitosan salts & bases and sodium hyaluronates that satisfy functional and regulatory specifications. These are well-characterized and documented biopolymers and biomaterials for use in the development of novel drug delivery therapies, in the formation of biostructures for tissue engineering, wound healing, implants and advanced biotechnology applications. They also have proven properties suitable for parenteral administration of challenging drugs and implants.

PRONOVA™ UP Ultra pure Sodium Alginates Pronova alginate is a linear copolymer with homopolymeric blocks of (14)-linked beta-D-Mannuronate (M) and its C-5 epimer alpha-L-guluronate (G) residues, respectively, covalently linked together in different sequences or blocks. Endotoxin (EU/g) is < _ 100. Grade

Viscosity (mPas)

Pronova UP LVM

20 - 200

Pronova UP MVM

> 200

Pronova UP LVG

20 - 200

Pronova UP MVG

> 200

Pronova UP Test Kit

Contains gram quantities of the above four UP products

PRONOVA™ SL Sterile Sodium Alginates Sterilizing alginate solutions may often be an obstacle in pharmaceutical and biomedical applications requiring sterility of the applied material. In particular, this relates to problems with polymer degradation during autoclaving or irradiation procedures. To meet customer demands, NovaMatrix offers PRONOVA SL alginate as a sterilized and lyophilized product. Endotoxin (EU/g) is < _ 100. Grade

Viscosity (mPas)

Pronova SLM20

20 - 100

Pronova SLM100

> 100

Pronova SLG20

20 - 100

Pronova SLG100

> 100

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A business unit of FMC BioPolymer

PROTASAN™ UP Ultra pure Chitosan salts PROTASAN ultrapure (UP) chitosan salts and bases is a linear polysaccharide composed of beta-(14)linked D-glucosamine (D) and 2-acetamido-2-deoxy-D-glucosamine. The products are characterized by specified parameters reflecting the key properties and purity profile of the material. With it's positively charged amino groups, chitosan differs from most polysaccharides that are neutral or negatively charged. Thus, chitosan becomes water soluble in acidic solutions. Grade

Description

Protasan UP CL 113

Chitosan Chloride Salt

Protasan UP CL 213

Chitosan Chloride Salt

Protasan UP G 113

Chitosan Glutamate Salt

Protasan UP G 213

Chitosan Glutamate Salt

Protasan UP Test Kit

Contains gram quantities of the above four UP products

SODIUM HYALURONATE Ultra pure Sodium Hyaluronate USP, JP, JCIC Sodium Hyaluronate Pharma Grade is a highly purified and well-characterized sodium hyaluronate developed for use in biomedical and pharmaceutical applications. It is manufactured at the NovaMatrix / FMC BioPolymer strategic partner Kibun’s state-of-the-art production facility in Japan. The fermentation of ultra pure sodium hyaluronate is made from non-animal origin material. Grade

Mol. Weight (kDa)

Pharma grade 80

620 - 1150

Pharma grade 150

1400 - 1800

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Roquette Freres ROQUETTE was founded in 1933 and ranks amongst the world's leading producers of starch derivatives and polyols for the pharma, food & cosmetic industry. It has a huge range of excipients and very specialized products that act as humectants, molecular encapsulation solutions, injectables, sweeteners, binders, diluents.... etc. Globally it has 13 production facilities manufacturing over 600 products and a sophisticated Research Centre at Lestrem, France where close to 350 scientists work, who are available to provide technical assistance to customers. Committed to strong customer service, Roquette have a world wide network of subsidiaries and agents.

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PEARLITOL® Mannitol USP/NF, EP, JP Mannitol is a polyol manufactured by a process based upon starch. It is remarkably stable and also soluble in different solvents. It occurs as a slightly sweet white crystalline powder, that gives a cooling sensation in the mouth. It is non-cariogenic, has low hygroscopicity and thus forms an ideal excipient for dry formulations.

Crystalline Mannitol Grade

Description

Application

Pearlitol PF (Mannitol PFG)

Pyrogen free

Diuretic-osmotic for injectable solutions

Pearlitol 25 C (Mannitol 25)

Extra fine particle size

Pearlitol 50 C (Mannitol 35)

Medium particle size

Diluent, excipient for unstable actives & flash release, freeze drying carrier and sweetener with cooling effect

Pearlitol 160 C (Mannitol 60)

Coarse particle size

Spray Dried Mannitol Grade

Description

Application

Pearlitol 100 SD

Fine particle size

Pearlitol 200 SD

Medium particle size

Excellent diluent-binders for direct compression applications (fast dissolving, chewable, oral dispersible, effervescent tablets)

Agglomerated Mannitol Grade

Description

Application

Pearlitol 300 DC

Fine particle size

Pearlitol 400 DC

Medium particle size

Excellent diluent-binder for direct compression applications and in addition can be used as neutral carriers onto which active substances are poured or sprayed

Pearlitol 500 DC

Coarse particle size

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NEOSORB® Sorbitol USP/NF, EP, JP Grade

Description

Application

Neosorb P 100 T

Extra fine particle size

Neosorb P 60 W

Fine particle size

Excellent excipient for direct compression of suckable and chewable tablets, diluent for sachet & sweetener for pharma chewing gums

Neosorb P 20/60

Medium particle size

Neosorb P 30/60

Coarse particle size

Neosorb PFG

Pyrogen free

Parenteral nutrition; used in combination with amino acids

Neosorb 70/70 B

Sorbitol solution Non crystallizing

Humectant and bulk sweetener for syrups, suspensions, oral ampoules, pastilles and lozenges

POLYSORB® Liquid Sorbitol, partially dehydrated EP Grade

Description

Application

Polysorb 85/70/00 (Anidrisorb 85/70)

Aqueous solution of D-Sorbitol and Sorbitans

A superior plasticizing agent in the manufacture of soft gelatin capsules

Grade

Description

Application

Solulys AST

Spray dried corn-steep powder

For seed culture as well as in main fermentation

Soluten 50

Cellulose free, high vegetable For main fermentation media protein

SOLULYS® Corn-steep powder

GLUCONO-DELTA-LACTONE USP/NF Grade

Description

Application

G-D-L G

Crystalline white powder, slightly sweet before developing an acid taste. Mean Diameter (µm) G: 790; T: 330

pH acidity regulator, source of gluconate ions and increases the efficacy of preservatives

G-D-L T

* Also available as Sodium Gluconate Salt

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MALTISORB® & LYCASIN® Maltitol USP/NF, EP Grade

Description

Application

Maltisorb P 90

Fine particle size

Maltisorb P 200

Coarse particle size

Diluent for tablets and sachets, excipient for coating with high sweetening power & good solubility. Used for chewable, suckable and effervescent tablets

Maltisorb 75/75

72% - 76% dry maltitol syrup

Lycasin 80/55

50% - 55% dry maltitol syrup

Liquid sweetener for syrups, suspensions, lozenges, oral ampoules, pastilles and pharma chewing gums

Lycasin HBC

Special grade maltitol syrup

Hard boiled candies

XYLISORB® Xylitol USP/NF, EP, JP Grade

Description

Application

Xylisorb 90

Fine particle size

Xylisorb 300

Medium particle size

Diluent for sachets, chewable & suckable tablets. Sugar free coating (non-cariogenic) with sweetening power identical to that of Sucrose.

Xylisorb 700 / PFG Pyrogen free, coarse particle size Parenteral nutrition; used in combination with amino acids

LYCOAT® Aqueous Film Coating System Lycoat is Roquette's innovation in conventional film coating. A new alternative for the formulator; it is patent protected and has exciting benefits like reduced coating time, instant dispersion at room temperature with no foam formation etc. Another important application of Lycoat is to manufacture Orodispersible strips. Grade

Description

Application

Lycoat RS

Modified peas starch based aqueous film coating system

Cold water soluble, easy-to-prepare system ensuring fast coating process giving a smooth, glossy & uniform colour tablet coat

ReadiLYCOATTM

Ready to use film coating system

Used for aesthetic and functional benefits in tablets with improved organoleptic properties, ease of solubilisation and process efficiency

Lycoat NG 73

Modified peas starch based aqueous film

Used in the manufacture of orally disintegrating films (mouth wafers)

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STARCH GMO Free Starch USP/NF, EP, JP Native Starches Grade

Description

Application

Maize Starch 5 % (Dried)

Extracted from maize. Microbiologically compliant

Dried maize starch is a low moisture grade for moisture sensitive drugs

Maize Starch B

Extracted from maize, wheat or potato origin. Microbiologically compliant

Diluent and disintegrant for tablets and capsules

Grade

Description

Application

Lycatab® PGS

Fully pregelatinised maize starch

Excellent binder for wet granulation

Lycatab® C

Partially pregelatinised maize starch

Versatile excipient optimised as a filler for hard gelatin capsules. Also used as a binder cum disintegrant for direct compression with self-lubricating property and as a binder for wet granulation

Lycatab® DSH

Partially hydrolyzed maize starch

Low viscosity, natural binder for wet granulation. Ready to use, easily dispersible, quickly soluble and no maturation time. It can also be directly incorporated in dry blends

Lycatab® Mineral CC

Compound of precipitated calcium carbonate granulated with maize starch

Direct compression of chewable calcium tablets with improved mouth-feel

Extra White Maize Starch Corn Starch 400 L Wheat Starch TB Potato Starch B

Modified Starches

HI-SWEET® High Fructose Corn Syrup (HFCS) Grade

Description

Application

Hi-Sweet 55

Contains minimum 55% fructose (DS basis)

Hi-Sweet 42

Contains minimum 42% fructose (DS basis)

Used as a bulk sweetner and viscosifier in medicated syrups and suspensions. Provides high sweetness and clear mouth feel compared to sucrose and invert sugar

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GLYCOLYS® Sodium Starch Glycolate USP/NF, EP, JP Grade

Description

Application

Glycolys

Standard grade - Type A

Conventional disintegrant for solid dosage forms. Used in both WG and DC processes

Glycolys LV

Low viscosity grade - Type A

Designed to resist high sheer in WG process

Glycolys Low pH

Acid stable grade - Type B

Designed to resist acidic pH in formulations

STARLACTM Spray-dried compound of Maize Starch & Lactose Monohydrate USP/NF, EP Grade

Description

Application

Starlac

Designed for direct compression with superior flowability and exceptional disintegration properties with superior storage stability

Direct compression filler for oro-dispersible tablets, low-dosage formulations, capsule filling and cores for coating

NUTRIOSE® Soluble Fibre Nutriose products are dextrins developed by Roquette's research centre as innovation soluble fibres with valuable technological advantages. Their chemical stability as well as their controlled powder properties make them flexible ingredients for a variety of pharmaceutical and nutraceutical applications. Grade

Description

Application

Nutriose FB

Wheat fibre

Nutriose FM

Maize fibre

For enteral nutrition and low calorie formulations. Has properties like high fibre content (85%), well tolerated digestion, low calorific value, non-cariogenic and low glycaemic & insulinaemic index

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KLEPTOSE® Betacyclodextrin USP/NF, EP, JPE & derivatives Betacyclodextrins and its hydroxy-propyl derivatives (HPBCD) are cyclic oligosaccharides obtained from starch by enzymatic cyclisation using enzymes called cycloglycosyl transferases. Its non-polar cavity allows the formation of complexes with actives in the solvent or dry phase. Used as encapsulating agents and solubility enhancers for tablets, capsules, sachets, syrups, solutions and oral suspensions. Grade

Description

Application

Kleptose STD

Standard grade

Inclusion in solvent phase

Kleptose DC

Granular grade

Direct compression

Kleptose 10

Micronised grade

Suitable for aerosols

Kleptose 7PC

Low water content grade

Inclusion in dry phase

Kleptose HPB

Hydroxy Propyl Betacyclodextrin Medium Molar Substitution

Increases water solubility of poorly soluble drugs and also suitable for parenteral use

Crysmeb®

Methyl Betacyclodextrin Low Molecular Substitution

Similar to Kleptose HPB. In addition it is intrinsically crystallisable and has low haemolytic power

GLUCOSE Dextrose USP/NF, EP, JP Grade

Description

Application

Lycadex® PF

Pyrogen free dextrose monohydrate

Dextrose Anhydrous PF

Pyrogen free dextrose anhydrous

Osmotic agent in injectable & dialysis solutions, parenteral nutrition and treatment of hypoglycaemia

Dextrose GC

Agglomerated dextrose monohydrate

Direct compression diluent with excellent compressability & flowability for tablets, sachets and capsule formulation

Roferose®

Dextrose Monohydrate

Diluent for tablets, capsules and sachets

Roclys®

Dextrose syrups without extensive hydrolysis

Flolys®

Dextrose syrups with more extensive hydrolysis

Inhibiting sucrose crystallization, texturizer and bulk sweetener in syrups, lozenges, pastilles and pharmaceutical chewing gums

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GLUCIDEX® Maltodextrin and Dried glucose syrup USP/NF, EP Grade

Description

Application

Glucidex 2 D

Maltodextrin with dextrose maximum 3

Soluble in water and offer high standard of organic, mineral and bacteriological purity

Glucidex 6 D

Maltodextrin with dextrose equivalent of 5 to 8

Glucidex 9 D

Maltodextrin with dextrose equivalent of 8 to 10

Used as diluent for tablets, capsules, sachets; spray-drying carrier and carbohydrate source in infant and enteral foods

Glucidex 12 D

Maltodextrin with dextrose equivalent of 11 to 14

Glucidex 17 D

Maltodextrin with dextrose equivalent of 15 to 18

Glucidex 19 D

Maltodextrin with dextrose equivalent of 18 to 20

Glucidex 21 D

Dried glucose syrup with dextrose equivalent of 20 to 23

Glucidex 33 D

Dried glucose syrup with dextrose equivalent of 31 to 34

Glucidex 47 D

Dried glucose syrup with dextrose equivalent of 45 to 48

Note : Also available in IT grades which provides free flowing properties and better solubilization due to its particular physical structure.

TACKIDEX® Dextrin USP/NF, EP Grade

Description

Application

Tackidex B 147

White dextrin from maize starch

Tablet & capsule filler, binder for tablet granulation, sugar coating ingredient, thickening agent for suspensions

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Shin-Etsu Chemical Co. Founded in Japan in 1926, SHIN-ETSU has grown to be a leader in many fields with a major presence in the arena of excipients required by the pharmaceutical industry. It is the world's largest MC & HPMC producer and ranks amongst the top five chemical companies, globally. Their products are pioneering innovations in use since decades with additions constantly being developed and introduced at regular intervals. Specialities include film coating materials, binders, water soluble cellulose ethers and derivatives, sustained release agents, enteric coating materials and several others making them indispensible in the development of new generation formulations.

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PHARMACOAT® Hydroxypropyl Methylcellulose USP/NF, EP, JP Pharmacoat is low viscosity Hydroxypropyl Methylcellulose initially developed as an under-coat for sugar coating. It is very versatile, gives an excellent finish and suitable for many applications in the design of film coated tablet formulations. It is also effective as a binder since it does not interact with drugs, has superior stability, non-ionic character and available in various viscosity grades. Grade

Description

Application

Viscosity (cps)

USP Substitution Type

Pharmacoat 603

3

2910

Wet granulation binder

Pharmacoat 603W

3

2910

White grade of 603

Pharmacoat 606

6

2910

Regular film coating

Pharmacoat 606W

6

2910

White grade of 606

Pharmacoat 606G

6

2910

Granular grade of 606 (disperses quickly)

Pharmacoat 615

15

2910

Film coating, greater film strength

Pharmacoat 645W

4.5

2910

White grade, short processing

4

2208

Sugar coating binder

Pharmacoat 904

HPMCP Hydroxypropyl Methylcellulose Phthalate USP/NF, EP, JP HPMCP is a phthalic half ester of HPMC. It is a solvent based enteric coating agent to protect drugs from degradation from gastric acid and to prevent them from causing side effects in the stomach. Grade

HPMCP HP-55

Description Dissolving pH*

Viscosity (cst)

> _5.5

40

HPMCP HP-55S HPMCP HP-50

Application

> _5.0

Regular grade

170

Greater film strength

55

Soluble at lower pH

* Mcllvaine's buffer (citric acid-Na2HPO4)

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METOLOSE® Hydroxypropyl Methylcellulose (HPMC) / Methylcellulose (MC) USP/NF, EP, JP Metolose is a non-ionic water soluble cellulose ether derived from pulp. It is available in a wide viscosity range from 4 cps to 100000 cps. It provides a variety of functions such as water retention, thickening, protective colloid, surface activity, sustained release etc. Shin-Etsu also manufactures special HPMC grades used as sustained release agents for matrix systems. Grade

Description Viscosity (cps)

Metolose 60SH-50

Application

USP Substitution Type

50

2910

Metolose 60SH-4000

4000

2910

Metolose 60SH-10000

10000

2910

50

2906

Metolose 65SH-4000

4000

2906

Metolose 90SH-100

100

2208

Metolose 90SH-4000

4000

2208

Metolose 90SH-15000

15000

2208

Metolose 90SH-100000

100000

2208

Metolose 90 SH-100SR

100

2208

Metolose 90SH-4000SR

4000

2208

100000

2208

Metolose 65SH-50

Metolose 90SH-100000SR

HPMC polymer used for sustained release, thickener, suspending agent and binder for tablets and granules. Also used for opthalmics

Special HPMC grades used as hydrophilic matrix agents allowing more controllable and reproducible drug release, thus providing consistency in the final product

Metolose SM-4

4

-

MC polymer used for granule coating

Metolose SM-15

15

-

Metolose SM-400

400

-

MC polymer used as granulating agent, emulsifying agent, thickener, bulk laxative, etc.

Metolose SM-4000

4000

-

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L-HPC Low substituted Hydroxypropyl Cellulose USP/NF, EP, JP L-HPC is a low substituted Hydroxypropyl ether of cellulose. It is insoluble in water and solvents but swells in water. It causes changes in the binding and disintegrating characteristics as a result of subtle changes in physical properties. Thus, it is widely used as dual-functional excipient (disintegrant/binder) for tablets, granules or other pharmaceutical solid dosage forms. Grade

Description

Application

Mean particle size * (µm) Particle type L-HPC LH-11

50

Highly fibrous

Direct Compression (anticapping)

L-HPC LH-21

40

Moderately fibrous

Regular grade (dry mixing, wet granulation)

L-HPC LH-22

40

Moderately fibrous

Lower hydroxypropoxy content (sometimes better disintegration)

L-HPC LH-31

20

Micronized

Micronized grade (pellet extrusion, layering)

L-HPC LH-32

20

L-HPC LH-B1

50

Lower hydroxypropoxy content Non fibrous

High bulk density grade used in direct compression or fluid bed granulation process especially for high load formulations

* Laser diffraction method

SHIN-ETSU AQOAT® (HPMCAS) Hydroxypropyl Methylcellulose Acetate Succinate USP/NF, JP Aqoat is a new enteric coating material for application in aqueous, solvent and dry coating system. Can also be used in the design of sustained release dosage form in combination with gastric soluble preparation. Grade

Description

Application

Dissolving pH*

Acetyl(%) / Succinoyl(%)

Aqoat AS-LF

≥ 5.5

8 / 15

Aqoat AS-MF

≥ 6.0

9 / 11

Aqoat AS-HF

≥ 6.5

Aqoat AS-LG

≥ 5.5

8 / 15

Aqoat AS-MG

≥ 6.0

9 / 11

Aqoat AS-HG

≥ 6.5

Micronized grades for aqueous and dry coating

12 / 6 Granular grades for solventbased coating

12 / 6

* Mcllvaine's buffer (citric acid-Na2HPO4 )

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Aqualon –

(A division of Hercules, Inc.) AQUALON has been delivering pharmaceutical performance since the 1950s, through the legacy of Hercules Inc. and Henkel GmbH. Aqualon was originally founded in 1987 as a joint venture between the water -soluble polymer groups of these two companies. Aqualon has it's headquarters, corporate research centre and pharmaceutical laboratory in Wilmington, Delaware, USA and production facilities in France, Netherlands and USA. Currently, their product mix includes a series of cellulose ethers that meet requirements for use as excipients in pharmaceutical formulations. All products comply with pharmacopoeial standards laid down by individual regulatory bodies. Aqualon products are well known for their exceptional and consistent quality.

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AQUALON® ETHYL CELLULOSE PHARM Ethyl Cellulose USP/NF, EP, JP Ethyl cellulose is a non-ionic ethyl ether of cellulose containing not less than 44% and not more than 51% of ethoxy groups, calculated on dried basis. They are soluble in a wide range of organic solvents. When water-soluble binders cannot be used, ethyl cellulose is often the polymer of choice. They are classified into a range of polymer viscosities for different applications. Grade EC N 7 Pharm

Viscosity range (cps)* Application 5.6 to 8

Micro encapsulation - Stabilize against active interactions, hydrolysis and oxidation

EC N 10 Pharm

8 to 11

EC N 14 Pharm

12 to 16

EC N 22 Pharm

18 to 24

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

EC N 50 Pharm

40 to 52

Flavor masking - Improved taste through suppression of strong flavors

EC N 100 Pharm

80 to 105

EC T 10 Pharm

8 to 11

Tablet coating - Impart sustained release to film coatings

Directly compressible, micronized grade with high ethoxyl content and low viscosity for optimized compactibility and good powder flow

* Determined using 5% ethyl cellulose in 80 parts toulene, 20 parts ethanol by weight.

NATROSOL® 250 PHARM Hydroxy Ethyl Cellulose USP/NF, EP Natrosol HEC is a non-ionic water-soluble cellulose ether, formed by reaction of cellulose with ethylene oxide. It is used as a modified release tablet matrix, a film former and a thickener, stabilizer & suspending agent for oral and topical applications when a non-ionic material is desired. Natrosol is easily dispersed in cold or hot water to give solutions of varying viscosities and desired properties, yet it is insoluble in organic solvents. Grade

Viscosity range (cps)* Application

Natrosol HHX Pharm

3500 - 5500 (at 1%)

Natrosol HX Pharm

1500 - 2500 (at 1%)

Natrosol M Pharm

4500 - 6500 (at 2%)

Natrosol G Pharm

250 - 400 (at 2%)

Natrosol L Pharm

75 - 150 (at 5%)

Modified release - provides effective diffusion limiting matrix systems Tablet coating - Imparts flexibility to films while providing a good barrier to water and oxygen transmission Solution thickening, stabilizing and suspending agent Controls rheology and provides pseudoplasticity

* Concentration in water, weight %. Viscosities determined at 25 0 C, using a Brookfield LVF viscometer.

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KLUCEL® Hydroxy Propyl Cellulose USP/NF, EP, JP Klucel is a non-ionic cellulose ether with a versatile combination of properties. It is soluble in many polar organic solvents and in water below 380 C, but is insoluble in water above 450 C. It's solutions are highly surface-active, with low surface and interfacial tensions. In films and coatings, Klucel is heat-sealable and it is extremely flexible without plasticizers. Grade

Viscosity range(cps)* Application

Klucel EF Pharm

300 - 600 (10%)

Klucel EXF Pharm (extra fine)

300 - 600 (10%)

Klucel LF Pharm

75 - 150 (5%)

Klucel JF Pharm

150 - 400 (5%)

Klucel JXF Pharm (extra fine)

150 - 400 (5%)

Klucel GF Pharm

150 - 400 (2%)

Klucel GXF Pharm (extra fine)

150 - 400 (2%)

Klucel MF Pharm

Tablet binding for immediate release - Yields unmatched tablet hardness and friability in wet granulation and direct compression or dry granulation Modified release - Provides effective diffusion limiting matrix systems Tablet coating - Imparts good flexibility and adhesion to films while providing a good barrier to water and oxygen transmission

4000 - 6500 (2%)

Klucel MXF Pharm (extra fine) 4000 - 6500 (2%) Klucel HF Pharm

1500 - 3000 (1%)

Klucel HXF Pharm (extra Fine) 1500 - 3000 (1%) * Concentration in water, weight %. Viscosities determined at 25 0 C, using a Brookfield LVF viscometer.

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BLANOSE® CELLULOSE GUM Sodium Carboxymethylcellulose USP/NF, EP, JP Blanose cellulose gum is the sodium salt of carboxymethylcellulose (CMC), purified to meet pharmaceutical standards. They are soluble in water but insoluble in organic solvents. Generally are used as thickeners, binders, stabilizers, suspending agents and rheology modifiers. Lower substitution types provide thixotropy and higher substitution types are used where smooth solutions are required. Grade

Viscosity range (cps)*

Application

Blanose 7H4F-PH

2500 - 4500 (1%)

Tablet coatings - Film former

Blanose 7HOF-PH

1000 - 2800 (1%)

Mucoadhesives - Absorbency

Blanose 7H3SF-PH

1000 - 2800 (1%)

Syrups & suspensions - Thickener, suspending agent

Blanose 7HF-PH

1500 - 2500 (1%)

Sustained release - Thickener, diffusion barrier

Blanose 7M31F-PH

1500 - 3100 (2%)

Bulk laxatives - Physiologically inert, high water binding capacity

Blanose 7M8SF-PH

200 - 800 (2%)

Blanose 7MF-PH

400 - 600 (2%)

Blanose 7M1F-PH

50 - 100 (2%)

Blanose 7LF-PH

25 - 50 (2%)

Blanose 9H4F-PH

2500 - 4500 (1%)

Blanose 9M31F-PH

1500 - 3100 (2%)

Blanose 9M8F-PH

400 - 800 (2%)

Blanose 12M8P

200 - 800 (2%)

Blanose 12M31P

1500 - 3100 (2%)

Ointments, creams and lotions - Stabilizer, thickener, film-former

* Concentration in water, weight %. Viscosities determined at 25 0 C, using a Brookfield LVF viscometer.

DS-Type

Substitution range

Sodium content, %

7

0,65 to 0,90 **

7,0 - 8,9

9

0,80 to 0,95

9,2 - 9,3

12 (for USP grades)

1,15 to 1,45

10,4 - 12,0

12 (for EP grades)

1,12 to 1,21

10,2 - 10,8

** in 7S and 7O types, the upper limit of substitution is 0,95.

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BASF Aktiengesellschaft BASF is the world's leading chemical company. As a transnational company, it maintains business relationships with customers in more than 170 countries and operates production facilities in 39 countries. BASF's association in India started way back in 1943. It's pharmaceutical involvement includes dozens of actives, excipients and vitamins. Excipients viz. Kollidon, Lutrol, Cremophor etc are familiar names even to students of pharmaceutical sciences. Over the years, several speciality products have been developed and today offer versatile choices to the modern day formulator. They maintain a close partnership with the industry.

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KOLLIDON® Polyvinylpyrrolidone (PVPK) USP/NF, EF, JP The soluble grades of Kollidon are obtained by free-radical polymerization of vinylpyrrolidone in water or isopropanol according to the cGMP regulations, yielding the chain structure of polyvinylpyrrolidone [1,141]. Because of its solubility in water and many organic solvents, it's high binding power and ability to form complexes, soluble PVP occupies a special position among the synthetic colloids. Kollidon is available in a wide range depending on their K-value and molecular weight. Grade

Description K-value

Application

Molecular weight

Kollidon 12 PF

10.2 - 13.8

Low

Kollidon 17 PF

15.3 - 18.0

Low

Kollidon 25

22.5 - 26.7

Medium

Kollidon 30

27.0 - 32.1

Medium

Kollidon 90 F

81.0 - 96.3

High

Pyrogen free grades for use as solubilzer, crystallization inhibitor, suspension stabilizer and lyophilization agent in injections and ophthalmic preparations Versatile and widely used as binders in tablets, capsules & granules, stabilizers in oral suspensions, film formers, dispersants for pigments, thickeners and bioavailability improvers A highly effective binder, stabilizer for oral and topical suspensions, thickener, hydrophilizer and pore former in medical devices

KOLLIDON® VA 64 Copolyvidone USP/NF, EP, JPE Grade

Description K-value

Kollidon VA 64 Kollidon VA 64 Fine

25.2 - 30.8

Application

Characteristics Copolymer of VinylpyrrolidoneVinylacetate in ratio of 6 : 4 by mass

Dry binder, Wet Binder, Film forming agent in coatings and topical sprays Fine particle size grade for increased tablet hardness resulting in less friability and better mechanical stability

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KOLLIDON® SR Polyvinyl Acetate and Povidone based excipient Grade

Description K-value

Kollidon SR

60.0 - 65.0

Application

Characteristics Mixture of 80% Polyvinyl acetate and 20% Povidone K 30

pH independent matrix former for direct compression of sustained release tablets, pellets and granules

KOLLIDON® CL Crosslinked Polyvinylpyrrolidone (Crosspovidone) USP/NF, EP, JPE Grade

Description

Application

Kollidon CL

Standard grade

Kollidon CL-F

Fine particle size grade

Kollidon CL-SF

Superfine particle size grade

Used as a super disintegrant in tablets for improving release of active substances. Fine grade is ideal for small tablets (less content uniformity problems). Superfine grade is for fast dispersible tablets (with superior mouth feel). Micronized grade is used as a stabilizer for suspensions

Kollidon CL-M

Micronized grade

KOLLICOAT® IR Graft copolymers Grade

Description

Application

Kollicoat IR

Polyvinyl alcohol polyethylene glycol graft copolymer, very soluble in water

Instant release coatings and quick dissolving formulations. Also used as a pore former in sustained release formulations and as a binder. It has enormous flexibility, low viscosity and rapid rate of dissolution besides not having to use a plasticizer

Kollicoat IR White

Graft copolymer of To produce white tablets or with a colour premix for coloured 75% polyvinyl tablets. Used also for taste masking, appearance enhancing alcohol units and and protection of light sensitive actives 25% polyethylene glycol units with other additions form an instant release white coating system

Kollicoat IR Protect

Coprocessed Provides excellent moisture protection and taste masking in product of Kollicoat addition to advantages of Kollicoat IR IR and PVA to form a homogenous powder

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KOLLICOAT® Methacrylic acid / Ethyl acrylate copolymers USP/NF, EP, JPE Kollicoat grades are state of the art aqueous coating agents characterized by excellent film forming properties, a reliable adjustment of release rates, easy and cost saving coating processes. Grade

Description

Application

Kollicoat MAE 30DP

Aqueous, milky white, low viscosity, fast to use dispersion with solid content of 30%

Kollicoat MAE 100P

White, redispersible powder preferred when subject to extreme climatic conditions in transport or storage

For white, coloured, & colourless enteric film coatings of pellets, crystals, soft gelatin capsules and other solid dosage forms. Also used as a moisture barrier, taste odour masking and a barrier between incompatible actives

Kollicoat EMM 30D

Aqueous dispersion of a copolymer derived from ethyl acrylate / methyl methacrylate with solid content of 30%

Sustained release, pH independent membrane coatings and matrix. Forms very flexible films without plasticizer and allows stable and reproducible drug release profiles. Also used for taste masking and moisture barrier applications

Kollicoat SR 30D

Aqueous dispersion of 27% polyvinyl acetate, 2.5% povidone & 0.3% sodium lauryl sulfate with solid content of 30%

pH-independent sustained release formulations (coating or matrix), taste masking and protective coatings

POVIDONE-IODINE PVP-Iodine USP/NF, EP, JP Grade

Description

Application

PVP-Iodine 30/06

Standard grade

Used as a disinfectant in topical formulations such as ointments, solutions, creams, ovula and others. It is applied in gargle solutions, surgical scrubs and soaps

PVP-Iodine 30/06 M10 Micronised grade

SOLUPHOR® P 2-Pyrrolidone, Distilled Grade

Description

Application

Soluphor P

Allows more rapid absorption of active substances on topical application of drugs

Solvent for veterinary injections. Also described for transdermal systems and for transmucosal application

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LUTROL® Plasticizers & Solubilizers Polyethylene Glycol / Macrogol USP/NF, EP Grade

Description

Application

Lutrol E 300

Molecular weight : 285 - 315 Viscosity : 5.4 - 6.4 cps

Lutrol E 400

Molecular weight : 380 - 420 Viscosity : 6.8 - 8.0 cps

Solvents for parenteral, topical, ophthalmic, oral, and rectal preparations. Widely used as an ointment base

Poloxamer USP/NF, EP Grade

Description

Application

Lutrol F 68

Poloxamer 188 (Block polymer of 81% PEG and 19% PPG)

Lutrol M 68

New, micronized grade of F 68 with mean particle size of 50 µm

Used as emulsifier, solubilizer, suspension stabilizer, thickener in liquids, orals, topicals, parenterals and for enhancing bioavailability in solid preparations

Lutrol F 127

Poloxamer 407 (Block polymer of 73% PEG and 27% PPG)

Lutrol M 127

New, micronized grade of F 127 with mean particle size of 50 µm

Micronized grades avoids segregation of powder blends, gives a homogenous mixture of actives and excipients, which results in content uniformity concerns with tablets

LUDIPRESS® Advanced excipient for direct compression Grade

Description

Application

Ludipress

Granules of Lactose Monohydrate, Povidone 30 and Crosspovidone

For production of fast disintegrating tablets by direct compression process

Ludipress LCE

Compound of Lactose Monohydrate and Povidone 30

Direct compression of lozenges, sublingual, chewable and effervescent tablets. Also suitable for controlled release formulations

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CREMOPHOR® Non-ionic surfactants USP/NF, EP Grade

Description

Application

Cremophor RH 40

Polyoxyl-40 Hydrogenated Castor Oil

Cremophor EL

Polyoxyl-35 Castor Oil (Standard Grade)

To solubilize vitamins, water-insoluble active substances and other hydrophobic substances in oral and topical liquid & semiliquid dosage forms

Cremophor ELP

Polyoxyl-35 Castor Oil (Extra Pure Grade)

Used as a solubilizer in parenteral dosage form especially for sensitive drugs

Cremophor A 6

Macrogol-6 cetostearyl ether

Cremophor A 25

Macrogol-25 cetostearyl ether

Non-ionic emulsifiers for production of ointments and creams based on oil-in-water emulsions / water-in-oil emulsions

SOLUTOL® HS 15 Macrogol-15-Hydroxystearate EP Grade

Description

Application

Solutol HS 15

Well-tolerated, efficient solubilizer For manufacturing aqueous parenteral in aqueous systems for preparations with vitamins and other lipophilic injectables active pharmaceutical ingredients

SICOVIT® Iron Oxide USP/NF, EP Grade

Description

Application

Sicovit Red 30 E 172

Red colour pigment

Stable colouring pigments approved for use in the pharma industry

Sicovit Yellow10 E 172 Yellow colour pigment Sicovit Black E 172

Black colour pigment

Sicovit Brown E 172

Brown colour pigment

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Asahi Kasei Chemicals Corporation ASAHI KASEI CHEMICALS CORPORATION, a member company of Asahi Kasei Group, was founded in 1931 and employs 4500 people. By year 2000, it had four production facilities in Japan and a consolidated net sales turnover of approx. 10 billion US Dollars. Their product line includes some very specialized excipients viz. Celphere (MCC Spheres), starch derivatives amongst others.

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CELPHERE® Microcrystalline Cellulose Spheres USP/NF, EP, JPE Grade Celphere SCP-100

Particle size range (µm) Description 75 - 212

Celphere CP-102

106 - 212

Celphere CP-203

150 - 300

Celphere CP-305

300 - 500

Celphere CP-507

500 - 710

Celphere CP 708

710 - 850

Application

High mechanical strength, low reactivity, high sphericity, fine & uniform particle size and optimum water absorption

Used as spherical seed core for drug layering & film coating and in the manufacture of granules with sustained-release, taste-masked and other special properties

Description

Application

Dry binder with a distinctive rod-form particle configuration that provides incomparable compactibility

Particularly effective in tableting large dose drugs, low compressible drugs, pressure sensitive drugs, coated granules and oral dispersible tablets

CEOLUS® KG Microcrystalline Cellulose USP/NF, EP, JP Grade

Particle size (µm)

Ceolus KG-802

50

Ceolus KG-1000

50

PCS® PC-10 Partly Pregelatinized Starch USP/NF, EP, JP Grade

Particle size (µm)

PCS PC-10

Description

Application

70

It is inert, pHindependent and has good flowability. It achieves disintegrating properties by swelling due to absorption of water

A stabilizer for moisturesensitive drugs, dissolution enhancer, carrier for hygroscopic ingredients and a granulation aid

Form

Description

Application

Low reactive, non-hygroscopic, heat & pH stable, with taste & smell masking effect

A compactible sugar-type filler & a taste masking agent for solid & liquid dosages

TREHALOSE Non-reducing Di-Saccharide Grade Trehalose P

Powder

Trehalose G

Granular

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Innophos INNOPHOS is the world’s leading manufacturer of highquality calcium phosphates for the pharmaceutical and food industry. Since 1930 they have been manufacturing calcium phosphates in their Chicago Heights, USA plant which operates to the highest standards, most with ISO 9002 and GMP accreditation. Their client base includes some of the world's leading pharmaceutical companies and is testament to the value of it's consistent ability to supply the highest quality products. Innophos subscribes to the principles of sustainable development. To establish their position as the market leaders in calcium phosphates; they continue to add to their product line and have made repeated improvements in their products and their plant's manufacturing capability.

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CALCIUM PHOSPHATE Calcium Phosphates find wide applications in direct compression and wet granulation tableting. It has many positive characteristics as an excipient, including good compressibility, wide compatibility, stability and white colour. They are used as compressible filler, flow agents and as a source of calcium and phosphorous.

Granular grades USP/NF, EP, JP Grade

Description

Application

Di-Tab®

Di-calcium phosphate dihydrate

Direct compression granulation, ordered mixing, flow agent, blend densifier, tablet punch polishing agent, time release agent and carrier of actives. Low lead filler and source of calcium & phosphorous

A-Tab®

Di-calcium phosphate anhydrous

Same as Di-Tab with added benefit in stability due to no water of hydration. Higher calcium & phosphorous content

Tri-Tab®

Tri-calcium phosphate anhydrous Direct compression granulation, glidant due to high surface area and carrier of actives. High calcium content nutritional products

Tri-Tab® WG

Tri-calcium phosphate anhydrous For wet granulation, higher density with similar benefits as Tri-Tab

TCP DCTM

Tri-calcium phosphate

Excellent for direct compression

Powder grades USP/NF, EP, JP Grade

Description

Application

Calipharm® D

Di-calcium phosphate dihydrate

Filler in wet granulation, vitamin premixes and nutritional drinks

Calipharm® A

Di-calcium phosphate anhydrous

Filler in wet granulation, chewable multivitamins and nutritional drinks

Calipharm® T

Tri-calcium phosphate anhydrous In antacid and other formulations for neutralizing properties. Nutritional drinks and calcium / phosphorous fortifications

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Domo DOMO, a subsidiary of The Royal Friesland Foods, Holland is a leading global manufacturer of high quality pharmaceutical lactose. With 30 years experience and a commitment to supply the highest quality products; DOMO offers a broad range of conventinal as well as directly compressible lactose for a variety of pharmaceutical applications. DOMO's distinctive product range of anhydrous, spraydried and monohydrate lactose are manufactured in their FDA inspected state-of-the-art facilities in The Netherlands which meet the standards set by ISO 9001 and HACCP. Their excipients are tailored to meet strict requirements for applications such as tablets, capsules and sachets.

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LACTOCHEM® Lactose Monohydrate USP/NF, EP, JP Lactochem is a white, crystalline, alpha monohydrate lactose powder. The water of crystallization is tightly bound and shows no chemical activity while bound. Mositure absorption is extremely low, even at high relative humidity. Lactochem is available in milled and sieved forms. Grade

Description

Application

Lactochem Powder

Milled Lactose

Widely used as fillers in wet granulation processes. Also used for capsule filling and powder mixtures

Sieved lactose

Prevents segregation in capsule based formulations, DC formulations and sachets

Lactochem Coarse Powder Lactochem Regular Powder Lactochem Fine Powder Lactochem Extra Fine Powder Lactochem Super Fine Powder Lactochem Microfine Lactochem Crystals Lactochem Coarse Crystals Lactochem Fine Crystals Lactochem Extra Fine Crystals

LACTOPRESS® Directly Compressible Lactose USP/NF, EP, JP Lactopress is a white free-flowing DC lactose powder and is available in two forms; spray-dried and anhydrous lactose. Both forms have good flowability and excellent compactibility characteristics making these products ideal for direct compression tabletting. Grade

Description

Lactopress Spray Dried 250 Lactopress Spray Dried

Spray Dried, DC Lactose Ideal for DC tabletting with excellent flow, high compressibility and enables good content uniformity

Lactopress Anhydrous 250

Anhydrous, DC Lactose

Lactopress Anhydrous Fine Powder

Application

Improves stability of moisture-sensitive actives as well as their dissolution due to it's high intrinsic solubility

Lactopress Anhydrous

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CP Kelco More than 30 years ago, CP KELCO pioneered the commercialization of xanthan gum and developed KELZAN® xanthan gum. Today, CP Kelco is the world leader in xanthan and other biopolymers produced by leading-edge fermentation technology. Their products, combined with an unsurpassed depth of technical expertise, bring unique functionality to a broad range of products and applications. With manufacturing facilities located in two continents, extensive processing technology, and research and development resources, CP Kelco have the ability to find the right solution for your specific product or processing needs.

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XANTURAL® Xanthan Gum USP/NF, EP, JP Xanthan Gum is an exocellular heteropolysaccharide produced by fermentation. It has a unique polymeric structure where chains tends to associate forming a complex network gel-like structure. When shear is applied, these hydrogen bonds are disrupted and a flowable liquid is produced. The process reverses when shear is removed. Hence, Xanthan Gum solutions exhibit extremely high viscosity at rest and very low viscosity when force is applied. Xantural grades give a clear, transparent gel. Grade

Description

Application

Xantural 180

Standard grade

Normal grade for suspensions

Xantural 75

Fine particle size grade

Used for dry mix powder suspensions, hydrophilic / controlled release tablets

Xantural 11K

Agglomerated grade

Used when good physical dispersion methods are not available and agitation is minimal

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Rio Tinto Minerals RIO TINTO MINERALS (LUZENAC) Group is a market focused Talc producer. As world leaders in this field, they are committed to setting the standards for the talc industry in areas such as innovation, technical assistance, product quality, health safety and the environment. Every year, Rio Tinto Minerals (Luzenac) Group produces and sells in excess of 1.4 million tonnes of talc from over 30 mines and processing plants in Europe, North and Central America and Asia Pacific. With the widest talc product range and unsurpassed applications expertise, they are the only talc producer that can meet all end-use requirements worldwide.

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TALC LUZENAC® PHARMA Talc USP/NF, EP, JP Talc is a purified and hydrated magnesium silicate. It is a natural material of mineral origin and sterilized for use in the pharmaceutical industry as a lubricant and diluent in solid dosage forms, dusting powder in topical preparations and also used to clarify liquids. The speciality of Luzenac talc is it’s fine particle size, extra white colour, grittiness free and it is also bacteria controlled. Grade

Description

Application

Talc Luzenac Pharma

Standard grade

Flow regulator (glidant), reduces fluctuations in tablet weight, enhances tablet homogeneity & quality and increases productivity

Talc Luzenac Pharma M

Micronised grade

Anti-tack agent for tablet coating, eliminates stickiness during drying, prevents agglomerations in the coater, reduces coating time and produces flawless coated products

Tal Luzenac Pharma UM Ultramicronised grade

Lubricant for easier tablet pressing, reduces friction, prevents binding during compression & ejection and guarantees smooth, crack-free results

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Ferro Industrias Quimicas FERRO - INDUSTRIAS QUIMICAS is a leading producer of performance materials sold to a broad range of applications. Ferro materials enhance the performance of products in a variety of end markets, including consumer electronics, telecommunications, pharmaceuticals, building and renovation, appliances, transportation, household furnishings, and industrial products. Ferro pharmaceutical and cosmetic products include Synpro Stearates used in a variety of applications.

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SYNPRO® STEARATES Stearates USP/NF, EP Synpro Stearates are special grade vegetable origin stearates. They are made from the salt obtained from a vegetable fatty acid conforming to USP/NF, EP and BP standards with Kosher certification. Widely used as lubricants and mold release agents; they are available in a very fine particle size white powder form which ensures consistent performance. Additionally, they are free from TSE/BSE, GMO, OVI, Gluten, Radiation, Additives and Glycol Ethers. Grade

Application

Synpro Magnesium Stearate VG

Added as a lubricant to granules in tablet-making

Synpro Zinc Stearate VG

Lubricant in tablet-making and protective application in the treatment of skin inflammation

Synpro Calcium Stearate VG

Added as a lubricant to granules in tablets and capsules

Synpro Sodium Stearate VG

Emulsifying and stiffening agent in topicals. An ingredient of Glycerin Suppositories

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Kronos International The KRONOS Group is one of the leading manufacturers of Titanium Dioxide with production facilities located in various European countries, Canada and the USA. All Kronos plants use modern, environment-friendly processes. Kronos have more than 80 years of experience in this industry. Besides being a world renowned supplier of Titanium Dioxide pigments for industrial applications, Kronos also produce a high purity grade for pharmaceuticals, cosmetics and foodstuffs having USP, BP and EU approval certification.

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KRONOS® 1171 Titanium Dioxide USP/NF, EP, JP Titanium Dioxide has a very high refractive index and consequently unique light scattering properties which are exploited in it's use as a white pigment and opacifier. Grade

Description

Kronos 1171 TiO2 E 171 Anatase grade, super white, fine particle size and bacteria controlled

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

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Health & Beauty Solutions HEALTH AND BEAUTY SOLUTIONS (AMCOL) is a manufacturer of speciality minerals, providing products and technologies for a wide range of pharmaceutical, industrial and consumerrelated markets worldwide. Established in 1927, it operates in more than 12 countries with over 1,200 employees. Health & Beauty Solutions’ smectite clays comply with the three United States Pharmacopeias-National Formulary (USP/NF) categories viz., Bentonite, Purified Bentonite and Magnesium Aluminium Silicate.

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MAGNABRITE® Magnesium Aluminium Silicate USP/NF, BP Magnabrite product line is a blend of highly refined, naturally occurring, complex colloidal white smectite clays. They are unique thixotropic additives for emulsion stabilizing, suspending, binding, gelling, bodying and disintegrating. Grade

Description

Application

Magnabrite HV

High viscosity grade

Exhibits excellent emulsification and thickening abilities in suspensions. Delivers high viscosity at low solids

Magnabrite K

Acid stable grade

Used to reduce thickening and flocculation in acidic pH levels of pharmaceutical acid suspensions

Magnabrite S

Standard grade

Used when medium viscosity, high brightness and ease of dispersion in pharmaceutical suspensions are desired

Magnabrite F

Micro fine particle size grade Used as an inert low-bulk disintegrant, excellent for large tablets where the actives are the major weight and bulk of the tablet

Magnabrite HS

High stability grade

Hydrates readily in warm or cold water producing high electrolyte stability

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Specialty Minerals Minerals Technologies produce mineral-based and synthetic mineral products for healthcare and other industries. They have two subsidiaries - SPECIALTY MINERALS INC. and MINTEQ INTERNATIONAL. Specialty Minerals are the world's largest producer of Calcium Carbonate.

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STURCAL® & CALOPAKE® Precipitated Calcium Carbonate USP/NF, EP, JP Precipitated Calcium Carbonate is manufactured via a series of controlled chemical reactions. Generally, quicklime (CaO) is mixed with water to form a slurry and carbon dioxide is added. This produces a very fine precipitated CaCo3 which is then dried and packaged. Different grades are available depending on particle size, shape, distribution, colour and purity. Grade

Description

Application

Sturcal L

Heavy grade

Used mainly in antacid tablets and dentifrice because of it's specific flow and polishing properties. Therapeutically used as a calcium supplement

Calopake

Extra light grade

Purified with ultra low lead used for food fortification, calcium supplements and other pharmaceutical and nutraceutical applications

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Tereos TEREOS, a part of the BeghinSay group was created in 2003 when two French market leaders got together. Tereos is today the world's second largest producer of sugar with plants in Europe, Africa and America. With 9000 employees and 26 plants; Tereos processes 10 million tons of beet and 10 million tons of sugar cane annually. For the pharmaceutical industry, Tereos offers a wide range of dry crystal sugars, liquid sugars and sugar specialities. Consistently pursuing it’s efforts to bring the best quality; Tereos has developed a perfect control over production and marketing of sucrose-based excipients.

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SUCROSE Sugar USP/NF, EP, JP Sucrose is an essential excipient for pharmaceutical products and a good way to give them a sweet taste. It is the reference sweetening flavour and also facilitates oral ingestion. Tereos produces a wide range of products in different forms and different particle sizes that enables many pharmaceutical uses for dry or liquid galenics.

Spray Dried Sucrose USP/NF, EP, JP Grade

Description

Application

Compressuc MS

Directly compressible sucrose with maltodextrins / inverted sugar

Compressuc PS

Directly compressible pure sucrose

A new generation of anhydrous DC Sucrose; it has remarkable free flowing, mixing and compressive properties thus making it an efficient excipient for chewables, efferrvescent and orodispersible tablets

Milled Sucrose USP/NF, EP, JP Grade

Description

Application

Icing Sugar

Milled Sucrose (100% pure)

Very fine powder and easily compressible; it dissolves quickly in water than regular sugar. Used for granulation, coating and in sachets

Icing Sugar with Starch Milled Sucrose with corn starch added as anti-caking agent Icing Sugar with Silica

Milled sucrose with colloidal silica added as fluidizing agent

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Agglomerated Sucrose USP/NF, EP, JP Grade

Description

Application

Alveosucre

Obtained by wet granulation of pure icing sugar followed by subsequent drying

Used for sachets and dry syrups. Highly absorbent, allows for structured mixtures with homogenetic distribution of actives while avoiding separation of ingredients. Instant cold dissolution

Alveosucre with Dextrine Obtained by wet granulation of pure icing sugar with dehydrated glucose syrup additives

For DC applications, allows very high densities. Instant cold dissolution

Pearl Sugar 30

Obtained by successive screenings of sugar agglomerates

For applications requiring a dry excipient as a fixing medium. The irregular surface of the agglomerates and it's narrow particle size distribution allows highly homogenous and structured mixes

Grade

Description

Application

Sucrose Solution

Limpid, clear, viscous sugar syrup

For syrups and coatings

Liquid Sucrose

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Screened Sucrose USP/NF, EP, JP Grade

Particle size

Application

Caster Sugar 250

200 – 300 µm / 70 – 50 mesh

Extremely pure crystalline powder with fine, low coefficient particle size facilitating dissolution and ensuring a homogenous mixture. Used for granulation, dry syrup and coating

Caster Sugar N°1 400

300 – 500 µm / 50 – 35 mesh

A highly pure fine-grain crystalline powder. Facilitates preparation of syrups due to higher dissolution rate than crystal sugar. Used for granulation, dry syrup and coating

Crystal Sugar N°1 600

500 – 700 µm / 32 – 25 mesh

Crystal Sugar N°1 700

500 – 800 µm / 35 – 22 mesh

A highly pure crystalline powder recommended for applications requiring high quality clear solutions or coatings. Used for syrups, dry syrups and coating

Crystal Sugar N°1 800

700 – 1000 µm / 25 – 18 mesh

Coarse grain and very high level of purity of this crystalline powder makes it easy to pour, transfer and stock in bulk. Used for syrups, dry syrups and coating

Crystal Sugar N°1 1350 1100 – 1600 µm / 17 – 12 mesh Large sized without fine particles prevents agglomeration. Appreciated for its technical qualitites, especially for slow melting Crystal Sugar N°1 2000 1750 – 2250 µm / 11 – 9 mesh operations. Used for syrups, dry syrups and coating

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Hanns G. Werner The HANNS G. WERNER GMBH + Co. KG founded in 1952 and located in Germany is a manufacturer of exceptionally high quality neutral pellets (sugar spheres) and globuli sacchari (sugar globules). Their brand PHARM-A-SPHERES is known globally for superior quality sugar spheres confirming to USP/NF & EP monograph. Werner’s special manufacturing process enables ideal spherical shape, smooth-nonporous-solvent resistant surface and high mechanical stability to their sugar spheres.

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PHARM-A-SPHERES® Sugar Spheres (Non-pareil seeds) USP/NF, EP Pharm-a-spheres are inert / neutral pellets composed of sucrose and maize starch. They offer an excellent quality, a narrow particle size range, high sphericity allowing a precise calculation of drug quantity to be sprayed, perfect flow characteristics and high mechanical stability thus ensuring very low friability. Pharma-spheres are a modern drug excipient with multiple applications and are well-suited for solving problems like insufficient flow characteristics, interaction of ingredients and retardation of drug action. Werner’s range of pharm-a-spheres covers the whole spectrum of diameters from 100 µm to 2000 µm. Mesh Size (ASTM)

Diameter in mm (µm)

120 – 140

0,106 – 0,125

100 – 120

0,125 – 0,150

80 – 100

0,150 – 0,180

70 – 80

0,180 – 0,212

60 – 70

0,212 – 0,250

50 – 60

0,250 – 0,300

45 – 50

0,300 – 0,355

45 – 60

0,250 – 0,355

40 – 60

0,250 – 0,425

40 – 50

0,300 – 0,425

40 – 45

0,355 – 0,425

35 – 55

0,355 – 0,500

35 – 50

0,300 – 0,500

35 – 45

0,400 – 0,450

35 – 40

0,425 – 0,500

30 – 35

0,500 – 0,600

25 – 30

0,600 – 0,710

20 – 25

0,710 – 0,850

18 – 20

0,850 – 1,000

16 – 20

0,850 – 1,180

16 – 18

1,000 – 1,180

14 – 16

1,180 – 1,400

12 – 16

1,400 – 1,700

12 – 14

1,400 – 1,700

10 – 12

1,700 – 2,000

Application Used as drug-free cores for controlled or sustained release technologies

* Special sizes and mixtures are also possible.

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Dead Sea Periclase DEAD SEA PERICLASE, a division of ICL Industrial Products is the world’s leading producer of Magnesia products of exceptionally high purity. They operate from two plants (Israel & France) using different processes, both engineered to produce the highest quality and complimentary range of Magnesia products. The waters of the Dead Sea are the most concentrated naturally occuring solutions of dissolved salts in the world. These are the brines which serve as raw material for DSP’s plant. DSP's Magnesium Oxide, Magnesium Carbonate and Magnesium Hydroxide are characterised by extremely low levels of all metals; specifically low levels of lead. They are available in a wide range of pharmaceutical grades to be used in antacid preparations, mineral supplements and for a variety of other applications.

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MAGNESIUM OXIDE USP/NF, EP, BP Grade

Description

Application

Magnesium Oxide HA

Heavy grade - Sieved

Magnesium Oxide HA4

Heavy grade - Micronised

For use in the manufacture of antacid preparations, mineral supplements, as a food additive for colour retention, pH modifier and in the production of pharmaceutical grade magnesium derivatives

Magnesium Oxide HA5

Heavy grade - Micronised

Magnesium Oxide DC

Granular; Directly compressible grade

PHRA 50

Active pharmaceutical ingredient

MAGNESIUM CARBONATE USP/NF, EP, BP Grade

Description

Magnesium Carbonate BMC Light grade Magnesium Carbonate Heavy

Heavy grade

Application For use in the manufacture of antacid preparations and mineral supplements. In food, used as an anti-caking, free flowing agent, colour retainer, dessicant or pH modifier

MAGNESIUM HYDROXIDE USP/NF, EP, BP Grade

Description

Application

Magnesium Hydroxide HD5

Lowest bulk density grade

Magnesium Hydroxide HD7

Low bulk density grade

Spray dried, directly compressible powders for use in the manufacture of antacid preparations and mineral supplements. Different bulk densities offer a choice of compounding possibilities for tablet and powder dosage system

Magnesium Hydroxide HD9

Medium bulk density grade

Magnesium Hydroxide HD12 High bulk density grade

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Scora Established in 1931, SCORA located in Caffiers, France is a specialist in calcium and magnesium derivatives. Their deep insight in the chemistry of calcium and magnesium, specialised dedicated equipments and unique production process enables Scora manufacture speciality products of the highest purity with exceptional properties particularly valued in the pharmaceutical and nutraceutical industry. Scora’s products comply to USP/NF, EP, JP and are produced according to GMP rules.

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SCORALITE® Calcium Carbonate USP/NF, EP, JP, BP Scoralite is a very pure, highly free flowing synthetic calcium carbonate manufactured by using a unique synthesis process. Production of Scralite is carried out according to GMP rules and is supplied under a C-O-S from the European pharmacopeia. Grade

Description

Application

Scoralite

Heavy grade

Scoralite LL

Heavy grade with Low Lead

Used in the manufacture of antacid preparations, osteoporosis treatment, tablets and production of pharmaceutical calcium derivatives. Also used for mineral supplements, food additives and production of high purity compounds

MAGNESIUM OXIDE USP/NF, EP, BP Grade

Description

Application

Light Magnesium Oxide

Light grade, free flowing powder Used as a pH modifier, viscosity regulator and as a mineral supplement. Also used in the manufacture of antacids

* Scora can also provide tailor-made grades of Magnesium Oxide

MAGNESIUM CARBONATE USP/NF, EP, BP Grade

Description

Magnesium Carbonate BMC Basic Magnesium Carbonate

Application Used in the manufacture of antacid preparations & tablets and the production of magnesium derivatives. Also used as an anti-caking & free flowing agent and as a mineral supplement

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Cytec Industries CYTEC is the world’s leading supplier of Docusate Sodium (Dioctyl Ester of Sodium Sulfosuccinate - DSS), a versatile and highly effective anionic surfactant. Cytec manufactures pharmaceutical grade DSS products to the highest quality standards under cGMP, ensuring exceptional quality and performance for use as either active ingredients or excipients / formulating aids. They comply with USP & EP and are compatible with a broad range of active drugs. They meet worldwide recognised standards of quality, strength, purity and potency.

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DOCUSATE SODIUM USP, EP Dioctyl Ester of Sodium Sulfosuccinate Docusate Sodium (DSS) is one of the most versatile and effective anionic surfactants (surface active agents). It is an excellent solubilizing, wetting, dispersing, and emulsifying agent beneficial for use in oral dosage forms. Grade

Appearance

Application

DSS 100 %

Rolls of waxlike plastic sheets

Aids the granulation process, improves tablet disintegration and dissolution, facilitates tablet coating, emulsifies gels & liquid suspensions.

DSS Granular 85 % White crystalline with Sodium Benzoate powder DSS 50 % in Polyethylene glycol

White to yellow, clear viscous liquid

Also used as an active ingredient for laxatives and stool softeners, prenatal and geriatric vitamin preparations and ear wax removal compounds.

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Stepan Co. STEPAN founded in 1932 is a global manufacturer of anionic surfactants, germicidal quaternary compounds and other speciality products that include flavours, emulsifiers and solubilizers. With headquaters in Illinois, USA it has twelve manufacturing locations worldwide and over 1500 employees. Stepan’s SLS (Sodium Lauryl Sulfate) is very popular in the pharmaceutical industry, is compliant with most pharmacopeias and has all regulatory approvals.

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STEPANOL® Sodium Lauryl Sulfate USP/NF, EP, JP, BP Stepanol WA-100 is sodium lauryl sulfate produced from the sulfation of fatty alcohol via Stepan's SO3 process. The product of this process is then spray dried to produce a high active powder of exceptional quality. Grade

Description

Application

Stepanol WA-100

Sodium Lauryl Sulfate

Tablet and capsule lubricant, wetting agent, anionic surfactant, emulsifying agent, skin penetrant and skin cleanser in topical applications

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GumBase Co. GUMBASE CO. founded in 1967 is a world leader in the manufacture of compressed powder gum base, chewing gum base and bubble gum base for the pharmaceutical, nutraceutical and confectionary industry. With headquarters in Italy it has sales in over 130 countries and delivers a range of more than 200 different gum base formulations supplied in five different shapes according to customer's requests on product pecularities. At GumBase Co. quality is a matter of constant dedication and improvements. It has achieved BRC (British Retail Consortium) certification which is a global standard that goes beyond other quality standards like HACCP and ISO

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GUM BASE Non-nutritive masticatory substance The chewing gum base is an inert, insoluble preparation designed to deliver flavours, minerals, vitamins, sweetners, functional and pharmaceutical active principles. It is not designed or intended to be swallowed but is removed and disposed adequately after consumption. In the pharma industry, it is now considered as a new, alternative drug delivery system. Unique formulations have been designed with gum base for smoking reduction, weight management, heart-burn relief, dry mouth relief, stress reduction, memory & concentration improvement, pain relief, breath freshening, dental health, etc. Grade

Description

MedGumBase®

Specific gum base Absorption through oral mucosa, good distribution of developed for medicated active principles, easy & pleasant administration, chewing gums consumer controlled dosage and kinetics controlled active principle release. Directly compressible Product can be taken anywhere at any time as it does not chewing gum base require liquids for swallowing and is ready-for-use in powder enabling a cold emergencies. and dry process which protects delicate functional ingredients / actives.

CPG®

Advantages

* Available in flavours as well as without flavours. Conventional chewing gum base and Bubble gum base can also be provided.

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Stearinerie Dubois Founded in 1820 in France, STEARINERIE DUBOIS develops, manufactures and sells a wide range of fatty acid esters specialities for the pharmaceutical, food and cosmetic industry. Their products coming from oleochemistry have outstanding properties and are used as lubricants, solubilizers, compressing agents, suppositories bases etc. With it’s plant located in Scoury, France; Stearinerie Dubois is committed to producing high quality products and has obtained the international ISO 9001 : 2000 certification. Their specialities comply to global pharmacopeias viz. USP/NF & EP, are exclusively of vegetable and/or synthetic origin and are widely used for tablets and granules, hard and soft capsules, solutions, creams and lotions, coating, suppositories etc.

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DUB MICROLUBTM Stearic Acid USP/NF, EP Stearic acid is a mixture of stearic acid (C18H36O2) and palmitic acid (C16H32O2). The content of stearic acid is not less than 40%. The content of palmitic acid is not less than 40% and the sum of the two is not less than 90%. Hard, white or faintly yellowish, somewhat glossy and crystalline solid or white / yellowish white powder; it’s odor and taste are slight, suggesting tallow. Grade

Description

Application

DUB Microlub 70

Stearic Acid 70% - Micronised powder

DUB Microlub 50

Stearic Acid 50% - Micronised powder

DUB PO 70

Stearic Acid 70% - Fine powder

Used as tablet lubricant. Micronised grades imparts a smooth surface to the film coated tablets. Also used as emulsifying and solubilizing agent in topical formulations.

DUB PO 50

Stearic Acid 50% - Fine powder

DUB 70 P

Stearic Acid 70% - Pellets

DUB 50 P

Stearic Acid 50% - Pellets

* Also available is Stearic Acid 95% in flakes form

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

Description

Application

DUB SE 3S

Sucrose tristearate

DUB SE 5S

Sucrose distearate

Used as tablet and / or capsule lubricant, solubilizing agent, foaming enhancer and as an emulsifier to stabilise oil-into water emulsions

DUB SE 11S

Sucrose stearate

DUB SE 15P

Sucrose palmitate

DUB SE 16P

Sucrose palmitate

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DUB MCTTM Medium Chain Triglycerides USP/NF, EP Medium chain triglycerides are a class of fatty acids. Their chemical composition is of a shorter length than the long-chain fatty acids present in most other fats and oils, which accounts for their name. They are also different from other fats in that they have a slightly lower calorie content and they are more rapidly absorbed and burned as energy, resembling carbohydrate more than fat. The unique metabolic and functional properties of MCT, a consequence of their chemical structure make them versatile ingredients in numerous pharmaceutical applications. Grade

Appearance

Application

DUB MCT 5545

Oily liquid

Used as plasticizer, tablet lubricant and as solutions & suspension base for parenterals. Also used for dietetic preparations (energy with low calorie)

DUB MCT 7030 DUB MCT 6535

DUB GMS Glyceryl Stearate EP Grade

Appearance

Application

DUB GMS

Liquid

Mild emulsifier, used as a co-emulsifier. Also used as a thickener for hard and soft capsules

DUB GMS SE

Pellets

DUB DBS Dibutyl Sebacate Grade

Appearance

Application

DUB DBS

Fatty liquid

Used as plasticizer for tablets and granules

DUB DBHG Glyceryl Dibehenate EP Grade

Appearance

Application

DUB DBHG

Fine, micronised powder

Used as lubricant for tablets. Also can be used as lipidic matrix for sustained release

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DUB PP Hemi-synthetic Glycerides USP/NF, EP DUB PP are hard fat suppository bases and are a mixture of triglycerides, diglycerides and monodiglycerides which may be obtained either by esterification of natural fatty acids with glycerol or by interesterification of natural fats. Each type of hard fat is characterised by it's melting point, its saponification value and its hydroxyl value. These suppository bases, DUB PP are made from vegetable fatty acids. They are presented in pellets form allowing an easier use and are non-toxic & neutral in active principles. Moreover, they do not contain any oxidizing nor stabilizing agent. Grade

Saponification Value Melting Point (C°)

Hydroxyl Value

DUB PP C 3

230 - 240

33 - 35

20 - 30

DUB PP CDL 1

225 - 245

33,5 - 35,5

≤ 15

DUB PP D 1

234 - 247

34 - 36

≤ 10

DUB PP E 1

235 - 245

35 - 36,5

≤ 10

DUB PP E 3

235 - 245

35 - 36,5

20 - 30

DUB PP F 1

235 - 245

36 - 37,5

≤ 10

DUB PP H 1

230 - 240

38 - 40

≤ 10

DUB PP M 1

223 - 233

42 - 44

≤ 10

DUB PP KC 3

225 - 240

33,5 - 35,5

20 - 30

DUB PP KCD 1

235 - 245

33,5 - 35,5

≤ 15

DUB PP KD 3

225 - 240

34 - 36

20 - 30

DUB PP KE 3

215 - 236

35,5 - 37,5

20 - 30

DUB PP KF 1

235 - 250

36 - 38

≤ 15

Application Multipurpose Suppository Bases

Specific Suppository Bases

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Lonza Lonza SpA ( Polynt SpA), a division of the Swiss-based Alusuisse-Lonza group manufactures a broad range of additives, polymers and speciality chemicals for the pharmaceutical and food industry. With over 5300 employees and sales worth CHF 1.7 billion; it has several plants in Europe, UK and USA. Lonza manufactures Malic Acid by hydration of Maleic Anhydride at high temperature and pressure in their very modern plant in Bargamo, Italy with world class accredition.

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MALIC ACID D-L Malic Acid USP/NF, EP Malic Acid is widely found in nature and is the predominant organic acid in many fruits and berries. It plays an essential role in carbohydrate metabolism and therefore used in the production of basic energy for cellular processes. In the pharmaceutical industy, malic acid is used by blending it with essences and flavours. It's acid taste builds up slowly at the begining but persists for a very long period. The final effect is to give an enhanced sensation of a stronger taste. Grade

Description

Malic acid granular

Has the ability to enhance the Used in throat lozenges, cough syrups, effect of the aromas used to effervescent powders and tablets mask the undesirable tastes and smells of medicinals

Malic acid fine granular Malic acid special fine granular

Application

Malic acid powder

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Musashino Chemical Laboratory MUSASHINO CHEMICAL LABORATORY LTD., are leading manufacturers of Lactic Acid, D-L-alanine and Pyruvic Acid. Established in 1949, they have fulfilled their mission with over a half century of accumulated research, development and production technology, using environmentally friendly facilities to produce highquality products that seek fine balance between the needs of the human race and the environment. Musashino's products are of excellent quality and are used for manufacturing pharmaceuticals, foods & brewing, cosmetics and other industrial products. Their products are used in a variety of applications all over the world.

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LACTIC ACID USP/NF, EP, JP Lactic acid is prepared synthetically by reaction between acetaldehyde and carbon monoxide at high temperature and pressure or by the hydrolysis of hexoses with sodium hydroxide. Grade

Description

Application

D-L Lactic Acid

Synthetic grade Purity 88.0% - 92.0%

In injections in the form of lactates, as an acidifying agent / acidulant and in topical formulations as a softener

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Glossary Brand Ac-Di-Sol Alveosucre Aqoat Aquacoat A-Tab Avicel CE Avicel PH Avicel RC/CL Blanose Calipharm Calopake Caster Sugar / Crystal Sugar Celphere Ceolus KG Compressuc Cremophor Crysmeb Dextrose Anhydrous PF Dextrose GC Di-Tab Docusate Sodium (DSS) DUB DBHG DUB DBS DUB GMS DUB MCT DUB Microlub DUB PP DUB SE Ethyl Cellulose Flolys G-D-L Glucidex Glycolys Hi-Sweet HPMCP Icing Sugar Kleptose Kleptose HPB Klucel Kollicoat IR Kollicoat MAE / EMM Kollicoat SR 30 D Kollidon Kollidon CL Kollidon SR Kollidon VA 64 Kronos 1171 Titanium Dioxide Lactic Acid Lactochem Lactopress Anhydrous 250 Lactopress Spray Dried 250 L-HPC Ludipress LustreClear LC 103

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Product

Company

Page

Croscarmellose Sodium (Crosslinked Sodium CMC) Agglomerated Sucrose Hydroxypropylmethylcellulose Acetate Succinate (HPMCAS) Aqueous Dispersion for modified release Dicalcium Phosphate Anhydrous, Granular (DCPDA) Microcrystalline Cellulose and Guar Gum Microcrystalline Cellulose (MCC) Microcrystalline Cellulose and Sodium CMC (Hydrocolloid) Sodium Carboxymethylcellulose (Na CMC) Calcium Phosphate Precipitated Calcium Carbonate (Extra Light) Screened Sucrose Microcrystalline Cellulose Spheres Microcrystalline Cellulose (Ultracompactible) Directly Compressible Sucrose Non-ionic surfactant Low MS Methyl Betacyclodextrin Injectable Glucose Anhydrous Directly Compressible Glucose Monohydrate Dicalcium Phosphate Dihydrate, Granular (DCPD) Dioctyl Ester of Sodium Sulfosuccinate Glyceryl Dibehenate Dibutyl Sebacate Glyceryl Stearate Medium Chain Triglycerides Stearic Acid Hemi-synthetic Glycerides Sucrose Esters Ethyl Cellulose Dextrose Syrup Glucono Delta Lactone Maltodextrin Sodium Starch Glycolate High Fructose Corn Syrup (HFCS) Hydroxypropylmethylcellulose Phthalate Milled Sucrose Betacyclodextrin Hydroxy Propyl Betacyclodextrin Hydroxy Propyl Cellulose PVA and PEG graft co-polymer for instant release Methacrylic Acid Copolymer / Ethyl Acrylate Aqueous dispersion of PVA and PVP Povidone (PVPK, 12PF, 17PF, 25, 30, 90F) Crosspovidone (Crosslinked PVP) Matrix Sustained Release Excipient Copolyvidone Vinylacetate Copolymer Anatase & Superwhite Grade D-L Lactic Acid Lactose Monohydrate DC Lactose DC Lactose Low-Substituted Hydroxypropyl Cellulose Advanced Excipient for direct compression MCC & Carrageenan based Aqueous Film Coating System

FMC BIOPOLYMER TEREOS SHIN-ETSU FMC BIOPOLYMER INNOPHOS FMC BIOPOLYMER FMC BIOPOLYMER FMC BIOPOLYMER AQUALON - HERCULES INNOPHOS SPECIALTY MINERALS TEREOS ASAHI-KASEI ASAHI-KASEI TEREOS BASF ROQUETTE ROQUETTE ROQUETTE INNOPHOS CYTEC STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS AQUALON - HERCULES ROQUETTE ROQUETTE ROQUETTE ROQUETTE ROQUETTE SHIN-ETSU TEREOS ROQUETTE ROQUETTE AQUALON - HERCULES BASF BASF BASF BASF BASF BASF BASF KRONOS MUSASHINO DOMO DOMO DOMO SHIN-ETSU BASF FMC BIOPOLYMER

11 59 28 12 42 11 10 11 32 42 56 60 40 40 58 38 23 23 23 42 68 75 75 75 75 74 76 74 30 23 19 24 22 21 26 58 23 23 31 35 36 36 34 35 35 34 52 80 44 44 44 28 37 12

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Brand Lutrol E Lutrol F Lycadex PF Lycasin Lycatab Lycatab Mineral CC Lycoat Magnabrite Magnesium Carbonate Magnesium Hydroxide Magnesium Oxide Malic Acid Maltisorb Marine Colloids MedGumBase / CPG Metolose SH Metolose SM Metolose SR Natrosol 250 Pharm Neosorb Nutriose PCS PC-10 Pearl Sugar Pearlitol Pharmacoat Pharm-a-spheres Polysorb 85/70/00 Pronova UP / SL Protacid Protanal Protasan UP PVP Iodine ReadiLYCOAT Roclys Roferose Scoralite Sicovit Sodium Hyaluronate Solulys AST Soluphor Soluten 50 Solutol HS 15 Starch Starlac Stepanol Sturcal L Sucrose Solution Synpro Stearates Tackidex Talc Luzenac Pharma Trehalose Tri-Tab Xantural Xylisorb

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Product

Company

Page

Polyethylene Glycol (PEG) / Macrogol Poloxamer Injectable Dextrose Monohydrate Maltitol Solution Modified Starch Compound of Calcium Carbonate and Maize Starch Peas Starch based Aqueous Film Coating System Magnesium Aluminium Silicate High Purity Magnesium Carbonate Spray Dried, DC Magnesium Hydroxide High Purity Magnesium Oxide D-L Malic Acid Maltitol Carrageenan Medicated Chewing Gum Base / DC Chewing Gum Base Hydroxypropyl Methylcellulose (HPMC - High viscosity) Methyl Cellulose (MC) Hydroxypropyl Methylcellulose (HPMC - Sustained Release grades) Hydroxy Ethyl Cellulose Sorbitol Soluble Fibre Partly Pregelatinised Starch Sucrose grains Mannitol / DC Manitol Hydroxypropyl Methylcellulose (HPMC - Low viscosity) Sugar Spheres (Non-Pareil Seeds) Aqueous Solution of D-Sorbitol & Sorbitan Ultrapure / Sterile Sodium Alginate Alginic Acid Alginate Ultrapure Chitosan Salt Povidone-Iodine Ready-to-use, Aqueous film coating system Dextrose Syrup Dextrose Monohydrate Calcium Carbonate of high purity Iron Oxide Pharma Grade Sodium Hyaluronate Corn-Steep powder 2-Pyrrolidone Cellulose free, high vegetable protein Macrogol-15-Hydroxystearate Maize (Corn) / Potato / Wheat Directly compressible Starch & Lactose compound Sodium Lauryl Sulfate Precipitated Calcium Carbonate (Heavy) Liquid Sucrose Synpro Stearates - Mg Stearate / Ca Stearate / Zn Sterate / Na Stearate Dextrin Talc Non-reducing Di-Saccharide Tricalcium Phosphate Anhydrous, Granular (TCP) Xanthan Gum Xylitol

BASF BASF ROQUETTE ROQUETTE ROQUETTE ROQUETTE ROQUETTE HBS (AMCOL) DEAD SEA / SCORA DEAD SEA DEAD SEA / SCORA LONZA ROQUETTE FMC BIOPOLYMER GUMBASE CO. SHIN-ETSU SHIN-ETSU SHIN-ETSU AQUALON - HERCULES ROQUETTE ROQUETTE ASAHI-KASEI TEREOS ROQUETTE SHIN-ETSU WERNER ROQUETTE NOVAMATRIX FMC BIOPOLYMER FMC BIOPOLYMER NOVAMATRIX BASF ROQUETTE ROQUETTE ROQUETTE SCORA BASF NOVAMATRIX ROQUETTE BASF ROQUETTE BASF ROQUETTE ROQUETTE STEPAN SPECIALTY MINERALS TEREOS FERRO ROQUETTE RIO TINTO (LUZENAC) ASAHI-KASEI INNOPHOS CP KELCO ROQUETTE

37 37 23 20 21 21 20 54 64 64 64 78 20 14 72 27 27 27 30 19 22 40 59 18 26 62 19 15 13 13 16 36 20 23 23 66 38 16 19 36 19 38 21 22 70 56 59 50 24 48 40 42 46 20

82

Signet Chemical Corporation Pvt. Ltd. Corporate Office: B-305, Neelam Centre Hind Cycle Road Worli, Mumbai 400 030 India Phone: +91 22 24937725 Fax: +91 22 24937726 Email: [email protected]

Warehouse: L-9, Shree Rajlaxmi Commercial Complex Kalher, Bhiwandi 421 302 Phone: +91 2522 277366 Fax: + 91 2522 277366 Email: [email protected]

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