01 Excipients Prelims 1 9 Handbook of Pharmaceutical Excipients Handbook of Pharmaceutical Excipients S I X T H E D I T I O N Edited by Raymond C Rowe BPharm, PhD, DSC, FRPharmS, FRSC, CPhys, MInstP C[.]
=VcYWdd`d[ E]VgbVXZji^XVa:mX^e^Zcih H^mi]ZY^i^dc :Y^iZYWn GVnbdcY8GdlZ!EVja?H]Zh`ZnVcYBVg^Vc:Fj^cc Handbook of Pharmaceutical Excipients Handbook of Pharmaceutical Excipients SIXTH EDITION Edited by Raymond C Rowe BPharm, PhD, DSC, FRPharmS, FRSC, CPhys, MInstP Chief Scientist Intelligensys Ltd, Stokesley, North Yorkshire, UK Paul J Sheskey BSc, RPh Application Development Leader The Dow Chemical Company, Midland, MI, USA Marian E Quinn BSc, MSc Development Editor Royal Pharmaceutical Society of Great Britain, London, UK London Chicago Published by the Pharmaceutical Press An imprint of RPS Publishing Lambeth High Street, London SE1 7JN, UK 100 South Atkinson Road, Suite 200, Grayslake, IL 60030-7820, USA and the American Pharmacists Association 2215 Constitution Avenue, NW, Washington, DC 20037-2985, USA # Pharmaceutical Press and American Pharmacists Association 2009 is a trade mark of RPS Publishing RPS Publishing is the publishing organisation of the Royal Pharmaceutical Society of Great Britain First published 1986 Second edition published 1994 Third edition published 2000 Fourth edition published 2003 Fifth edition published 2006 Sixth edition published 2009 Typeset by Data Standards Ltd, Frome, Somerset Printed in Italy by L.E.G.O S.p.A ISBN 978 85369 792 (UK) ISBN 978 58212 135 (USA) All rights reserved No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without the prior written permission of the copyright holder The publisher makes no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made A catalogue record for this book is available from the British Library Contents Preface x Arrangement xi Acknowledgments xiii Notice to Readers xiii International Steering Committee Editorial Staff xv Contributors xvi About the Editors xx New Monographs xxi Related Substances xxii Bibliography xxiv Abbreviations xxv Units of Measurement xxvii xiv Benzalkonium Chloride 56 Benzethonium Chloride 59 Benzoic Acid Benzyl Alcohol 61 64 Benzyl Benzoate Boric Acid 66 68 Bronopol 70 Butylated Hydroxyanisole Butylated Hydroxytoluene 73 75 Butylene Glycol Butylparaben 77 78 82 Monographs A Acacia C Calcium Acetate Acesulfame Potassium Acetic Acid, Glacial Calcium Alginate Calcium Carbonate 83 86 Acetone Calcium Chloride 89 Acetyltributyl Citrate Acetyltriethyl Citrate 10 Calcium Hydroxide Calcium Lactate 91 92 Adipic Acid Agar 11 13 Calcium Phosphate, Dibasic Anhydrous Calcium Phosphate, Dibasic Dihydrate 94 96 Albumin 14 Calcium Phosphate, Tribasic 99 Alcohol Alginic Acid 17 20 Calcium Silicate Calcium Stearate 101 103 Aliphatic Polyesters Alitame 23 28 Calcium Sulfate Canola Oil 105 108 Almond Oil Alpha Tocopherol 29 31 Carbomer 110 Aluminum Hydroxide Adjuvant 34 Carbon Dioxide Carboxymethylcellulose Calcium 115 117 Aluminum Monostearate Aluminum Oxide 35 37 Carboxymethylcellulose Sodium Carrageenan 118 122 Aluminum Phosphate Adjuvant Ammonia Solution 38 39 Castor Oil 126 Ammonium Alginate 41 Castor Oil, Hydrogenated Cellulose, Microcrystalline 128 129 Ammonium Chloride Ascorbic Acid 42 43 Ascorbyl Palmitate Aspartame 46 48 Cellulose, Microcrystalline and Carboxymethylcellulose Sodium Cellulose, Powdered 134 136 Attapulgite 51 Cellulose, Silicified Microcrystalline Cellulose Acetate 139 141 Cellulose Acetate Phthalate 143 Ceratonia Ceresin 146 148 B Bentonite 53 vi Contents Cetostearyl Alcohol 150 Erythritol 251 Cetrimide 152 Ethyl Acetate 253 Cetyl Alcohol Cetylpyridinium Chloride 155 157 Ethyl Lactate Ethyl Maltol 256 257 Chitosan Chlorhexidine 159 162 Ethyl Oleate Ethyl Vanillin 259 261 Chlorobutanol 166 Ethylcellulose 262 Chlorocresol Chlorodifluoroethane (HCFC) 168 171 Ethylene Glycol Stearates Ethylene Vinyl Acetate 267 268 Chlorofluorocarbons (CFC) Chloroxylenol 173 176 Ethylparaben 270 Cholesterol 178 F Citric Acid Monohydrate Coconut Oil 181 184 Fructose Fumaric Acid 273 276 Colloidal Silicon Dioxide Coloring Agents 185 189 Copovidone Corn Oil 196 199 G Gelatin 278 Corn Starch and Pregelatinized Starch 200 Glucose, Liquid Glycerin 282 283 Cottonseed Oil Cresol 202 203 Glyceryl Behenate 286 Croscarmellose Sodium Crospovidone 206 208 Glyceryl Monooleate Glyceryl Monostearate 288 290 Cyclodextrins 210 Glyceryl Palmitostearate Glycine 293 295 Cyclomethicone 215 Glycofurol Guar Gum 297 298 Denatonium Benzoate Dextrates 217 218 H Hectorite 301 Dextrin Dextrose 220 222 Heptafluoropropane (HFC) 303 Dibutyl Phthalate 225 Hexetidine Hydrocarbons (HC) 304 306 Dibutyl Sebacate Diethanolamine 227 228 Hydrochloric Acid Hydrophobic Colloidal Silica 308 309 Diethyl Phthalate Difluoroethane (HFC) 230 232 Hydroxyethyl Cellulose 311 Dimethicone 233 Hydroxyethylmethyl Cellulose Hydroxypropyl Betadex 314 315 Dimethyl Ether Dimethyl Phthalate 235 236 Hydroxypropyl Cellulose Hydroxypropyl Cellulose, Low-substituted 317 322 Dimethyl Sulfoxide Dimethylacetamide 238 241 Hydroxypropyl Starch 325 Disodium Edetate 242 Hypromellose Hypromellose Acetate Succinate 326 330 Docusate Sodium 244 Hypromellose Phthalate 333 D E Edetic Acid Erythorbic Acid I 247 250 Imidurea Inulin 337 339 Contents vii Iron Oxides 340 Methionine 436 Isomalt 342 Methylcellulose 438 Isopropyl Alcohol Isopropyl Myristate 346 348 Methylparaben Mineral Oil 441 445 Isopropyl Palmitate 350 Mineral Oil, Light Mineral Oil and Lanolin Alcohols 447 449 Monoethanolamine 450 Monosodium Glutamate Monothioglycerol 452 454 Myristic Acid Myristyl Alcohol 455 456 K Kaolin 352 L Lactic Acid 355 Lactitol Lactose, Anhydrous 357 359 Lactose, Inhalation 362 Lactose, Monohydrate Lactose, Monohydrate and Corn Starch 364 370 Lactose, Monohydrate and Microcrystalline Cellulose 371 Lactose, Monohydrate and Povidone 373 N Neohesperidin Dihydrochalcone Neotame 458 460 Nitrogen Nitrous Oxide 461 463 Lactose, Monohydrate and Powdered Cellulose 374 O Lactose, Spray-Dried Lanolin 376 378 Octyldodecanol Oleic Acid 465 466 Lanolin, Hydrous Lanolin Alcohols 380 382 Oleyl Alcohol Olive Oil 468 470 Lauric Acid 383 Lecithin Leucine 385 387 Linoleic Acid 389 M P Palmitic Acid Paraffin 473 474 Peanut Oil Pectin 476 478 Macrogol 15 Hydroxystearate 391 Pentetic Acid 480 Magnesium Aluminum Silicate Magnesium Carbonate 393 397 Petrolatum Petrolatum and Lanolin Alcohols 481 484 Magnesium Oxide Magnesium Silicate 400 402 Phenol Phenoxyethanol 485 488 Magnesium Stearate 404 Phenylethyl Alcohol 490 Magnesium Trisilicate Maleic Acid 408 410 Phenylmercuric Acetate Phenylmercuric Borate 492 494 Malic Acid Maltitol 411 414 Phenylmercuric Nitrate Phospholipids 496 499 Maltitol Solution 416 Phosphoric Acid 503 Maltodextrin Maltol 418 421 Polacrilin Potassium Poloxamer 504 506 Maltose Mannitol 422 424 Polycarbophil Polydextrose 509 513 Medium-chain Triglycerides 429 Poly (DL-Lactic Acid) 515 Meglumine Menthol 431 433 Polyethylene Glycol Polyethylene Oxide 517 522 viii Contents Polymethacrylates 525 Sodium Citrate Dihydrate 640 Poly(methyl vinyl ether/maleic anhydride) 534 Sodium Cyclamate 643 Polyoxyethylene Alkyl Ethers Polyoxyethylene Castor Oil Derivatives 536 542 Sodium Formaldehyde Sulfoxylate Sodium Hyaluronate 645 646 Polyoxyethylene Sorbitan Fatty Acid Esters Polyoxyethylene Stearates 549 554 Sodium Hydroxide Sodium Lactate 648 650 Polyoxylglycerides 557 Sodium Lauryl Sulfate 651 Polyvinyl Acetate Phthalate Polyvinyl Alcohol 562 564 Sodium Metabisulfite Sodium Phosphate, Dibasic 654 656 Potassium Alginate Potassium Alum 566 567 Sodium Phosphate, Monobasic Sodium Propionate 659 661 Potassium Benzoate 569 Sodium Starch Glycolate 663 Potassium Bicarbonate Potassium Chloride 570 572 Sodium Stearyl Fumarate Sodium Sulfite 667 669 Potassium Citrate Potassium Hydroxide 574 576 Sodium Thiosulfate Sorbic Acid 671 672 Potassium Metabisulfite Potassium Sorbate 577 579 Sorbitan Esters (Sorbitan Fatty Acid Esters) Sorbitol 675 679 Povidone 581 Soybean Oil 682 Propionic Acid Propyl Gallate 586 587 Starch Starch, Pregelatinized 685 691 Propylene Carbonate Propylene Glycol 590 592 Starch, Sterilizable Maize Stearic Acid 695 697 Propylene Glycol Alginate 594 Stearyl Alcohol 700 Propylparaben Propylparaben Sodium 596 599 Sucralose Sucrose 701 703 Pyrrolidone 600 Sucrose Octaacetate Sugar, Compressible 707 709 Sugar, Confectioner’s 710 Sugar Spheres Sulfobutylether b-Cyclodextrin 712 714 Sulfur Dioxide Sulfuric Acid 718 719 Sunflower Oil 721 Suppository Bases, Hard Fat 722 R Raffinose 603 S Saccharin Saccharin Sodium 605 608 Safflower Oil 610 Saponite Sesame Oil 612 614 Shellac Simethicone 616 619 T Tagatose 727 Sodium Acetate 620 Talc 728 Sodium Alginate Sodium Ascorbate 622 625 Tartaric Acid Tetrafluoroethane (HFC) 731 733 Sodium Benzoate Sodium Bicarbonate 627 629 Thaumatin Thimerosal 735 736 Sodium Borate 633 Thymol 739 Sodium Carbonate Sodium Chloride 635 637 Titanium Dioxide Tragacanth 741 744 Contents ix Trehalose 746 Wax, White 779 Triacetin 748 Wax, Yellow 780 Tributyl Citrate Tricaprylin 749 751 Triethanolamine Triethyl Citrate 754 756 Triolein 757 X Xanthan Gum Xylitol 782 786 V Vanillin Vegetable Oil, Hydrogenated 760 762 Vitamin E Polyethylene Glycol Succinate 764 W Water Wax, Anionic Emulsifying 766 770 Wax, Carnauba 772 Wax, Cetyl Esters Wax, Microcrystalline 774 775 Wax, Nonionic Emulsifying 777 Z Zein Zinc Acetate 790 791 Zinc Stearate 793 Appendix I: Suppliers Directory 795 Appendix II: List of Excipient ‘E’ Numbers Appendix III: List of Excipient ‘EINECS’ Numbers 847 849 Appendix IV: List of Excipient Molecular Weights 852 Index 855