Handbook of Pharmaceutical Excipients FIFTH EDITION Edited by Raymond C Rowe BPharm, PhD, DSc, FRPharmS, CChem, FRSC, CPhys, MlnstP Chief Scientist Intelligensys Ltd Billingham, UK Paul J Sheskey BSc, RPh Technical Services Leader The Dow Chemical Company Midland Ml, USA Sian C Owen BSc, MA Development Editor Royal Pharmaceutical Society of Great Britain London, UK APhA London Chicago (RP) Pharmaceutical Press
Contents International Steering Committee ix Editorial Staff ix Contributors x About the Editors xii New Monographs xiii Related Substances xiv Preface xvi Arrangement xvii Acknowledgments xix Notice to Readers xix Bibliography xx Abbreviations xx Units of Measurement xxii Ascorbyl Palmitate Aspartame Attapulgite Bentonite Benzalkonium Chloride Benzethonium Chloride Benzoic Acid Benzyl Alcohol Benzyl Benzoate Boric Acid Bronopol Butylated Hydroxyanisole 51 53 56 58 61 64 66 69 72 74 76 79 Butylated Hydroxytoluene 81 Monographs Butylparaben 83 Calcium Alginate 86 Acacia 1 Calcium Carbonate 89 Acesulfame Potassium 4 Calcium Phosphate, Dibasic Anhydrous 93 Acetic Acid, Glacial 6 Calcium Phosphate, Dibasic Dihydrate 96 Acetone 8 Calcium Phosphate, Tribasic 100 Acetyltributyl Citrate 10 Calcium Stearate 102 Acetyltriethyl Citrate 12 Calcium Sulfate 105 Agar 14 Canola Oil 108 Albumin 16 Carbomer 111 Alcohol 18 Carbon Dioxide 116 Alginic Acid 21 Carboxymethylcellulose Calcium 118 Aliphatic Polyesters 24 Carboxymethylcellulose Sodium 120 Alitame 28 Carrageenan 124 Almond Oil 30 Castor Oil 128 Alpha Tocopherol 32 Castor Oil, Hydrogenated 130 Aluminum Hydroxide Adjuvant 36 Cellulose, Microcrystalline 132 Aluminum Oxide 38 Cellulose, Powdered 136 Aluminum Phosphate Adjuvant 40 Cellulose, Silicified Microcrystalline 139 Aluminum Stearate 42 Cellulose Acetate 142 Ammonia Solution 44 Cellulose Acetate Phthalate 145 Ammonium Alginate 46 Ceratonia 148 Ascorbic Acid 48 Cetostearyl Alcohol 150
VI Contents Cetrimide Cetyl Alcohol Cetylpyridinium Chloride Chitosan Chlorhexidine Chlorobutanol Chlorocresol Chlorodifluoroethane (HCFC) Chlorofluorocarbons (CFC) Chloroxylenol Cholesterol Citric Acid Monohydrate Colloidal Silicon Dioxide Coloring Agents Copovidone Corn Oil Cottonseed Oil Cresol Croscarmellose Sodium Crospovidone 152 155 157 159 163 168 171 174 176 180 182 185 188 192 201 204 206 208 211 214 Ethyl Oleate Ethyl Vanillin Ethylcellulose Ethylene Glycol Palmitostearate Ethylene Vinyl Acetate Ethylparaben Fructose Fumaric Acid Gelatin Glucose, Liquid Glycerin Glyceryl Behenate Glyceryl Monooleate Glyceryl Monostearate Glyceryl Palmitostearate Glycofurol Guar Gum Hectorite Heptafluoropropane (HFC) Hexetidine 274 276 278 283 285 287 290 293 295 299 301 304 306 308 311 313 315 318 321 323 Cyclodextrins 217 Hydrocarbons (HC) 325 Cyclomethicone 222 Hydrochloric Acid 328 Denatonium Benzoate 224 Hydroxyethyl Cellulose 330 Dextrates 226 Hydroxyethylmethyl Cellulose 334 Dextrin 228 Hydroxypropyl Cellulose 336 Dextrose 231 Hydroxypropyl Cellulose, Low-substituted 341 Dibutyl Phthalate 234 Hydroxypropyl Starch 344 Dibutyl Sebacate 236 Hypromellose 346 Diethanolamine 238 Hypromellose Acetate Succinate 350 Diethyl Phthalate 240 Hypromellose Phthalate 354 Difluoroethane (HFC) 242 Imidurea 359 Dimethicone 244 Inulin 362 Dimethyl Ether 246 Iron Oxides 364 Dimethyl Phthalate 248 Isomalt 366 Dimethyl Sulfoxide 250 Isopropyl Alcohol 371 Dimethylacetamide 253 Isopropyl Myristate 374 Disodium Edetate 255 Isopropyl Palmitate 376 Docusate Sodium 257 Kaolin 378 Edetic Acid 260 Lactic Acid 381 Erythorbic Acid 264 Lactitol 383 Erythritol 266 Lactose, Anhydrous 385 Ethyl Acetate 268 Lactose, Monohydrate 389 Ethyl Lactate 270 Lactose, Spray-Dried 396 Ethyl Maltol 272 Lanolin 399
Contents VII Lanolin Alcohols Lanolin, Hydrous 402 404 Petrolatum and Lanolin Alcohols Phenol 512 514 Laurie Acid Lecithin 406 409 Phenoxyethanol Phenylethyl Alcohol 517 519 Leucine 412 Phenylmercuric Acetate 521 Linoleic Acid 414 Phenylmercuric Borate 524 Macrogol 15 Hydroxystearate 416 Phenylmercuric Nitrate 526 Magnesium Aluminum Silicate 418 Phosphoric Acid 530 Magnesium Carbonate 422 Polacrilin Potassium 532 Magnesium Oxide 426 Poloxamer 535 Magnesium Silicate 428 Polycarbophil 539 Magnesium Stearate 430 Polydextrose 542 Magnesium Trisilicate 434 Polyethylene Glycol 545 Malic Acid 436 Polyethylene Oxide 551 Maltitol 438 Polymethacrylates 553 Maltitol Solution 440 Polyfmethyl vinyl ether/maleic anhydride) 561 Maltodextrin 442 Polyoxyethylene Alkyl Ethers 564 Maltol 445 Polyoxyethylene Castor Oil Derivatives 572 Maltose 447 Polyoxyethylene Sorbitan Fatty Acid Esters 580 Mannitol 449 Polyoxyethylene Stearates 585 Medium-chain Triglycerides 454 Polyvinyl Acetate Phthalate 589 Meglumine 457 Polyvinyl Alcohol 592 Menthol 459 Potassium Alginate 594 Methylcellulose 462 Potassium Benzoate 596 Methylparaben 466 Potassium Bicarbonate 598 Mineral Oil 471 Potassium Chloride 600 Mineral Oil, Light 474 Potassium Citrate 603 Mineral Oil and Lanolin Alcohols 476 Potassium Hydroxide 605 Monoethanolamine 478 Potassium Metabisulfite 607 Monosodium Glutamate 480 Potassium Sorbate 609 Monothioglycerol Myristic Acid 482 484 Povidone Propionic Acid 611 617 Neohesperidin Dihydrochalcone 486 Propyl Gal late 619 Nitrogen 488 Propylene Carbonate 622 Nitrous Oxide 490 Propylene Glycol 624 Octyldodecanol 492 Propylene Glycol Alginate 627 Oleic Acid 494 Propylparaben 629 Oleyl Alcohol 496 2-Pyrrolidone 633 Olive Oil 498 Raffinose 635 Palmitic Acid 501 Saccharin 638 Paraffin 503 Saccharin Sodium 641 Peanut Oil 505 Saponite 644 Pectin 507 Sesame Oil 646 Petrolatum 509 Shellac 649
VIII Contents Simethicone Sodium Acetate Sodium Alginate Sodium Ascorbate Sodium Benzoate Sodium Bicarbonate Sodium Borate Sodium Chloride Sodium Citrate Dihydrate Sodium Cyclamate Sodium Hyaluronate Sodium Hydroxide Sodium Lactate Sodium Lauryl Sulfate Sodium Metabisulfite Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Sodium Propionate Sodium Starch Glycolate Sodium Stearyl Fumarate Sodium Sulfite Sorbic Acid Sorbitan Esters (Sorbitan Fatty Acid Esters) Sorbitol Soybean Oil Starch Starch, Pregelatinized Starch, Sterilizable Maize Stearic Acid Stearyl Alcohol Sucralose Sucrose Sugar, Compressible Sugar, Confectioner's Sugar Spheres Sulfobutylether P-Cyclodextrin Sulfuric Acid Sunflower Oil Suppository Bases, Hard Fat Talc Tartaric Acid Tetrafluoroethane (HFC) Thaumatin Thimerosal 652 654 656 659 662 665 669 671 675 678 681 683 685 687 690 693 696 699 701 705 708 710 713 718 722 725 731 734 737 740 742 744 748 750 752 754 758 760 762 767 770 772 775 777 Thymol Titanium Dioxide Tragacanth Trehalose Triacetin Tributyl Citrate Triethanolamine Triethyl Citrate Vanillin Vegetable Oil, Hydrogenated Water Wax, Anionic Emulsifying Wax, Carnauba Wax, Cetyl Esters Wax, Microcrystalline Wax, Nonionic Emulsifying Wax, White Wax, Yellow Xanthan Gum Xylitol Zein Zinc Acetate Zinc Stearate Appendix 1: Suppliers' Directory 835 Appendix II: List of Excipient 'E' Numbers 882 Appendix III: List of Excipient 'EINECS' Numbers Appendix IV: List of Excipient Molecular Weights Index 889 884 886 780 782 785 788 790 792 794 796 798 800 802 807 809 811 813 815 817 819 821 824 828 830 832