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`Argentum Pharmaceuticals v. Cipla Ltd
`IPR201 7-00807
`
`CIP2156
`
`CIP2156
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
`
`
`
`
`
`

`

`
`
`
`
`Handbook of
`
`PHARMACEUTICAL
`
`
`
`TS
`
`
`
`Third Edition
`
`Edited by
`
`Arthur Ha Kibbe, Ph.D.
`Professor and Chair
`
`Department of Pharmaceutical Sciences
`Wilkes University School of Pharmacy
`Wilkes—Barre, Pennsylvania
`
`
`
`American Pharmaceutical Association
`
`Washington, DC.
`
`(RP)
`
`Pharmaceulical Press
`
`~
`
`London, United Kingdom
`
`CIP2156
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
`
`

`

`Published by the American Pharmaceutical Association
`2215 Constitution Avenue NW, Washington, DC 20037-2985, USA
`www. aphanet. org
`and the Pharmaceutical Press
`
`1 Lambeth High Street, London SE1 7JN, UK
`www.pharmpress.com
`
`© 1986, 1994, 2000 American Pharmaceutical Association and Pharmaceutical Press
`
`First edition 1986
`Second edition 1994
`Third edition 2000
`
`Printed in the United States of America
`
`ISBN: 0-85369-381-1 (UK)
`ISBN: O—917330-96-X (USA)
`
`Library of Congress Cataloging-in-Publication Data
`Handbook of pharmaceutical excipients / edited by Arthur H. Kibbe.~-3rd ed.
`p.
`; cm.
`Includes bibliographical references and index.
`ISBN 0-917330-96-X
`
`1. Excipients—-Handbooks, manuals, etc.
`Pharmaceutical Association.
`
`I. Kibbe, Arthur H. II. American
`
`[DNLM: 1. Excipients——Handbooks. QV 735 H236 2000]
`R3201 .E87 H36 2000
`
`A catalogue record for this book is available from the British Library,
`
`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.
`
`Managi’iig Editor: Melanie Segala
`Copyeditor:
`Paul Gottehrer
`Indexer:
`Lillian Rodberg
`Compositor:
`Roy Barnhill
`Cover Designer:
`Tim Kaage
`
`CIP2156
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
`
`

`

`646 Index
`
`HFC (difluoroethane), 184
`hydrocarbons (HC), 236
`nitrogen, 352
`nitrous oxide, 353, 354
`tetrafluoroethane (HFC), 560
`Air displacement agents
`carbon dioxide, 83
`nitrogen, 352'
`Airvol, 424
`Akucell, 87
`Alba red (D&C red #39), 147
`Albaline, 345
`Albucorm, 5
`Albumin, 5
`bovine serum, 6
`human solution, 5
`Albuminar; 5
`Albumini humani solutio, 5
`Albuminisol, 5
`Albumin solution, 5
`Albusp'an, 5
`Albutein, 5
`Alcohol(s), 7
`absolute, 8
`B—aminoethyl, 350
`benzyl, 41
`cetearyl, 112
`cetostearyl, 112, 120, 538, 586
`cetyl, 113, 117, 538
`dehydrated, 8
`denatured, 8
`dilute, 8
`furfuryl, 230
`B—hydroxyethyl phenyl, 370
`isopropyl, 8, 263
`lanolin, 139, 287, 288-290, 346, 348, 349,
`363, 365
`mineral oil, 346, 348, 349
`octadecyl, 537
`paraffin, 365
`petrolatum, 289, 363, 365
`B—phenylethyl, 372
`2-phenylethyl, 372
`phenylethyl, 127, 372
`phenylic, 367
`polyvinyl, 424
`sec-propyl, 263
`propyl, 264
`propylic, 264
`stearyl, 113, 120, 537, 635
`[5,15,B-trichloro-tert—butyl, 126
`W001, 288, 365
`Alcohol benzylicus, 41
`Alcohol cetylicus, 117
`Alcohol cetylicus et stearylicus, 112
`Alcohol isopropylicus, 263
`Alcohol stearylicus, 537
`Alcoholis adipis lanae, 288
`Alcoramnosan, 240
`Aldehyde
`ethylprotocatechuic, 208
`methylprotocatechoic, 576
`vanillin, 576
`Aldo MS, 225
`Aldo M0, 223
`Aleuritic acid, 463
`
`Alfadex, 165
`Algin, 465
`Alginate, 6
`Alginic acid, 10, 445, 446, 465, 466
`Aliphatic polyesters, 13, 272, 273
`Alixural purple SS (D&C Violet #2 lake), 148
`Alizarin cyanine (D&C green #5), 147
`Alizarin cyanine (D&C green #5 lake), 148
`Alizurol purple SS (D&C Violet #2), 147
`Alkalizing agents
`diethanolamine (DEA), 180
`monoethanolamine, 350
`potassium citrate, 429
`sodium bicarbonate, 474
`sodium citrate, 482
`triethanolamine, 572
`Alkamuls SMS, 511
`Alkamuls STS, 511
`Alkylbenzyldimethylammonium chloride, 33
`Alkyl benzyl dimethyl ammonium chloride, 33
`Alkyldimethyl(phenylmethyl)ammonium
`chloride, 33
`Allomalenic acid, 213
`Allura red AC (D&C red #40), 147
`Alpha—carotene, 146
`Alpha—cyclodextrin, 165
`Alpha—cyclosamylose, 165
`Alpha—dextrin, 165
`Alpha tocopherol, 18
`d—Alpha tocopherol, 19
`d—Alpha tocopheryl acetate, 19
`dlLAlpha tocopheryl acetate, 19
`d—Alpha tocopheryl acid succinate, 19
`all-Alpha tocopheryl acid succinate, 19
`Alphazurine FG (D&C blue #4), 147
`Alphazurine FG (D&C blue #4 lake), 148
`Alumina, 149
`Aluminum magnesium silicate, 295
`Aluminum powder, 149
`Aluminum silicate, hydrated, 269
`Alvanol, 424
`Amally, 313
`Amberlite IRP-88, 383
`Amberlite resins, physico—chemical properties
`summary, 384
`Amerchol CAB, 365
`Americhol L-IOI, 349
`Amido, 522
`Amidon, 522
`Amilo, 522
`2—Aminoethanol, 350
`B-Aminoethyl alcohol, 350
`3—Amino—N—(oc—carboxyphenethyl)succinamic
`acid N-methyl ester, 27
`3-Arnino—N—(oc—methoxycarbonylphenethyl)—
`succinnamic acid, 27
`Ammonio methacrylate copolymer, 401
`Ammonium, saccharin, 455
`Ammonium citrate, ferric, 149
`Ammonium ferrocyanide, ferric, 149
`Amorphous wax, 591
`Amylopectin, 527
`_ oc—Amylose, 527
`Amylum, 522
`Anatase titanium dioxide, 565
`Anhydride, titanic, 565
`
`1,4—Anhydro—D-glucitol, 51 l
`Anhydrosorbital monoisostearate, 511
`Anhydrosorbitol monostearate, 511
`Anhydrous citric acid, 141
`Anhydrous dextrose, 177
`Anhydrous dibasic calcium phosphate, 60
`Anhydrous dibasic sodium phosphate, 493
`Anhydrous Emcompress, 60
`Anhydrous 4—O-OL-D-glucopyranosyl—B-D—
`glucopyranose, 322
`Anhydrous lanolin, 286
`Anhydrous magnesium carbonate, 301
`Anhydrous monobasic sodium phosphate,
`496
`,
`Anhydrous potassium citrate, 430
`Anhydrous silicic acid, light, 143
`Anhydrous sodium citrate, 483
`Anhydrous sodium propionate, 499
`Anhydrous sodium salt, 499
`Anhydrous sodium sulfite, 491
`Anion-exchange Amberliz‘e resins, 384
`Anionic emulsifying wax, 585
`Annatto extract, 149
`Anthocyanins, 146
`Anthracine 12, 49
`Anticaking agents
`calcium phosphate, tribasic, 68
`magnesium trisilicate, 309
`talc, 555
`Anticoagulants
`editic acid (EDTA), 191
`Antimicrobial preservatives. See also
`Antiseptics; Disinfectants
`'
`acids
`benzoic, 38
`editic (EDTA), 191
`phenolic, 367
`sorbic, 508
`alcohols, 7
`benzyl, 41
`isopropyl, 263
`benzethonium chloride, 33
`bronopol, 46
`butylparaben, 53
`cetrimide, 114
`chlorhexidine, 121
`chlorobutanol, 126
`chlorocresol, 129
`cresol, 158
`ethylparaben, 205
`glycerol, 220
`imidurea, 261
`methylparaben, 340
`phenol, 367
`phenoxyethanol, 370
`phenylethyls, alcohol, 372
`phenylmercuric acetate, 374, 378, 381
`phenylmercuric borate, 377, 381
`phenylmercuric nitrate, 379
`potassium scrbate, 431
`propylene glycol,’442
`propylparaben, 450
`sodium benzoate, 471
`sodium propionate, 498
`sorbic acid, 508
`thimerosol, 562
`
`CIP2156
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
`
`

`

`Antioxidant synergists
`editic acid (EDTA), 191
`Antioxidants
`acids
`ascorbic, 21
`fumaric, 213
`malic, 311
`alpha tocopherol, 18
`ascorbic acid palmitate, 25
`butylated hydroxyanisole, 49
`propyl gallate, 447
`sodium ascorbate, 468
`sodium metabisulfite, 490
`Antiseptics, 46. See also Antimicrobial
`preservatives; Disinfectants
`benzalkonium chloride, 33
`cetrimide, 114
`chlorhexidine, 121
`phenylmercuric acetate, 374, 378
`phenylmercuric borate, 377
`phenylmercuric nitrate, 379
`thimerosol, 562
`APM, 27
`Apple acid, 311
`Aquacaat, 195
`Aqua purificata, 580
`Aquasorb, 87
`Aquateric, 99
`Aracel I6], 225
`Aracel I69, 225
`Arachis oil, 360
`Arachis oleum, 360
`Arcton, 134
`Argilla, 269
`Arlacel C, 5L1
`Arlacel 20, 511
`Arlacel 40, 511
`Arlacel 60, 511
`Arlacel 80, 511
`Arlacel 83, 511
`Arlacel 85, 511
`Arlacel I80, 223
`Arlacel 987, 511
`Arlatone, 412
`Armostat 801, 225
`Armotan M5, 511
`Arman/m ML, 511
`Armotan M0, 511
`Armotan MP, 511
`Ascorbic acid, 21, 26
`Ascorbic acid 6-hexadecanoate, 25
`L—Ascorbic acid monosodium salt, 468
`Ascorbilis palmitas, 25
`Ascorbyl palmitate, 23, 25, 469
`Aspartame, 4, 27
`N-Ot—L-Aspartyl—L—phenylalanine l-methyl
`ester, 27
`Aspartyl phenylarrune methyl ester, 27
`Assugrin, 485
`A—TAB, 60
`Atlas G-595, 223
`Atlas G-3712, 407
`Atlas 110K, 511
`Atmos 150, 225
`A17an 67, 84, 124, 225
`Avedex, 172
`
`Avicel, 102
`Aytex R 522
`Azote, 352
`
`B—1459, 599
`Bacteriostatic water, for injection, 583
`Bases
`for medicated confectionery
`polydextrose, 389
`sucrose, 539
`ointment
`alcohols, 288, 365
`lanolin, 286, 290
`paraffin, 358
`petrolatum, 362
`polyethylene glycol, 392
`organic, meglumine, 332
`suppository, 398, 579
`hard fat, 550
`polyethylene glycol, 392
`Basic phenylmercury nitrate, 379
`Beeswax, white, 595
`Beetroot red (betanin), 146
`Beet sugar, 539
`1,2-Benisothiazolin—3-one 1,1-dioxide, 454
`Benne oil, 460
`Bentonite, 30, 269
`Bentonite magma, 32
`Bentonitum, 30
`Benzalkonii chloridum, 33
`Benzalkonium chloride, 33
`Benzene, B-hydroxyethyl, 372
`1,2—Benzenedicarboxylic acid, 182
`1,2-Benzenedicarboxylic acid dibutyl ester,
`183
`Benzeneethanol, 372
`Benzeneformic acid, 38
`Benzenemethanol, 41
`Benzenocarboxylic acid, 38
`Benzenylcarboxylate, 44
`Benzethonium chloride, 35
`1,2-Benzisothiazol-3(2H)—one 1,1 dioxide, 454
`Benzoic acid, 38, 472
`Benzoic acid benzyl ester, 44
`Benzoic acid phenylmethyl ester, 44
`Benzoic sulfimide, 454
`Benzosulfimide, 454
`1 ,2-Benzothiazolin-3—one 1,1-dioxide sodium
`salt, 457
`Benzyl alcohol, 41
`Benzyl benzoate, 44
`Benzyl carbinol, 372
`Benzylis benzoas, 44
`Benzylmethanol, 372
`Benzyl phenylformate, 44
`Beta—apo—8’-carotenal, 146
`Beta-apo—8’—carotenoic acid, ethyl ester of
`(C30), 146
`Beta—carotene, 146, 149, 150
`Beta—cycloamylose, 165
`Beta cyclodextrin, 165
`Betacyclodextrinun, 165
`Betadex, 165
`Beta—dextrin, 165
`Betanin (beetroot red), 146
`Beta tocopherol, 20
`
`Index 647
`
`Betonite, 298
`BFI (Brittle Fracture Index), 637
`BHA, 49
`'
`Bicarbonate
`
`potassium, 476
`sodium, 474
`Binders
`acacia, 1
`alginic acid, 10
`carboxymethylcellulose, 87
`cellulose
`
`hydroxyethyl, 240
`hydroxypropyl, 244, 249
`dextrin, 172
`flavoring fixative, ethylcellulose, 195
`gelatin, 215
`glucose, liquid, 218
`guar gum, 232
`hydrogenated vegetable oil, type I, 578
`hydroxyethyl cellulose, 240
`hydroxypropyl methylcellulose, 252
`liquid glucose, 218
`magnesium aluminum silicate, 295
`maltodextrin, 317
`methylcellulose, 252, 336
`polyethylene oxide, 399
`polymethacrylates, 401
`povidone, 433
`sodium alginate, 465
`starch, 522, 528
`vegetable oil, hydrogenated, type I, 578
`zein, 606
`Biopure 100, 261
`Biphosphate, sodium, 496
`N,N”—Bis(4—chlorophenyl)-3,1,2-diimino-
`2,4, 1 1,13—tetraaztetradecane—
`diimidarnine, 121
`1,4—Bis(2-ethylhexyl) ester, 188
`Bis(2—ethylhexyl) sodium sulfosuccinate, 188
`1,2—Bis(2-ethylhexyl) sulfosuccinate, 189
`Bis(hydroxyethyl)amine, 180
`Bismuth oxychloride, 149
`1,6—Bis[N’-(p—chlorophenyl)]—N5‘ biguanido
`hexane, 121
`Bisomel, 265
`Bis—sorb, 531
`Bisulfite, 491
`BKC, 33
`Black PN, 150
`Blanose, 87
`Bleached shellac, 462
`Bleached wax, 595
`Blue coloring agents, 147
`BNPDBronosal, 46
`Boletic acid, 213
`Bolus alba, 269
`Bonding Index (B1), 637
`Borate
`
`phenylmercuric, 375, 377, 562
`phenylmercury, 377
`Borculo whey products, lactoses, 279, 282
`Bourbonal, 208
`Bovine serum albumin, 6
`Brazil wax, 587
`Breox PEG, 392
`Brij, 407
`
`
`
`
`
`CIP2156
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
`
`