Handbook of
`
`Pharmaceutical Excipients
`
`FOURTH EDITION
`
`Edited by
`
`Raymond C Rowe
`BPharm, PhD, DSc, FRPhcirmS, CChem, FRSC, CPhys, M|nstP
`
`Senior Principal Scientist
`AstraZeneca
`
`Macclestield, UK
`
`Paul J Sheskey
`BSc, RPh
`
`Technical Service Leader
`
`Water Soluble Polymers R&D
`
`The Dow Chemical Company
`Midland
`
`MI, USA
`
`Paul J Weller
`
`BSc, MSc, CChem, MRSC
`
`Publisher - Science and Practice
`
`Royal Pharmaceutical Society of Great Britain
`London, UK
`
`London a Chicago
`
`h
`Pharmaceutical Press
`
`APE‘;
`American
`Pharmaceutical
`Association
`
`Amgen Ex. 2010
`
`Complex Innovations v. Amgen
`
`|PR2016-00085
`
`Amgen Ex. 2010
`Complex Innovations v. Amgen
`IPR2016-00085
`
`

`
`_
`Published by the Pharmaceutical Press
`Publications division of the Royal Pharmaceutical Society of Great Britain
`
`.
`
`I Lambeth High Street, London SE1 7JN, UK
`I00 South..Atkinson Road, Suite 206, Grayslake, IL 600307820, USA
`
`and the American Pharmaceutical Association
`22l5 Constitution Avenue NW, Washington, DC 20037-2985, USA I
`
`© Pharmaceutical Press and American Pharmaceutical Association 2003
`
`is a trade mark of Pharmaceutical Press
`
`First edition published 1986
`Second edition published 1994
`Third edition published 2000
`Fourth edition published 2003
`
`Text design by Barker Hilsdon, Lyme Regis
`Typeset by Bibliocraft Ltd, Dundee
`Printed in Great Britain by The Bath Press, Bath
`
`ISBN 0 85369 472 9 (UK)
`ISBN 1 58212 022 6 (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
`
`Library of Congress Cataloging-in-Publication Data
`Handbook of pharmaceutical excipients.— 4th ed. / edited by Raymond C.
`Rowe, Paul]. Sheskey, Paul]. Weller.
`p. ; cm.
`Includes bibliographical references and index.
`ISBN 1-58212-022-6 (alk. paper) —ISBN 0—85369—472—9 (alk. paper)
`1. Excipients-Handbooks, manuals, etc.
`[DNLM: 1. Excipients—Handbooks. QV 735 H236 2003] I. Rowe, Raymond
`C. II. Sheskey, Paul]. III. Weller, Paul].
`
`RS201.E87H36 2003
`615’.19—dc21
`
`2003002641
`
`

`
`Contents
`
`international Steering Committee
`Editorial Staff
`ix
`Contributors
`
`x
`
`ix
`
`About the Editors
`
`xiii
`
`New Monographs
`Related Substances
`
`xiv
`xv
`
`Preface
`
`xvii
`
`Acknowledgments
`Notice to Readers
`
`xix
`xix
`
`xx
`Bibliography
`xxi
`Abbreviations
`Units of Measurement
`
`xxii
`
`Monographs
`
`Acacia
`
`Acesulfame Potassium
`
`Acetic Acid, Glacial
`
`Acetyltributyl Citrate
`
`Acetyltriethyl Citrate
`Albumin
`
`Benzyl Benzoate
`
`Bronopol
`
`Butylated Hydroxyanisole
`Butylated Hydroxytoluene
`
`Butylparaben
`Calcium Carbonate
`
`Calcium Phosphate, Dibasic Anhydrous
`Calcium Phosphate, Dibasic Dihydrate
`
`Calcium Phosphate, Tribasic
`Calcium Stearate
`
`Calcium Sulfate
`
`Canola Oil
`
`Carbomer
`
`Carbon Dioxide
`
`\l01C»J—-
`
`Carboxymethylcellulose Calcium
`Carboxymethylcellulose Sodium
`
`Carrageenan
`Castor Oil
`
`Castor Oil, Hydrogenated
`
`Cellulose, Microcrystalline
`
`1 1
`
`Cellulose, Powdered
`
`56
`
`58
`
`61
`
`63
`
`65
`
`68
`
`72
`
`74
`
`78
`
`80
`
`83
`
`86
`
`89
`
`93
`
`95
`
`97
`
`101
`
`104
`
`106
`
`108
`
`112
`
`Alcohol
`
`Alginic Acid
`
`Aliphatic Polyesters
`Alitame
`
`Almond Oil
`
`Alpha Tocopherol
`Ammonia Solution
`
`Ascorbic Acid
`
`Ascorbyl Palmitate
`
`Aspartame
`
`Attapulgite
`Bentonite
`
`Benzalkonium Chloride
`
`Benzethonium Chloride
`
`Benzoic Acid
`
`Benzyl Alcohol
`
`13
`
`16
`
`19
`
`23
`
`25
`
`27
`
`3O
`
`32
`
`35
`
`37
`
`40
`
`42
`
`45
`
`48
`
`50
`
`53
`
`Cellulose, Silicitied Microcrystalline
`Cellulose Acetate
`
`Cellulose Acetate Phthalate
`
`Ceratonia
`
`Cetostearyl Alcohol
`Cetrimide
`
`Cetyl Alcohol
`Chitosan
`
`Chlorhexidine
`
`Chlorobutanol
`
`Chlorocresol
`
`Chlorodiiluoroethane (HCFC)
`
`Chlorotluorocarbons (CFC)
`
`Chloroxylenol
`Cholesterol
`Citric Acid Monohydrate
`
`_,_I:. __‘I
`_.;.’.i'_.‘i*“ "
`
`115
`
`117
`
`120
`
`123
`
`125
`
`127
`
`130
`
`132
`
`136
`
`141
`
`144
`
`147
`
`149
`
`153
`
`155
`
`158
`
`

`
`vi
`
`Contents
`
`Colloidal Silicon Dioxide
`
`Coloring Agents
`Corn Oil
`
`Cottonseed Oil
`
`Cresol
`
`Croscarmellose Sodium
`
`Crospovidone
`
`Cyclodextrins
`
`Cyclomethicone
`Denatonium Benzoate
`
`Dextrates
`
`Dextrin
`
`Dextrose
`
`Dibutyl Phthalate
`
`Dibutyl Sebacate
`Diethanolamine
`
`Diethyl Phthalate
`
`Ditluoroethane (HFC)
`Dimethicone
`
`Dimethyl Ether
`
`Dimethyl Phthalate
`
`161
`
`165
`
`174
`
`176
`
`178
`
`181
`
`184
`
`186
`
`191
`
`193
`
`195
`
`197
`
`200
`
`203
`
`205
`
`207
`
`209
`
`21 1
`
`213
`
`215
`
`217
`
`219
`
`Hydrocarbons (HC)
`
`Hydrochloric Acid
`
`Hydroxyethyl Cellulose
`
`Hydroxyethylmethyl Cellulose
`Hydroxypropyl Cellulose
`Hyd roxypropyl Cellulose, Low-substituted
`
`Hypromellose
`
`Hypromellose Phthalate
`lmidurea
`
`lsopropyl Alcohol
`
`lsopropyl Myristate
`
`lsopropyl Palmitate
`Kaolin
`
`Lactic Acid
`
`Lactitol
`
`Lactose
`
`Lanolin
`
`Lanolin, Hydrous
`Lanolin Alcohols
`
`Lecithin
`
`Magnesium Aluminum Silicate
`
`278
`
`281
`
`283
`
`287
`
`289
`
`294
`
`297
`
`301
`
`306
`
`309
`
`312
`
`314
`
`316
`
`319
`
`321
`
`323
`
`333
`
`336
`
`338
`
`340
`
`343
`
`Dimethyl Sultoxide
`Docusate Sodium
`
`Edetic Acid
`
`Ethyl Acetate
`
`Ethyl Maltol
`
`Ethyl Oleate
`
`Ethyl Vanillin
`
`Ethylcellulose
`
`Ethylene Glycol Palmitostearate
`Ethylparaben
`Fructose
`
`Fumaric Acid
`
`Gelatin
`
`Glucose, Liquid
`Glycerin
`
`Glyceryl Behenate
`
`Glyceryl Monooleate
`
`Glyceryl Monostearate
`Glyceryl Palmitostearate
`Glycoturol
`Guar Gum
`
`Heptatluoropropane (HFC)
`Hexetidine
`
`222
`
`225
`
`229
`
`231
`
`233
`
`235
`
`237
`
`242
`
`244
`
`247
`
`250
`
`252
`
`255
`
`257
`
`260
`
`262
`
`264
`
`267
`
`269
`
`271
`
`274
`
`276
`
`Magnesium Carbonate
`
`Magnesium Oxide
`
`Magnesium Silicate
`
`Magnesium Stearate
`
`Magnesium Trisilicate
`Malic Acid
`
`Maltitol
`
`Maltitol Solution
`
`Maltodextrin
`
`Maltol
`
`Maltose
`
`Mannitol
`
`Medium-chain Triglycerides
`Meglumine
`Menthol
`
`Methylcellulose
`
`Methylparaben
`Mineral Oil
`
`Mineral Oil, Light
`Mineral Oil and Lanolin Alcohols
`
`Monoethanolamine
`
`Monosodium Glutamate
`
`Monothioglycerol
`
`347
`
`350
`
`352
`
`354
`
`358
`
`360
`
`362
`
`364
`
`366
`
`369
`
`371
`
`373
`
`378
`
`381
`
`383
`
`386
`
`390
`
`395
`
`398
`
`400
`
`402
`
`404
`
`406
`
`

`
`Nitrogen
`Nitrous Oxide
`
`Oleic Acid
`
`Olive Oil
`
`Paraffin
`
`Peanut Oil
`
`Petrolatum
`
`Petrolatum and Lanolin Alcohols
`
`Phenol
`Phenoxyethanol
`Phenylethyl Alcohol
`Phenylmercuric Acetate
`Phenylmercuric Borate
`Phenylmercuric Nitrate
`Phosphoric Acid
`Polacrilin Potassium
`
`Poloxamer
`Polydextrose
`Polyethylene Glycol
`Polyethylene Oxide
`Polymethacrylates
`Polyoxyethylene Alkyl Ethers
`Polyoxyethylene Castor Oil Derivatives
`Polyoxyethylene Sorbitan Fatty Acid Esters
`Polyoxyethylene Stearates
`Polyvinyl Acetate Phthalate
`Polyvinyl Alcohol
`Potassium Benzoate
`
`Potassium Bicarbonate
`Potassium Chloride
`Potassium Citrate
`Potassium Hydroxide
`Potassium Metabisulfite
`
`Potassium Sorbate
`Povidone
`Propionic Acid
`Propyl Gallate
`Propylene Carbonate
`Propylene Glycol
`Propylene Glycol Alginate
`Propylparaben
`F
`Saccharin
`
`Saccharin Sodium
`Sesame Oil
`
`Contents
`
`vii
`
`<
`
`V
`
`408
`410
`
`412
`
`414
`
`417
`
`419
`
`421
`
`424
`
`426
`429
`431
`433
`436
`438
`442
`444
`
`447
`451
`454
`460
`462
`469
`474
`479
`484
`488
`491
`493 --
`
`495
`497
`500
`502
`504
`
`506
`508
`514
`516
`519
`521
`524
`526
`529
`
`532
`535
`
`Shellac
`Simethicone
`
`Sodium Alginate
`
`Sodium Ascorbate
`
`Sodium Benzoate
`
`Sodium Bicarbonate
`
`Sodium Chloride
`
`Sodium Citrate Dihydrate
`
`Sodium Cyclamate
`Sodium Hydroxide
`Sodium Lauryl Sulfate
`Sodium Metabisulfite
`Sodium Phosphate, Dibasic
`Sodium Phosphate, Monobasic
`Sodium Propionate
`Sodium Starch Glycolate
`
`Sodium Stearyl Fumarate
`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, Confectionef’s
`Sugar Spheres
`Sulfuric Acid
`Sunflower Oil
`
`Suppository Bases, Hard Fat
`Talc
`Tartaric Acid
`Tetrafluoroethane (HFC)
`Thimerosal
`Titanium Dioxide
`Tragacanth
`Trehalose
`Triacetin
`
`Tributyl Citrate
`Triethanolamine
`
`538
`541
`
`543
`
`546
`
`549
`
`552
`
`556
`
`560
`
`563
`566
`568
`571
`574
`577
`579
`581
`
`585
`588
`591
`596
`600
`603
`609
`612
`615
`618
`620
`622
`
`626
`. 628
`630
`632
`634
`
`636
`641
`644
`646
`648
`651
`654
`657
`659
`
`661
`663
`
`

`
`viii
`
`Contents
`
`Triethyl Citrate
`
`Vanillin
`
`Vegetable Oil, Hydrogenated
`Water
`
`Wax, Anionic Emulsiiying
`
`Wax, Carnauba
`
`Wax, Cetyl Esters
`
`Wax, Microcrystalline
`
`Wax, Nonionic Emulsitying
`
`Wax, White
`
`665
`
`667
`
`669
`
`672
`
`677
`
`679
`
`681
`
`683
`
`685
`
`687
`
`Wax, Yellow
`Xanthan Gum
`
`Xylitol
`Zein
`
`Zinc Stearate
`
`689
`691
`
`694
`698
`
`700
`
`703
`Appendix I: Suppliers Directory
`743
`Appendix H: List of Excipient ’E’ Numbers
`Appendix III: List of Excipient ’EINECS’ Numbers
`Appendix IV: List of Excipient Molecular Weights
`Index
`757
`
`745
`747
`
`

`
`Preface
`
`PHARMACEUTICAL DOSAGE FORMS contain both pharma-
`cologically active compounds and excipients added to aid the
`formulation and manufacture of the subsequent dosage form
`for administration to patients. Indeed, the properties of the final
`dosage form (i.e. its bioavailability and stability) are, for the
`most part, highly dependent on the excipients chosen, their
`concentration and interaction with both the active compound
`and each other. No longer can excipients be regarded simply as
`inert or inactive ingredients, and a detailed knowledge not only
`of the physical and chemical properties but also of the safety,
`handling and regulatory status of these materials is essential for
`formulators throughout the world. In addition, the growth of
`novel forms of delivery has resulted in an increase in the number
`of the excipients being used and suppliers of excipients have
`developed novel excipient mixtures and new physical forms to
`improve their properties. The Handbook of Pharmaceutical
`Excipients has been conceived as a systematic, comprehensive
`resource of information on all of these topics.
`The first edition of the Handbook was published in 1986
`and contained 145 monographs. This was followed by the
`second edition in 1994 containing 203 monographs and the
`third edition in 2000 containing 210 monographs. Since the
`release of the third edition two CD-ROM editions have also
`been released: Pharmaceutical Excipients 2000 included the
`same material as
`the third edition, and Pharmaceutical
`Excipients 2001, which included 20 new monographs.
`This new printed edition with its companion CD-ROM
`contains 250 monographs authored by experts in pharmaceu-
`tical formulation or excipient manufacture from around the
`world. All the monographs have been reviewed and revised in
`the light of current knowledge. There has been a greater
`emphasis on including published data from primary sources
`although some data from laboratory projects included in
`previous editions have been retained where relevant. Varia-
`tions in test methodology can have significant effects on the
`data generated (especially in the case of the compactability of
`an excipient), and thus cause confusion. As a consequence, the
`editors have been more selective in including data relating to the
`physical properties of an excipient. However, comparative data
`that show differences between either source or batch of a
`specific excipient ‘have been retained as this was considered _
`_ relevant to the behavior of a material in practice. The Suppliers
`Directory (Appendix I) has also been completely updated with
`many more international suppliers included.
`.
`In a systematic and uniform manner, the Handbook of
`Pharmaceutical Excipients collects essential data on the physi-
`cal properties of excipients such as: boiling point, bulk and tap
`density, compression characteristics, hygroscopicity,
`flow-
`ability, melting point, moisture content, moisture-absorption
`isotherms, particle size distribution, rheology, specific surface
`area, and solubility. Scanning electron microphotographs
`(SEMS) are also included for many of the excipients. The
`Handbook contains information from various international
`sources
`and personal observation and comments
`from
`monograph authors, steering committee members, and the
`editors.
`
`All of the monographs in the Handbook are thoroughly
`cross-referenced and indexed so that excipients may be identi-
`fied by either a chemical, a nonproprietary, or a trade name.
`Most monographs list related substances to help the formulator
`to develop a list of possible materials for use in a new dosage
`form or product. Related substances are not directly substitu-
`table for each other but, in general, they are excipients that have
`been used for similar purposes in various dosage forms.
`The Handbook of Pharmaceutical Excipients is a compre-
`hensive,‘uniform guide to the uses, properties, and safety of
`pharmaceutical excipients, and is an essential reference source
`for those involved in the development, production, control, or
`regulation of pharmaceutical preparations. Since many phar-
`maceutical excipients are also used in other applications, the
`Handbook ofPl7armaceutical Excipients will also be of value to
`persons with an interest in the formulation or production of
`confectionery, cosmetics, and food products.
`
`Arrangement
`
`The information consists of monographs that are divided into
`22 sections to enable the reader to find the information of
`interest easily. Although it was originally intended that each
`monograph contain only information about a single excipient, it
`rapidly became clear that some substances or groups of sub-
`stances should be discussed together. This ‘gave rise to such
`' monographs‘ as ‘Coloring Agents’ and ‘Hydrocarbons’. In addi-
`tion, some materials have more than one monograph depending
`on the physical characteristics of the material, e.g. Starch versus
`Pregelatinized Starch. Regardless of the complexity of the
`monograph they are all divided into 22 sections as follows:
`
`1 Nonproprietary Names
`2 Synonyms
`3 Chemical Name and CAS Registry Number
`4 Empirical Formula and Molecular Weight
`5 Structural Formula
`6 Functional Category
`7 Applications in Pharmaceutical Formulation or Technology
`8 Description
`9 Pharmacopeial Specifications
`10 Typical Properties
`11 Stabilityand Storage Conditions
`12 Incompatibilities
`13 Method of Manufacture
`14 Safety
`15 Handling Precautions
`16 Regulatory Status
`17 Related Substances
`18 Comments
`
`19 Specific References
`20 General References
`21 Authors
`22 Date of Revision
`
`Descriptions of the sections appear ‘below with information
`from an example monograph if needed.
`
`xvii
`
`

`
`xviii
`
`Preface
`
`lists the excipient names
`Section 1, Nonproprietary Names,
`used in the current British Pharmacopoeia, European Pharma-
`copeia, Japanese Pharmacopeia, and the United States Pharma-
`copeia/National Formulary.
`
`lists other names for the excipient,
`Section 2, Synonyms,
`including trade names used by suppliers (shown in italics).
`The inclusion of one supplier’s trade name and the absence of
`others should in no way be interpreted as an endorsement of
`one supplier’s product over the other. The large number of
`suppliers internationally makes it impossible to include all the
`trade names.
`
`Section 3, Chemical Name and CAS Registry Number, indicates
`the unique Chemical Abstract Services number for an excipient
`along with the chemical name, e.g., Acacia [9000-01-5].
`
`Sections 4 and 5, Empirical Formula and Molecular Weight and
`Structural Formula, are self-explanatory. Many excipients are
`not pure chemical substances, in which case their composition
`is described either here orvin Section 8.
`
`,
`
`lists the function(s) that an
`Section 6, Functional Category,
`excipient is generally thought to perform, e.g., diluent, emulsi-
`fying agent, etc.
`
`in Pharmaceutical Formulation or
`Section 7, Applications
`Technology, describes the various applications of the excipient.
`
`Section 8, Description, includes details of the physical appear-
`ance of the excipient, e.g., white or yellow flakes, etc.
`
`Section 9, Pharmacopeial Specifications, briefly presents the
`compendial standards for the excipient. Information included
`is obtained from the British Pharmacopoeia (BP), European
`Pharmacopeia (PhEur), Japanese Pharmacopeia (JP), and _the
`United
`States Pharmacopeia/National Formulary
`(USP/
`USPNF). ‘Information from the JP, USP and USPNF are
`included if the substance is in those compendia. Information
`from the PhEur is also included. If the excipient is not in the
`PhEur but is included in the BP, information is included from
`the BP. Pharmacopeias are continually updated with most now
`being produced as annual editions. However, although efforts
`were made to include up-to-date information at the time of
`publication of the Handbook, the reader is advised to consult
`the most current pharmacopeias or supplements.
`
`Section 10, Typical Properties, describes the physical properties
`of the excipient which are not shown in Section 9. All data are
`for measurements made at 20°C unless otherwise indicated.
`Where the solubility of the excipient is described in words, the
`following terms describe the solubility ranges:
`
`Very soluble
`Freely soluble
`Soluble
`Sparingly soluble
`Slightly soluble
`Very slightly soluble
`Practically insoluble
`or insoluble_
`
`1 part in less than 1
`1 part in 1-10
`1 part in 10-30
`1 part in 30-100
`‘ 1 part in 100-1000
`1 part in 1000-10 000
`1 part in more than 10 000
`.
`
`\
`
`Where practical, data typical of the excipient or comparative
`data representative of different grades or sources of a material
`are included, the data being obtained from either the primary
`or the manufacturers’ literature. In previous editions of the
`
`Handbook a laboratory project was undertaken to determine
`data for a variety of excipients and in some instances this data
`has been retained. For a description of the specific methods used
`to generate the data readers should consult the appropriate
`previous edition(s) of the Handbook.
`
`Section 11, Stability and Storage Conditions, describes the
`conditions under which the bulk material as received from the
`supplier should be stored. In addition some monographs report
`on storage and stability of the dosage forms that contain the
`excipient.
`
`Section 12, incompatibilities, describes the reported incompat-
`ibilities for the excipient either with other excipients or with
`active ingredients. If an incompatibility is not listed it does not
`mean it does not occur but simply that it has not been reported
`or is not well known. Every formulation should be tested for
`incompatibilities prior to use in a commercial product.
`
`Section l3, Method of Manufacture, describes the common
`methods of manufacture and additional processes that are
`used to give the excipient its physical characteristics. In some
`cases the possibility of impurities will be indicated in the
`method of manufacture.
`
`Section 14, Safety, describes briefly the types of formulations in
`which the excipient has been used and presents relevant data
`concerning possible hazards and adverse reactions that have
`been reported. Relevant animal toxicity data are also shown.
`
`Section 15, Handling Precautions, indicates possible hazards
`associated with handling the excipient and makes recommen-
`dations for suitable containment and protection methods. A
`familiarity with current good laboratory practice (GLP) and
`current good manufacturing practice (GMP) and standard
`chemical handling procedures is assumed.
`
`Section 16, Regulatory Status, describes the accepted uses in
`foods and licensed pharmaceuticals where known. However,
`the status of excipients varies from one nation to another, and
`appropriate regulatory bodies should be consulted for guidance.
`
`Section 17, Related Substances, lists excipients similar to the
`excipient discussed in the monograph.
`
`includes additional information and
`Section 18, Comments,
`observations relevant to the excipient.‘ Where appropriate, the
`different grades of the excipient available are discussed. Com-
`ments are the opinion of the listed author(s) unless referenced or
`indicated otherwise.
`
`Section l9, Specific References, is a list of references cited within
`the monograph.
`
`lists references which have
`Section 20, General References,
`general information about this type of excipient or the types
`of dosage forms made with these excipients.
`
`Section 21, Authors, lists the current authors of the monograph
`in alphabetical order. Authors of previous versions of the
`monograph are shown in previous printed editions of the text.
`
`indicates the date on which
`‘Section 22, Date of Revision,
`changes were last made to the text of the monograph.
`
`

`
`Index
`
`Note:
`
`Greek characters (0L, [3, y ctc.), numerical prefixes (5’-, 1,2— etc.) and prefixes such as para, ortho, O-, N-, D-, L- etc. are excluded
`from alphabetization; page numbers in bold refer to monograph titles.
`
`905 (mineral hydrocarbons), 395, 398, 417
`
`A-17, 278
`A-31, 278
`A-46, 279
`A-70, 278
`ABIL, 213, 214
`Abrasives
`dibasic anhydrous calcium phosphate,
`72
`dibasic dihydrate calcium phosphate, 74
`Absolute alcohol, 14
`Absorbable dusting powder, 612
`Absorbable gelatin, 252
`Acacia, 1, 29, 124, 272
`Acaciae gummi, 1
`Acacia gum, 1
`Accelerate, 99
`Ac-Di-Sol, 181
`Acesulfame K, 3
`Acesulfame potassium, 3, 24
`aspartame synergy, 39
`with sodium cyclamate, 564
`sweetness us. sucrose, 3
`Acesulfamum kalicum, 3
`Acetic acid
`(2~butenylidene), 588
`dilute, 6
`ethyl ester, 229
`glacial, 5
`Acetic acid, 6
`Acetic ester, 229
`Acetic ether, 229
`Acetone chloroform, 141
`Acetoxyethane, 229
`Acetoxyphenylmercury, 433
`[3-Acetoxytributyl ester, 9
`Acetylated lanolin, 334
`Acetylbutyl citrate, 7
`Acetyl cellulose, 117
`Acetylcitric acid, 7
`2-Acetyloxy tributyl ester, 7
`Acetyl phthalyl cellulose, 120
`Acetyltributyl citrate, 7, 10, 662, 665, 666
`Acetyltriethyl citrate, 8, 9, 662, 665, 666
`Acide phosphorique, 442
`Acid fosforico, 442
`Acidifying agents, 5
`citric acid monohydrate, 15 8
`hydrochloric acid, 281
`diluted, 282
`lactic acid, 319
`phosphoric acid, 442
`propionic acid, 514
`sulfuric acid, 632
`
`tartaric acid, 644
`Acid sodium phosphate, 577
`Acidulants
`fumaric acid, 250
`lactic acid, 319
`malic acid, 360
`monobasic sodium phosphate, 577
`phosphoric acid, 442
`tartaric acid, 644
`Acidum aceticum glaciale, 5
`Acidum alginicum, 16
`Acidum ascorbicum, 32
`Acidum benzoicum, 50
`Acidum citricum anhydricum, 160
`Acidum citricum monohydricum, 158
`Acidum edeticum, 225
`Acidum hydrochloricum concentratum, 281
`Acidum hydrochloricum dilutum, 282
`Acidum lacticum, 319
`Acidum methacrylicum et ethylis acrylas
`polymerisatum 1:1, 462
`Acidum rnethacrylicum et ethylis acrylas
`polymerisatum 1:1 dispersio 30 per
`centum, 462
`Acidum methacrylicum et methylis
`methacrylas polymerisatum 1:1, 462
`Acidum methacrylicum et methylis
`methacrylas polymerisatum 1:2, 462
`Acidum oleicum, 412
`Acidum phosphoricum concentratum, 442
`Acidum phosphoricum dilutum, 443
`"
`Acidum sorbicum, 588
`Acidum stearicum, 615
`Acidum sulfuricum, 632
`Acidum tartaricum, 644
`Acriflavine hydrochloride, 43
`Acritamer, 89
`‘Acrylic acid polymers, 89
`Actapulgite, 40
`Activated attapulgite, 40, 41
`Adeps lanae, 333
`Adeps lanae cum aqua, 336
`Adeps lanae hydrogenatus, 334
`Adeps neutralis, 636
`Adeps solidus, 636
`Adhesives
`see also Mucoadhesives
`carbomers, 89, 92
`dextrin, 197
`hypromellose, 297
`Adsorbents
`attapulgite, 40
`bentonite, 42
`colloidal silicon dioxide, 161
`kaolin, 316
`
`magnesium aluminum silicate, 343
`microcrystalline cellulose, 108
`powdered cellulose, 112
`Aduantose 100, 371, 372
`Adi/antose PS 95, 247
`Aero Flo 20, 323
`Aero Flo 65, 323
`Aero Flo 95, 323
`Aeropres, 279
`Aeropres 17, 278
`Aeropres 31, 278
`Aeropres 108, 278
`Aerosil, 161
`Aerosol propellants see Propellants
`Aerosol Solvent Extraction Systems (ASES),
`carbon dioxide, 94
`Aethylis acetas, 229
`Aethylium aceticum, 229
`Aextreff CT, 419
`Agidol, 63
`Air displacement gases
`carbon dioxide, 93
`nitrogen, 408
`Airvol, 491
`A/zofine, 669
`Akosoft, 636
`A/eosol, 636
`Akucell, 97
`Alabaster, 83
`Albagel, 42
`Alberger, 556
`Albucorm, 11
`Albumin, 11
`human, 11
`Albuminar, 11
`Albumini humani solutio, 11
`Albumin solution, human, 11
`Albumisol, 11
`Albuspan, 11
`Albutein, 11
`Alcohol, 13
`absolute, 14
`dehydrated, 15
`dilute, 14, 15
`Alcohol benzylicus, 53
`Alcohol cetylicus, 130
`Alcohol cetylicus et stearylicus, 125
`Alcohol denaturants
`denatonium benzoate, 193, 194
`diethyl phthalate, 209
`Alcoholes adipis lanae, 338
`Alcoholia lanae, 338
`Alcohol isopropylicus, 309
`Alcohol stearylicus, 618
`Alcolanum, 338
`
`751
`
`

`
`752
`
`lndex
`
`Alconznmosan, 283
`Aldo MO, 252
`Aleuritic acid, 539
`Alfadex, 186
`Algin, 543
`Alginic acid, 16, 525, 544
`calcium salt, 544 ‘
`potassium salt, 544
`propylene glycol ester, 524
`sodium salt, 543
`Aliphatic polyesters, 19, 320
`Alitame, 23
`Alkalizing agents
`ammonia solution, 30
`diethanolamine, 207
`monoethanolamine, 402
`potassium bicarbonate, 495
`potassium citrate, 500
`potassium hydroxide, 502
`sodium bicarbonate, 552
`sodium citrate dihydrate, 560
`sodium hydroxide, 566
`triethanolamine, 663
`Alkylbenzyldimethylammonium chloride,’ 45
`Alkyldimethyl(phenylmethyl)ammonium
`chloride, 45
`Alkyl dimethyl benzyl ammonium chloride,
`45
`Alkyltrimethylammonium bromides, 128
`Allomaleic acid, 250
`Allomalenic acid, 250
`Allopurinol, 219
`Almond oil, 25, 233
`refined, 26
`Alpha-cycloamylose, 186
`Alpha-cyclodextrin, 186
`Alpha—dextrin, 186
`_
`Alpha tocopherol, 27, 28,‘ 35
`see also Tocopherol
`and ascorbyl palmitate, 27
`and lecithin, 27
`and linoleic acid, 27
`and methyl linolenate, 27
`natural, 28
`synthetic, 27
`(2R,4’R,8’R)-Alpha-tocopherol, 27
`d-Alpha tocopherol, 27, 28
`A
`dl—Alpha tocopherol, 27
`Alpha—tocopherolum, 27
`d-Alpha tocopheryl acetate, 28
`dl-Alpha tocopheryl acetate, 28
`d—Alpha tocopheryl acid succinate, '28, 29
`dl—Alpha tocopheryl acid succinate, 28, 29
`Altalc, 641
`4
`Alumini magnesii silicas, 343
`Aluminium magnesium silicate, 343
`Aluminosilicic acid, 343
`Aluminum hydroxide, 350
`Aluminum magnesium salt, 343
`Aluminum magnesium silicate, 343 '
`Aluminum silicate, 246
`hydrated, 42, 44, 316, 317
`hydrous, 316
`Amalty, 362
`Amberlite IRP—64, 445
`Amberlite IRP-88, 444
`Amerclaol CAB, 424
`Amerckol L-101, 400
`Amido, 603
`Amidon, 603
`Amilo, 603
`5-Amino—1,3-his(2—ethylhexyl)hexahydro-5-
`methylpyrimidine, 276
`
`5—Amino-1,3-di(B-ethylhexyl)hexahydro-5-
`methylpyrimidine, 276
`2—Amino—2-deoxy-(1,4)-B-D-glucopyranan,
`132
`B—(1,4)-2-Amino-2-deoxy-D-glucose, 132
`2-Aminoethanol, 402
`B-Aminoethyl alcohol, 402
`3-Amino-N-(on-catboxyphenethyl)succinamic
`acid N-methyl ester, 37
`3—Amino-N-(ot-
`methoxycarbonylphenethyl)succinamic
`acid, 37
`Ammonia, 30
`Ammoniaca, 30
`Ammoniacum, 30
`Ammoniae solution concentrata, 30
`Ammonia solution, 30
`concentrated, 30
`dilute, 31
`strong, 30
`Ammonia water, 31
`Ammonio methacrylate copolymer, 462
`Amorphous lactose, 323, 327
`Amorphous wax, 683
`Amygdalae oleum raffinatum, 26
`Amygdalae oleum virginum, 25
`Amylopectin, 607
`oi-Amylose, 607
`Amylum, 603
`Amylum pregelificatum, 609
`Anatase titanium dioxide, 651
`Anhydrite, 83
`Anhydrous calcium hydrogen phosphate, 72
`Anhydrous calcium sulfate, 83
`Anhydrous citric acid, 159, 552
`Anhydrous dextrose, 201, 202
`Anhydrous dibasic calcium phosphate, 72
`Anhydrous dihasic sodium phosphate, 574
`Anhydrous disodium hydrogen phosphate,
`574
`
`Anhydrous ethanol, 14
`Anhydrous D-(+)-glucopyranose, 201
`Anhydrous glucose, 201
`Anhydrous gypsum, 83
`Anhydrous lactose, 323
`Anhydrous cc-lactose, 323
`Anhydrous B-lactose, 323
`Anhydrous lanolin, 333
`Anhydrous monobasic sodium phosphate,
`577
`Anhydrous sodium citrate, 561
`Anhydrous sodium dihydrogen phosphate,
`577
`
`Anhydrous sodium propionate, 5 80
`Anhydrous sodium sulfite, 572
`Anhydrous sulfate of lime, 83
`Anhydrous trisodium citrate, 561
`An/aydrox, 323
`Anionic emulsifying wax see Emulsifying
`wax, anionic
`Anionic surfactants see Surfactants, anionic
`Annalin, 84
`Antibacterial agents
`see also Antiseptics; Disinfectants;
`Preservatives
`benzoic acid, 51, 52
`chlorocresol, 144
`diazolidinyl urea, 307
`dimethyl sulfoxide, 220
`glacial acetic acid, 5
`imidurea, 306
`iodine/edetic acid, 226
`phenylmercuric acetate, 434
`
`phenylmercuric borate, 436
`phenylmercuric hydroxide, 439
`potassium sotbate, 506
`sodium hydroxide, 567
`sorbic acid, 506, 507
`Antibacterial preservatives see Antibacterial
`agents; Preservatives
`Antibrowning agents, sodium metabisulfite,
`571
`Anticaking agents
`calcium phosphate, tribasic, 78
`calcium silicate, 359
`colloidal silicon dioxide, 161
`magnesium silicate, 352
`magnesium trisilicate, 358
`talc, 641
`Anticapping agents see ‘Cap locking’
`preventatives
`Anticoagulants
`citric acid monohydrate, 158
`disodium edetate, 225
`Antidusting agents, polyethylene alkyl ethers,
`470
`Antifoaming agents
`dimethicone, 213
`polypropylene glycol 2000, 475
`simethicone, 541
`Antifungal agents
`see also Preservatives
`benzoic acid, 50
`butylparaben, 65
`chlorocresol, 144-145
`dimethyl sulfoxide, 220
`ethylparaben, 244
`glacial acetic acid, 5
`imidurea, 306
`methylparabens, 390
`phenylmercuric acetate, 434
`phenylmercuric borate, 436
`phenylmercuric hydroxide, 439
`potassium sorbate, 506
`propylparaben, 526
`sodium propionate, 579
`sorbic acid
`sporocides, chlorocresol, 144-145
`Vanillin, 667
`Antimicrobial preservatives see Antibacterial
`agents; Antifungal agents; Preservatives
`Arztimol, 549
`Antioxidants
`see also Preservatives
`alpha tocopherol, 27, 87
`ascorbic acid, 32
`ascorbyl palmitate, 35
`butylated hydroxyanisole, 61, 516
`butylated hydroxytoluene, 63, 516
`carbon dioxide, 93
`chelating agents, 225, 250
`ethyl oleate, 233
`fumaric acid, 250
`malic acid, 360
`monothioglycerol, 406
`phosphoric acid, 442
`potassium metabisulfite, 504
`propionic acid, 514
`propyl gallate, 516, 518
`sodium ascorbate, 546
`sodium bisulfite, 572
`sodium metabisulfite, 571, 572
`sodium sulfite, 572
`synergists
`citric acid monohydrate, 158
`tartaric acid, 644
`
`

`
`tocopherol (see.Antioxidants, alpha
`tocopherol)
`vitamin E, 29
`Antiseptics
`benzalkonium chloride, 45
`benzethonium chloride, 48
`bronopol, 58
`cetrimide, 127
`chlorhexidine, 136
`chloroxylenol, 153
`phenol, 426
`phenylmercuric borate, 436
`phenylmercuric nitrate, 438
`thimerosal, 648
`Antiviral agents
`benzalkonium chloride, 46
`butylated hydroxytoluene, 63
`cellulose acetate phthalate (CAP), 120
`sodium hydroxide, 567
`Apifll, 689
`APM, 37
`Apple acid, 360, 361
`Aqua, 672
`Aqua ammonia, 30
`Aquacoat cPD, 120
`Aquacoat ECD, 237
`Aqualon, 237
`Aqua purificata, 672
`Aquasorb, 97
`Arabic gum, 1
`Aracel 165, 265
`Arachidic acid
`cottonseed oil, 176
`peanut oil, 419
`sunflower oil, 634
`Arachidis oleum, 419
`' Arachis oil, 419
`Araldite 502, 203
`Arbocel, 112
`Arcto/1, 149
`Arcton 22, 148
`Argilla, 316
`Argobase EU, 424
`Argou/ax, 338
`Arlacel 186, 262
`Arlatone, 474
`Arlatone 983, 265
`Arosol, 429
`Artificial sweeteners
`see Sweetening agents
`Artificial vinegar, 6
`Ascorbic acid, 32, 36, 225, 547
`incompatibilities
`sodium starch glycolate, 582
`sucrose, 624
`L—(+)—Ascorbic acid, 32
`Ascorbic acid ethyl oleate, 233
`L-Ascorbic acid 6—hexadecanoate, 35
`L—Ascorbic acid monosodium salt, 546
`L-Ascorbic acid 6—palmitate, 35
`Ascorbylis palmitas, 35
`Ascorbyl palmitate, 34, 35, 547
`and alpha tocopherol, 27
`Aspartame, 24, 37
`acesulfame potassium synergy, 39
`with saccharin, 531
`with saccharin sodium, 534
`sweetness vs. sucrose, 37
`Aspartamum, 37
`3-(L—Aspartyl-D-alaninamido)-2,2,4,4-
`tetramethylthietane, 23
`L-Aspartyl-D-alanine~N—(2,2,4,4—
`tetramethylthietan-3-yl)amide, 23
`
`N—<x-L-Aspartyl-L—phenylalanine 1-methyl
`ester, 37
`L-or-Aspartyl-N-(2,2,4,4-tetramethyl-3-
`thietanyl)-D-alaninamidc anhydrous,
`23
`Aspartyl phenylamine methyl ester, 37
`A-TAB, 72, 73
`ATEC, 7
`ATEC, 9
`Atlas G-695, 262
`Attaclay, 40
`Attacote, 40
`Attagel, 40
`Attapulgite, 40, 346
`activated, 40, 41
`Attapulgus, 40
`A1/atec/7, 395
`Avedex, 197
`A1/icel CE~15, 110
`A1/icel CL-611, 110
`Auicel PH, 108
`A1JicelRC-581, 110
`Al/icel RC-591, 110
`Auol, 130
`A1/Olin, 217
`Aytex P, 603
`Azeite, 414 A
`Azote, 408
`
`Bactericides see Antibacterial agents
`Bacteriostatic water for injection, 675
`Baking soda, 552
`' Barcroft, 68
`Barcroft CS90, 71
`Barcroft CX50, 71
`Barcroft CZ50, 71
`Barrier creams, 685
`Basic phenylmercury nitrate, 438
`Bassorin, 654
`Beeswax, 689
`white, 687
`Beet sugar, 622
`Behenic acid
`peanut oil, 419
`sunflower oil, 634
`Benecel, 386
`Benecel MHPC, 297
`Benne oil, 535
`Bentonite, 42, 317, 346
`methylparabens incompatibility, 392
`purified, 44
`sol/gel ‘preparation, 43
`Bentonite magma, 44
`Bentonitum, 42
`Benzalkonii chloridum, 45
`Benzalkonium chloride, 45, 49, 440
`adverse effects, 46
`alternatives, thimerosal, 648‘
`synergists, 225
`Benzenecarboxylic acid, 50
`1,2-Benzenedicarboxylate, 217
`Benzenedicarboxylic acid, 203
`1,2-Benzenedicarboxylic acid
`dibutyl ester, 203
`diethyl ester, 209
`dimethyl ester, 217
`Benzene-o-dicarboxylic acid di-11-butyl ester,
`203
`Benzeneethanol, 431
`Benzeneformic acid, 50
`Benzenemethanol, 53
`Benzethonii chloridum, 48
`Benzethonium chloride, 47, 48
`
`Index
`
`753
`
`1,2-Benzisothiazolin-3-one 1,1-dioxide, 529
`sodium salt, 532
`1,2-Benzisothiazol-3(2H)-one 1,1-dioxide
`sodium salt, 5 32
`Benzoate of potash, 493
`Benzoate of soda, 549
`Benzoic acid, 50, 360, 494, 550
`_ benzyl ester, 56
`phenylmethyl ester, 56
`potassium salt, 493
`sodium salt, 549
`Benzoic sulfimide, 529
`Benzosulfimide, 529
`Benzyl alcohol, 5 3
`Benzylbenzenecarboxylate, 56
`Benzyl benzoatc, 56
`Benzyl carbinol, 431
`Benzyldiethyl[(2,6- ~
`xylylcarbamo1yl)methyl]ammonium
`benzoate
`anhydrous, 193
`monohydratc, 193
`Benzyldimethyl-[2-[2-(p-1,1,3,3—
`tetramethylbutylphenoxy)
`ethoxy]ethyl]ammonium chloride