Committee since the third edition. He is a Technical Service Leader in the Water Soluble Polymers, Pharmaceutical R&D Group at The Dow Chemical Company in Midland, Michigan, USA. Paul received his BSc degree in pharmacy from Ferris State University. Previously, he has worked as a research pharmacist in the area of solid dosage form development at the Perrigo Company and the Upjohn (Pharmacia) Company. Paul has authored numerous journal articles in the area of pharmaceutical technology. He is a member of the AAPS, Controlled Release Society, and the Institute for Briquetting and Agglomeration. ˆ n C Owen Sia BSc, MA Siaˆn Owen has been involved with the Handbook of Pharmaceutical Excipients since the fourth edition, as a contributor and Steering Committee member. Siaˆn received her BSc degree in pharmacology from the University of Sunderland, and her MA in biotechnological law and ethics from the University of Sheffield. Acetyltributyl Citrate slightly irritating to the eyes and may be irritating to the respiratory system as a mist or at elevated temperatures. Gloves and eye protection are recommended for normal handling, and a respirator is recommended when using acetyltributyl citrate at elevated temperatures. 16

Volume 1 cubic inch (in3) = 1.63871  10–5 cubic meter (m3) 1 cubic foot (ft3) = 2.83168  10–2 cubic meter (m3) 1 cubic yard (yd3) = 7.64555  10–1 cubic meter (m3) 1 pint (UK) = 5.68261  10–4 cubic meter (m3) 1 pint (US) = 4.73176  10–4 cubic meter (m3) 1 gallon (UK) = 4.54609  10–3 cubic meter (m3) 1 gallon (US) = 3.78541  10–3 cubic meter (m3)

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Acacia is mainly used in oral and topical pharmaceutical formulations as a suspending and emulsifying agent, often in combination with tragacanth. It is also used in the preparation of pastilles and lozenges, and as a tablet binder, although if used incautiously it can produce tablets with a prolonged disintegration time. Acacia has also been evaluated as a bioadhesive;(1) and has been used in novel tablet formulations,(2) and modified release tablets.(3) See Table I. Acacia is also used in cosmetics, confectionery, food products, and spray-dried flavors.(4) See also Section 18. Table I: Acetyltriethyl citrate is used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritating material. However, ingestion of large quantities may be harmful. LD50 (cat, oral): 8.5 g/kg(7) LD50 (mouse, IP): 1.15 g/kg LD50 (rat, oral): 7 g/kg 15 Acesulfame potassium possesses good stability. In the bulk form it shows no sign of decomposition at ambient temperature over many years. In aqueous solutions (pH 3.0–3.5 at 208C) no reduction in sweetness was observed over a period of approximately 2 years. Stability at elevated temperatures is good, although some decomposition was noted following storage at 408C for several months. Sterilization and pasteurization do not affect the taste of acesulfame potassium.(5) The bulk material should be stored in a well-closed container in a cool, dry place. 12

BP: Glacial acetic acid JP: Glacial acetic acid PhEur: Acidum aceticum glaciale USP: Glacial acetic acid Abbreviations DSC EC e.g. EINECS et al EU FAO FAO/ WHO FCC FDA FD&C FFBE g GMP GRAS HC HCFC HFC HIV HLB HSE i.e. IM INN IP ISO IU IV J JP JPE kcal kg kJ kPa L LAL LC50 LD50 LdLo m m2 m3 M max MCA approximately. Addendum. acceptable daily intake. approximately. atmosphere. British Approved Name. boiling point. British Pharmacopoeia. British Standard (specification). British Standards Institution. calorie(s). Chemical Abstract Service. The Handbook of Pharmaceutical Excipients is internationally recognized as the world’s most authoritative source of information on pharmaceutical excipients. It is the definitive comprehensive guide to uses, properties and safety of excipients providing scientists and researchers with a one stop resource when researching an excipient. Acetyltributyl citrate is used to plasticize polymers in formulated pharmaceutical coatings,(1–5) including capsules, tablets, beads, and granules for taste masking, immediate release, sustained-release and enteric formulations.

thanks for their support over many years. Thanks are also extended to excipient manufacturers and suppliers who provided helpful information on their products. Thanks are also gratefully extended to the staff of the Pharmaceutical Press and American Pharmacists Association who were involved in the production of the Handbook: Eric Connor, Tamsin Cousins, Simon Dunton, Laurent Galichet, Julian Graubart, Louise McIndoe, Karl Parsons, Paul Weller, and John Wilson. Once again, the diligent copy-editing and challenging questions asked by Len Cegielka helped the authors and editors, we hope, to express their thoughts clearly, concisely, and accurately. Raymond C Rowe, Paul J Sheskey and Siaˆn C Owen August 2005 GE Amidon Pharmacia Corporation Kalamazoo, Michigan, USA GP Andrews The Queen’s University of Belfast Belfast, UK Acetone is considered moderately toxic, and is a skin irritant and severe eye irritant. Skin irritation has been reported due to its defatting action, and prolonged inhalation may result in headaches. Inhalation of acetone can produce systemic effects such as conjunctival irritation, respiratory system effects, nausea, and vomiting.(5) LD50 LD50 LD50 LD50 differential scanning calorimetry. European Community. exemplit gratia, ‘for example’. European Inventory of Existing Commercial Chemical Substances. et alii, ‘and others’. European Union. Food and Agriculture Organization of the United Nations. Food and Agriculture Organization of the United Nations and the World Health Organization. Food Chemicals Codex. Food and Drug Administration of the USA. designation applied in USA to dyes permitted for use in foods, drugs, and cosmetics. Flat face beveled edge. gram(s). Good Manufacturing Practice. generally recognized as safe by the Food and Drug Administration of the USA. hydrocarbon. hydrochlorofluorocarbon. hydrofluorocarbon. human immunodeficiency virus. hydrophilic–lipophilic balance. Health and Safety Executive (UK). id est, ‘that is’. intramuscular. International Nonproprietary Name. intraperitoneal. International Organization for Standardization. International Units. intravenous. joule(s). Japanese Pharmacopeia. Japanese Pharmaceutical Excipients kilocalorie(s). kilogram(s). kilojoule(s). kilopascal(s). liter(s). Limulus amoebocyte lysate. a concentration in air lethal to 50% of the specified animals on inhalation. a dose lethal to 50% of the specified animals or microorganisms. lowest lethal dose for the specified animals or microorganisms. meter(s). square meter(s). cubic meter(s). molar. maximum. Medicines Control Agency (UK). mg MIC min mL mm mM mm2 mm3 mmHg mmol mN mol mp mPa MPa mg mm N nm o/w o/w/o Pa pH PhEur pKa pph ppm psia RDA rpm s SC SEM SI TPN TWA UK US or USA USAN USP USPNF UV v/v v/w WHO w/o w/o/w w/v w/w

Acetone reacts violently with oxidizing agents, chlorinated solvents, and alkali mixtures. It reacts vigorously with sulfur dichloride, potassium t-butoxide, and hexachloromelamine. Acetone should not be used as a solvent for iodine, as it forms a volatile compound that is extremely irritating to the eyes.(4) 13 Abbreviations Some units, terms, and symbols are not included in this list as they are defined in the text. Common abbreviations have been omitted. The titles of journals are abbreviated according to the general style of the Index Medicus.  Ad ADI approx atm BAN bp BP BS BSI cal CAS

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Steurnagel CR. Latex emulsions for controlled drug delivery. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. New York: Marcel Dekker, 1989: 1–61. 5 Gutierrez-Rocca JC, McGinity JW. Influence of aging on the physical-mechanical properties of acrylic resin films cast from aqueous dispersions and organic solutions. Drug Dev Ind Pharm 1993; 19(3): 315–332. 6 Siepmann J, Lecomte F, Bodmeier R. Diffusion-controlled drug delivery systems: calculation of the required composition to achieve desired release profiles. J Control Release 1999; 60(2–3): 379–389. 7 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 58–59. All of the 400+ monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names. It is internationally recognised as the authoritative source of information on pharmaceutical excipients and a comprehensive guide to uses, properties and safety.