Handbook of pharmaceutical excipients: 6th Revised edition

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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. 4 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. 5 Repka MA, Gerding TG, Repka SL. Influence of plasticisers and drugs on the physical-mechanical properties of hydroxypropylcellulose films prepared by hot melt extrusion. Drug Dev Ind Pharm 1999; 25(5): 625–633. 6 Lieb S, Szeimies RM, Lee G. Self-adhesive thin films for topical delivery of 5-aminolevulinic acid. Eur J Pharm Biopharm 2002; 53(1): 99–106. 7 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 3512. 8 Goulas AE, Riganakos KA, Ehlermann DA, et al. Effect of highdose electron beam irradiation on the migration of DOA and ATBC plasticizers from food-grade PVC and PVDC/PVC films, respectively, into olive oil. J Food Prot 1998; 61(6): 720–724. 9 Dorfer CE, Kim TS, Steinbrenner H, et al. Regenerative periodontal surgery in interproximal intrabony defects with biodegradable barriers. J Clin Peridontol 2000; 27(3): 162–168. 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. Acetic acid Activated attapulgite Aleuritic acid d-Alpha tocopherol d-Alpha tocopheryl acetate dl-Alpha tocopheryl acetate d-Alpha tocopheryl acid succinate dl-Alpha tocopheryl acid succinate Aluminum distearate Aluminum monostearate Amylopectin a-Amylose Anhydrous citric acid Anhydrous sodium citrate Anhydrous sodium propionate Artificial vinegar Bacteriostatic water for injection Bentonite magma Beta tocopherol Beta-carotene n-Butyl lactate Butylparaben sodium Calcium ascorbate Calcium cyclamate Calcium polycarbophil Calcium propionate Calcium silicate Calcium sorbate Calcium sulfate hemihydrate Capric acid Carbon dioxide-free water Cationic emulsifying wax Ceratonia extract Cetylpyridinium bromide Chlorhexidine acetate Chlorhexidine gluconate Chlorhexidine hydrochloride Chlorodifluoromethane Chlorophenoxyethanol Corn syrup solids m-Cresol o-Cresol p-Cresol Crude olive-pomace oil Cyclamic acid De-aerated water Dehydrated alcohol Delta tocopherol Denatured alcohol Dextrose anhydrous Diazolidinyl urea Dibasic potassium phosphate Diethylene glycol monopalmitostearate Dilute acetic acid Dilute alcohol 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

Identification Characters pH (10 g/L solution) Polymers and aggregates Potassium Sodium Heme Aluminum Sterility Hepatitis B surface antigen Pyrogens Total protein for 4 g in 100 mL for 5 to 25 g in 100 mL Protein composition Prekallikrein activator Saccharin ammonium Saccharin calcium Self-emulsifying glyceryl monostearate Shellolic acid Sodium bisulfite Sodium borate anhydrous Sodium edetate Sodium erythorbate Sodium laurate Sodium myristate Sodium palmitate Sodium sorbate Sodium sulfite heptahydrate Soft water Sorbitol solution 70% Spermaceti wax Stearalkonium hectorite Sterile water for inhalation Sterile water for injection Sterile water for irrigation Sunset yellow FCF Synthetic paraffin DL-(
)-Tartaric acid Tartrazine Theobroma oil Tocopherols excipient Tribasic sodium phosphate Trimethyl-b-cyclodextrin Trimethyltetradecylammonium bromide Trisodium edetate Virgin olive oil Water for injection White petrolatum Zinc propionate 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 Agar is widely used in food applications as a stabilizing agent. In pharmaceutical applications, agar is used in a handful of oral tablet and topical formulations. It has also been investigated in a number of experimental pharmaceutical applications including as a sustained-release agent in gels, beads, microspheres, and tablets.(1–4) It has also been reported to work as a disintegrant in tablets.(5) Agar has been used in a floating controlled-release tablet; the buoyancy in part being attributed to air entrapped in the agar gel network.(6) It can be used as a viscosity-increasing agent in aqueous systems. Agar can also be used as a base for nonmelting, and nondisintegrating suppositories.(7) Agar has an application as a suspending agent in pharmaceutical suspensions.(8) 8

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New chapters providing support to the formulator, such as excipient selection for orally inhaled and also injectable formulations

Aqueous solutions are subject to bacterial or enzymatic degradation but may be preserved by initially boiling the solution for a short time to inactivate any enzymes present; microwave irradiation can also be used.(5) Aqueous solutions may also be preserved by the addition of an antimicrobial preservative such as 0.1% w/v benzoic acid, 0.1% w/v sodium benzoate, or a mixture of 0.17% w/v methylparaben and 0.03% propylparaben. Powdered acacia should be stored in an airtight container in a cool, dry place. Similar action to glidants, however, they may slow disintegration and dissolution. The properties of glidants and lubricants differ, although some compounds, such as starch and talc, have both actions. Dilute acetic acid Comments: a weak solution of acetic acid which may contain between 6–10% w/w of acetic acid. See Section 18. 18 The Handbook of Pharmaceutical Excipients is internationally recognised as the world’s most authoritative source of information on pharmaceutical excipients. It provides you with a one stop resource when researching an excipient for use. The 400+ monographs are also thoroughly cross referenced and indexed to allow their identification by chemical, non proprietary or trade names.

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A specification for acetone is included in the Japanese Pharmaceutical Excipients (JPE).(7) The EINECS number for acetone is 200-662-2.