Handbook of pharmaceutical excipients: 6th Revised edition

Product Information

Acacia is available as white or yellowish-white thin flakes, spheroidal tears, granules, powder, or spray-dried powder. It is odorless and has a bland taste. 9 Albumin human (USP 28) Albumin human is a sterile nonpyrogenic preparation of serum albumin that is obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The source material is tested for the absence of hepatitis B surface antigen. It is made by a process that yields a product safe for intravenous use. Albumin solution, human (PhEur 2005) Human albumin solution is an aqueous solution of protein obtained from plasma. Separation of the albumin is carried out under controlled conditions so that the final product contains not less than 95% albumin. Human albumin solution is prepared as a concentrated solution containing 150–250 g/L of total protein or as an isotonic solution containing 35–50 g/L of total protein. A suitable stabilizer against the effects of heat such as sodium caprylate (sodium octanoate) or N-acetyltryptophan or a combination of these two at a suitable concentration, may be added, but no antimicrobial preservative is added at any stage during preparation Acidity/alkalinity: pH = 6.7–7.3 for a 1% w/v solution, in 0.9% w/v sodium chloride solution, at 208C. 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

millimeter of mercury (mmHg) = 133.322 pascals (Pa) 1 pound per square inch (psi) = 6894.76 pascals (Pa) Surface tension 1 dyne per centimeter (dyne/cm) = 1 millinewton per meter (mN/m) Temperature Celsius (8C) = (1.8  8C) þ 32 Fahrenheit (8F) Fahrenheit (8F) = (0.556  8F) –17.8 Celsius (8C) Viscosity (dynamic) 1 centipoise (cP) = 1 millipascal second (mPa s) 1 poise (P) = 0.1 pascal second (Pa s) Notice to Readers The Handbook of Pharmaceutical Excipients is a reference work containing a compilation of information on the uses and properties of pharmaceutical excipients, and the reader is assumed to possess the necessary knowledge to interpret the information that the Handbook contains. The Handbook of Pharmaceutical Excipients has no official status and there is no intent, implied or otherwise, that any of the information presented should constitute standards for the substances. The inclusion of an excipient, or a description of its use in a particular application, is not intended as an endorsement of that excipient or application. Similarly, reports of incompatibilities or adverse reactions to an excipient, in a particular application, may not necessarily prevent its use in other applications. Formulators should perform suitable experimental studies to satisfy themselves and regulatory bodies that a formulation is efficacious and safe to use. While considerable efforts were made to ensure the accuracy of the information presented in the Handbook, neither the publishers nor the compilers can accept liability for any errors or omissions. In particular, the inclusion of a supplier within the Agar is widely used in food applications and has been used in oral and topical pharmaceutical applications. It is generally regarded as relatively nontoxic and nonirritant when used as an excipient. LD50 LD50 LD50 LD50 15 Mainly natural or synthetic polymers e.g. starches, sugars, sugar alcohols and cellulose derivatives In addition to glacial acetic acid, many pharmacopeias contain monographs for diluted acetic acid solutions of various strengths. For example, the USPNF 23 has a monograph for acetic acid, which is defined as an acetic acid solution containing 36.0–37.0% w/w of acetic acid. Similarly, the BP 2004 contains separate monographs for glacial acetic acid, acetic acid (33%), and acetic acid (6%). Acetic acid (33%) BP 2004 contains 32.5–33.5% w/w of acetic acid. Acetic acid (6%) BP 2004 contains 5.7–6.3% w/w of acetic acid. The JP 2001 also contains a monograph for acetic acid that specifies that it contains 30.0–32.0% w/w of acetic acid. A specification for glacial acetic acid is contained in the Food Chemicals Codex (FCC). The EINECS number for acetic acid is 200-580-7. 19Acesulfame K; E950; 6-methyl-3,4-dihydro-1,2,3-oxathiazin4(3H)-one 2,2-dioxide potassium salt; Sunett; Sweet One. 3 Acetyltriethyl citrate is used to plasticize polymers in formulated pharmaceutical coatings.(1) The coating applications include capsules, tablets, beads and granules for taste masking, immediate release, sustained-release and enteric formulations.(2–5) It is also used in diffusion-controlled release drug delivery systems.(6) Length 1 angstrom (a˜) = 10–10 meter (m) 1 inch (in) = 2.54  10–2 meter (m) 1 foot (ft) = 3.048  10–1 meter (m) 1 yard (yd) = 9.144  10–1 meter (m)

Sweetman SC, ed. Martindale: The Complete Drug Reference, 34th edn. London: Pharmaceutical Press, 2005: 1645. 2 Fenner PJ, Williamson JA. Worldwide deaths and severe envenomation from jellyfish stings. Med J Aust 1996; 165: 658–661. 3 Milner SM. Acetic acid to treat Pseudomonas aeruginosa in superficial wounds and burns. Lancet 1992; 340: 61. 4 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 15–16. 5 Health and Safety Executive. EH40/2002: Occupational Exposure Limits 2002, Sudbury: Health and Safety Executive, 2002. Acidity/alkalinity: pH = 2.4 (1 M aqueous solution); pH = 2.9 (0.1 M aqueous solution); pH = 3.4 (0.01 M aqueous solution). Boiling point: 1188C Dissociation constant: pKa = 4.76 Flash point: 398C (closed cup); 578C (open cup). Melting point: 178C Refractive index: n20 D = 1.3718 Solubility: miscible with ethanol, ether, glycerin, water, and other fixed and volatile oils. Specific gravity: 1.045 11 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

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). Observe normal precautions appropriate to the circumstances and quantity of material handled. Acacia can be irritant to the eyes and skin and upon inhalation. Gloves, eye protection, and a dust respirator are recommended. 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 Acacia is incompatible with a number of substances including amidopyrine, apomorphine, cresol, ethanol (95%), ferric salts, morphine, phenol, physostigmine, tannins, thymol, and vanillin. An oxidizing enzyme present in acacia may affect preparations containing easily oxidizable substances. However, the enzyme may be inactivated by heating at 1008C for a short time; see Section 11. Many salts reduce the viscosity of aqueous acacia solutions, while trivalent salts may initiate coagulation. Aqueous solutions carry a negative charge and will form coacervates with gelatin and other substances. In the preparation of emulsions, solutions of acacia are incompatible with soaps. 13 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

Albumin is primarily used as an excipient in parenteral pharmaceutical formulations, where it is used as a stabilizing agent for formulations containing proteins and enzymes.(2) Albumin has also been used to prepare microspheres and microcapsules for experimental drug-delivery systems.(3) As a stabilizing agent, albumin has been employed in protein formulations at concentrations as low as 0.003%, although concentrations of 1–5% are commonly used. Albumin has also been used as a cosolvent(4) for parenteral drugs, as a cryoprotectant during lyophilization, and to prevent adsorption of other proteins to surfaces. Therapeutically, albumin solutions have been used parenterally for plasma volume replacement and to treat severe acute

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Jensen JL, Appel LE, Clair JH, Zentner GM. Variables that affect the mechanism of drug release from osmotic pumps coated with acrylate/methacrylate copolymer latexes. J Pharm Sci 1995; 84: 530–533. 2 Gutierrez-Rocca JC, McGinity JW. Influence of water soluble and insoluble plasticizer on the physical and mechanical properties of acrylic resin copolymers. Int J Pharm 1994; 103: 293–301. 3 Lehmann K. Chemistry and application properties of polymethacrylate coating systems. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. New York: Marcel Dekker, 1989: 153–245.