Handbook of pharmaceutical excipients: 6th Revised edition

Product Information

Included in the FDA Inactive Ingredients Guide (inhalation solution; oral tablets; topical preparations). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines licensed in the UK. 17 Improve the flow of powders during tablet manufacturing by reducing friction and adhesion between particles. Also used as anti-caking agents. hamster, oral): 6.1 g/kg(10) (mouse, oral): 16.0 g/kg (rabbit, oral): 5.8 g/kg (rat, oral): 11.0 g/kg

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 Improve acceptability to patients, aid identification and prevent counterfeiting. Increase stability of light-sensitive drugs. Acacia is used in cosmetics, foods, and oral and topical pharmaceutical formulations. Although it is generally regarded as an essentially nontoxic material, there have been a limited number of reports of hypersensitivity to acacia after inhalation or ingestion.(6,7) Severe anaphylactic reactions have occurred following the parenteral administration of acacia and it is now no longer used for this purpose.(6) The WHO has not set an acceptable daily intake for acacia as a food additive because the levels necessary to achieve a desired effect were not considered to represent a hazard to health.(8) LD50 (hamster, oral): >18 g/kg(9) LD50 (mouse, oral): >16 g/kg LD50 (rabbit, oral): 8.0 g/kg 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 substances should be discussed together. This gave rise to such monographs as ‘Coloring Agents’ and ‘Hydrocarbons’. In addition, 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 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Acetic acid; artificial vinegar; dilute acetic acid. Acetic acid Comments: a diluted solution of glacial acetic acid containing 30–37% w/w of acetic acid. See Section 18. Artificial vinegar Comments: a solution containing 4% w/w of acetic acid.

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 GRAS listed. Accepted for use in Europe as a food additive. Included in the FDA Inactive Ingredients Guide (oral preparations and buccal or sublingual tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines licensed in the UK. 17 The information below shows imperial to SI unit conversions for the units of measurement most commonly used in the Handbook. SI units are used throughout with, where appropriate, imperial units reported in parentheses. Area 1 square inch (in2) = 6.4516  10–4 square meter (m2) 1 square foot (ft2) = 9.29030  10–2 square meter (m2) 1 square yard (yd2) = 8.36127  10–1 square meter (m2) Density 1 pound per cubic foot (lb/ft3) = 16.0185 kilograms per cubic meter (kg/m3) Energy 1 kilocalorie (kcal) = 4.1840  103 joules (J)

Acesulfame potassium occurs as a colorless to white-colored, odorless, crystalline powder with an intensely sweet taste. 9 Observe normal precautions appropriate to the circumstances and quantity of the material handled. When heated to decomposition, agar emits acrid smoke and fumes. 16

The following new monographs have been added to the Handbook of Pharmaceutical Excipients, 5th edition. Acetone Agar Aluminum Hydroxide Adjuvant Aluminum Oxide Aluminum Phosphate Adjuvant Ammonium Alginate Aluminum Stearate Boric Acid Calcium Alginate Cetylpyridinium Chloride Copovidone Dimethylacetamide Disodium Edetate Erythorbic Acid Erythritol Ethyl Lactate Ethylene Vinyl Acetate Hectorite Hydroxypropyl Starch Hypromellose Acetate Succinate Inulin Iron Oxides Isomalt Lactose, Anhydrous Lactose, Monohydrate Lactose, Spray-Dried Acetyltriethyl citrate is prepared by the esterification of citric acid with ethanol followed by acylation with acetic anhydride. 14 Acidity/alkalinity: pH = 4.5–5.0 (5% w/v aqueous solution) Acid value: 2.5 Hygroscopicity: at relative humidities of 25–65%, the equilibrium moisture content of powdered acacia at 258C is 8–13% w/w, but at relative humidities above about 70% it absorbs substantial amounts of water. Solubility: soluble 1 in 20 of glycerin, 1 in 20 of propylene glycol, 1 in 2.7 of water; practically insoluble in ethanol (95%). In water, acacia dissolves very slowly, although almost completely after two hours, in twice the mass of water leaving only a very small residue of powder. The solution is colorless or yellowish, viscous, adhesive, and translucent. Spray-dried acacia dissolves more rapidly, in about 20 minutes. Specific gravity: 1.35–1.49 Viscosity (dynamic): 100 mPa s (100 cP) for a 30% w/v aqueous solution at 208C. The viscosity of aqueous acacia solutions varies depending upon the source of the material, processing,