Handbook of pharmaceutical excipients: 6th Revised edition

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You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer albumin loss. However, the benefits of using albumin in such applications in critically ill patients has been questioned.(5) 8 GRAS listed. Accepted as a food additive in Europe. Included in the FDA Inactive Ingredients Guide (injections, nasal, ophthalmic, and oral preparations). Included in parenteral and nonparenteral preparations licensed in the UK. 17

Descriptions of the sections appear below with information from an example monograph if needed. Section 1, Nonproprietary Names, lists the excipient names used in the current British Pharmacopoeia, European Pharmacopeia, Japanese Pharmacopeia, and the United States Pharmacopeia/National Formulary. Section 2, Synonyms, lists other names for the excipient, 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 Boiling point: 56.28C Flash point: –208C Melting point: 94.38C Refractive index: n20 D = 1.359 Solubility: soluble in water; freely soluble in ethanol (95%) Vapor pressure: 185 mmHg at 208C 11 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. 19 Section 13, 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 recommendations for suitable containment and protection methods. A familiarity with current good laboratory practice (GLP) and MP Mullarney Pfizer Inc Groton, CT, USA S Murdande Pfizer Inc Groton, CT, USA RA Nash St John’s University Jamaica, NY, USA S Nema Pfizer Inc Chesterfield, MO, USAGlacial and diluted acetic acid solutions are widely used as acidifying agents in a variety of pharmaceutical formulations and food preparations. Acetic acid is used in pharmaceutical products as a buffer system when combined with an acetate salt such as sodium acetate. Acetic acid is also claimed to have some antibacterial and antifungal properties.

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: Identification Specific gravity Refractive index Acidity Water Heavy metals Assay (anhydrous basis) 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 Bhardwaj TJ, Kanwar M, Lal R, Gupta A. Natural gums and modified natural gums as sustained release carriers. Drug Dev Ind Pharm 2000; 26(10): 1025–1038. 2 Sakr FM, El-Said Y, El-Helw A. Design and evaluation of a dry solidification technique for preparing pharmaceutical beads. STP Pharma Sci 1995; 5(4): 291–295. 3 Boraie NA, Naggar VF. Sustained release of theophylline and aminophylline from agar tablets. Acta Pharm Jugosl 1984; 34(Oct–Dec): 247–256. 4 Nakano M, Nakamura Y, Takikawa K, et al. Sustained release of sulfamethizole from agar beads. J Pharm Pharmacol 1979; 31: 869–872. 5 Fassihi AR. Characteristics of hydrogel as disintegrant in solid dose technology. J Pharm Pharmacol 1989; 54: 59–62. 6 Desai S, Boston S. A floating controlled-release drug delivery system: in vitro–in vivo evaluation. Pharm Res 1993; 10: 1321– 1325. 7 Singh KK, Deshpande SG, Baichwal MR. Studies on suppository bases: design and evaluation of sodium CMC and agar bases. Indian Drugs 1994; 31(April): 149–154. 8 Kahela P, Hurmerinta T, Elfving R. Effect of suspending agents on the bioavailability of erythromycin ethylsuccinate mixtures. Drug Dev Ind Pharm 1978; 4(3): 261–274. 9 Gennaro AR, ed. Remington: The Science and Practice of Pharmacy, 20th edn. Baltimore: Lippincott Williams & Wilkins, 2000: 1030. 10 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 90–91. Acesulfame potassium is synthesized from acetoacetic acid tertbutyl ester and fluorosulfonyl isocyanate. The resulting compound is transformed to fluorosulfonyl acetoacetic acid amide, which is then cyclized in the presence of potassium hydroxide to form the oxathiazinone dioxide ring system. Because of the strong acidity of this compound, the potassium salt is produced directly. An alternative synthesis route for acesulfame potassium starts with the reaction between diketene and amidosulfonic acid. In the presence of dehydrating agents, and after neutralization with potassium hydroxide, acesulfame potassium is formed. 14

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The USP 28 describes albumin human as a sterile nonpyrogenic preparation of serum albumin obtained from healthy human donors; see Section 13. It is available as a solution containing 4, 5, 20, or 25 g of serum albumin in 100 mL of solution, with not less than 96% of the total protein content as albumin. The solution contains no added antimicrobial preservative but may contain sodium acetyltryptophanate with or without sodium caprylate as a stablizing agent. The PhEur 2005 similarly describes albumin solution as an aqueous solution of protein obtained from human plasma; see Section 13. It is available 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. Not less than 95% of the total protein content is albumin. 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. Aqueous albumin solutions are slightly viscous and range in color from almost colorless to amber depending upon the protein concentration. In the solid state, albumin appears as brownish amorphous lumps, scales, or powder. 9 BP: Glacial acetic acid JP: Glacial acetic acid PhEur: Acidum aceticum glaciale USP: Glacial acetic acid The PhEur 2005 provides monographs on acacia and spraydried acacia, while the USPNF 23 describes acacia in a single monograph that encompasses tears, flakes, granules, powder, and spray-dried powder. The JP 2001 also has monographs on acacia and powdered acacia. See Table II. Table II:

New chapters providing support to the formulator, such as excipient selection for orally inhaled and also injectable formulations Related Substances Methylparaben potassium Methylparaben sodium N-Methylpyrrolidone Microcrystalline cellulose and carboxymethylcellulose sodium Microcrystalline cellulose and carrageenan Microcrystalline cellulose and guar gum Modified lanolin Monobasic potassium phosphate Montmorillonite Myristyl alcohol Neotrehalose Normal magnesium carbonate Octyl gallate Oleyl oleate Olive-pomace oil Palmitin Pharmaceutical glaze Phenoxypropanol Polacrilin Poly(methyl methacrylate) Potassium bisulfite Potassium myristate Potassium propionate Powdered fructose Propan-1-ol (S)-Propylene carbonate Propylparaben potassium Propylparaben sodium Purified bentonite Purified stearic acid Quaternium 18-hectorite Rapeseed oil Refined almond oil Refined olive-pomace oil 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

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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) 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