Handbook of pharmaceutical excipients: 6th Revised edition

Product Information

Albumin Osmolarity: a 4–5% w/v aqueous solution is isoosmotic with serum. Solubility: freely soluble in dilute salt solutions and water. Aqueous solutions containing 40% w/v albumin can be readily prepared at pH 7.4. The high net charge of the peptide contributes to its solubility in aqueous media. The seven disulfide bridges contribute to its chemical and spatial conformation. At physiological pH, albumin has a net electrostatic charge of about –17. Aqueous albumin solutions are slightly viscous and range in color from almost colorless to amber depending on the protein concentration. 11 Appendix I: Suppliers’ Directory 835 Appendix II: List of Excipient ‘E’ Numbers 882 Appendix III: List of Excipient ‘EINECS’ Numbers 884 Appendix IV: List of Excipient Molecular Weights 886 Index 889

used to generate the data readers should consult the appropriate previous edition(s) of the Handbook. Acid value: 0.02 Boiling point: 2948C (decomposes) Flash point: 1888C Pour point: 438C Solubility: soluble 1 in 140 of water; miscible with acetone, ethanol, and propan-2-ol. Viscosity (dynamic): 54 mPa s (54 cP) at 258C. 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. 16part in less than 1 1 part in 1–10 1 part in 10–30 1 part in 30–100 1 part in 100–1000 1 part in 1000–10 000 1 part in more than 10 000 Acetone is a colorless volatile, flammable, transparent liquid, with a sweetish odor and pungent sweetish taste. 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. Acacia storage conditions, pH, and the presence of salts. Viscosity increases slowly up to about 25% w/v concentration and exhibits Newtonian behavior. Above this concentration, viscosity increases rapidly (non-Newtonian rheology). Increasing temperature or prolonged heating of solutions results in a decrease of viscosity owing to depolymerization or particle agglomeration. See also Section 12.

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 Section 16, Regulatory Status, describes the accepted uses in foods and licensed pharmaceuticals where known. However, the status of excipients varies from one nation to another, and appropriate regulatory bodies should be consulted for guidance. 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, USANonproprietary Names Synonyms Chemical Name and CAS Registry Number Empirical Formula and Molecular Weight Structural Formula Functional Category Applications in Pharmaceutical Formulation or Technology Description Pharmacopeial Specifications Typical Properties Stability and Storage Conditions Incompatibilities Method of Manufacture Safety Handling Precautions Regulatory Status Related Substances Comments Specific References General References Authors Date of Revision 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) A specification for acetone is included in the Japanese Pharmaceutical Excipients (JPE).(7) The EINECS number for acetone is 200-662-2. Acesulfame potassium occurs as a colorless to white-colored, odorless, crystalline powder with an intensely sweet taste. 9

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

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. Anderson DMW, Dea ICM. Recent advances in the chemistry of acacia gums. J Soc Cosmet Chem 1971; 22: 61–76. Anderson DM, Douglas DM, Morrison NA, Wang WP. Specifications for gum arabic (Acacia Senegal): analytical data for samples collected between 1904 and 1989. Food Add Contam 1990; 7: 303–321. Aspinal GO. Gums and mucilages. Adv Carbohydr Chem Biochem 1969; 24: 333–379. Whistler RL. Industrial Gums. New York: Academic Press, 1959.

Acesulfame K; E950; 6-methyl-3,4-dihydro-1,2,3-oxathiazin4(3H)-one 2,2-dioxide potassium salt; Sunett; Sweet One. 3 Protect tablet from the environment (air, light and moisture), increase the mechanical strength, mask taste and smell, aid swallowing, assist in product identification. Can be used to modify release of the active ingredient. May contain flavours and colourings. 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 mouse, oral): 3.0 g/kg(5) (mouse, IP): 1.297 g/kg (rabbit, oral): 5.340 g/kg (rabbit, skin): 0.2 g/kgAgar solutions are most stable at pH 4–10. Agar should be stored in a cool, dry, place. Containers of this material may be hazardous when empty since they retain product residues (dust, solids). 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 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 Acetyltriethyl citrate should be stored in dry, closed containers at temperatures not exceeding 388C. When stored in accordance with these conditions, acetyltriethyl citrate is a stable product. 12 Section 17, Related Substances, lists excipients similar to the excipient discussed in the monograph.