U.S. PHARMACOPEIA

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BIOAVAILABILITY
Bioavailability, or the extent to which the therapeutic constituent of a pharmaceutical dosage form intended for oral or topical use is available for absorption, is influenced by a variety of factors. Among the inherent factors known to affect absorption are the method of manufacture or method of compounding; the particle size and crystal form or polymorph of the drug substance; and the diluents and excipients used in formulating the dosage form, including fillers, binders, disintegrating agents, lubricants, coatings, solvents, suspending agents, and dyes. Lubricants and coatings are foremost among these. The maintenance of a demonstrably high degree of bioavailability requires particular attention to all aspects of production and quality control that may affect the nature of the finished dosage form.