Summary
THERE is increasing evidence to indicate that the bioavailability of different oral solid dosage formulations of the same drug may show significant clinical variations, even when such formulations satisfy pharmacopoeial specifications and standards for chemical equivalence. Formulation factors affecting the dissolution rates of drugs from tablets and capsules, and thus influencing their absorption characteristics, include the surface area, polymorphic form, solvates and salt of the drug, the excipients and the process of manufacture. Therapeutic equivalence of different formulations of the same drug can at present only be established by testing in man.
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Corrigan, O.I., Timoney, R.F. Some aspects of the influence of formulation on the bioavailability of drugs from solid dosage forms. Ir J Med Sci 143, 197–207 (1974). https://doi.org/10.1007/BF03004763
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DOI: https://doi.org/10.1007/BF03004763