BIOPHARMACEUTICS [PHCT 434]

All pharmaceuticals, from the generic analgesic tablet in the community pharmacy to the state-of-the-art immunotherapy in specialized hospitals, undergo extensive research and development prior to approval by the U.S. Food and Drug Administration (FDA). The physicochemical characteristics of the active pharmaceutical ingredient (API, or drug substance), the dosage form or the drug, and the route of administration are critical determinants of the in-vivo performance, safety and efficacy of the drug product. The properties of the drug and its dosage form are carefully engineered and tested to produce a stable drug product that upon administration provides the desired therapeutic response in the patient. Both the pharmacist and the pharmaceutical scientist must understand these complex relationships to comprehend the proper use and development of pharmaceuticals.

Biopharmaceutics is the science that examines this interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption. Thus, Biopharmaceutics involves factors that influence (1) the stability of the drug within the drug product, (2) the release of the drug from the drug product, (3) the rate of dissolution/release of the drug at the absorption site, and (4) the systemic absorption of the drug.



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