Resumen

DAZA CALDERON, MARIA LUISA. Biodisponibilidad y bioequivalencia in vitro en cápsulas de amoxicilina de 500 mg comercializados en Bolivia. Rev.Cs.Farm. y Bioq [online]. 2013, vol.1, n.1, pp.93-104. ISSN 2310-0265.

Abstract The Biodisponibility and Bioequiva-lence studies allow to demonstrate if the active principle has the same pharmacoki-netic performance in the generic drug as the standard set up in a country, to con-sider them interchangeable and to guar-antee through these tests that they must be developed as a demand to the generic drugs. In this way to contribute to have a true Guarantee of Quality of drugs like the Drugs Law and the Good Manufacture Practices were been approved in Bolivia of approved in Bolivia on December of 1996. The amoxycillin is an antibiotic of wide spectre very used in our country, it belongs the first class in the Biopharmaceutical Classification System (BCS), and therefore the execution of in vitro Biodisponibility and Bioequivalence studies by dissolution profiles have been justified. An in vitro Biodisponibility and Bio-equivalence study of the amoxycillin trihy-drate (capsules of 500 mg) of four national and foreign laboratories of more sale in the Bolivian market was carried out in this re-search, through an experimental and statis-tical design, set up in official documents of the United States Pharmacopoeia (USP). To the four products (three lots for product) were made the analysis of quality control for solid oral pharmaceutical forms, then to choose the lots that enter to bio-equivalence study it makes the Kinetic Analysis of the dissolution profiles of dissolved percentage accumulated versus time with a valuated method analytic, and these profiles are compared through the statistical method, IndependentModel with the Similarity Factor. It concludes that the products of the study are bioequivalentand interchangeable to each other, since in our country the innovative product is not marketed and it doesn't have a product of Reference settled down by the competentauthorities.

Palabras clave : Biodisponibility; Bioequivalence; dissolution profiles.

        · resumen en Español     · texto en Español     · Español ( pdf )