In Vitro and In Vivo Evaluation of Different Solid Dosage Forms Containing Captopril

Current Health Sciences Journal

G.A. ABDALRBreplacement¹ 

关键词: captopril formulations;    release kinetics;    bioequivalence;    square root law;   

DOI  :  10.12865/CHSJ.43.03.05

学科分类：医学（综合）

来源: Universitatea de Medicina si Farmacie din Craiova / University of Medicine and Pharmacy

【 摘 要 】

Aim. Comparison of Captopril generic formulations on the Romanian market with the reference formulation Capoten (Bristol Myers Squibb), in terms of in vitro release kinetics of active substance and in vivo pharmacokinetics. Materials and methods. Dissolution studies were performed using Apparatus 1 (Basket), DT 800H, Erweka, Germany in acidic medium (0.01 N hydrochloric acid) and an agitation speed of 50 rpm. Experiments were run on 12 tablets of each formulation. Quantification of Captopril was achieved by using a spectrophotometric method, λ=205nm. Clinical pharmacokinetics was determined in the frame of four different bioequivalence studies comparing a single dose four different Captopril 50mg generic tablet products to the innovator drug, Capoten 50mg (Bristol Myers Squibb). Results. Different batches of the reference formulations achieved dissolution profiles of the same form and very closed to each other at all dissolution points. Dissolution profiles of the tested formulations.

【 授权许可】

Unknown