Nadda Nadeem
Central America
Research Article
Biowaiver Studies of Atenolol Tablets (100mg) - An Alternative to In Vivo Bioequivalence Studies
Author(s): Shahnaz Usman, Alam Alam, Nadda Nadeem, Rameesha Khawar and Zainab IntesarShahnaz Usman, Alam Alam, Nadda Nadeem, Rameesha Khawar and Zainab Intesar
The aim of present study was to compare the quality of atenolol tablets and examine the possibility of biowaiver study for approval of generic drugs without additional in vivo bioequivalence study. Atenolol, a cardio selective β-blocker, could be clearly classified into BCS Class III and may be evaluated under biowaiver conditions. Due to the importance of atenolol and availability of different generics in a community basis, four products available in Ras Al Khaimah were analyzed. Four brands of atenolol 100 mg tablets have been evaluated using some quality control parameters, such as weight variation, hardness, content assay, disintegration and dissolution test. In vitro dissolution testing can be used in some cases not only to determine the quality of the pharmaceutical products but also to demonstrate bioequivalence to the generic product. Similarity factor (f2) and Difference.. View More»
