IN VITRO-IN VIVO BIO-EQUIVALENCE CORRELATION STUDY OF ATENOLOL, AND ITS BRANDS OF IMMEDIATE RELEASE TABLET UNDER BIO-WAIVER CONDITIONS
The aim of present study is to examine the in-vitro-in-vivo correlation (IVIVC) of immediate release product. Atenolol 100mg and its brands of immediate release dosage forms. Atenolol is clearly classified into BCS class III, and could be evaluated under bio waiver conditions. The in vitro parameters employed were hardness, weight uniformity, friability, disintegration time, absolute drug content, dissolution rate (in 0.1 N Hydrochloric acid, phosphate buffer and acetate buffer at 37ºC), and dissolution efficiencies were also analyzed. The in-vitro dissolution study was performed on the brands, according to FDA,USP dissolution profile in three different PH (1.2),(4.5), and (6.8) at 37ºC, using the USP apparatus II, then f1, f2 were determined for the time intervals of 10, 15, 30, 45 and 60 minutes, and dissolution efficiencies were calculated. MINITAB 14 statistical program used for in vitro-in vivo correlation, level A was done for reference product. A non linear relation was established which is typical for immediate release formulation, of class III.
Peer Review History:
Received 20 September 2019; Revised 16 December; Accepted 7 January, Available online 15 January 2020
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Average Peer review marks at initial stage: 3.0/10
Average Peer review marks at publication stage: 7.0/10
Name: Dr. Hayriye Eda Şatana Kara
Affiliation: Gazi University, Turkey
Name: Dr. Nicola Micale
Affiliation: University of Messina, Italy
Comments of reviewer(s):