| dc.description.abstract | Abstract: The availability of multiple brands
for a single drug places health professionals
and patients in a dilemma of drug
substitution. Hence, evaluating
bioequivalence of different brands compared
to respective innovator drug is a timely need.
This study was performed to compare the in
vitro bioequivalence of commercially
available brands of atenolol 50 mg tablets in
the Sri Lankan market. Four different brands
of atenolol 50 mg tablets (A1 – A4) and the
innovator drug (A5) were selected for the
study. All the tablets were tested for
organoleptic properties, uniformity of
weight, thickness and diameter, hardness,
friability, assay percentage and dissolution.
To evaluate in vitro bioequivalence of the
selected drugs, their dissolution profiles
were compared with the innovator drug
using calculated fit factors (difference and
similarity factors) and dissolution
efficiencies of respective brands. The results
of organoleptic properties of all the tested
tablets showed no sign of defects. Tablets’
thickness, diameter and hardness complied
with the general standards. All the tested
tablets complied with the British
Pharmacopoeial (BP) standards for
uniformity of weight, friability, assay
percentage and dissolution. Tablets; A1-A4
had similarity factors above 50 and the
difference factors below 15 revealing that
their dissolution profiles are similar to the
innovator product. According to the
dissolution efficiency calculations, only A1,
A2, and A3 of the selected brands of atenolol
50 mg tablets were similar with the
innovator. Hence, the brands; A1, A2 and A3
could be regarded as bioequivalent thus
expected to produce similar therapeutic
effects. | en_US |
