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BIOEQUIVALENCE STUDY OF PROPRANOLOL TABLETS
Zabidah Ismail, Mohd Suhaimi Abdul Wahab, Abdul Rashid Abdul Rahman
Abstract
The purpose of this study is to compare the bioavailability of a test tablet
of propranolol (RAZA propranolol, Pharmaniaga) against an innovator product
(Inderal, Astra Zeneca). The study was performed in eighteen healthy male volunteers
for a single 2 x 40 mg dose of propranolol tablets. The study design used was
a randomized, double blind two-period crossover design. Blood samples were
collected before and within 24 hours after drug administration and plasma propranolol
concentration was determined using HPLC method. Statistical analysis of the
propranolol data indicated that none of the accepted parameters for drug bioavailability
(AUC0 to 24hr, AUC0 to ∞ ,tmax and Cp max ) were significantly different between treatments for
the single dose data. Parameters of AUC0 to 24hrof 630.4±285.0
ng.hr/ml vs 635.6±351.0 ng.hr/ml, AUC0 to ∞, 670.2±299.2
ng.hr/ml vs 685.0±350.2 ng.hr/ml, tmax1.3±0.5 hr vs 1.6±0.8
hr and Cpmax115.3±53.4 ng/ml vs 117.5±77.3 ng/ml were
obtained with test and reference formulations respectively. The 95% confidence
interval of the log of ratio of AUC0 to 24hr, AUC0 to ∞ and
Cp max were within the range of 0.80-1.25. It can be indicated that
the two tablet dosage forms (i.e. RAZA and Inderal) showed similar bioavailability
and are therefore considered bioequivalent.
Keywords
propranolol, bioequivalence, bioavailability, pharmacokinetics
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