Bioavailability and Pharmacokinetic Studies of Rofecoxib Solid Dispersion
2013
The present investigation deals with the determination of bioavailability of Rofecoxib solid dispersion
compared to pure rofecoxib (RFB). The study of a non-blinded, open-label, crossover design was conducted in six healthy
volunteers. Blood samples were collected for 12 h at specified intervals of time after the administration of formulations
and analysed by suitable HPLC method. The pharmacokinetic parameters such as maximum plasma concentration (C max ),
time to reach (t max ), elimination rate constant (K el ) biological half-life (t 1/2 ), absorption rate constant (K a ) and area under
curve (AUC 0-12 and AUC 0- ) were determined. Significant difference in the bioavailability of pure rofecoxib and solid
mixture of rofecoxib prepared using hupu gum as carrier has been reported from the studies. The Peak plasma
concentrations (C max ) of 8.34 ng/mL at t max of 4 h and C max of 76.84 ng/mL at t max of 3 h were observed for RFB and solid
mixture respectively. The results clearly indicated an enhancement in the bioavailability of rofecoxib in solid mixture
preparation.
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