Abstract
Dissolution studies of three marketed brands of ibuprofen sustained-release (SR) capsules were conducted on USP XIX dissolution apparatus 1, using buffers simulating the gastrointestinal tract (GIT) pHs. The products showed almost identical drug release pattern in dissolution studies. A single-dose crossover oral bioavailability study revealed statistically significant differences in Cmax, Tmax, AUC and percent bioavailability values among the SR products but no such differences are evident in the t1/2a, Ka, t1/2e, and Ke. Retard quotient values were used to evaluate the sustained-release nature of the products. Statistical moment parameters such as MRT, MAT, and MDT were related with the dissolution parameters. Statistically significant correlations were observed between MRTin vitro and MRTin vivo or MDTin vivo T50% and Tmax; and T90%, and Cmax, or AUC120. The determination of MRTin vitro, T50%, and T90%, may be useful as quality control parameters to which each batch of the ibuprofen SR products could be submitted.
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