Uji Dissolusi Terbanding Sediaan Padat Gemfibrozil Generik dan Merk Dagang yang Beredar di Indonesia
A comparative dissolution study on nine solid dosage forms containing gemfibrozil had been done using a method from the Indonesian Pharmacopoeia 4th edition. Products tested were 3 generics and 6 branded names marketed in Indonesia. The aim of this study was to obtain the in-vitro biopharmaceutics quality data from the generic and branded gemfibrozil products available in the market. The dissolution test was performed by using the paddle method in medium 0.2 M phosphate buffer pH 7.5 ± 0.05 and the analysis was done using spectrophotometer UV at the maximum wavelength of 278 nm. GF7, a generic product, was chosen as an innovator. The dissolution profiles of the innovator and copied products were compared by using a similarity factor (f2). Results showed that f2 < 50%, there was a significant difference between the innovator and other products (P<0.05). These were confirmed by the x-ray diffraction analysis which showed a difference of crystallinity degree of each products.
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