Uji Dissolusi Terbanding Sediaan Padat Gemfibrozil Generik dan Merk Dagang yang Beredar di Indonesia
ABSTRACT: 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.
Kata kunci: gemfbrozil; profl dissolusi; dissolusi terbanding; indeks
kristalinitas
Penulis: Henny Lucida, Dachriyanus,
Elyunaida
Kode Jurnal: jpfarmasidd170127
