Studi Disolusi Terbanding Tablet Komparator dan Generik Glibenklamida 5 MG Menggunakan Parameter Difference Factor (f2) dan Similarity Factor (f1)
Abstract: Dissolution testing
is an essential requirement for the development, establishment of in Vitro dissolution
and in Vivo performance (I VIV R), registration and quality control Of solid
oral dosage forms. The objective of the present study was to compare
dissolution profile of glibenclamide 5 mg tablet between generic and inovator
product from commercial market, using independent model. Samples of
glibenclamide 5 mg tablets was used on the batch number are the Same design for
each other product. The dissolution test were perfoming using USP 23 apparatus
2, in pH 7,40 buffer phosphate, employing 900 ml of dissolution medium at a
temperature of 37 ±0,5 ˚C and an agitation rate of 75 rpm with spesification
performed at 15, 30, 45, 60 and 120 minutes. Comparison between dissolution
profiles was achieved using a difference factor (f1) and simmilarity factor (f2)
methods in inovator product and generic \ product. The results showed that
dissolution profiles of product B (generic) has similar with product A
(inovator) where difference factor (f1) value is 5,53% and simmilarity factor
(f2) is 99,29 %
Penulis: Sutriyo
Kode Jurnal: jpfarmasidd120142
