Perpustakaan Digital ITB

Background and objectives: The aim of this experiment was to study the effect of pH and various surfactants to the dissolution rate of glibenclamide (GC) tablets. The comparison was done between innovator product and generic products which are conunercially available in the Indonesian market. GC is a poorly water-insoluble drug which is classified as a Class II drug according to the Biopharmaceutical Classification System (BCS). GC has a history of low bioavailability, which is attributed to its poor dissolution properties and also water-insoluble drug in physiological pH. Methods: The dissolution rate of GC was measured in the pH range at 1.2, 4.5 to 6.8 with and without 1% sodium lauryl sulfate (SLS), 1% Tween 80(T80), and 1% Cetyltrimethylammonium bromide (CTBA) as surfactant. The dissolution was done by using paddle dissolution apparatus (USP type 2), total of 900 ml of dissolution medium was used at 100 rpm stirring speed and the sampling time was set to 10, 20, 30, 40, 50, 60 minutes. I.JV spectrophotometric method was used in determination released of GC. The concentration was measured at 275 rim. Results: The dissolution rate of GC increased with increasing of pH and with addition of 1% of surfactant in an approximately additive manner. The dissolution medium of pH 6.8 phosphate buffer containing 1% CTAB produced the highest dissolution rate. The generic drug that is used in this study showed similar dissolution rate to the innovator product, in all dissolution condition. The similarity of generic drug and innovator drug, expressed in F2 value, was in range of 70.6% -75.3% in all dissolution medium