UJI DISOLUSI DAN KONDISI UJI DISOLUSI BIORELEVAN TABLET CANDESARTAN CILEXETIL

• Main Author: T Pohan, Tania
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/50020
• Institution: Institut Teknologi Bandung

Candesartan cilexetil is antihypertensive agent belongs to Angiotensin Receptor Blocker (ARB) that classified into Biopharmaceutical Classification System (BCS) class II. Dissolution test is carried out to determine in vitro characteristic and performance of the drug. The result of dissolution testing sometimes is not correlated with the in vivo characteristics especially for the drug that has low solubility and permeability. Therefore, dissolution condition that can simulate in vivo condition is needed to get better correlation with the in vivo. This research was originally designed to develop the the dissolution test conditions of candesartan cilesetil tablet which have a good correlation with the in vivo result through the comparative dissolution test with its innovator product. This study include a literature review of various aspect related to development of dissolution test which estimated to have good in vitro-in vivo correlation through comparative dissolution test of various generic products with the innovator product. This literatur study show that biorelevant dissolution test for candesartan cilexetil tablet can be carried out using aparatus II (paddle) 50 rpm for 60 minutes with biorelevant medium such as FaSSGF, FaSSIF, FeSSGF, FeSSIF. However, due to very low solubility in the medium, sink condition cannot be achived at volumes that relate to physiological conditions. Experiments that have been done are making calibration curve using UV spechtrophotometer on three compendial dissolution mediums : HCl 0,1 N pH 1,2 0,7% Tween 20; dapar pH 4,5 0,7% Tween 20; dapar pH 6,8 0,7% Tween 20 and dissolution test for innovator product and copy product CC1 in phosphate buffer pH 6,8 0,7% Tween 20. Similarity factor (f2) of 6 unit dosage innovator product and CC1 product in phospate buffer pH 6,8 0,7% Tween 20 is 43,14. The two products are predicted to be not similar.