PERBANDINGAN BIOAVAILABILITAS ALOPURINOL DALAM SEDIAAN GENERIK DAN PATEN SECARA IN VITRO

Abstract

COMPARATIVE IN VITRO BIOAVAILABILITY OF ALLOPURINOL IN GENERIC AND ITS PATENT PRODUCT Dina Nugraheni1, Henna Rya Sunoko2 Backgrounds:Generic medicine is often considered to have lower quality than that of patent medicine. Therefore research to compare bioavailability between generic and patent medicines should be held. Medicine which is available in generic and patent is Allopurinol. Because of its wide uses, Allopurinol was chosen as samples in this research. Objectives: This research is aimed to assess bioavailability and bioequivalency of both generic and patent Allopurinol in vitro. Methods: The research was held in Pharmacy Laboratory of Medical Faculty Diponegoro University and Balai Penelitian Obat dan Makanan of Central Java. It was an observational research. The samples were Allopurinol 100 mg tablets both from patent and generic medicines, 6 tablets each. Dissolution test was performed in accordance with Farmakope Indonesia IV, 1995. Data were taken from soluble active substances collected from dissolution tester and measured by spectrophotometer. The data then were processed by SPSS 13,00 for Windows. Results: Research showed that the average of soluble active substances of Allopurinol generic medicine in point 1 (92.37032 %); point 2 (90.46601 %); point 3 ( 92.7234 %); and point 4 (93.75079 %). While from the patent medicine in point 1 (91.65548 %); point 2 (97.05873 %); point 3 ( 99.39425 %); point 4 (94.65085 %). The comparison of active substances in point 3 (peak point) between generic and patent medicine was significantly different (p=0,000). But the concentrations of the active substances of both medicines were in the range of standard requirement according to Farmakope Indonesia IV, 1995, that Latar Belakang : Obat generik masih sering dianggap mempunyai mutu yang lebih rendah daripada obat paten. Untuk itu diperlukan penelitian guna meyakinkan bahwa mutu obat generik tidak lebih rendah daripada obat paten. Salah satu obat yang terdapat dalam sediaan generik dan paten adalah Alopurinol. Oleh karena obat ini sering digunakan, maka obat ini dipilih sebagai sampel dalam penelitian. Tujuan : Penelitian ini bertujuan mengetahui bioavailabilitas dan bioekivalensi Alopurinol dari sediaan generik dan paten secara in vitro.