PERBANDINGAN BIOAVAILABILITAS ( BIOEKIVALENSI ) OBAT CIMETIDINE DALAM SEDIAAN GENERIK DAN PATEN SECARA IN VITRO

Abstract

COMPARISON OF BIOAVAILABILITY (BIOEQUIVALENCY) GENERIC CIMETIDINE AND PATENT CIMETIDINE IN VITRO Ari Ardiarini Adhi Atmojo* Henna Rya Sunoko** Background : There were an opinion in the society that quality of Generic medicine was lower than that of Patent medicine,due to less information of the content of Generik medicine to the medicine consumers. This research compared bioavailability of Generic Cimetidine and Patent Cimetidine. Method : This research was conducted in Pharmacy Laboratory Medical Faculty of Diponegoro University and BPOM Central Java. It was an analytic observational research. The samples were 1 type of Generic Cimetidine 200 mg (6 tablets) and 1 type of Patent Cimetidine 200 mg (6 tablets). The data were taken from the measurement of medicine active substance concetration. Resulted from spectofotometer reading, and then processed by SPSS 13.00 for Windows program. Result : Research shows that the average of active substance concentration soluble in Generic Cimetidine at point 1 (56,17251%); point 2 (80,49131%); point 3 (82,9142%); point 4 (80,2784%), where the average of active substance concentration soluble in Patent Cimetidine at point 1 (80,14459%); point 2 (78,01548%); point 3 (99,90728%); point 4 (96,07878%). The comparison of active substance concentration between Generic and Patent Cimetidine at point 3 (the peak concetration) resulted significant difference (p=0,012) Conclusion : Patent Cimetidine has higher solubilities than that of Generic Cimetidine. Patent Cimetidine has higher bioavailability than Generic Cimetidine and both of them are not bioequivalens.However, Generic Cimetidine still in accordance with the requiretment stated in Farmakope Indonesia. Keyword : Bioavailability, bioequivalency, cimetidine