STUDI KOMPARATIF MUTU FISIKOKIMIA DAN PROFIL DISOLUSI TERBANDING TABLET PARASETAMOL BERMEREK DAN GENERIK

Abstract

Generic drugs are often perceived to have lower quality compared to branded drugs; therefore, scientific evidence is needed to ensure their equivalence. Paracetamol was selected as the model drug because it is an analgesic-antipyretic with the highest consumption rate in the community and is classified as a Biopharmaceutics Classification System (BCS) class I drug, making the demonstration of equivalence through comparative dissolution testing highly crucial. This study aimed to compare the physicochemical quality and in vitro bioequivalence profile between generic paracetamol tablets and two branded products (Brand A and Brand B). The evaluation methods included physical quality tests (organoleptic properties, weight uniformity, hardness, friability, and disintegration time), assay determination using UV-Vis spectrophotometry, and comparative dissolution testing using the basket method (100 rpm in phosphate buffer pH 6.8). Equivalence parameters were assessed based on Dissolution Efficiency (DE) and similarity factor (f2). The results showed that all samples met the requirements for physical quality tests and assay (98.54%–103.66%) according to the Indonesian Pharmacopoeia standards. In the dissolution test, all products demonstrated rapid drug release, reaching more than 80% within 5 minutes. Similarity factor analysis yielded f2 values of 98.02 (Generic vs Brand A) and 96.45 (Generic vs Brand B), indicating identical dissolution profiles as the f2 values were ≥ 50. In conclusion, generic paracetamol tablets have comparable physicochemical quality and dissolution profiles to branded products, indicating similar in vitro bioequivalence potential.