In Vitro Bioequivalence Test and Physical Properties Test of Branded and Generic Medicinal Products Containing Paracetamol

Abstract

Paracetamol is one of the drugs that are analgesic and antipyretic which is widely consumed by the public. Paracetamol circulating in Indonesia consists of products with trade names (branded) and generic logo. One effort is to guarantee the quality of drug products by conducting bio-equivalence tests on drug products. This study aims to determine differences in the parameters of physical properties and in vitro bioecivalence comparisons of Paracetamol tablets in branded and generic drug products. Determination of dissolved levels of paracetamol tablets using uv-vis spectrophotometer at wavelength 244 nm. The parameters observed are the Q45 value and similarity factor (f2).Methods of this research is non experimental with sampling taken from 2 products, generic products (A) and branded products (B) from Asy Safiira Pharmacy in Rembang. The test parameters of physical properties include uniformity of weight, hardness, friability, thickness, diameter, and disintegration time meanwhile the dissolution test was conducted using basket method of dissolution testing. Data obtained compared to Indonesian edition IV pharmacopoeia and other appropriate literature.Results of the physical properties study of paracetamol tablets on generic products and branded products, including uniformity of weight, obtained average weight results of generic tablet 537.82 mg and of branded products 600.685 mg, hardness of generic tablet was 5.2 meanwhile branded products was 4, fragility of generic products was 0.0021 meanwhile branded products was 0.0156, thickness of generic product was 1.2 meanwhile branded products was 0.5, the disintegration time of generic products was 1.21 minutes meanwhile branded products was 1.10 minutes, hereby the results of physical properties study of generic (A) and branded (B) paracetamol tablets have fulfilled the requirements in Indonesian Pharmacopoeia Edition III and IV and the results of dissolved levels test showed that at minutes 45 almost all drugs, both generic products and branded products, have released 100% of the drug. Conclusions of the physical properties study of paracetamol tablets in generic products and trademarks include uniformity of weight, hardness, friability, thickness, diameter, disintegration time of tablets is that the results meet the requirements in Indonesian Pharmacopoeia Edition III and IV. The value of thesimilarity factor (f2) for generic products and branded products as test products has no resemblance to branded products with an average price of f2 184.57%.