UJI DISINTEGRASI DAN DISOLUSI TERBANDING TABLET ALOPURINOL GENERIK BERMEREK DAN GENERIK BERLOGO YANG BEREDAR DI PASARAN

Bambang Hernawan Nugroho, Yandi Syukri, Anik Ariyani

Abstract


ABSTRACT
Allopurinol is a pyrimidine derivative that effective to normalize levels of uric acid in blood
and urine. Allopurinol is very slightly soluble in water, but it has high permeability (BCS class II) so
that the dissolution is an important determine to express the drug bioavailability. Additional material
differences and the production process of each plant can cause differences in the quality of the
resulting allopurinol tablets. This study aimed to compare the quality of branded generic and
generic products allopurinol tablets in the quality of disintegration and dissolution. This study used 5
kinds branded generic (A, B, C, D, E) and 5 kinds of generic products (F, G, H, I, J). Disintegration
test carried out according to USP-NF 32
nd
edition by the medium of water at 37 ± 2°C. Dissolution
tests conducted according to USP-NF 32
nd
edition using apparatus 2 (paddle methode), the speed
of rotation 75 rpm, in 0.01 N HCl medium at 37 ± 0.5°C. The data obtained compared with the
requirements listed in the Indonesia Pharmacopoeia 4
th
edition and USP-NF 32
nd
edition, and then
statistically analyzed by T test at 95% confidence interval. Results of disintegration and dissolution
tests met the requirements in the literature. Statistical test results showed that products had
different disintegration and dissolution profile.

Keywords: allopurinol, disintegration, dissolution, tablets


Full Text:

PDF