Development of Indapamide Sustained Release Tablet using Methocel K15 MCR and a Comparative Study with a Reference Produ

Abstract

Indapamide, a low-dose thiazide-type diuretic, is used for the treatment of essential hypertension. In
this study, we developed an indapamide sustained release formulation using Methocel K15 MCR (a modified
hydroxypropyl methylcellulose), lactose and magnesium stearate considering technical feasibility and performed a
comparative study with the release pattern of the reference product, Natrilix SR® tablet. The tablets showed
sustained release curves at pH 6.8 phosphate buffer for up to 12 h. The data obtained from the dissolution profiles
were compared in the light of different kinetics models and the regression coefficients were also compared. The
kinetics of dissolution fit the Higuchi kinetics model. The release rate decreased exponentially with the addition of
Methocel K15 MCR. Indapamide release rate was observed to be the highest with the lowest concentration of
Methocel K15 MCR used in the present study. On the other hand, Indapamide release rate was the lowest when
Methocel K15 MCR concentration was 25%. Stability tests of the drug pellets showed no notable changes in the rate
of drug release, related substances and drug content.