Development and Optimization of Sustained Released Matrix Tablet of Ambroxol Hydrochloride Using Central Composite Design

摘要

The objective of the current study was to design an oral sustained release matrix tablet of Ambroxol hydrochloride and to optimize the drug release profile using central composite design. Polymeric matrix tablets were prepared by direct compression using Methocel K15M CR as matrix former. A central composite design for 2 factors at 3 levels was employed to systematically optimize drug release profile. Methocel K15M CR (XJ andPVP K 30(X) were taken as independent variables. Five dependent variables were selected: percent drug release at lh, 4h, 8h, time required for 50% drug release and mean dissolution time (MDT). Polynomial mathematical models, generated for various response variables using multiple linear regression analysis, were found to be statistically significant (p<0.05). Dissolution studies were carried out in 900 ml 0,1 NHClfor 2 hours followed by 900 ml phosphate buffer (pH 6.8) for subsequent 6 hours. The release mechanism was explored and explained by zero order, first order, Higuchi's and Korsmeyer's equation. The drug release followed both diffusion and erosion mechanism in all cases. Calculated similarity factor (f2