Devolopement and Optimization of Sustained Released Matrix Tablet of Ambroxol Hydrochloride Using Central Composite Desingn

Abstract:

The objective of the current study was to design an oral sustained release matrix tablet of Ambroxol hydrochloride and to optimixe the drug release profile using central composite design. polymeric matrix tablets were prepared by direct copmprssion using methocel k 15m CR as martix former. A central composite design for 2 factors at 3 levels was employed to systematically optimixe drug release profile. Methocel k 15 M CR(X2) were taken as independent Variables. Five dependent Variables were Selected:Percent drug release at 1h 4h 8h time required for 50% drug release and mean dissolution time (MTD) . polynomial mathematical models generated for various response variables using multiple linear regression analysis . were found to be statistcally significant (p<0.05). Dissolution studies were carried out in 900ml 0.1 NHCL for 2 hours follwed bt 900ml phosphate buffer (pH 6.8) for subsequent 6 hours. The release mechanism was explored and explained by zero order .first order . Higuchis and korsmeyers equation. The drug release followed both diffusion and erosion mechanism in all cases. calculated similarity factor ( f2>96) indicated that there was no difference between predicted and expermentally observed drug release profiles for optimixed formualtion.

Key words matrix tablet Ambroxol hydrochlorid polyvinylpyrrolidone Hydroxy propyl methylcellulose central composite design.