Abstract

FORMULATION AND EVALUTION OF SUSTAINED RELEASED MATRIX PELLETS OF DILTIAZEM HCL BY: EXTRUSION AND SPHERONIZATION

Giram P.S. and Bare A.R* and Puranik P.K.

Abstract

Aim of this study is to prepare matrix pellets of antihypertensive drug [Diltiazem HCl ]by extrusion –spheronization technique,and formulating the sustained release pellets without coating by using hydrophobic and hydrophilic matrix forming polymer like Ethylcellulose and HPMC K15M Drug -polymer interaction was studied by FTIR and confirmed by DSC. Different preliminary batches were performed and among that polymers in the ratio 3:1EC:HPMC K15 M batch pellets have good morphological properties and desire drug release. A 32 factorial design was used to determine the effects of the dependent and independent variables.It was concluded that significant effects were exerted not only by the operational parameters, but also by the nature of the wetting agent (liquid),binder conc. and effect of plasticizer. Friability,Content uniformity determined and in vitro drug release characteristics was studied as per USP XXIV monograph and surface morphology and particle size analysis was done by photomicroscopy. Selction and optimization was carried by using design expert 8.07.1 software.and kinetics of drug release determined by pcp v3 disso software.

Keywords: pelletization,extrusion spheronization, Ethylcellulose, HPMCK15M, Diltiazem HCl as model drug.