TRIMETAZIDINE HYDROCHLORIDE MICROSPHERES FOR THE MANAGEMENT OF STABLE ANGINA PECTORIS: INFLUENCE OF PROCESS PARAMETERS

Senthamarai R., Ismail A. M. and Saraswathi S.*

ABSTRACT

The present study was undergone to investigate the effect of two major process parameters such as drug polymer concentration and stirring rate in the formulation of Trimetazidine hydrochloride microspheres. Nine different batches (F1-F9) of Trimetazidine loaded eudragit microspheres were developed using a novel W/O/O double emulsion solvent evaporation technique. Effect of process parameters on morphology, percentage yield, particle size, percentage drug content, encapsulation efficiency, in vitro drug release and release kinetics of all batches were investigated. From the analysis, it was observed that, the two process parameters have played important roles in controlling the performance of formulated microspheres such as percentage yield, particle size distribution, encapsulation efficiency, in vitro drug release but little effect on micromorphology, percentage of drug content and release kinetics. From the outcome of results, it was concluded that the experimental parameters have greater influence on microspheres and the formulation F5 with drug: polymer ratio of 1:2 prepared at 500-700 rpm as stirring speed showed a spherical shaped microspheres with narrow particle size distribution, maximum encapsulation efficiency and release up to 24h with non-fickian zero order release kinetics.

Keywords: Trimetazidine Hydrochloride, Eudragit microshperes, Drug: polymer concentration, Stirring rate.