Abstract

FORMULATION AND EVALUATION OF SAFINAMIDE LOADED MICROSPHERE FOR CONTROLLED RLEASE

Sujatha*, Abhilash R. and Darshitha R.

ABSTRACT

The objective of the present study was to microencapsulating the Safinamide to provide controlled release and minimizing local side effect. The microspheres containing Safinamide were prepared with Ethyl cellulose and HPMC K15M by using solvent evaporation method. The formulation were subjected to various evaluation parameters like % practical yield, particle size distributions, flow properties, actual drug content, entrapment efficiencies ratio, invitro release studies and stability studies. The drug loaded microspheres show 67.0 to 81.5 % drug entrapment, angle of repose was in the range of 19o75” to 30o56”. Bulk and tapped densities showed good packability and Carr’s index ranges from 14.37 to 19.96. Most of the isolated microspheres were of particle size range 113 to 655mm. The drug loaded in HPMC K15M and Ethyl cellulose microspheres was stable and compatible, as confirmed by FTIR studies. In vitro drug release studies were carried out up to 8 h in two different pH media i.e. acid buffer (pH 1.2) and phosphate buffer (pH 7.4) and the effect of the variation in polymer ratio on drug dissolution was evaluated according to dissolution test results. The dissolution data were plotted according to the four different kinetic models. In vitro dissolution studies showed that zero-order, Hixson-crowell and Higuchi model release characteristics were exhibited. The stability studies of formulation F2 and F7 indicates that 25oC is a suitable.

Keywords: Microspheres, Solvent evaporation, Controlled release, Safinamide, Gelatin and Ethyl cellulose.