Controlled Release Nifedipine Microparticles from Starch Acetate : DESIGN AND EVALUATION OF A CONTROLLED RELEASE MICROPARTICLES FROM STARCH ACETATE

The present investigation involves development of a CR Nifedipine microparticulate system utilizing starch acetate as the rate controlling polymer. SA was manufactured in house form native starches and characterization for degree of substitution (dS) and acetyl content among other parameters. An emulsification solvent evaporation technique was followed to develop microparticles of varying drug- polymer ratio's with triethyl citrate plasticizers at different levels. The prepared microparticles were subjected to standard evaluation such as yield, particle size, surface topography, drug content and in vitro dissolution studies.The development formulations were subsequently optimized through a simplex lattice mixture design to predict the optimum formulations matching the target official release profiles. It was found that two blend of development formulations, namely F1: F5 (0.822:0.1780) and F5: F13 (0.041:0.959) could closely resemble official specification and hence were optimum. The developed multiparticulate systems of Nifedipine are expected to provide a better clinical option for treatment of persistent/chronic angina and hypertension.