EFFECT OF PLASTICIZER ON STABILITY OF BUDESONIDE (C.R) MUPS PREPARED BY AQUEOUS POLYMER LAYERING

The present study was designed to investigate the effect of two different types of plasticizers, i.e., Triethyl citrate (TEC) and Acetyl tri butyl citrate on the in vitro release kinetics of Budesonide from sustained-release pellets during initial and stability conditions. Ethyl cellulose aqueous dispersion (Aqua coat ECD 30) is used as the release-retarding polymer. Both plasticizers were used at 10 % to 30% (w/w) of Aqua coat ECD 30. Sugar spheres #16/20 were used as core pellets. Dissolution study was performed by using USP apparatus II with sinker in 0.1 N HCl followed by 7.5 pH phosphate buffer. Trails planned with water insoluble plasticizer like acetyl tri butyl citrate showed comparative dissolution profile with innovator during initial condition but during accelerated stability conditions like 40ºC 75% RH for 6M dissolution profile was found to be on lower side when compared with innovator. Hence trails were planned with water soluble plasticizer like tri ethyl citrate showed comparable dissolution profile with innovator during initial and stability conditions. Different trails were planned with different concentrations of tri ethyl citrate from 10% to 50 % w/w of the polymer. Among them tri ethyl citrate with 30% w/w of polymer showed optimum dissolution profile during initial and stability conditions. Further increase in tri ethyl citrate concentration to 50% w/w of polymer dissolution profile was found to be in lower side in initial condition.