ABSTRACT:
The purpose of this work was to characterize the solid state properties of ternary solid dispersion of hydroxypropylmethylcellulose and Eudragit polymers and a model drug nifedipine by melt (fusion) technique. The solid dispersions were prepared in methanol by heating in water bath maintained at 70°C. Different batches were prepared by using hydroxypropylmethylcellulose K- 4M and Eudragit RS-100 in the concentrations ranging from 0.5 to 4 for one polymer keeping concentration of other polymer constant and vice-versa. Drug excepients interaction study was carried out using Fourier Transform Infra Red spectroscopic technique. The dissolution studies of nifedipine solid dispersions were performed using Apparatus II of USP XXIII in simulated gastric fluid containing 10 % methanol for a period of 10 hours. The aliquots were analysed by using UV-visible spectrophotometer at ?max = 338 nm. The in-process and finished products were evaluated for micromeritic properties. The nature of nifedipine in formulation was studied by powder X- ray diffraction, Fourier transform infra red spectroscopy and differential scanning calorimetry for crystallinity and molecular interaction. The solid dispersion containing HPMC K-4M and Eudragit RS-100 in the ratio of 4:1 showed release only up to 58.99% where as batch (F9) containing 2:1.5 proportion showed 89.10 % release in the 12 hours respectively.