Abstract. Drug-polymer miscibility is one of the fundamental prerequisite for the successful design and development of amorphous solid dispersion formulation. The purpose of the present work is to provide an example of the theoretical estimation of drug-polymer miscibility and solubility on the basis of FloryHuggins (F-H) theory and experimental validation of the phase diagram. The F-H interaction parameter, χ d-p , of model system, aceclofenac and Soluplus, was estimated by two methods: by melting point depression of drug in presence of different polymer fractions and by Hildebrand and Scott solubility parameter calculations. The simplified relationship between the F-H interaction parameter and temperature was established. This enabled us to generate free energy of mixing (ΔG mix ) curves for varying drugpolymer compositions at different temperatures and finally the spinodal curve. The predicted behavior of the binary system was evaluated through X-ray diffraction, differential scanning calorimetry, and in vitro dissolution studies. The results suggest possibility of employing interaction parameter as preliminary tool for the estimation of drug-polymer miscibility.

Sustained release solid dispersion of venlafaxine hydrochloride, an antidepressant agent, was prepared by the spray drying technique using various concentration of ethyl cellulose. Characterization was done using thermal analysis (DSC), X-ray diffraction (XRD) and infrared spectroscopy (FTIR). Drug content and dissolution rate studies and its kinetics were also performed. Dissolution studies revealed that the drug release from the solid dispersion matrix was significantly reduced.