tailieunhanh - Construction and validation of binary phase diagram for amorphous solid dispersion using flory–huggins theory

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 Flory– Huggins (F–H) theory and experimental validation of the phase diagram. The F–H interaction parameter, χd-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. | Construction and validation of binary phase diagram for amorphous solid dispersion using flory huggins theory