Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2486337 | Journal of Pharmaceutical Sciences | 2011 | 12 Pages |
Abstract
Miscibility of drug and polymer is one of the key parameters in amorphous formulation design. The purpose of this work is to provide a theoretical approach to evaluate miscibility between drug and polymer in amorphous solid dispersions. The model system is indomethacin and polyvinylpyrrolidone-vinyl acetate copolymer. The Flory-Huggins (F-H) interaction parameter, Ï, of drug and polymer was estimated at different temperatures by two methods: melting point depression of drug in various polymer ratios at the melting temperature, and Hildebrand and Scott solubility parameter calculation at 25°C. The simplified firstâorder relation between the F-H interaction parameter and temperature was established. This allows the construction of a temperature-composition phase diagram of a twoâcomponent amorphous system. The spinodal curve was generated and provides an insight into the thermodynamic stability of an amorphous solid dispersion at various temperatures. The predicted stability of the model system was compared with the experimental data. The merits and deficiency of the proposed approach were fully discussed. © 2011 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 100:3196-3207, 2011
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Authors
Yinyan Zhao, Petra Inbar, Hitesh P. Chokshi, A. Wasseem Malick, Duk Soon Choi,