4.5 Article

Evaluation of Predictive Models for Stable Solid Solution Formation

Journal

JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 100, Issue 2, Pages 667-680

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1002/jps.22313

Keywords

amorphous; crystallinity; extrusion; glass transition; solid solution; solid state; thermal analysis; melting point depression; solubility parameter

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The objective of this study was to evaluate predictive models for stable solid solution formation and to find a quick and successful approach for miscibility screenings. The results show that the interpretation of the chemical structure and the crystallinity by X-ray powder diffraction measurements as well as the determination of melting point depressions and melting enthalpies are beneficial tools to predict the miscibility of drugs and carriers. A combined approach of prediction tools is highly appropriate, as no single technique may yield all the required information. Nevertheless, the evaluation of the melting behavior via differential scanning calorimetry has the highest impact. (C) 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:667-680, 2011

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