期刊
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
卷 107, 期 -, 页码 40-48出版社
ELSEVIER
DOI: 10.1016/j.ejpb.2016.06.015
关键词
Amorphous solid dispersion; DSC; Hot-melt extrusion; Melt rheology; Solubility
资金
- BASF SE
A new predictive micro-scale solubility and process model for amorphous solid dispersions (ASDs) by hot-melt extrusion (HME) is presented. It is based on DSC measurements consisting of an annealing step and a subsequent analysis of the glass transition temperature (T-g). The application of a complex mathematical model (BCKV-equation) to describe the dependency of T-g on the active pharmaceutical ingredient (API)/polymer ratio, enables the prediction of API solubility at ambient conditions (25 degrees C). Furthermore, estimation of the minimal processing temperature for forming ASDs during HME trials could be defined and was additionally confirmed by X-ray powder diffraction data. The suitability of the DSC method was confirmed with melt rheological trials (small amplitude oscillatory system). As an example, ball milled physical mixtures of dipyridamole, indomethacin, itraconazole and nifedipine in poly(vinylpyrroli done-co-vinylacetate) (copovidone) and polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (Soluplus((R))) were used. (C) 2016 Elsevier B.V. All rights reserved.
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