Melt-based screening method with improved predictability regarding polymer selection for amorphous solid dispersions

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
Carolin AuchKarsten Mäder

Abstract

The predictability of preformulation screening tools for polymer selection in amorphous solid dispersions (ASD) regarding supersaturation and precipitation was systematically examined. The API-polymer combinations were scaled up by means of hot-melt extrusion and spray-drying to verify the predictions. As there were discrepancies between a solvent-based screening and performance of ASD, a new screening tool with improved predictability at minimal investments of time and material is presented. The method refinement resulted in a better correlation between the screening and ASD prototypes. So far, a purely solvent-based screening was used which consisted of film casting by rapid solvent evaporation. This approach was improved by applying a heating step after film casting. Four representative polymers were tested with two different model active pharmaceutical ingredients (API) under non-sink dissolution conditions. Polyvinylpyrrolidone (PVP) based polymers showed no benefit towards pure API in the solvent-based screening but good supersaturation as ASD formulations. The extrudates with the cellulose derivatives hydroxypropylmethylcellulose acetate succinate (HPMCAS) and cellulose acetate phthalate (CAP) showed lower supersaturatio...Continue Reading

Citations

May 15, 2019·Pharmaceutics·Ann-Christin JacobsenAnnette Bauer-Brandl
May 7, 2019·Pharmaceutical Development and Technology·Sadegh Poozesh, Seid Mahdi Jafari
Jan 1, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Karsten FlügelMarkus Thommes
Jan 28, 2020·Biomacromolecules·Alexandra K AbelMatthew L Becker

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