Rheological analysis of itraconazole-polymer mixtures to determine optimal melt extrusion temperature for development of amorphous solid dispersion

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
Nayan SolankiAbu T M Serajuddin

Abstract

The objective of this investigation was to develop a systematic method for the determination of optimal processing temperatures of drug-polymer mixtures for the development of amorphous solid dispersion (ASD) by melt extrusion. Since melt extrusion is performed at high temperature, it is essential that the processing temperature should be as low as possible to minimize degradation of drug and polymer, and yet the temperature should be high enough that the drug-polymer mixture attains certain viscosity that is extrudable and the drug dissolves in the molten polymer. By using itraconazole (ITZ) and polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft co-polymer (Soluplus®, BASF) as, respectively, the model drug and the polymeric carrier, melt viscosities of drug-polymer mixtures with 5, 10, 20 and 30% ITZ were studied as functions of temperature and angular frequency. All these concentrations were below the miscibility limit as it was shown separately by film casting that ITZ was miscible with the polymer up to 40%. Since the angular frequency of a rheometer may not be high enough to simulate the shear rate within an extruder, torque analysis as a function of temperature during melt extrusion of selected drug-polymer...Continue Reading

Citations

Sep 19, 2020·Drug Development and Industrial Pharmacy·Hao WuXue Ke
Mar 22, 2019·Pharmaceuticals·Justyna Knapik-KowalczukMarian Paluch
Oct 19, 2020·International Journal of Pharmaceutics·Guluzar Gorkem BuyukgozRajesh N Davé
Mar 1, 2021·International Journal of Pharmaceutics·Yee Mon Than, Varin Titapiwatanakun
May 28, 2021·Molecular Pharmaceutics·Samarth D ThakoreArvind K Bansal
Mar 9, 2019·Molecular Pharmaceutics·Justyna Knapik-KowalczukMarian Paluch

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