Predicting physical stability of ternary amorphous solid dispersions using specific mechanical energy in a hot melt extrusion process

International Journal of Pharmaceutics
Masataka HanadaRobert O Williams

Abstract

This study focuses on the relationship between drug dissolution properties, physical stability against recrystallization, and specific mechanical energy (SME) from a hot melt extrusion (HME) process of ternary amorphous solid dispersions (ASDs) containing indomethacin (IND), HPMC and mesoporous silica (XDP) prepared using different HME screw condition (the number of kneading zones/rotation speed). The screw condition greatly influenced the amorphous characteristics of the processed material and SME values. The higher SME samples demonstrated a larger parachute effect in dissolution test and reduced the rate of recrystallization upon exposure to elevated temperature/humidity conditions, which can be explained from the enhanced miscibility and interactions of IND/HPMC/XDP. The molecular investigation by solid-state NMR (ssNMR) suggested that higher SME input produced better IND/HPMC miscibility and interaction. Interestingly, XDP showed distinct contacts with IND and HPMC in the high-SME samples. The IND-HPMC interaction is not sufficient to maintain a highly mixed ASD at a high drug load without the assistance of XDP. Therefore, SME is a critical parameter for predicting enhanced dissolution and physical stability of IND in ASDs...Continue Reading

Citations

Jan 18, 2019·Drug Development and Industrial Pharmacy·Scott V JermainRobert O Williams
Feb 26, 2019·Journal of Food Science·José Agustín Tapia-HernándezFrancisco Rodríguez-Félix
Apr 23, 2019·Expert Opinion on Drug Delivery·Venkata Raman KallakuntaMichael A Repka
Dec 18, 2019·Magnetic Resonance in Chemistry : MRC·Jinglin YinXueqian Kong
Jul 16, 2020·Advanced Pharmaceutical Bulletin·Avinash Ramrao Tekade, Jyoti Narayan Yadav
Sep 19, 2020·Drug Development and Industrial Pharmacy·Hao WuXue Ke
Dec 1, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Arun ButreddyMichael A Repka
Nov 13, 2020·AAPS PharmSciTech·Daniel A DavisRobert O Williams
Mar 31, 2021·Advanced Drug Delivery Reviews·Stephen A Thompson, Robert O Williams
Apr 23, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Phuong H L TranThao T D Tran
May 13, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Urvi H GalaRobert O Bill Williams
May 28, 2021·Molecular Pharmaceutics·Samarth D ThakoreArvind K Bansal
May 22, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Samuel SolomonAhmad B Albadarin

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