Compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying

The present study explored vacuum drum drying (VDD) as an alternative technology for amorphous solid dispersions (ASDs) manufacture compared to hot-melt extrusion (HME) and spray drying (SD) focusing on downstream processability (powder properties, compression behavior and tablet performance). Riton...

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Autores principales: Barbara V. Schönfeld, Ulrich Westedt, Karl G. Wagner
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Lenguaje:EN
Publicado: Elsevier 2021
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spelling oai:doaj.org-article:8862951727d84012b6a643ea188fb0552021-11-26T04:39:44ZCompression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying2590-156710.1016/j.ijpx.2021.100102https://doaj.org/article/8862951727d84012b6a643ea188fb0552021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2590156721000311https://doaj.org/toc/2590-1567The present study explored vacuum drum drying (VDD) as an alternative technology for amorphous solid dispersions (ASDs) manufacture compared to hot-melt extrusion (HME) and spray drying (SD) focusing on downstream processability (powder properties, compression behavior and tablet performance). Ritonavir (15% w/w) in a copovidone/sorbitan monolaurate matrix was used as ASD model system. The pure ASDs and respective tablet blends (TB) (addition of filler, glidant, lubricant) were investigated. Milled extrudate showed superior powder properties (e.g., flowability, bulk density) compared to VDD and SD, which could be compensated by the addition of 12.9% outer phase. Advantageously, the VDD intermediate was directly compressible, whereas the SD material was not, resulting in tablets with defects based on a high degree of elastic recovery. Compared to HME, the VDD material showed superior tabletability when formulated as TB, resulting in stronger compacts at even lower solid fraction values. Despite the differences in tablet processing, tablets showed similar tablet performance in terms of disintegration and dissolution independent of the ASD origin. In conclusion, VDD is a valid alternative to manufacture ASDs. VDD offered advantageous downstream processability compared to SD: less solvents and process steps required (no second drying), improved powder properties and suitable for direct compression.Barbara V. SchönfeldUlrich WestedtKarl G. WagnerElsevierarticleRitonavirHot-melt extrusionSpray dryingVacuum drum dryingAmorphous solid dispersionCompression analysisPharmacy and materia medicaRS1-441ENInternational Journal of Pharmaceutics: X, Vol 3, Iss , Pp 100102- (2021)
institution DOAJ
collection DOAJ
language EN
topic Ritonavir
Hot-melt extrusion
Spray drying
Vacuum drum drying
Amorphous solid dispersion
Compression analysis
Pharmacy and materia medica
RS1-441
spellingShingle Ritonavir
Hot-melt extrusion
Spray drying
Vacuum drum drying
Amorphous solid dispersion
Compression analysis
Pharmacy and materia medica
RS1-441
Barbara V. Schönfeld
Ulrich Westedt
Karl G. Wagner
Compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying
description The present study explored vacuum drum drying (VDD) as an alternative technology for amorphous solid dispersions (ASDs) manufacture compared to hot-melt extrusion (HME) and spray drying (SD) focusing on downstream processability (powder properties, compression behavior and tablet performance). Ritonavir (15% w/w) in a copovidone/sorbitan monolaurate matrix was used as ASD model system. The pure ASDs and respective tablet blends (TB) (addition of filler, glidant, lubricant) were investigated. Milled extrudate showed superior powder properties (e.g., flowability, bulk density) compared to VDD and SD, which could be compensated by the addition of 12.9% outer phase. Advantageously, the VDD intermediate was directly compressible, whereas the SD material was not, resulting in tablets with defects based on a high degree of elastic recovery. Compared to HME, the VDD material showed superior tabletability when formulated as TB, resulting in stronger compacts at even lower solid fraction values. Despite the differences in tablet processing, tablets showed similar tablet performance in terms of disintegration and dissolution independent of the ASD origin. In conclusion, VDD is a valid alternative to manufacture ASDs. VDD offered advantageous downstream processability compared to SD: less solvents and process steps required (no second drying), improved powder properties and suitable for direct compression.
format article
author Barbara V. Schönfeld
Ulrich Westedt
Karl G. Wagner
author_facet Barbara V. Schönfeld
Ulrich Westedt
Karl G. Wagner
author_sort Barbara V. Schönfeld
title Compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying
title_short Compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying
title_full Compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying
title_fullStr Compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying
title_full_unstemmed Compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying
title_sort compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying
publisher Elsevier
publishDate 2021
url https://doaj.org/article/8862951727d84012b6a643ea188fb055
work_keys_str_mv AT barbaravschonfeld compressionofamorphoussoliddispersionspreparedbyhotmeltextrusionspraydryingandvacuumdrumdrying
AT ulrichwestedt compressionofamorphoussoliddispersionspreparedbyhotmeltextrusionspraydryingandvacuumdrumdrying
AT karlgwagner compressionofamorphoussoliddispersionspreparedbyhotmeltextrusionspraydryingandvacuumdrumdrying
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