Compression of amorphous solid dispersions prepared by hot-melt extrusion, spray drying and vacuum drum drying.
| Autor: | Schönfeld BV; Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.; AbbVie Deutschland GmbH & Co. KG, Knollstraße 50, 67061 Ludwigshafen, Germany., Westedt U; AbbVie Deutschland GmbH & Co. KG, Knollstraße 50, 67061 Ludwigshafen, Germany., Wagner KG; Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany. |
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| Jazyk: | angličtina |
| Zdroj: | International journal of pharmaceutics: X [Int J Pharm X] 2021 Nov 03; Vol. 3, pp. 100102. Date of Electronic Publication: 2021 Nov 03 (Print Publication: 2021). |
| DOI: | 10.1016/j.ijpx.2021.100102 |
| Abstrakt: | 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. Competing Interests: Barbara Schönfeld and Ulrich Westedt are employees of AbbVie and may own AbbVie stock. Barbara Schönfeld is a PhD student and Karl G. Wagner is a professor at the University of Bonn. They have no additional conflicts of interest to report. (© 2021 The Authors.) |
| Databáze: | MEDLINE |
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