Tableting behavior of freeze and spray-dried excipients in pharmaceutical formulations.

Autor: Madi C; Univ. Bordeaux, CNRS, Bordeaux INP, I2M, UMR 5295, F-33400, Talence, France; Arts et Metiers Institute of Technology, CNRS, Bordeaux INP, Hesam Universite, I2M, UMR 5295, F-33400 Talence, France., Hsein H; Univ. Bordeaux, CNRS, Bordeaux INP, I2M, UMR 5295, F-33400, Talence, France; Arts et Metiers Institute of Technology, CNRS, Bordeaux INP, Hesam Universite, I2M, UMR 5295, F-33400 Talence, France. Electronic address: hassana.hsein@u-bordeaux.fr., Busignies V; Univ. Bordeaux, CNRS, Bordeaux INP, I2M, UMR 5295, F-33400, Talence, France; Arts et Metiers Institute of Technology, CNRS, Bordeaux INP, Hesam Universite, I2M, UMR 5295, F-33400 Talence, France., Tchoreloff P; Univ. Bordeaux, CNRS, Bordeaux INP, I2M, UMR 5295, F-33400, Talence, France; Arts et Metiers Institute of Technology, CNRS, Bordeaux INP, Hesam Universite, I2M, UMR 5295, F-33400 Talence, France., Mazel V; Univ. Bordeaux, CNRS, Bordeaux INP, I2M, UMR 5295, F-33400, Talence, France; Arts et Metiers Institute of Technology, CNRS, Bordeaux INP, Hesam Universite, I2M, UMR 5295, F-33400 Talence, France.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2024 May 10; Vol. 656, pp. 124059. Date of Electronic Publication: 2024 Mar 28.
DOI: 10.1016/j.ijpharm.2024.124059
Abstrakt: Most of biopharmaceuticals, in their liquid form, are prone to instabilities during storage. In order to improve their stability, lyophilization is the most commonly used drying technique in the pharmaceutical industry. In addition, certain applications of biopharmaceutical products can be considered by oral administration and tablets are the most frequent solid pharmaceutical dosage form used for oral route. Thus, the tableting properties of freeze-dried products used as cryo and lyoprotectant could be a key element for future pharmaceutical developments and applications. In this study, we investigated the properties that might play a particular role in the specific compaction behavior of freeze-dried excipients. The tableting properties of freeze-dried trehalose, lactose and mannitol were investigated and compared to other forms of these excipients (spray-dried, commercial crystalline and commercial crystalline milled powders). The obtained results showed a specific behavior in terms of compressibility, tabletability and brittleness for the amorphous powders obtained after freeze-drying. The comparison with the other powders showed that this specific tableting behavior is linked to both the specific texture and the physical state (amorphization) of these freeze-dried powders.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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