دورية أكاديمية
Exploring the effect of raw material properties on continuous twin-screw wet granulation manufacturability.
| العنوان: | Exploring the effect of raw material properties on continuous twin-screw wet granulation manufacturability. |
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| المؤلفون: | Peeters M; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent 9000, Oost-Vlaanderen, Belgium., Barrera Jiménez AA; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent 9000, Oost-Vlaanderen, Belgium; BIOMATH, Department of Data Analysis and Mathematical Modelling, Ghent University, Coupure links 653, Ghent 9000, Oost-Vlaanderen, Belgium., Matsunami K; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent 9000, Oost-Vlaanderen, Belgium; BIOMATH, Department of Data Analysis and Mathematical Modelling, Ghent University, Coupure links 653, Ghent 9000, Oost-Vlaanderen, Belgium. Electronic address: Kensaku.Matsunami@UGent.be., Van Hauwermeiren D; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent 9000, Oost-Vlaanderen, Belgium; BIOMATH, Department of Data Analysis and Mathematical Modelling, Ghent University, Coupure links 653, Ghent 9000, Oost-Vlaanderen, Belgium., Stauffer F; Product Design & Performance, UCB, Braine l'Alleud 1420, Belgium., Arnfast L; Discovery, Product Development & Supply, Janssen R&D, Beerse B-2340, Belgium., Vigh T; Discovery, Product Development & Supply, Janssen R&D, Beerse B-2340, Belgium., Nopens I; BIOMATH, Department of Data Analysis and Mathematical Modelling, Ghent University, Coupure links 653, Ghent 9000, Oost-Vlaanderen, Belgium., De Beer T; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent 9000, Oost-Vlaanderen, Belgium. |
| المصدر: | International journal of pharmaceutics [Int J Pharm] 2023 Oct 15; Vol. 645, pp. 123391. Date of Electronic Publication: 2023 Sep 09. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 7804127 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3476 (Electronic) Linking ISSN: 03785173 NLM ISO Abbreviation: Int J Pharm Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Amsterdam, Elsevier/North-Holland Biomedical Press. |
| مواضيع طبية MeSH: | Bone Screws* , Technology, Pharmaceutical*/methods, Particle Size ; Solubility ; Wettability ; Drug Compounding/methods ; Tablets |
| مستخلص: | Twin-screw wet granulation (TSWG) stands out as a promising continuous alternative to conventional batch fluid bed- and high shear wet granulation techniques. Despite its potential, the impact of raw material properties on TSWG processability remains inadequately explored. Furthermore, the absence of supportive models for TSWG process development with new active pharmaceutical ingredients (APIs) adds to the challenge. This study tackles these gaps by introducing four partial least squares (PLS) models that approximate both the applicable liquid-to-solid (L/S) ratio range and resulting granule attributes (i.e., granule size and friability) based on initial material properties. The first two PLS models link the lowest and highest applicable L/S ratio for TSWG, respectively, with the formulation blend properties. The third and fourth PLS models predict the granule size and friability, respectively, from the starting API properties and applied L/S ratio for twin-screw wet granulation. By analysing the developed PLS models, water-related material properties (e.g., solubility, wettability, dissolution rate), as well as density and flow-related properties (e.g., flow function coefficient), were found to be impacting the TSWG processability. In addition, the applicability of the developed PLS models was evaluated by using them to propose suitable L/S ratio ranges (i.e., resulting in granules with the desired properties) for three new APIs and related formulations followed by an experimental validation thereof. Overall, this study helped to better understand the effect of raw material properties upon TSWG processability. Moreover, the developed PLS models can be used to propose suitable TSWG process settings for new APIs and hence reduce the experimental effort during process development. 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 © 2023 Elsevier B.V. All rights reserved.) |
| المشرفين على المادة: | 0 (Tablets) |
| تواريخ الأحداث: | Date Created: 20230911 Date Completed: 20231009 Latest Revision: 20231018 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1016/j.ijpharm.2023.123391 |
| PMID: | 37696346 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1873-3476 |
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| DOI: | 10.1016/j.ijpharm.2023.123391 |