دورية أكاديمية
Exploring the relationship between bulk Young's Modulus of materials and milling efficiency during wet bead milling of pharmaceutical compounds.
| العنوان: | Exploring the relationship between bulk Young's Modulus of materials and milling efficiency during wet bead milling of pharmaceutical compounds. |
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| المؤلفون: | Salahshoor Z; Drug Product Development, Medicine Development & Supply, GSK R&D, PA, USA., Desai PM; Drug Product Development, Medicine Development & Supply, GSK R&D, PA, USA. Electronic address: parind.m.desai@gsk.com., Chattoraj S; Drug Product Development, Medicine Development & Supply, GSK R&D, PA, USA. Electronic address: sayantan.x.chattoraj@gsk.com., Lam S; Drug Substance Development, Medicine Development & Supply, GSK R&D, PA, USA. |
| المصدر: | International journal of pharmaceutics [Int J Pharm] 2024 Jul 20; Vol. 660, pp. 124365. Date of Electronic Publication: 2024 Jun 21. |
| 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: | Particle Size* , Drug Compounding*/methods , Elastic Modulus*, Pharmaceutical Preparations/chemistry ; Suspensions ; Chemistry, Pharmaceutical/methods ; Excipients/chemistry |
| مستخلص: | Wet bead milling (WBM) is one of the main approaches for manufacturing long acting injectable (LAI) suspensions, wherein the particle size of an Active Pharmaceutical Ingredient (API) is reduced in a liquid vehicle via grinding. A common challenge observed during WBM is long milling time to achieve target particle size, resulting in poor milling efficiency. The objective of this work was to identify potential API attributes predictive of milling efficiency during WBM. In this study, physical and mechanical properties of nine APIs were characterized. Formulations with these APIs were manufactured using WBM. Bulk Young's Modulus was identified to have a significant influence on the rate of particle attrition. The rank order of Young's Moduli of the APIs was consistent with that of milling efficiency, estimated by an empirical function defined in this study called Milling Resistance (ϕ), representing the holistic impact of milling time, tip speed, bead loading, and batch to chamber volume ratio. The identification of such intrinsic material properties, which provide an early evaluation of potential manufacturing risks, is beneficial to product development, as these assessments can be performed with limited quantities of materials and help identify and design out scale-up challenges. 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.) |
| فهرسة مساهمة: | Keywords: Long Acting Injectables (LAIs); Manufacturing; Material Sparing Approach; Materials Science Tetrahedron (MST); Wet Bead Milling; Young’s Modulus |
| المشرفين على المادة: | 0 (Pharmaceutical Preparations) 0 (Suspensions) 0 (Excipients) |
| تواريخ الأحداث: | Date Created: 20240623 Date Completed: 20240712 Latest Revision: 20240712 |
| رمز التحديث: | 20240713 |
| DOI: | 10.1016/j.ijpharm.2024.124365 |
| PMID: | 38909922 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1873-3476 |
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| DOI: | 10.1016/j.ijpharm.2024.124365 |