کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8513019 | 1556489 | 2018 | 70 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Sticking and Picking in Pharmaceutical Tablet Compression: An IQ Consortium Review
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
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چکیده انگلیسی
Sticking and picking during tablet manufacture has received increasing interest recently, as it causes tablet defects, downtime in manufacturing, and yield losses. The capricious nature of the problem means that it can appear at any stage of the development cycle, even when it has been deemed as low risk by models, tests, and previous experience. In many cases, the problem manifests when transferring the process from one manufacturing site to another. Site transfers are more common now than in previous times because of the multinational nature of drug product manufacturing and the need for redundancy in manufacturing networks. Sticking is a multifactorial problem, so one single “fix” is unlikely to solve it completely, and “solutions” addressing one problem may exacerbate another. A broad-based strategy involving the API, formulation, tablet tooling, and the manufacturing process is the most likely approach to provide a robust and lasting solution. When faced with a sticking problem for the first or subsequent time, the formulator should address, in a structured way, a range of possible causes and remedies. In this article, we focus on current research and practice; on some of the common causes of sticking; mitigation and resolution strategies and solutions; and possible future directions in research.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 107, Issue 9, September 2018, Pages 2267-2282
Journal: Journal of Pharmaceutical Sciences - Volume 107, Issue 9, September 2018, Pages 2267-2282
نویسندگان
Sayantan Chattoraj, Patrick Daugherity, Todd McDermott, Angela Olsofsky, Wyatt J. Roth, Mike Tobyn,