کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8514047 | 1556503 | 2017 | 71 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Lyophilized Drug Product Cake Appearance: What Is Acceptable?
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کلمات کلیدی
CQATg′Amorphous - آمورفGlass transition - انتقال شیشهStability - ثباتDrying - خشک کردنFreeze drying - خشک کردن منجمدProcessing - در حال پردازشglass transition temperature - دمای انتقال شیشهProtein formulation - فرمول پروتئینFormulation - فرمولاسیونCollapse temperature - فروپاشی دمایLyophilization - لیوفیلیزاسیونCritical quality attribute - ویژگی کیفی بحرانی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
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چکیده انگلیسی
Cake appearance is an important attribute of freeze-dried products, which may or may not be critical with respect to product quality (i.e., safety and efficacy). Striving for “uniform and elegant” cake appearance may continue to remain an important goal during the design and development of a lyophilized drug product. However, “sometimes” a non-ideal cake appearance has no impact on product quality and is an inherent characteristic of the product (due to formulation, drug product presentation, and freeze-drying process). This commentary provides a summary of challenges related to visual appearance testing of freeze-dried products, particularly on how to judge the criticality of cake appearance. Furthermore, a harmonized nomenclature and description for variations in cake appearance from the ideal expectation of uniform and elegant is provided, including representative images. Finally, a science and risk-based approach is discussed on establishing acceptance criteria for cake appearance.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 106, Issue 7, July 2017, Pages 1706-1721
Journal: Journal of Pharmaceutical Sciences - Volume 106, Issue 7, July 2017, Pages 1706-1721
نویسندگان
Sajal Manubhai Patel, Steven L. Nail, Michael J. Pikal, Raimund Geidobler, Gerhard Winter, Andrea Hawe, Juan Davagnino, Shailaja Rambhatla Gupta,