کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2486104 | 1114375 | 2007 | 31 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The Challenge of Drying Method Selection for Protein Pharmaceuticals: Product Quality Implications
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کلمات کلیدی
Atomization - اتمسفرEvaporation - تبخیرProtein stabilization - تثبیت پروتئینSurface analysis - تجزیه و تحلیل سطحMolecular mobility - تحرک مولکولیSpray drying - خشک کردن اسپریSpray freeze drying - خشک کردن انجماد اسپریVacuum drying - خشک کردن خلاءFreeze drying - خشک کردن منجمدElectron spectroscopy for chemical analysis - طیف سنج الکترونی برای تجزیه و تحلیل شیمیاییGlass dynamics - پویایی شیشه
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
Numerous drying methods are used to dry solutions of proteins in the laboratory and/or in pharmaceutical manufacturing. In this review article, we will discuss many of these drying methods. We will briefly introduce and compare the unit operations involved in the drying methods to give an insight on thermal history, and the different stresses that a drying method can present to an active ingredient, particularly for protein molecules. We will review and compare some important physicoâchemical properties of the dried powder that result from using different drying methods such as specific surface area, molecular dynamics, secondary structure (for protein molecules), and composition heterogeneity. We will discuss some factors that might lead to differences in the physicoâchemical properties of different powders of the same formulation prepared by different techniques. We will examine through a literature review how differences in some of these properties can affect storage stability. Also, we will review process modifications of the basic drying methods and how these modifications might impact physicoâchemical properties, inâprocess stability and/or storage stability of the dried powders. © 2007 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 96:1886-1916, 2007
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 8, August 2007, Pages 1886-1916
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 8, August 2007, Pages 1886-1916
نویسندگان
Ahmad M. AbdulâFattah, Devendra S. Kalonia, Michael J. Pikal,