کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2486110 | 1114375 | 2008 | 26 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Drying-Induced Variations in Physico-Chemical Properties of Amorphous Pharmaceuticals and Their Impact on Stability (I): Stability of a Monoclonal Antibody*
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کلمات کلیدی
composition heterogeneityProtein stabilization - تثبیت پروتئینMolecular mobility - تحرک مولکولیStructural relaxation time - زمان آرامش ساختاریProtein secondary structure - ساختار ثانویه پروتئینSpecific surface area - سطح خاصElectron spectroscopy for chemical analysis - طیف سنج الکترونی برای تجزیه و تحلیل شیمیاییSurface coverage - پوشش سطحGlass dynamics - پویایی شیشه
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
The present study was conducted to investigate the impact of drying method and formulation on the storage stability of IgG1. Formulations of IgG1 with varying levels of sucrose with and without surfactant were dried by different methods, namely freeze drying, spray drying, and foam drying. Dried powders were characterized by thermal analysis, scanning electron microscopy, specific surface area (SSA) analysis, electron spectroscopy for chemical analysis (ESCA), solid state FTIR, and molecular mobility measurements by both isothermal calorimetry and incoherent elastic neutron scattering. Dried formulations were subjected to storage stability studies at 40°C and 50°C (aggregate levels were measured by size exclusion chromatography initially and at different time points). Both drying method and formulation had a significant impact on the properties of IgG1 powders, including storage stability. Among the drying methods, SSA was highest and perturbations in secondary structure were lowest with the sprayâdried preparations. Sucroseârich foams had the lowest SSA and the lowest protein surface accumulation. Also, sucroseârich foams had the lowest molecular mobility (both fast dynamics and global motions). Stability studies showed a logâlinear dependence of physical stability on composition. Preparations manufactured by “Foam Drying” were the most stable, regardless of the stabilizer level. In proteinârich formulations, freezeâdried powders showed the poorest storage stability and the stability differences were correlated to differences in secondary structure. In stabilizerârich formulations, stability differences were best correlated to differences in molecular mobility (fast dynamics) and total protein surface accumulation. © 2007 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 96:1983-2008, 2007
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 8, August 2007, Pages 1983-2008
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 8, August 2007, Pages 1983-2008
نویسندگان
Ahmad M. AbdulâFattah, Vu TruongâLe, Luisa Yee, Lauren Nguyen, Devendra S. Kalonia, Marcus T. Cicerone, Michael J. Pikal,