کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2485838 | 1114368 | 2012 | 23 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Assessing the performance of amorphous solid dispersions
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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
The characterization and performance of stable amorphous solid dispersion systems were evaluated in 40 research papers reporting active pharmaceutical ingredient (API) dissolution and bioavailability from various systems containing polymers. The results from these studies were broadly placed into three categories: amorphous dispersions that improved bioavailability (â¼82% of the cases), amorphous dispersions possessing lower bioavailability than the reference material (â¼8% of the cases), and amorphous dispersions demonstrating similar bioavailabilities as the reference material (â¼10% of the cases). A comparative analysis of these studies revealed several in vitro and in vivo variables that could have influenced the results. The in vitro factors compared primarily centered on dissolution testing and equipment, content and amount of dissolution media, sink or nonsink conditions, agitation rates, media pH, dissolution characteristics of the polymer, and dispersion particle size. The in vivo factors included reference materials used for bioavailability comparisons, animal species utilized, fasting versus fed conditions, and regional differences in gastrointestinal (GI) content and volume. On the basis of these considerations, a number of recommendations were made on issues ranging from the assessment of physical stability of API-polymer dispersions to in vivo GI physiological factors that require consideration in the performance evaluation of these systems. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 4, April 2012, Pages 1355-1377
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 4, April 2012, Pages 1355-1377
نویسندگان
Ann Newman, Gregory Knipp, George Zografi,