کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2487662 | 1114426 | 2007 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Studies of variability in dissolution testing with USP apparatus 2*
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موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
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چکیده انگلیسی
In this study, gauge repeatability and reproducibility (gauge R&R) was used to analyze variability for USP apparatus 2 dissolution measurement systems. Experiments were designed to assess the variability due to apparatus, operator, and sample tablet. Since dissolution testing is a destructive test, a nested model was used for data analysis. Additionally, perturbation tests with both disintegrating and nondisintegrating tablets were performed to study the variability due to sample position within the dissolution vessel. For the gauge R&R study, two wellâtrained chemists used two mechanically calibrated USP apparatus 2 units. Six tests were performed by each operator on each apparatus. Evaluation of dissolution test results at 30Â min using an internal DPA calibrator tablet NCDA#2 (10Â mg prednisone) indicates that the main contribution to the total variance, approximately 70%, is due to the sample tablets, approximately 25% is from the apparatus and approximately 5% is due to the operators. There is no significant difference between operators and apparatuses as shown by the gauge R&R studies. In addition, dissolution results can be strongly affected by the position of the tablet within the vessel. Similarity (f1) and dissimilarity (f2) factors were calculated to statistically evaluate differences between perturbed and normal dissolution tests. © 2007 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 96: 1794-1801, 2007
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 7, July 2007, Pages 1794-1801
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 7, July 2007, Pages 1794-1801
نویسندگان
Zongming Gao, Terry W. Moore, Anjanette P. Smith, William H. Doub, Benjamin J. Westenberger,