کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2487166 | 1114406 | 2006 | 13 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics
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کلمات کلیدی
Blend uniformity analysisUV/Vis spectroscopy - UV / Vis spectroscopyPrincipal component analysis - تحلیل مولفههای اصلی یا PCAMultivariate analysis - تحلیل چندمتغیرهPartial least squares - حداقل مربعات جزئی principal component regression - رگرسیون مولفه اصلیNear-infrared spectroscopy - طیف شناسی فروسرخ نزدیکProcess analytical technology (PAT) - فن آوری تحلیلی فرآیند (PAT)Mixing - مخلوط کردن
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله

چکیده انگلیسی
The Process Analytical Technology (PAT) initiative, undertaken by the Food and Drug Administration (FDA), paves the way for improvement of drug manufacturing through real-time measurements that allow better process understanding. This study is the third and final Part in a series of studies that represent an integrated approach for real-time blend uniformity assessment using near-infrared (NIR) technology. In this study, the development of a quantitative NIR model for prediction of blending end point is presented. Process signature was built into NIR calibration models by using blend samples that were collected from actual blend experiments under different processing conditions. Evaluation of various calibration algorithms including principal component regression (PCR), partial least squares (PLS), and multi-term linear regression (MLR) was performed. It was found that linear regression, using a single wavelength, yielded optimum calibration and prediction results. The blending profiles predicted by the NIR quantitative model correlated well to those determined by the UV reference analytical method. Characterization of intra-shell versus inter-shell powder mixing kinetics and its implication in sensor positioning was also performed and will be discussed. © 2005 Wiley-Liss, Inc. and the American Pharmacists Association
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 95, Issue 2, February 2006, Pages 422-434
Journal: Journal of Pharmaceutical Sciences - Volume 95, Issue 2, February 2006, Pages 422-434
نویسندگان
Arwa S. El-Hagrasy, James K. III,