کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2487954 | 1114445 | 2006 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A process analytical technology approach based on near infrared spectroscopy: Tablet hardness, content uniformity, and dissolution test measurements of intact tablets
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کلمات کلیدی
Dissolution - انحلال Compaction - تراکمProcess analytical technology - تکنولوژی تحلیلی فرایندPartial least squares - حداقل مربعات جزئی Discriminant partial least squares - حداقل مربعات جزئی جزئیPharmaceuticals - داروهاIntact tablets - قرصهای دست نخوردهNear Infrared spectroscopy - نزدیک به طیف سنجی مادون قرمزContent uniformity - یکنواختی محتوا
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Near infrared spectroscopy (NIRS) is a nondestructive analytical technique that enables simultaneous measurements of chemical composition (viz. the content in active pharmaceutical ingredient, API) and various physical properties (viz. tablet hardness and dissolution profile) in pharmaceutical tablets. In this work, partial least squares (PLS) calibration models and discriminant partial least squares (DPLS) classification models were constructed by using calibration sets consisting of laboratory samples alone. The laboratory samples were mixtures of the API and excipients that were pressed into tablets. API content, tablet hardness, and dissolution measurements of intact tablets were made by using three different calibration models that are fast-results can be obtained within a few seconds-, simple and robust-they involve minimal analyst intervention-, and clean-they use no toxic reagent and produce no toxic waste. Based on the results, the proposed NIR method is an effective alternative to current reference methods for the intended purpose. The advantages provided by NIR spectroscopy in this context confirm its potential for inclusion in process analytical technologies in the pharmaceutical industry.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 95, Issue 10, October 2006, Pages 2137-2144
Journal: Journal of Pharmaceutical Sciences - Volume 95, Issue 10, October 2006, Pages 2137-2144
نویسندگان
Marcelo Blanco, Manel Alcalá, Josep M. González, Ester Torras,