کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5821185 | 1557417 | 2011 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Real-time predictions of drug release and end point detection of a coating operation by in-line near infrared measurements
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
علوم دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Real-time predictions of drug release and end point detection of a coating operation by in-line near infrared measurements Real-time predictions of drug release and end point detection of a coating operation by in-line near infrared measurements](/preview/png/5821185.png)
چکیده انگلیسی
The aim of this work was to carry out real-time near infrared (NIR) predictions of drug release from sustained release coated tablets and to determine end point of coating operation.In-line measurements were ensured by implementation of a NIR probe inside a pan coater. Tablets were coated using a functional aqueous dispersion of ethylcellulose blended with PVA-PEG graft copolymer to obtain a controlled drug release dosage form over 16Â h. Samples were collected at regular intervals and subjected to a standardized curing step. Percentages of released drug at 4Â h, 8Â h and 12Â h were selected to describe the controlled drug release of cured tablets. These dissolution criteria were used as reference values to calibrate NIR spectral information and to develop three partial least squares regressions.Low predictive errors of 1.7%, 1.9% and 1.5%, respectively, were obtained. The coating operation was stopped while desired dissolution criteria were achieved, corresponding to a coating level around 10%.The present study demonstrated that real-time NIR measurements could be performed on non-finished drug products to predict dissolution properties of cured coated tablets. This novel and innovative approach fulfils the expectations of ICH Q8 guideline on pharmaceutical development, in terms of process understanding and process analytical technology (PAT) control strategy. This approach should be however adapted to curing operation to allow a real-time release testing.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: International Journal of Pharmaceutics - Volume 421, Issue 2, 15 December 2011, Pages 237-243
Journal: International Journal of Pharmaceutics - Volume 421, Issue 2, 15 December 2011, Pages 237-243
نویسندگان
Claire Gendre, Mathieu Boiret, Muriel Genty, Pierre Chaminade, Jean Manuel Pean,