کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
7632541 | 1494663 | 2012 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Strategies for multivariate modeling of moisture content in freeze-dried mannitol-containing products by near-infrared spectroscopy
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کلمات کلیدی
APImean prediction errorSNVMSCOSCRMSECVMPENIRPLSPCA - PCAStandard normal variate - استاندارد عادیPrincipal component analysis - تحلیل مولفههای اصلی یا PCAOrthogonal signal correction - تصحیح سیگنال ارتوگنالFreeze-Drying - خشککردن انجمادیRelative humidity - رطوبت نسبیprincipal component regression - رگرسیون مولفه اصلیRoot mean square error of cross validation - ریشه میانگین خطای مربع اعتبارسنج متقابل استNear-infrared spectroscopy - طیف شناسی فروسرخ نزدیکFreeze-dried - فریز شده خشک شدهMannitol - مانیتولMoisture content - محتوای رطوبتMultivariate modeling - مدل سازی چند متغیرهActive Pharmaceutical Ingredient - مواد اولیه دارویی فعالprincipal component - مولفه های اصلیNear-infrared - نزدیک مادون قرمزPCR - واکنش زنجیرهٔ پلیمرازKarl Fischer - کارل فیشر
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله

چکیده انگلیسی
Accurate determination of residual moisture content of a freeze-dried (FD) pharmaceutical product is critical for prediction of its quality. Near-infrared (NIR) spectroscopy is a fast and non-invasive method routinely used for quantification of moisture. However, several physicochemical properties of the FD product may interfere with absorption bands related to the water content. A commonly used stabilizer and bulking agent in FD known for variation in physicochemical properties, is mannitol. To minimize this physicochemical interference, different approaches for multivariate correlation between NIR spectra of a FD product containing mannitol and the corresponding moisture content measured by Karl Fischer (KF) titration have been investigated. A novel method, MIPCR (Main and Interactions of Individual Principal Components Regression), was found to have significantly increased predictive ability of moisture content compared to a traditional PLS approach. The philosophy behind the MIPCR is that the interference from a variety of particle and morphology attributes has interactive effects on the water related absorption bands. The transformation of original wavelength variables to orthogonal scores gives a new set of variables (scores) without covariance structure, and the possibility of inclusion of interaction terms in the further modeling. The residual moisture content of the FD product investigated is in the range from 0.7% to 2.6%. The mean errors of cross validated prediction of models developed in the investigated NIR regions were reduced from a range of 24.1-27.6% for traditional PLS method to 15.7-20.5% for the MIPCR method. Improved model quality by application of MIPCR, without the need for inclusion of a large number of calibration samples, might increase the use of NIR in early phase product development, where availability of calibration samples is often limited.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 70, November 2012, Pages 202-211
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 70, November 2012, Pages 202-211
نویسندگان
Wai Lam Yip, Ingvil Gausemel, Sverre Arne Sande, Knut Dyrstad,