کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2487164 | 1114406 | 2006 | 15 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation
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کلمات کلیدی
Static charge - اتهام استاتیکParticle size - اندازه ذراتPrincipal component analysis - تحلیل مولفههای اصلی یا PCAMultivariate analysis - تحلیل چندمتغیرهMoisture sorption - جذب رطوبتPhysical characterization - خصوصیات فیزیکیExperimental design - طراحی تجربیNear-infrared spectroscopy - طیف شناسی فروسرخ نزدیکProcess analytical technology (PAT) - فن آوری تحلیلی فرآیند (PAT)Blend uniformity - یکنواختی مخلوط کنید
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله

چکیده انگلیسی
Experimental design, multivariate data acquisition, and analysis in addition to real time monitoring and control through process analyzers, represent an integrated approach for implementation of Process Analytical Technology (PAT) in the pharmaceutical industry. This study, which is the first in a series of three parts, uses an experimental design approach to identify critical factors affecting powder blending. Powder mixtures composed of salicylic acid and lactose were mixed in an 8 qt. V-blender. D-optimal design was employed to characterize the blending process, by studying the effect of humidity, component concentration, and blender speed on mixing end point. Additionally, changes in particle size and density of powder mixtures were examined. A near-infrared (NIR) fiber-optic probe was used to monitor mixing, through multiple optical ports on the blender. Humidity, component concentration, and blender speed were shown to have a significant impact on the blending process. Furthermore, humidity and concentration had a significant effect on particle size and density of powder mixtures. NIRS was sensitive to changes in physicochemical properties of the mixtures, resulting from process variables. Proper selection of NIR spectral preprocessing is of ultimate importance for successful implementation of this technology in the monitoring and control of powder blending and is 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 392-406
Journal: Journal of Pharmaceutical Sciences - Volume 95, Issue 2, February 2006, Pages 392-406
نویسندگان
Arwa S. El-Hagrasy, Frank D'Amico, James K. III,