کد مقاله کد نشریه سال انتشار مقاله انگلیسی ترجمه فارسی نسخه تمام متن
2083214 1545317 2016 5 صفحه PDF سفارش دهید دانلود رایگان
عنوان انگلیسی مقاله ISI
A practical approach for the scale-up of roller compaction process
ترجمه فارسی عنوان
رویکرد عملی برای افزایش روند فشردگی غلتک
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کلمات کلیدی
فشرده سازی غلتک، افزایش مقیاس، انتقال فناوری، مدل آماری، آیا، گرانوله
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیوتکنولوژی یا زیست‌فناوری
چکیده انگلیسی

An alternative approach for the scale-up of ribbon formation during roller compaction was investigated, which required only one batch at the commercial scale to set the operational conditions.The scale-up of ribbon formation was based on a probability method. It was sufficient in describing the mechanism of ribbon formation at both scales. In this method, a statistical relationship between roller compaction parameters and ribbon attributes (thickness and density) was first defined with DoE using a pilot Alexanderwerk WP120 roller compactor. While the milling speed was included in the design, it has no practical effect on granule properties within the study range despite its statistical significance. The statistical relationship was then adapted to a commercial Alexanderwerk WP200 roller compactor with one experimental run. The experimental run served as a calibration of the statistical model parameters. The proposed transfer method was then confirmed by conducting a mapping study on the Alexanderwerk WP200 using a factorial DoE, which showed a match between the predictions and the verification experiments. The study demonstrates the applicability of the roller compaction transfer method using the statistical model from the development scale calibrated with one experiment point at the commercial scale.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 106, September 2016, Pages 15–19
نویسندگان
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