دانلود مقاله ISI انگلیسی شماره 146116
کد مقاله سال انتشار مقاله انگلیسی ترجمه فارسی تعداد کلمات
146116 2018 49 صفحه PDF سفارش دهید 12872 کلمه
خرید مقاله
پس از پرداخت، فوراً می توانید مقاله را دانلود فرمایید.
عنوان انگلیسی
Pharmaceutics, Drug Delivery and Pharmaceutical TechnologyApplication of the Quality by Design Approach to the Freezing Step of Freeze-Drying: Building the Design Space
منبع

Publisher : Elsevier - Science Direct (الزویر - ساینس دایرکت)

Journal : Journal of Pharmaceutical Sciences, Available online 9 February 2018

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چکیده انگلیسی

The present work shows a rational method for the development of the freezing step of a freeze-drying cycle. The current approach to the selection of freezing conditions is still empirical and nonsystematic, thus resulting in poor robustness of control strategy. The final aim of this work is to fill this gap, describing a rational procedure, based on mathematical modeling, for properly choosing the freezing conditions. Mechanistic models are used for the prediction of temperature profiles during freezing and dimension of ice crystals being formed. Mathematical description of the drying phase of freeze-drying is also coupled with the results obtained by freezing models, thus providing a comprehensive characterization of the lyophilization process. In this framework, deep understanding of the phenomena involved is required, and according to the Quality by Design approach, this knowledge can be used to build the design space. The step-by-step procedure for building the design space for freezing is thus described, and examples of applications are provided. The calculated design space is validated upon experimental data, and we show that it allows easy control of the freezing process and fast selection of appropriate operating conditions.

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پس از پرداخت، فوراً می توانید مقاله را دانلود فرمایید.