کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2083225 1545317 2016 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Dissolution and disintegration kinetics of high-active pharmaceutical granules produced at laboratory and manufacturing scale
ترجمه فارسی عنوان
سینتیک ریزش و تجزیه گرانول های فعال دارویی تولید شده در مقیاس آزمایشگاهی و تولیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیوتکنولوژی یا زیست‌فناوری
چکیده انگلیسی

The effect of process scale-up from 4 to 400-L high-shear granulator on the release kinetics of the active ingredient from pharmaceutical granules has been investigated. The dissolution and disintegration rates of the granules were measured simultaneously by the combination of UV/vis spectroscopy and static light scattering. The granule batches were found to consist of sub-populations with qualitatively different dissolution behavior: “weaker” granules that disintegrated during dissolution, and “stronger” granules that retained their size and from which the active ingredient was gradually leached. The existence of these sub-populations was attributed to non-uniform distribution of normal and shear forces that prevail in granulators of different size. This hypothesis was confirmed by preparing granules at increasing values of the Froude number at the 4-L scale, and observing a transition from the break-up dissolution mode to the leaching dissolution mode with increasing granule densification. The simultaneous observation of solute concentration and particle size distribution during granules dissolution proved to be a useful tool for the understanding of dissolution mechanisms and for identifying non-uniformities of process conditions that can occur during scale-up.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 106, September 2016, Pages 107–116
نویسندگان
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