کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5550314 1557287 2017 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Analysis of the origins of content non-uniformity in high-shear wet granulation
ترجمه فارسی عنوان
تجزیه و تحلیل ریشه های غیر یکنواخت محتوای در گرانوله مرطوب برشی بالا
کلمات کلیدی
جداسازی، مخلوط کردن پودر، توده ی مرطوب، گرانوله، یکنواختی محتوا،
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی علوم دارویی
چکیده انگلیسی

In this study, the origins of granule content non-uniformity in the high-shear wet granulation of a model two-component pharmaceutical blend were investigated. Using acetaminophen as the active pharmaceutical ingredient (API) and microcrystalline cellulose as the excipient, the distribution of the API across the granule size classes was measured for a range of conditions that differed in the duration of the initial dry mixing stage, the overall composition of the blend and the wet massing time. The coarse granule fractions were found to be systematically sub-potent, while the fines were enriched in the API. The extent of content non-uniformity was found to be dependent on two factors - powder segregation during dry mixing and redistribution of the API between the granule size fractions during the wet massing phase. The latter was demonstrated in an experiment where the excipient was pre-granulated, the API was added later and wet massed. The content non-uniformity in this case was comparable to that obtained when both components were present in the granulator from the beginning. With increasing wet massing time, the extent of content non-uniformity decreased, indicating that longer wet massing times might be a solution for systems with a natural tendency for component segregation.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: International Journal of Pharmaceutics - Volume 528, Issues 1–2, 7 August 2017, Pages 578-585
نویسندگان
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