کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5550687 1557298 2017 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
A novel methodology to study polymodal particle size distributions produced during continuous wet granulation
ترجمه فارسی عنوان
یک روش جدید برای مطالعه توزیع اندازه ذرات چندجملهای تولید شده در گرانولاسیون مرطوب مداوم است
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی علوم دارویی
چکیده انگلیسی

It is important during powder granulation to obtain particles of a homogeneous size especially in critical situations such as pharmaceutical manufacture. To date, homogeneity of particle size distribution has been defined by the use of the d50 combined with the span of the particle size distribution, which has been found ineffective for polymodal particle size distributions. This work focuses on demonstrating the limitations of the span parameter to quantify homogeneity and proposes a novel improved metric based on the transformation of a typical particle size distribution curve into a homogeneity factor which can vary from 0 to 100%. The potential of this method as a characterisation tool has been demonstrated through its application to the production of granules using two different materials. The workspace of an 11 mm twin screw granulator was defined for two common excipients (α-lactose monohydrate and microcrystalline cellulose). Homogeneity of the obtained granules varied dramatically from 0 to 95% in the same workspace, allowing identification of critical process parameters (e.g. feed rate, liquid/solid ratio, torque velocities). In addition it defined the operational conditions required to produce the most homogeneous product within the range 5 μm-2.2 mm from both materials.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: International Journal of Pharmaceutics - Volume 519, Issues 1–2, 15 March 2017, Pages 230-239
نویسندگان
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