کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5809750 1556163 2016 28 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Methodology of oral formulation selection in the pharmaceutical industry
ترجمه فارسی عنوان
روش شناسی انتخاب ترکیب دهانی در صنعت داروسازی
کلمات کلیدی
انتخاب فرمولاسیون، صنعتی، در دسترس بودن زیستی دهان، نادر محلول است استراتژی فرمول بندی،
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی

Pharmaceutical formulations have to fulfil various requirements with respect to their intended use, either in the development phase or as a commercial product. New drug candidates with their specific properties confront the formulation scientist with industrial challenges for which a strategy is needed to cope with limited resources, stretched timelines as well as regulatory requirements. This paper aims at reviewing different methodologies to select a suitable formulation approach for oral delivery. Exclusively small-molecular drugs are considered and the review is written from an industrial perspective. Specific cases are discussed starting with an emphasis on poorly soluble compounds, then the topics of chemically labile drugs, low-dose compounds, and modified release are reviewed. Due to the broad scope of this work, a primary focus is on explaining basic concepts as well as recent trends. Different strategies are discussed to approach industrial formulation selection, which includes a structured product development. Examples for such structured development aim to provide guidance to formulators and finally, the recent topic of a manufacturing classification system is presented. It can be concluded that the field of oral formulation selection is particularly complex due to both multiple challenges as well as opportunities so that industrial scientists have to employ tailored approaches to design formulations successfully.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutical Sciences - Volume 87, 25 May 2016, Pages 136-163
نویسندگان
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