کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10158201 | 1666516 | 2018 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A Tutorial for Developing a Topical Cream Formulation Based on the Quality by Design Approach
ترجمه فارسی عنوان
یک آموزش برای توسعه یک فرمول کرم موضعی بر اساس روش کیفیت طراحی شده
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کلمات کلیدی
کیفیت با طراحی، مشخصات کیفیت محصول هدف، ویژگی های کیفیت بحرانی، ویژگی های مهم انتقادی، پارامترهای پردازش بحرانی،
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
چکیده انگلیسی
The pharmaceutical industry has entered in a new era, as there is a growing interest in increasing the quality standards of dosage forms, through the implementation of more structured development and manufacturing approaches. For many decades, the manufacturing of drug products was controlled by a regulatory framework to guarantee the quality of the final product through a fixed process and exhaustive testing. Limitations related to the Quality by Test system have been widely acknowledged. The emergence of Quality by Design (QbD) as a systematic and risk-based approach introduced a new quality concept based on a good understanding of how raw materials and process parameters influence the final quality profile. Although the QbD system has been recognized as a revolutionary approach to product development and manufacturing, its full implementation in the pharmaceutical field is still limited. This is particularly evident in the case of semisolid complex formulation development. The present review aims at establishing a practical QbD framework to describe all stages comprised in the pharmaceutical development of a conventional cream in a comprehensible manner.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 107, Issue 10, October 2018, Pages 2653-2662
Journal: Journal of Pharmaceutical Sciences - Volume 107, Issue 10, October 2018, Pages 2653-2662
نویسندگان
Ana Simões, Francisco Veiga, Carla Vitorino, Ana Figueiras,