کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10162744 | 1114358 | 2013 | 5 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
How do Formulation and Process Parameters Impact Blend and Unit Dose Uniformity? Further Analysis of the Product Quality Research Institute Blend Uniformity Working Group Industry Survey
ترجمه فارسی عنوان
چگونه فرمولاسیون و پارامترهای فرآیندی تأثیر مخلوط و انحراف واحد را دارا هستند؟ تجزیه و تحلیل بیشتر از موسسه تحقیقات کیفیت محصول مخلوط یکنواختی گروه کار گروه بررسی
دانلود مقاله + سفارش ترجمه
دانلود مقاله ISI انگلیسی
رایگان برای ایرانیان
کلمات کلیدی
یکنواختی محتوا، فرمول بندی، مخلوط کردن، در حال پردازش، تکنولوژی پودر، فرم دوز جامد دانه بندی،
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
چکیده انگلیسی
Responses from the second Product Quality Research Institute (PQRI) Blend Uniformity Working Group (BUWG) survey of industry have been reanalyzed to identify potential links between formulation and processing variables and the measured uniformity of blends and unit dosage forms. As expected, the variability of the blend potency and tablet potency data increased with a decrease in the loading of the active pharmaceutical ingredient (API). There was also an inverse relationship between the nominal strength of the unit dose and the blend uniformity data. The data from the PQRI industry survey do not support the commonly held viewpoint that granulation processes are necessary to create and sustain tablet and capsule formulations with a high degree of API uniformity. There was no correlation between the blend or tablet potency variability and the type of process used to manufacture the product. Although it is commonly believed that direct compression processes should be avoided for low API loading formulations because of blend and tablet content uniformity concerns, the data for direct compression processes reported by the respondents to the PQRI survey suggest that such processes are being used routinely to manufacture solid dosage forms of acceptable quality even when the drug loading is quite low. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:982-986, 2013
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 102, Issue 3, March 2013, Pages 982-986
Journal: Journal of Pharmaceutical Sciences - Volume 102, Issue 3, March 2013, Pages 982-986
نویسندگان
Bruno C. Hancock, Salvador Garcia-Munoz,