کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1224353 967920 2007 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Development of a semi-automated chemical stability system to analyze solution based formulations in support of discovery candidate selection
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Development of a semi-automated chemical stability system to analyze solution based formulations in support of discovery candidate selection
چکیده انگلیسی
A semi-automated chemical stability system was developed, validated, and implemented to assess the chemical and physical stability (24 h) of intravenous and oral solution based formulations in support of preliminary in vivo drug discovery studies. The system utilizes a single Agilent 1100 LC and Xterra column with multiple UV wavelength monitoring. Mobile phase selection, either basic or acidic, is selected base upon on the physico-chemical properties of the test compound. The system was validated against 14 new chemical entities across multiple therapeutic areas. The results indicated that drug discovery compounds could be accurately quantified (<2% R.S.D.) in a wide range of formulation vehicles in greater than 90% of the test cases. This method can be used as a quantitative tool for triaging formulation variables and packaging configurations to quickly develop stable solutions for dosing.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 43, Issue 2, 17 January 2007, Pages 522-526
نویسندگان
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