کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2484928 | 1114340 | 2010 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Risk Assessment and Physicochemical Characterization of a Metastable Dihydrate API Phase for Intravenous Formulation Development
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Risk Assessment and Physicochemical Characterization of a Metastable Dihydrate API Phase for Intravenous Formulation Development Risk Assessment and Physicochemical Characterization of a Metastable Dihydrate API Phase for Intravenous Formulation Development](/preview/png/2484928.png)
چکیده انگلیسی
(1S,5R)-2-{[(4S)-azepan-4-ylamino]carbonyl}-7-oxo-2,6-diazabicyclo[3.2.0] heptane-6-sulfonic acid (Compound 1) is a β-lactamase inhibitor for intravenous administration. The objective of this preformulation study was to determine the most appropriate form of the API for development. Compound 1 can exist as an amorphous solid and four distinct crystalline phases A, B, C, and D in the solid state. Slurry experiments along with analysis of physicochemical properties were used to construct a phase diagram and select the most suitable form of the API for development. In aqueous formulations, the dihydrate form of the API was predominant and, due to the more favorable solubility and dissolution profile required for preclinical and clinical studies, a metastable form of the API was selected, and the risks associated with developing this form were evaluated.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 12, December 2010, Pages 4973-4981
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 12, December 2010, Pages 4973-4981
نویسندگان
Christopher J. Mortko, Agam R. Sheth, Narayan Variankaval, Li Li, Brian T. Farrer,