کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10162278 | 1114324 | 2014 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
SolidâState Characterization and Transformation of Various Creatine Phosphate Sodium Hydrates
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
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چکیده انگلیسی
Creatine phosphate sodium (CPS) salt is a firstâline cardiovascular drug for severe diastolic heart failure. The drug exists in different hydrate forms. The marketed drug form was determined as CPS·4.5H2O (H1); however, the reference standard was supplied as CPS·6H2O (H2). In this work, we present two newly identified hydrate forms: a thermodynamically stable low hydrate form, CPS·1.5H2O (H3), and a pressureâsensitive transit form, CPS·7H2O (H4). The hydrate forms were discovered through a comprehensive solidâstate screening experiment and fully characterized using a range of analytical techniques including Xâray powder diffraction (XRPD), FTIR, Raman spectroscopy, hotâstage microscopy (HSM), thermogravimetric analysis, and differential scanning calorimetry. Stability tests revealed that H3 was the most stable hydrate under thermal stimulation. H4 is a pressureâsensitive hydrate and easily transforms to H2 and then H1 upon grinding. The form transformation process was closely monitored using the HSM, variableâtemperature XRPD (VTâXRPD), and VTâRaman spectroscopy techniques. Specifically, the transformation of H4 to H1 is characterized in a singleâcrystalâtoâsingleâcrystal transformation process. The newly discovered hydrate form H3 has superior physicochemical properties than the marketed forms and is worthy of further development. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:3688-3695, 2014
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 11, November 2014, Pages 3688-3695
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 11, November 2014, Pages 3688-3695
نویسندگان
Yun Xu, Linglei Jiang, Ying Huang, JianâRong Wang, Xuefeng Mei,