Pharmalytical Summit 2021: A Virtual Forum presented by Rigaku is happy to present Harsh Shah, Ph.D. of J-Star Research Inc.
A primary anti-coagulant narrow therapeutic index drug, warfarin sodium, poses a high risk of thrombosis or excessive bleeding with sudden death. The root cause for these risks is not well established. It has been hypothesized that a freely soluble crystalline warfarin sodium (WARC) transforms to non-crystalline warfarin sodium (WARNC) under stress conditions and that the WARNC can later transform to the poorly soluble un-ionized form. This transformation could directly lead to dissolution failure in-vivo and could be responsible for the increased clinical risks. The study presented here focused on systematically characterizing solid form changes and 2-propanol (IPA) content under different environmental conditions followed by a low volume 2-stage dissolution method to mimic in vivo GIT behavior.
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