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Dear group members,
I would like to know about regulatory stand for use of TPGS in
preparing solutions for IV infusion/bolus. There are number of
publication and patents that claim use of TPGS for solubilizing
highly insolubvle drugs like paclitaxel. It was also reported by
Eastman (innovators) that this molecule is quit safe and FDA approved
it for oral dosing. However, to my knowledge, TPGS is approved for
parenterals. Can anyone provide latest developments?
Secondly, if an excipients was not approved by FDA, can I use it for
formulating NCEs (If, we are going to carry out all preclinical and
clinical studies with the same formulations)?
Wish you all A Happy New Year.
Thanks and regards
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