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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 insoluble drugs like paclitaxel for IV. 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
not 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)?
Thanks and regards
Manthena Varma
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The following message was posted to: PharmPK
Dear Manthena,
if you want to use an excipient which is not already approved (for
clinical studies), you should anticipate issues raised by the FDA. If
you can show that the ingredient is safe as well as inactive its use
should be accepted. It is relevant to think that as far as an
excipient is not approved it should be considered as a potential drug
until someone shows it is inactive, non-toxic ...and useful for the
drug dosage form design.
Considering an excipient that is still approved for the oral route I
assume that you should give evidence that IV dosing does not exhibit
a new tox effect.
Hope this helps,
Best regards,
Frederic
Frederic Doc
ACRITER - drug discovery consulting
www.acriter-consulting.com
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