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The following message was posted to: PharmPK
Dear Manthena:
We have used 30% water containing up to 10% TPGS in iv
formulations for several PK studies (mainly for
pre-clinical studies with rats) with great success.
Whether this amount (up to 3.3% TPGS in total
formulation) is acceptable for GLP Tox studies or not
I do not know. I have a felling it should be given the
acceptable oral limits and applying safety factor of
300. Literature talks about oral limits of TPGS and I
have not found anything on iv yet. For a single dose
administration it should be fine. Can others in the
list share their experience?
Rostam
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