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Dear all,
We are gearing up to do some PK studies in dogs (beagles) and I assume that whatever vehicle used in the rats will be acceptable for the dog. Just wanted to confirm this assumption with the experts out there.
Thanks,
Tai
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The following message was posted to: PharmPK
I seem to remember that Cremophor EL should be avoided in dogs due to
histamine release. From my own (limited) experience, dogs are prone to
histamine release and hypersensitivity reactions.
Best regards,
Frederik
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Similar kind of reaction have also been seen with Tweens. So should be avoided in dogs. Solutol provides a greater solublizing action with lesser side effects in dogs.
Thanks
Maninder
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The following message was posted to: PharmPK
The selection of vehicle should be made on a case by case basis. It is surely doable but with a sanity check.
As a diligence check, the enabling excipients (wetting agent, surfactants, polymers, solubilizers) used in test item formulation should be within their NOEL or NOAEL levels, specially at the highest dose intended to be dosed. There are some instances like Frederik mentioned regarding the specific cases of histamine release with Cremophores (but it happens primarily upon IV administration, in my personal experience cremophores are well tolerated after oral administration and hence histamine mediated side effects are generally not seen as they probably are not absorbed per se).
Also a vehicle control group can also be tested before the main course of study.
Hope this will answer your queries.
regards,
Vaibhav
Vaibhav Sihorkar, Ph.D.
[Head, Pharmaceutical Development]
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