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I wish to test my NCE i.v. formulation for precipitation (if any) with
whole blood under in-vitro conditions before injecting it to the
animal.
Would appreciate if some one could give me a protocol for that.
Nikhil
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The following message was posted to: PharmPK
Dear Nikhil,
to appreciate the potential precipitation at the injection point I used
to design dilution studies at 1:1, 1:5 and 1:10 (v/v : partiton between
drug formulation volume and whole blood volume). Some seconds of vortex
and a visual observation are oftenly sufficient to determine wether a
precipitation is supposed to occur.
Hope this helps,
Frederic Doc
Acriter - drug discovery consulting
www.acriter-consulting.com
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The following message was posted to: PharmPK
Dear Frederic
This is in referance to studing the precipitation of Drug (dissolved in
organic solvent)at injection site.
1) Does you are using Fresh blood or Blood spiked with anticoagulant?
2) In case of Trace leval of precipitation, which is difficult to
observe
Visualy--
Can we centrifuged and analysed the samples?
Vinod Patil.
Wockhardt Research Center.
Aurangabad.
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The following message was posted to: PharmPK
Dear Vinod,
sorry for this late reply.
1- we used to perform precipitation studies in "fresh" blood.
2- What we expected to occur was a massive precipitation of the active
drug. If you just have a "trace level", as you mentioned, we conclude
that dosing is OK as we consider that at the injection site there may
be a quite rapid dilution due to the circulation flow.
Hope this helps,
Frederic
Frederic Doc
ACRITER - drug discovery consulting
visit our web site at : http://www.acriter-consulting.com
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