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I need some clarification regarding the GI stability and metabolism
studies for drugs in the presence of formulated excepients such as
span 80(sorbitan mono oleate).
The drug is acidic nature, poorly soluble in water (400ng/ml) and
highly lipophilic in nature (LogD=5.8 at 6.5 pH).
This drug has shown good activity in in vitro and failure in invivo.
As such the drug can not be useful to carry out the gastrointestinal
stability and metabolism studeis.
Present there is availability of an injection (I.M) which contains
Sorbiton mono oleate (1:2 i.e drug: sorbiton mono oleate) and which
is higly solble in aqueous media.
We didn't have any data of metabolism and gastro intestinal
stability data for this drug. Present we are trying to screening
these parametrs by using the above injectionsolution. The out come
results can be reliable?
For gastrointestinal stability i can perform the experiments in the
presense of some markers (the drugs which are unstable in GI fluids)
to proove that there is no effect of excepient and the results
obtained for the drug may be accurate.
please suggest me
I am looking forward for ur mails
thanking you one and all
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