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As per your expert comments, i re-conducted P-gp modulation study and changed aggressive
formulation (containing PEG 400,Ethanol and water) to mild suspension (0.5% MC+Tween 80).
As a result i am getting clear drug drug interaction now. AUC is increasing by 3 folds as
compared to no change in aggressive formulation which may indicate impact of soluble
formulation (highly permeable drug) on under predictable efflux property of P-gp.
But basic problem is remain same.
1) I am not able to calculate other parameters of pharmacokinetics (change in clearance,
t1/2, Vd ) as time Vs Plasma concentration graph is some what plateau (could be due to
precipitation of formulation in GIT and was not observed in aggressive formulation)
2) What strategy in terms of formulation (suspension formulation or soluble formulation
)should i use to carry out in-vitro DDI (P-gp based models) studies as i am worried about
the same result (under predictability of power of P-gp efflux while selecting soluble
formulation) of not getting any interaction?
I would like to thank once again to all of you for giving such a wonderful comments. --
BITS-Pilani, Hyderabad Campus,
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