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Sincerely,
I am formulating on drug formulation intended to GI local acting with
drug which shows pH independent insolubility. I need a suggestions
about in vitro dissolution test for insoluble pH independent drug
indented to acting in GI. Also it must not desorbed in the bloodstorm.
Actually it is necessary to testing on dissolution GI local acting
preparation as a specification's parametar?
Thank you in anticipation.
Best Regards, Ljiljana Krsteska
Ljiljana Krsteska,M.S.Pharm
R&D Project Leader
Research & Development/GMP compliance
ALKALOID AD - Skopje
Blvd.Aleksandar Makedonski 12,
1000 Skopje, Republic of Macedonia
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Dear Krsteska,
Since your drug is insoluble irrespective of the
pH, simple sodium CMC suspension can deliver your drug to the GIT
(Intended). To ascertain invitro dissolution profile I would prefer
Simulated Gastric intestinal Fluid(Fasted/Fed state) as a dissolution
media, because it contains some surfactants which will mimic/closeness
the invivo performance of your drug. Further You cant always
anticipate nill absorption in the blood stream, where as you can have
some control value to postulate the activity of your drug is just
because of the local activity and not due to the systemic one.
Hope this reply may be of your interest.
Best regards
Devarajan
Formulation Research.
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