PharmPK Discussion - IP AUC>IV AUC

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On 27 Oct 2000 at 16:40:29, sunil v (sunil_nish.-at-.yahoo.com) sent the message


Dear Sir,

During the bioavailability studies of a NCE, we are getting strange
results where the Intraperitoneal AUC of the drug was 150% of IV AUC.
Repeat experiments yielded similar experiments. I would be grateful
if somebody could through some light on the this.

Regards,

Sunil V (Scvientist, Formulation Development Department)

Torrent Research Centre,

Gandhinagar, Gujarat, INDIA.

Ph: 091-2712-659124

Fax: 091-2712-659135

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On 1 Nov 2000 at 12:23:56, "vinay patil" (vbp_76.-a-.hotmail.com) sent the message


dear sir,
it would be very difficult to comment with this much data. try
validating your analytical method. i dont know whether you have used
HPLC method. if yes whether internal standard was used. ploblem may
occure if extraction is not proper.

vinay
Senior research fellow,
Pune.

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On 3 Nov 2000 at 13:04:45, bvatul.aaa.ufl.edu sent the message


Hello Sunil
It would be better if you could check your results by
infusing (few minutes) the same dose into portal vein.
This will remove any doubts about the exactness of dose
administration which might result in the differences
you are observing. It will be better if you can check
two or three time points (intraperitoneal vs
intraportal) of their concentrations and compare the
results.Hope your dose is not high to saturate the
liver.

Hope this helps

Atul

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On 3 Nov 2000 at 13:05:17, Chandrani Gunaratna (prema.-at-.bioanalytical.com) sent the message


  Enterohepatic circulation perhaps. I remember seeing this issue
being addressed before in this forum.

Chandrani Gunaratna

Chandrani Gunaratna, Ph.D.
Senior Research Scientist
Bioanalytical Systems
2701 Kent Avenue
West Lafayette, IN 47906
(765)463-4527

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On 6 Nov 2000 at 12:57:52, "Ronald Kavanagh 301-827-4254 FAX 301-827-4264" (KAVANAGHR.-at-.cder.fda.gov) sent the message


One possible explanation could be flip-flop kinetics. Have you compared
the apparent elimination half-lives?

Ronald E. Kavanagh. B.S. Pharm., Pharm.D., Ph.D.

Food & Drug Administration
Office of Clinical Pharmacology and Biopharmaceutics
5600 Fishers Lane	HFD-870
Rockville, MD  20857

Phone:	301-827-4254	FAX:	301-827-4264
Office:	Parklawn (PKLN) 17B-30	e-mail:	kavanaghr.-a-.cder.fda.gov

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