Cmax At 2 hours after IV bolusBack to the Top
We have dosed to 4 monkeys with 14C water soluble NCE by intravenous
route
(bolus) . And we found a very complicated pk profile with a Cmax after 2
hours ( with tree points before Cmax). The profile is like the product
have
a absorption phase. All possible methodology mistakes have been checked.
Anybody have the some problem some times? Anybody have some explication
for
this behavior?
thank you for any help
Dr Chazaro.
Un Veracruzana
Mexico
[Could the NCE precipitate in blood, filtered by lung and re-dissolve?
- db]
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Could it form a depot after injection? Localized or quick distribution
followed by a slow release from tissue depot (like Gentamicin but
extreme behavior).
Just a thought!
Pravin
--
Pravin Jadhav
Graduate Student
Department of Pharmaceutics
MCV/Virginia Commonwealth University
DPE1/CDER/OCPB/Food and Drug Administration
Phone: (301) 594-2623
Fax: (301) 480-3212
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Hi
There could be several reasons to the observation you saw. i have a few
question from you to ask.
1. is there a possibility of a faulty IV injection. Did you see the
injection site for abnormal appearances?
2. Was the IV injection a bolus or infusion?
3. What was the first sample time point?
4.My next question would be are you measuring total radioactivity or
parent only?
If you are measuring total radioactivity and assuing that the injection
was given correctly then there could be a possibility of a metabolite
being formed which could be increasing with time and that could give
misleading profiles.
This is all i can say at this point.
manish
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It can happen that small particles get stuck in lung capillaries and
then
slowly disperse. Another option to consider,
Kim
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Are you measuring radioactivity or the parent drug? If radioactivity
is
being measured, the peak concentration may be due to a metabolite.
Armen P. Melikian, PharmD, PhD
President
Drug Development Resources, LLC
338 Morris Avenue
Mountain Lakes, NJ 07046
Tel: 973-658-3510
Fax: 973-402-5992
[That could be the problem if the metabolite only was being measured -
db]
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