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Dear friends
we are working with NCE which is poorly soluble and highly lipophilic
in nature.
pharmacokinetic studies was conducted in rabbits (25 mg/kg dose, oral
route)using SMEDDS (self emulsifying drug delivery system)
formulation. (half life 10 hours, Cmax-1696 ng/ml, Tmax-12.hrs)
The mean kinetic time profile data as follows..
Time Conc in ng/ml
0.5 386.00
1 488.00
2 580.00
4 614.00
6 685.00
8 1270.00
10 1340.00
12 1696.00
24 865.00
48 450.00
72 20.00
96 0.00
Now we would like to conduct Kinetic studies in IV route(1.5 mg/kg)
( Bioavailability studies) based on the above data can any one plz
suggest the sample time points for IV route.
For Pharmacokinetics in Oral route is above time points are
sufficient ? or require to add any extra time points.
your comments and suggestions are more appreciable..
Thanks in advance..
Regards
Ravi.
Ravi Sheshala
School Of Pharmaceutical Sciences,
Universiti Sains malaysia,
11800, Penang,
Malaysia
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The following message was posted to: PharmPK
Dear Ravi Sheshala: Hi
1- Oral route;
i) Since your peak time was at 12hrs and the next sampling time was
at 24hrs,therefor, you should have at least two to four sampling
times to refine your Cmax and Tmax( e.g. 11, 13, 15 and 16hrs).
ii) For elimination phase also you should expand the sampling time to
characterize the elimination phase(e.g. 30, 36, 42 and 60hrs).
2- IV route :you can use the same the timing suggested for oral and
insert two timing such as 3 and 5hrs. Good luck and best regard.
Khalil I M Al-Khamis, Ph.D
Professor of Clinical Pharmacy, College of Pharmacy
KSU, Kingdom of Saudi Arabia.
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Dear Ravi,
Your Oral PK data seems to be good as you choosed the time points in
a better way.
It would have been better if you choosed 11, 13 and 15 h time points
in oral study since your Tmax was at 12 h.
But as the limitation for total time points is there it is ok.
Now for I.V. route to show the better profile it is advised to
collect sample at 10 min also along with the same points like your
oral and I think you can avoid 96 h time point in this
hope this helps
Thanks
Rajareddy Kallem
Asso scientist
DMPK lab,
Dr.Reddys labs,
India.
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Dear Ravi,
In my opinion, since it is an IV kintic study you can
exclude Time points 48, 72 and 96 hrs from your collection and
include additional 2 time points upto 1 hr collection
With regards
Dr. Abhijit Vichare
M.V.Sc (Pharmacology & Toxicology)
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