PharmPK Discussion - Itraconazole bioequivalence

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On 20 Sep 2000 at 10:26:19, "Dr M G Neale" (mgneale.at.email.msn.com) sent the message


Can anyone offer advice/references on conducting bioequivalence studies with
itraconazole, in particular the detail of design.  Also, there is clearly
well documented interaction with food for this drug; is it necessary to
conduct further food interaction studies when developing new formulations?

Many thanks in anticipation.

Michael G Neale BPharm, PhD
9 Welland Road, Barrow-upon-Soar
Loughborough, Leicestershire, LE12 8NA
Tel/Fax 44 1509 412204

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On 28 Sep 2000 at 10:25:51, kwon.-at-.cnu.ac.kr sent the message


Dear Michael

  Cocerning your query on BE study design of the itraconazole.

  Clinically, the method of administration of itraconazole is well
defined already to administer
after meal.  So we think the bioequivalence of itraconazole
could(should) be studied after meal.
Our government(KFDA) urge to study not only after meal but also
without meal to prove
bioequivlence of itraconazole with single dose of 100mg(1 capsule,
lowest usual dose).
  For this, should have Cp detection limit of 1ng/ml(HPLC) as the
absorption without meal is quite low.
Theoretically,  200mg(usual dose) or even 400mg (as the accumulation
factor of itraconazole is about  2)
should be OK for the single dose of itraconazole but KFDA try to make
things worst,
I do not know why...

General 2x2 Latin square cross over design with 24 -28 volunteers,
sampling time for 72 hrs (over 3 half lives)
should be OK.      Hope this would be help

Kwon
Professor in Pharmacy

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On 29 Sep 2000 at 11:56:08, mohanms.-at-.drreddys.com sent the message


Dear Dr Kwon,

Can I get a reference of the Bioanalytical Method capable of detecting 1ng
/ ml
of Itraconazole by HPLC.Iam interested to know about the detector used and
the method.

Regards

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On 7 Oct 2000 at 13:07:08, K. I. Kwon (kwon.-a-.cnu.ac.kr) sent the message


Dear Michael

  There are some papers concerning the itraconazole HPLC assay
with detection limit of 1ng/ml.
One for animal study is
Drug Development and Industrial Pharmacy 26(1), 27-34 (2000), Marcek Dekker
It has quite simple sample purification but no clean baseline for human plasma.

The other one for human study is
J. Chromatography, Biomedical Applications, 413(1987) 332-337, Elsavier
It is quite complicated back extraction method with UV detector
operating at 254nm.
We could confirm the method successfully.

Good luck

Kwon

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