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Dear all,
Does anyone know about PK values from nasal sprays? Can anyone help
me with some papers regarding this issue? We are especially focused
on corticosteroids formulations.
Thank you in advance.
Rafael E. Barrientos Astigarraga, BChem, Ph.D
MAGABI Pesq. Clin. Farm. Ltda.
Tel. (+55-11)5521 0232
rafael.barrientos.-a-.magabi.com.br
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Rafael,
Nasal corticosteroids are usually topical in action, with little or
no measurable systemic distribution.
Frank Bales
frankbales.-at-.msn.com
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Frank and Rafael,
I was associated with a nasal spray steroid a number of years ago
that was topical in action, but the FDA insisted we conduct a PK
bioequivalence (i.e., measure systemic drug levels) for a formulation
change. It became easier to conduct the study than to go back and
forth with regulators. Of course, there was minimal systemic
exposure in either formulation, but I guess that was what the FDA was
looking for. It was ultimately approved.
Regarding nasal spray PK, previous message:
Nasal corticosteroids are usually topical in action, with little or
no measurable systemic distribution.
Tom
Thomas L. Tarnowski, Ph.D.
650 692-9296
ttarnowski1.-a-.aol.com
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Tom,
Regarding PK and system dose from nasal sprays
Yes, Tom, my prejudice is that this is mainly a formulation/actuation
issue: systemic dosing routes being due to either breathing in small
droplets; or swallowing what were large droplets, usually from a
narrow plume angle spray. In vitro tests are now used to measure and
control these attributes now.
Frank
frankbales.-a-.msn.com
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The following message was posted to: PharmPK
Tom and Frank,
Thank you for your contributions. I have performed a search regarding
this
issue and I could find some reviews on the nasal spray using
corticosteroids
as active ingredient. In some of them (for example J. Allergy Clin
Immunol,
108(1) S26, 2001) I found that for Budesonide and Triamcinolone
acetonide it
is possible to find very low plasma levels.
My question is: Have anyone ever worked before on this matter? My
focus is
on the analytical part for BE of nasal sprays.
Thank you in advance,
Rafael E. Barrientos Astigarraga
MAGABI Pesq. Clin. Farm. Ltda.
Tel. (+55-11)5521 0232
rafael.barrientos.aaa.magabi.com.br
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i thing you can go for senitive bioanalytical techniques like LC MS/
MS with good extraction method. This could be possible for your problem.
A.karthik
DMPK LAB,DISCOVERY RESEARCH
DR REDDYS LABORATORIES LTD
MIYAPUR
HYDERABAD
500049
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)