PharmPK Discussion - BE of nicotine patch products

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On 29 Jun 2004 at 19:41:38, "Peter W. Mullen" (pmullen.-at-.kemic.com) sent the message

Dear PharmPKers:
I'm seeking advice and information re. the conduct of a comparative
BA-BE study of two different "antismoking" skin patch products
containing nicotine, one of which uses a rate-controlling membrane to
release drug to the skin.
Am I correct in assuming that the regulatory (statistical) requirements
for establishing average bioequivalence for such products are
essentially the same as those pertaining to orally administered drugs?
Thanks,
Peter

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On 1 Jul 2004 at 11:19:14, "Graham Mould" (gmould.at.gcpl.co.uk) sent the message

Dear Peter,
We have performed a number of comparisons using transdermal
formulations and
provided the comparator is suitable, then yes, the requirements are the
same, although you may wish to look at average steady-state
concentrations
following single and multiple doses.
Have we met some 5-6 years ago?  If so give us a call and we may be
able to
help further.
Best wishes
Graham
Graham Mould
Guildford Clinical Pharmacology Unit
Unit 34,
Surrey Technology Centre
Occam Road
Guildford
GU2 7YG

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On 2 Jul 2004 at 10:43:20, b pradeep (pradeepbhadauria.-a-.sify.com) sent the message

Dear Peter,
A classical BA/BE approach based on systemic exposure data is what is
applicable for Transdermal Patches also.Either an Average or if
justifiable an Individual Bioequivalnce approach can be considered.As
these drug products are usually associated with high degree of
variability and hence a Replicate design study should be preferred for
these dosage forms.
Apart from this, a data on residual drug content in each patch after
application period may be asked by agency to calculate the dose for
mass balancing.
A BE/BE study should be the next step to the skin irritation and skin
sensitization studies mandatory by agency.
I hope this suffices,
Kind Regards,
Pradeep S Bhadauria
RANBAXY RESEARCH LABORATORIES,
INDIA.

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