Bioequivalence and Bioavailability Forum

Dear Ratnakar,

BE studies should reflect the recommended use -

For example - Nicotine Chewing Gum

PIL says -
1) Chew, park, Chew
Chew (when you have urge to smoke (chewing releases nicotine))
Park (rest between gum and cheek)
Chew (when you have again urge to smoke)

So your study should reflect this (Chew-Park-Chew)

As urge to smoke depends on the individual, to harmonize, we need to fix the chewing rate and chewing time for the study

Eg: - 10 chews/min for 15 minutes

2) "Don't eat or drink for 15 minutes before chewing nicotine gum"

Instruct subjects not to take water for a particular time before and after dosing

In the same way -

Chewing tablet -

1) Harmonize Chewing rate -

Place tablet on the tongue - suck - move to the right cheek - Place on the tongue - suck - move to left cheek …………….until tablet gets dissolved completely

Eg: For every 10 seconds move from one side to the other (sucking once) until the tablet completely dissolves

Instruct subjects not to chew or swallow the gum/tablet; if so eliminate them from the study

Hope you understood the concept

Regards,
Bharathi