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Dear All,
Does any one have the idea how to conduct BE studies for an ODT when
the reference product is conventional tablets. BE studies is to be
carried out with water or without water. Any guidance available.
Thanks in advance
Regards,
Nirav
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Dear Nirav,
I think this would fall under suitability petitions (for FDA
submissions).
You may have to follow the routine procedures used for each dosage forms
i.e. to use 240 mL of water for the conventional tablets (reference),
and then to dose the ODT (test) without water (as would be used by the
patients), followed by the use of 240 mL of water for rinsing the mouth
and to nullify the effect that may arise due to diff. in water intake
during the BE study.
If your molecule has the ability to be absorbed through the buccal
cavity (oral mucosa), you may have to be bit cautious, as that may lead
to a significant difference in the rate of absorption and may be the
extent as well.
Hope this helps. Request other experts views on the same.
Regards,
Hitesh K Maheshwari
Hikma Pharmaceuticals
Amman, Jordan.
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Dear Hitesh,
Thank you very much for the response. In case if there is buccal
absorption, can you tell from your experience, what time after dosing
should water be given so that there is no effect on the rate and
extent of absorption.
With kind regards,
Nirav Kamdar
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