Ramesh Ramalingam
Junior

India,
2018-04-13 10:52

Posting: # 18679
Views: 1,346
 

 Oral Dispersible Tablet BE study USFDA submission [Regulatives / Guidelines]

Dear All,

Till now , FDA has not issued the general invivo BE study recommendation to conduct the ODT (oral Dispersible Tablet) BE study. Could any one please suggest the drug administration procedure for oral Dispersible Tablet in bioequivalence study (If product specific BE study recommendation not issued).

:confused:

Regards,
Ramesh.R:
jag009
Hero

NJ,
2018-04-13 21:23

@ Ramesh Ramalingam
Posting: # 18680
Views: 1,028
 

 Oral Dispersible Tablet BE study USFDA submission

Hi,

» Till now , FDA has not issued the general invivo BE study recommendation to conduct the ODT

I did a bunch of them a few years back but ours were NDAs (505b2s, ODTs vs reg tablets). Tablet on tongue, subject can't chew but can "suck" (you know, the small movement of your tongue like when you swallow something) on the tablet. After 10 or 30 seconds (don't remember details) check mouth. Once everything is disappear, then we give water...
anky1212
Junior

India,
2018-05-31 13:37

@ jag009
Posting: # 18831
Views: 590
 

 Oral Dispersible Tablet BE study USFDA submission

Hi,

We did such studies in which we had allowed subject to wet the mouth by swallowing 20 mL of water directly before placing the investigational product on the tongue. After placing tablet on tongue, subject was asked not to chew or crush the tablet and after 30 seconds mouth was checked. We did not provided water as PIL mentioned use of tablet with or without tablet.
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