BE in orodispersible tablets [Design Issues]

posted by Dr_Dan  – Germany, 2011-04-11 17:32 (5556 d 08:43 ago) – Posting: # 6888
Views: 4,374

Dear ElMaestro
I have never used an orodispersible tablet myself and therefore I can not imagine what will happen. According to the guideline it is recommended wet the mouth by swallowing 20 ml of water directly before applying the ODT on the tongue. Further fluid intake is not allowed earlier than 1 hour after administration. And now my question: Should the volunteer be advised to swallow the dispersed tablet and if yes when? How can I ensure that the drug reaches the GI tract in more or less the same time in all volunteers?
If the originator SmPC tells me that the ODT can also be taken as an oral suspension I think then I should prefer this kind of application, right? In this context I would like to know the amount of water you need to prepare a suspension (240 ml?). The guideline does not mention suspensions....
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

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