Imran
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Mumbai,
2007-04-12 14:33
(7006 d 06:30 ago)

Posting: # 666
Views: 5,012
 

 Issues in Dispersible tablet [Design Issues]

Dear All,

We are planning biostudy on dispersible tablet, in this we are going to compare Test formulation (dispersible tablet) with reference formulation (oral solution). Test formulation will be dispersed in 30 ml of water and Reference formulation will be a 25 ml solution.

My question is how much volume of water should be administered with Test or Reference Formulation at the time of dosing, ie, either 240 ml or less.


Please clarify.

Shankar NJ
Helmut
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Vienna, Austria,
2007-04-14 22:05
(7003 d 22:58 ago)

@ Imran
Posting: # 671
Views: 3,929
 

 Suggested Administration

Dear Shankar / Imran!

❝ We are planning biostudy on dispersible tablet, in this we are going to

❝ compare Test formulation (dispersible tablet) with reference formulation

❝ (oral solution). Test formulation will be dispersed in 30 ml of water and

❝ Reference formulation will be a 25 ml solution.


May I assume you will adminster both formulations (dispersion/solution) from a small cup?

❝ My question is how much volume of water should be administered with Test

❝ or Reference Formulation at the time of dosing, ie, either 240 ml or

❝ less.


Try to follow the administration you have planned to be stated in the SPC / the product's labeling.
Whatever volume you are aiming at, this volume should be the total during administration in the study. If you administer the dispersion from a small cup, you should rinse the cup a least once with a defined amount of water (some particles show nasty adhesion).
If you want to go with 240 ml total, fine:
test: 30 ml dispersion + 30 ml rinse + 180 ml water
ref.: 25 ml solution + 25 ml rinse + 190 ml water

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