Bioequivalence and Bioavailability Forum • Dispersible tablets and Oral suspension

Dispersible tablets and Oral suspension [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2013-11-13 12:46 (4611 d 01:04 ago) – Posting: # 11875
Views: 4,448

Dear Kumar Naidu
Both formulations are IR formulation. Your orodispersable tablet (ODT) is formulated to quickly disperse in the mouth. In case of a low soluble drug (and your drug is such a BCS class II or IV drug, otherwise the reference would not be a suspension but a solution) there should be no problem to calculate sample size based on the other formulation as long as your ODT is taken with water.
I hope this helps.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Fast Dissolve Tablet Versus Immediate Release Tablet kranti 2013-06-19 09:39
- Fast Dissolve Tablet Versus Immediate Release Tablet Dr_Dan 2013-06-19 12:49
  - Fast Dissolve Tablet Versus Immediate Release Tablet kranti 2013-06-19 13:56
    - Fast Dissolve Tablet Versus Immediate Release Tablet jag009 2013-06-19 19:54
    - Fast Dissolve Tablet Versus Immediate Release Tablet Dr_Dan 2013-06-20 09:53
      - Fast Dissolve Tablet Versus Immediate Release Tablet kranti 2013-06-24 10:45
        
        Dispersible tablets and Oral suspension kumarnaidu 2013-11-12 10:58
        
        Dispersible tablets and Oral suspensionDr_Dan 2013-11-13 11:46
        
        Dispersible tablets and Oral suspension kumarnaidu 2013-11-14 06:29