Bioequivalence and Bioavailability Forum

Dear Mr.Shyam,

If you gone through the FDA recommendation for Ranitidine Effervescent tablets it states that "The following passage is reproduced from the Dosage and Administration section of the labeling":
Tablets should not be chewed, swallowed whole, or dissolved on the tongue. Dissolve 1 tablet in no less than 5 mL (1 teaspoonful) of water in an appropriate measuring cup. Wait until the tablet is completely dissolved before administering the solution.
Subsequently, after swallowing the solution, any residue should be re-suspended in 240 mL of water and swallowed by the subjects.

Kindly be informed that the dosing of Effervescent tablets in BE study will be based on the mode of drug administration provided in the Patient Information Leaflet or Prescribing Information of the Reference product you are going to compare with your formulation.

The text given in the Guidance "Wait until the tablet is completely dissolved before administering the solution" is only to emphasis that the effervescent tablet need to get dissolved completely before administration to the subjects.

Don't get confused with the BE waiver given for Oral solution. It is normally recommended to do BE study with Effervescent tablets.