BE of Effervescent Tablets [Study Performance]
Dear Dr. Ohlbe and Dr.S.Gunasakaran,
Thanks for your reply. if we read the dosage and administration of Ranitidine Effervescent Tablets, it states - Preparation of ZANTAC 25 EFFERdose Tablets: 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 to the infant/child. The solution may be administered to infants by medicine dropper or oral syringe.
If we take the example of only ranitidine, we know that Ranitidine is soluble in water and we will get drug solution before we administered the dosage.
Still I am not convince for BE study of Ranitidine Effevescent Tablets.
when posology of formulation states that "can be swallowed as such" (e.g. Prednisolon Soluble tablets 5 mg- EU SPC) then I agree that we need to perform BE study on worst case situation. Please comment on the same also. (whether my assumption is correct???).
Thanks for your reply. if we read the dosage and administration of Ranitidine Effervescent Tablets, it states - Preparation of ZANTAC 25 EFFERdose Tablets: 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 to the infant/child. The solution may be administered to infants by medicine dropper or oral syringe.
If we take the example of only ranitidine, we know that Ranitidine is soluble in water and we will get drug solution before we administered the dosage.
Still I am not convince for BE study of Ranitidine Effevescent Tablets.
when posology of formulation states that "can be swallowed as such" (e.g. Prednisolon Soluble tablets 5 mg- EU SPC) then I agree that we need to perform BE study on worst case situation. Please comment on the same also. (whether my assumption is correct???).
Complete thread:
- BE of Effervescent Tablets joyjac 2012-01-12 09:45
- BE of Effervescent Tablets MGR 2012-01-12 12:14
- Check absorption! Helmut 2012-01-13 17:11
- BE of Effervescent Tablets shyam_5p 2012-01-31 06:55
- BE of Effervescent Tablets Ohlbe 2012-01-31 17:55
- BE of Effervescent Tablets shyam_5p 2012-02-01 04:01
- BE of Effervescent Tablets drgunasakaran1 2012-01-31 18:01
- BE of Effervescent Tabletsshyam_5p 2012-02-08 11:24
- BE of Effervescent Tablets Ohlbe 2012-01-31 17:55
- BE of Effervescent Tablets MGR 2012-01-12 12:14