Celecoxib capsules falls under BCS class II.
For Biowaiver application the product must be rapidly dissolving (NLT 85% in 30 mins) in standard media at pH 6.8 - rpm 75 or 100 .
The dossier submitted - dissolution limits provided in Process validation and stability studies from myside is NLT 70 % in 45 mins .
I have carried out dissolution of my product and it is passing in 85% in 30 mins ,Now i wish to apply for biowaiver .Will it be accepted by showing CDP even if PV and stab are done with limits of NLT 75% in 45 mins