Bioequivalence and Bioavailability Forum

Dear Mr MGR,

❝ Can we do a sprinkle study for a DR tablet, USFDA submission? If so could you please provide the guidelines link or so?

Yes. You need to conduct Sprinkle fasting study with Doxycycline Delayed release tablets for FDA submission.

The RLD for Doxycycline Delayed release tablets is Doryx of Mayne Pharma. As per the prescribing information of Doryx, DORYX (Doxycycline Hyclate Delayed-Release Tablets, USP), for oral administration, contain specially coated pellets of doxycycline hyclate.
DORYX Tablets may also be administered by carefully breaking up the tablet and sprinkling the tablet contents (delayed-release pellets) on a spoonful of applesauce.
Hence, you need to break the tablets and sprinkle the tablet contents (delayed-release pellets) on a spoonful of applesauce in the Sprinkle Fasting BE study.