Bioequivalence and Bioavailability Forum

Dear MGR,

You can refer section III C: Bioavailability/Bioequivalence Recommendations on below mentioned link.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240243.pdf

Sprinkle study over soft food is reccomended by FDA in case of multiple unit dosage forms (beads / granules / pellets). In case of capsule containing beads / granules / pellets, capsule content is sprinked over soft food (apple sauce)and then to be dosed to each volunteer. For detailed study descrption, you can also refer Clinical Pharmacology and Biopharmaceutics review of Namenda XR capsules 28 mg (drugs@fda) in which sprinkle study were carried out by innovator.

I think Doxycycline DR tablet is also a MUPS stretegy and it might be disintegrate when sprinked over apple sauce.

I hope this might be of some use.


Regards,
Samaya.

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.