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.