NON-MUCOADHESIVE FILM DOSAGE FORMS

摘要

Orally disintegrating film dosage forms for delivering active pharmaceutical agents, methods of formulating the dosage forms to retard absorption through the oral mucosa, and methods of using the dosage forms for the treatment of various medical conditions are provided.

主权项

1) A non-mucoadhesive orally disintegrating film, able to disintegrate upon contact with saliva in the buccal cavity within about sixty seconds, comprising donepezil or a pharmaceutically acceptable salt thereof in combination with a hydrophilic binder and a water-soluble diluent, wherein:
a) said film is characterized predominantly by gastrointestinal absorption when placed on the tongue, allowed to disintegrate, and subsequently swallowed; b) said film comprises from about 2.5 to about 20 mg of donepezil or a pharmaceutically acceptable salt thereof; c) said donepezil hydrochloride is present in an amount of from about 0.05% to about 50% (w/w), based on the total weight of the film, d) said film has a Tmax of from about 3 to about 4 hours, and e) said donepezil or pharmaceutically acceptable salt thereof has an absolute bioavailability in said film of about 100%.