Non-mucoadhesive film dosage forms

A non-mucoadhesive orally disintegrating film, able to disintegrate upon contact with saliva in the buccal cavity within about sixty seconds, comprising a defined amount of an active pharmaceutical agent, or a pharmaceutically acceptable salt thereof, 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 is bioequivalent to an immediate release tablet or capsule or orally dissolving/dispersing tablet (ODT) that comprises said active pharmaceutical agent or a pharmaceutically acceptable salt thereof in said defined amount;
• and
• c) said film comprises from about 0.05% to about 50% (w/w) of said active pharmaceutical agent, based on the total weight of the formulation.

A non-mucoadhesive orally disintegrating film, able to disintegrate upon contact with saliva in the buccal cavity within about sixty seconds, comprising a defined amount of an active pharmaceutical agent, or a pharmaceutically acceptable salt thereof, 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 0.05% to about 50% (w/w) of said active pharmaceutical agent, based on the total weight of the formulation;
• and
• c) said film has:
• i) a Tmax greater than about 4.5 hours;
• ii) an absolute bioavailability of greater than about 65%, optionally with a Tmax greater than about 1.5 hours;
• iii) an absolute bioavailability of from about 45% to about 65%, and a Tmax of less than 3.0 hours;
• iv) a Tmax of from 3.0 to 4.5 hours;
• or
• v) a Tmax of less than 1.0 hours.