Loxapine film oral dosage form

A loxapine film oral dosage form, comprising:

• loxapine salt, free base, or prodrug in an amount that is effective to provide relief from acute agitation associated with schizophrenia or bipolar 1 disorder via transmucosal delivery route;
• a pH stabilizer added in an amount of from 0.5% to 10% of the weight of the film oral dosage form, which amount of pH stabilizer is sufficient to maintain a neutral pH of from 6 to 8 to enhance absorption of the loxapine salt, free base or prodrug through oral mucosa;
• a penetration enhancer in an amount effective to promote absorption of loxapine via oral mucosa;
• and
• the loxapine salt, free base, or prodrug dispersed in a polymeric film forming system including at least one film forming polymer, the film forming system formulated to reside in the buccal cavity or sublingual region of a subject being administered the loxapine film oral dosage form for a period of from 10 minutes to one hour, wherein the film forming system includes polyvinylpyrrolidone in an amount of 5% to 50% of the weight of the film oral dosage form, which amount of polyvinylpyrrolidone is sufficient to concurrently maintain neutral pH of from 6 to 8 during absorption of the loxapine salt, free base or prodrug through oral mucosa while maintaining the loxapine salt, free base or prodrug in a highly dissolved form to promote rapid transmucosal absorption and rapid onset of a therapeutic effect.