SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
The present invention relates to products and methods for treatment of various symptoms in a patient, including treatment of pain suffered by a patient. The invention more particularly relates to self-supporting dosage forms which provide an active agent while providing sufficient buccal adhesion of the dosage form. Further, the present invention provides a dosage form which is useful in reducing the likelihood of diversion abuse of the active agent.
1 - 65 . (canceled)
66 . A self-supporting film dosage composition comprising:
a. a polymeric carrier matrix;
b. apomorphine or a pharmaceutically acceptable salt thereof as an agonist; and
c. a buffer, wherein the ratio of said buffer to apomorphine or a pharmaceutically acceptable salt thereof is from about 2:1 to about 1:5 by weight, the self-supporting film dosage composition comprising at least a first region and at least a second region;
wherein said polymeric carrier matrix comprises polyethylene oxide, pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, or a combination thereof and
said composition further comprises glycerol, glycerol monoacetate, diacetate or triacetate, triacetin, polysorbate, cetyl alcohol, propylene glycol, sorbitol, sodium diethylsulfosuccinate, triethyl citrate, or tributyl citrate,
wherein the at least first region and the at least second region are arranged in a film dosage, the agonist is contained in at least the first region and the buffer is contained in at least the second region; and said film dosage provides a local pH of between about 5 to about 9; and
wherein said self-supporting film dosage composition disperses in an oral cavity in about 30 minutes or less.
67 . The self-supporting film dosage composition of claim 66 , wherein said composition contains from about 2 to about 16 mg of apomorphine or a pharmaceutically acceptable salt thereof.
68 . The self-supporting film dosage composition of claim 66 , wherein said composition disperses and dissolves in the oral cavity between about 1 minute and about 3 minutes.
69 . The self-supporting film dosage composition of claim 66 , wherein the self-supporting film dosage composition is a self-supporting layered film dosage composition.
70 . The self-supporting film dosage composition of claim 66 , wherein said composition further comprises an FD&C coloring agent.
71 . The self-supporting film dosage composition of claim 66 , wherein said composition further comprises glycerol.
72 . The self-supporting film dosage composition of claim 66 , wherein said composition further comprises a sweetener.
73 . The self-supporting film dosage composition of claim 72 , wherein said sweetener is sucralose.
74 . The self-supporting film dosage composition of claim 66 , wherein said self-supporting film dosage composition has a thickness of from 0.1 to 10 mils.
75 . The self-supporting film dosage composition of claim 66 , wherein the dosage contains regions of differing dissolution rates.
76 . The self-supporting film dosage composition of claim 66 , wherein the composition is a dual region product.
77 . The self-supporting film dosage composition of claim 66 , wherein the buffer includes a first buffering system.
78 . The self-supporting film dosage composition of claim 77 , wherein the self-supporting film dosage composition further includes a second buffering system.