Sublingual and buccal film compositions

Abstract

The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.

What is claimed is: 
     
         1 . A method for treating an opioid narcotic dependence in a patient in need thereof comprising sublingually or buccally administering to the patient a mucoadhesive polymeric film that comprises from about 2-16 mg buprenorphine, and that produces a Cmax of buprenorphine between about 0.624 ng/ml and about 5.638 ng/ml and an AUC of buprenorphine from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml in the patient, to treat the opioid narcotic dependence. 
     
     
         2 . The method of  claim 1 , wherein the mucoadhesive polymeric film further comprises naloxone and produces a Cmax of naloxone from about 41.04 pg/ml to about 323.75 pg/ml and an AUC of naloxone from about 102.88 hr/ng/ml to about 812.00 hr*ng/ml in the patient. 
     
     
         3 . A method for treating an opioid narcotic dependence in a patient in need thereof comprising sublingually or buccally administering to the patient a mucoadhesive film that produces a Cmax of buprenorphine between about 0.624 ng/ml and about 5.638 ng/ml and an AUC of buprenorphine from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml in the patient to treat the opioid narcotic dependence; wherein the film comprises a polymeric carrier matrix, about 2-16 mg of buprenorphine or a pharmaceutically acceptable salt thereof, naloxone or a pharmaceutically acceptable salt thereof, and a buffer; and wherein the ratio of buprenorphine to naloxone is about 6:1 to 2:1. 
     
     
         4 . The method of  claim 3 , wherein the buffer provides a local pH from about 2-4 in the presence of saliva. 
     
     
         5 . The method of  claim 3 , wherein the buffer provides a local pH from 5.5-6.5 in the presence of saliva. 
     
     
         6 . The method of  claim 3  to produce a Cmax of naloxone between about 41.04 pg/ml and about 323.75 pg/ml in the patient. 
     
     
         7 . The method of  claim 3 , wherein the buffer comprises sodium citrate, citric acid, or a combination thereof. 
     
     
         8 . The method of  claim 3 , wherein the buffer comprises acetic acid, sodium acetate, or a combination thereof. 
     
     
         9 . A film formulation comprising a mucoadhesive polymeric carrier matrix; about 2-16 mg of buprenorphine or a pharmaceutically acceptable salt thereof; naloxone or a pharmaceutically acceptable salt thereof; and a buffer to provide a local pH from about 2-4 or about 5.5-6.5 in the presence of saliva; and wherein the ratio of buprenorphine to naloxone is about 6:1 to 2:1. 
     
     
         10 . The film formulation of  claim 9 , wherein the local pH is from about 2-4. 
     
     
         11 . The film formulation of  claim 9 , wherein the local pH is from about 5.5-6.5. 
     
     
         12 . The film formulation of  claim 9 , wherein the mucoadhesive polymeric carrier matrix comprises polyethylene oxide having a molecular weight from about 100,000 to about 900,000.