Buprenorphine-Wafer for Drug Substitution Therapy

Abstract

The present invention relates to oral pharmaceutical dosage forms comprising buprenorphine with the dosage form releasing buprenorphine instantly upon oral, preferably sublingual, application of the dosage form. The present invention also relates to the use of such dosage forms for treating pain in a human or animal or for drug substitution therapy in drug-dependent human subjects.

What is claimed: 
     
         1 . A method of treating pain in a subject in need thereof, the method comprising contacting an oral mucosal surface of the subject in need thereof with a mucoadhesive film dosage form comprising:
 a) an amount of buprenorphine, or an equivalent amount of a pharmaceutically acceptable salt thereof, sufficient to provide an average buprenorphine C max  of less than 2.5 ng/ml and an average buprenorphine AUC 0-48  of less than 15 (hrs*ng)/ml;   b) at least one non-gelatin polymeric film-forming material selected from the group consisting of carboxymethylcellulose sodium, hydroxyethyl cellulose, hydroxypropylcellulose, and combinations thereof, in which the buprenorphine or the equivalent amount of the pharmaceutically acceptable salt thereof is dissolved or homogeneously dispersed;   
       wherein
 within less than 5 minutes after contacting the subject's oral mucosal surface with the mucoadhesive film dosage form, substantially all of the buprenorphine or the pharmaceutically acceptable salt thereof contacts the mucosal surface of the subject's oral cavity. 
 
     
     
         2 . The method of  claim 1 , wherein mucoadhesive film dosage form further comprises a pH modifier. 
     
     
         3 . The method of  claim 2 , wherein mucoadhesive the pH modifier is selected from the group consisting of citric acid, tartaric acid, phosphoric acid, hydrochloric acid, and maleic acid. 
     
     
         4 . The method of  claim 1 , wherein mucoadhesive the film dosage form further comprises at least one of sodium dihydrogen or disodiumhydrogen phosphate, sodium tartrate, sodium ascorbate, citric acid, tartartic acid, adipinic acid, ascorbic acid, acetic acid, or lactic acid. 
     
     
         5 . The method of  claim 1 , wherein the mucoadhesive film dosage form achieves a buprenorphine tmax from approximately 45 to approximately 90 minutes. 
     
     
         6 . The method of  claim 1 , wherein the mucoadhesive film dosage form is administered once a day, every two days, every three days, or less frequently. 
     
     
         7 . The method of  claim 1 , wherein the mucoadhesive film dosage form further comprises a flavoring agent. 
     
     
         8 . The method of  claim 7 , wherein the flavoring agent is selected from the group consisting of mint, raspberry, licorice, orange, lemon, grapefruit, caramel, vanilla, cherry grape, and combinations thereof.