Nefopam dosage forms and methods of treatment

Abstract

Dosage forms containing nefopam, nefopam metabolite, nefopam prodrug, isomers thereof or combinations of the foregoing, optionally an acid, and optionally an opioid analgesic and/or NSAID, and associated methods for treating various types of pain in patients.

1 . A pharmaceutical tablet comprising a homogenous matrix that comprises nefopam, nefopam metabolite, nefopam prodrug, isomer thereof or combinations of the foregoing, a carboxylic acid, and a modified release material. 
     
     
         2 . The tablet of  claim 1  wherein the carboxylic acid is citric acid, fumaric acid, tartaric acid, or a combination thereof. 
     
     
         3 . The tablet of  claim 1  wherein the modified release material comprises a controlled release material selected from the group consisting of alkylcelluloses, acrylic and methacrylic acid polymers and copolymers, cellulose ethers, and combinations thereof. 
     
     
         4 . The tablet of  claim 1  wherein the modified release material comprises an enteric polymer selected from the group consisting of shellac, methacrylic acid copolymers, cellulose acetate phthalate, hydroxypropylmethylcellulose phthalate, hydroxypropylmethylcellulose acetate succinate, cellulose acetate trimellitate, polyvinyl acetate phthalate and combinations thereof. 
     
     
         5 . The tablet of  claim 1  wherein the matrix further comprises an opioid analgesic, NSAID, or combination thereof. 
     
     
         6 . A method of treating pain in a patient comprising administering to the patient the tablet of  claim 1 . 
     
     
         7 . A method of treating pain in a patient comprising administering to the patient the tablet of  claim 5  wherein the dose of opioid analgesic is about 50-70% of the normal dose. 
     
     
         8 . An orally-disintegrating tablet comprising nefopam, nefopam metabolite, nefopam prodrug, isomers thereof or combinations of the foregoing and a carboxylic acid. 
     
     
         9 . The orally-disintegrating tablet of  claim 8  wherein the carboxylic acid is citric acid, fumaric acid, tartaric acid, or a combination thereof. 
     
     
         10 . A method of treating pain in a patient comprising administering the orally-disintegrating tablet of  claim 8 . 
     
     
         11 . The method of  claim 10  wherein the orally-disintegrating tablet is administered sublingually or buccally. 
     
     
         12 . The orally-disintegrating tablet of  claim 8  further comprising an opioid analgesic, NSAID, or combination thereof. 
     
     
         13 . A method of treating pain in a patient comprising administering the orally-disintegrating tablet of  claim 12 . 
     
     
         14 . The method of  claim 13  wherein the orally-disintegrating tablet is administered sublingually or buccally. 
     
     
         15 . The orally-disintegrating tablet of  claim 12  wherein the dose of the opioid analgesic is about 50-70% of the normal dose.