Pharmaceutical composition, comprising polmacoxib and pregabalin, for treatment of pain

Abstract

The present invention relates to a composition comprising polmacoxib and pregabalin. The present invention relates to a pharmaceutical composition and a drug or pain reliever, which each comprise the two active ingredients of polmacoxib and pregabalin and, more particularly, to a drug or pain reliever for treatment of moderately severe, acute, chronic, or neuropathic pain attributed to inflammation and various factors, an effect thereof, and a use thereof.

What is claimed is: 
     
         1 . A method of treating pain, comprising administering a combination of polmacoxib and pregabalin to a subject, wherein the weight ratio of polmacoxib to pregabalin is from 1:1 to 1:300. 
     
     
         2 . The method of  claim 1 , the weight ratio of polmacoxib to pregabalin is from 1:1 to 1:150. 
     
     
         3 . The method of  claim 1 , wherein the pain comprises acute or chronic pain caused by inflammation or neuropathy. 
     
     
         4 . The method of  claim 1 , wherein the pain comprises neurogenic pain, diabetic neuropathy, pain caused by generalized anxiety disorder, fibromyalgia, hyperalgesia, allodynia, cancer pain, osteoarthritis, rheumatoid arthritis, spondylitis, frozen shoulder, lumbodynia, or sciatica. 
     
     
         5 . The method of  claim 1 , wherein each of polmacoxib and pregabalin is a separate pharmaceutical formulation. 
     
     
         6 . The method of  claim 5 , wherein the pharmaceutical formulation of pregabalin comprises 75 mg to 300 mg pregabalin. 
     
     
         7 . The method of  claim 6 , wherein the pharmaceutical formulation of pregabalin comprises 75 mg to 150 mg pregabalin. 
     
     
         8 . The method of  claim 5 , wherein the pharmaceutical formulation of polmacoxib comprises 1 mg to 5 mg polmacoxib. 
     
     
         9 . The method of  claim 8 , wherein the pharmaceutical formulation of polmacoxib comprises 1 mg to 2 mg polmacoxib. 
     
     
         10 . The method of  claim 1 , wherein polmacoxib and pregabalin are in a single pharmaceutical formulation. 
     
     
         11 . The method of  claim 10 , wherein the single pharmaceutical formulation comprises 0.1% to 10% by weight of polmacoxib and 10% to 50% by weight of pregabalin based on the total weight of the pharmaceutical formulation. 
     
     
         12 . The method of  claim 10 , wherein the single pharmaceutical formulation comprises 75 mg to 300 mg pregabalin. 
     
     
         13 . The method of  claim 12 , wherein the single pharmaceutical formulation comprises 75 mg to 150 mg pregabalin. 
     
     
         14 . The method of  claim 10 , wherein the single pharmaceutical formulation comprises 1 mg to 5 mg polmacoxib. 
     
     
         15 . The method of  claim 14 , wherein the single pharmaceutical formulation comprises 1 mg to 2 mg polmacoxib. 
     
     
         16 . The method of  claim 10 , wherein the single pharmaceutical formulation is in the form of a double-layered tablet having a bi-layered structure, or a multi-layered tablet having a multi-layered structure, in which polmacoxib, pregabalin or a mixture thereof is separated into each individual layer. 
     
     
         17 . The method of  claim 16 , wherein the bi-layered or the multi-layered tablet comprises at least a sustained release layer and an immediate release layer. 
     
     
         18 . The method of  claim 17 , wherein the sustained release layer comprises pregabalin and the immediate release layer comprises polmacoxib. 
     
     
         19 . The method of  claim 17 , wherein pregabalin is in a sustained release layer, or pregabalin is in both an immediate release layer and a sustained release layer. 
     
     
         20 . The method of  claim 10 , wherein the composition further comprises a pharmaceutically acceptable coating base and/or a pharmaceutically acceptable carrier or excipient.