Two-component pharmaceutical composition for the treatment of pain

Abstract

The present invention is directed to a pharmaceutical composition that includes a combination of about 2-5 milligrams of a non-steroidal anti-inflammatory drug and from about 2-30 milligrams of an opioid analgesic in a single pharmaceutical dosage unit that can provide effective pain management with the added benefit of reduced side effects such as withdrawal and gastrointestinal disorders. The non-steroidal anti-inflammatory drug may be piroxicam and the opioid analgesic may be buprenorphine. The present invention also provides for a method of managing pain in a patient that includes administering the pharmaceutical composition previously described. The pharmaceutical composition previously described may be administered in a single or multiple dosage regimen.

1 . A pharmaceutical dosage unit comprising about 2-5 milligrams of a non-steroidal anti-inflammatory drug and about 2-30 milligrams of an opioid analgesic.  
   
   
       2 . The pharmaceutical dosage unit of  claim 1 , wherein the non-steroidal anti-inflammatory drug is present in an amount of about 2-3 milligrams.  
   
   
       3 . The pharmaceutical dosage unit of  claim 1 , wherein the non-steroidal anti-inflammatory drug is present in an amount of about 2 milligrams.  
   
   
       4 . The pharmaceutical dosage unit of  claim 1 , wherein the non-steroidal anti-inflammatory drug is piroxicam.  
   
   
       5 . The pharmaceutical dosage unit of  claim 1 , wherein the opioid analgesic is present in an amount of about 2-15 milligrams.  
   
   
       6 . The pharmaceutical dosage unit of  claim 1 , wherein the opioid analgesic is present in an amount of about 2 milligrams.  
   
   
       7 . The pharmaceutical dosage unit of  claim 1 , wherein the opioid analgesic is buprenorphine.  
   
   
       8 . The pharmaceutical dosage unit of  claim 1 , wherein the pharmaceutical dosage unit is delivered by sublingual, mucosal, parenteral, intravenous, intramuscular, transdermal administration and combinations thereof.  
   
   
       9 . The pharmaceutical dosage unit of  claim 1 , wherein the dosage unit manages pain with reduced side effects.  
   
   
       10 . The pharmaceutical dosage unit of  claim 9 , wherein the side effect is gastrointestinal ulceration, abdominal pain, cramping, nausea, gastritis, kidney disease, angiodema, pancreatitis, gastrointestinal bleeding, liver toxicity, or combinations thereof.  
   
   
       11 . The pharmaceutical dosage unit of  claim 9 , wherein the side effect is opioid withdrawal.  
   
   
       12 . A pharmaceutical combination dosage unit comprising a low effective amount of piroxicam and a high effective amount of buprenorphine for management of pain with reduced side effects.  
   
   
       13 . The pharmaceutical combination dosage unit of  claim 12 , wherein the side effect is gastrointestinal ulceration, abdominal pain, cramping, nausea, gastritis, kidney disease, angiodema, pancreatitis, gastrointestinal bleeding, liver toxicity, or combinations thereof.  
   
   
       14 . The pharmaceutical combination dosage unit of  claim 12 , wherein the pharmaceutical combination dosage unit is delivered by sublingual, mucosal, parenteral, intravenous, intramuscular, transdermal administration and combinations thereof.  
   
   
       15 . A method of treating pain in a patient comprising administering, in a single or multiple dosage regimen, a pharmaceutical dosage unit, the dosage unit including about 2-5 milligrams of piroxicam in combination with about 2-30 milligrams of buprenorphine.  
   
   
       16 . The method of  claim 15 , piroxicam is present in an amount of about 2-3 milligrams and buprenorphine is present in an amount of about 2-15 milligrams.  
   
   
       17 . The method of  claim 15 , wherein piroxicam is present in an amount of about 2.5 milligrams and buprenorphine is present in an amount of about 2 milligrams.  
   
   
       18 . The method of  claim 15 , wherein the pharmaceutical dosage unit is delivered by sublingual, mucosal, parenteral, intravenous, intramuscular, transdermal administration and combinations thereof.  
   
   
       19 . The method of  claim 15 , wherein the pharmaceutical dosage unit manages pain with reduced side effects.  
   
   
       20 . The method of  claim 19 , wherein the side effect is gastrointestinal ulceration, abdominal pain, cramping, nausea, gastritis, kidney disease, angiodema, pancreatitis, gastrointestinal bleeding, liver toxicity, or combinations thereof.