Acetaminophen-Pregabalin Combinations And Methods Of Treating Pain

Abstract

Compositions and methods for an injectable liquid formulation for reducing consumption or need of a postoperative analgesic compound by a patient are presented. The pharmaceutical formulation can contain a non-opioid analgesic and a gabapentinoid, and can be administered prior to surgery to reduce postoperative pain.

What is claimed is: 
     
         1 . A method of treating pain in a subject in need thereof, the method comprising administering to the subject a therapeutically-effective amount of a liquid unit dosage form, wherein the liquid unit dosage form comprises:
 a) a gabapentinoid, wherein the gabapentinoid is pregabalin, or a pharmaceutically acceptable salt thereof;   b) acetaminophen;   c) a pH-adjusting agent; and   d) water;   wherein the liquid unit dosage form has a pH of between 5 and 7;   wherein the gabapentinoid is present in the liquid unit dosage form in an amount from about 0.1 mg/mL to about 50 mg/mL; and   wherein the acetaminophen is present in the liquid unit dosage form in an amount from about 2 mg/mL to about 20 mg/mL.   
     
     
         2 . The method of  claim 1 , wherein the gabapentinoid is the pharmaceutically acceptable salt of pregabalin. 
     
     
         3 . The method of  claim 1 , wherein the liquid unit dosage form further comprises an acid, a conjugate base of the acid, or both the acid and the conjugate base of the acid. 
     
     
         4 . The method of  claim 3 , wherein the acid is citric acid, acetic acid, or phosphoric acid. 
     
     
         5 . The method of  claim 1 , wherein the liquid unit dosage form further comprises an isotonicity inducing agent. 
     
     
         6 . The method of  claim 5 , wherein the isotonicity inducing agent is sodium chloride or mannitol. 
     
     
         7 . The method of  claim 1 , wherein the pH-adjusting agent is sodium hydroxide. 
     
     
         8 . The method of  claim 1 , wherein the pH-adjusting agent is hydrochloric acid. 
     
     
         9 . The method of  claim 1 , wherein the gabapentinoid is present in the liquid unit dosage form in an amount from about 0.1 mg/mL to about 50 mg/mL. 
     
     
         10 . The method of  claim 1 , wherein the acetaminophen in present in the liquid unit dosage form in an amount from about 2 mg/mL to about 20 mg/mL. 
     
     
         11 . The method of  claim 1 , wherein the liquid unit dosage form further comprises a decomposition product of the gabapentinoid at a level of no more than about 5%. 
     
     
         12 . The method of  claim 11 , wherein the decomposition product of the gabapentinoid is 4-(2-methylpropyl)pyrrolidin-2-one. 
     
     
         13 . The method of  claim 1 , wherein the liquid unit dosage form further comprises a decomposition product of the acetaminophen at a level of no more than about 0.5%. 
     
     
         14 . The method of  claim 13 , wherein the decomposition product of the acetaminophen is 4-aminophenol. 
     
     
         15 . The method of  claim 1 , wherein the pH of the liquid unit dosage form is 5. 
     
     
         16 . The method of  claim 1 , wherein the pH of the liquid unit dosage form is about 5.5. 
     
     
         17 . The method of  claim 1 , wherein the pH of the liquid unit dosage form is about 6. 
     
     
         18 . The method of  claim 1 , wherein the pain is postoperative pain. 
     
     
         19 . The method of  claim 1 , wherein the liquid unit dosage form is administered to the subject within 24 hours prior to the subject undergoing a surgical procedure. 
     
     
         20 . The method of  claim 1 , wherein the liquid unit dosage form is administered to the subject simultaneously with the subject undergoing a surgical procedure. 
     
     
         21 . The method of  claim 1 , wherein the liquid unit dosage form is administered to the subject within 24 hours after the subject has undergone a surgical procedure. 
     
     
         22 . The method of  claim 1 , wherein the administration is intravenous administration. 
     
     
         23 . The method of  claim 1 , wherein the administration is intramuscular administration or subcutaneous administration. 
     
     
         24 . The method of  claim 1 , wherein the pharmaceutical composition is administered from a bag, a glass vial, or a prefilled syringe. 
     
     
         25 . The method of  claim 1 , wherein the bag is a polymer bag, and optionally wherein the bag is further packaged in an aluminum over-pouch that optionally contains an oxygen scavenger.