Formulation for use in a method of treatment of pain

Abstract

Formulations, methods of manufacturing, methods of stabilizing, kits, and uses as medicament are provided, for example for the treatment of pain. The formulations can comprise gabapentin optionally combined with at least one non-opioid pain drug in an aqueous carrier. The pharmaceutical formulation can have a pH of about 2.0 to about 10.0. The at least one non-opioid pain drug can be acetaminophen. The components can be included in any amount suitable for purposes of obtaining properties desirable for an injectable infusion, for example an intravenous infusion.

1 - 32 . (canceled) 
     
     
         33 . A pharmaceutical composition comprising, in a unit dosage form, an analogue of gamma-aminobutyric acid and an aqueous carrier, wherein the pharmaceutical composition exhibits no more than about 6% degradation of the analogue of gamma-aminobutyric acid after sterilization of the pharmaceutical composition, as determined by HPLC assay. 
     
     
         34 . The pharmaceutical composition of  claim 33 , wherein the sterilization comprises filtration. 
     
     
         35 . The pharmaceutical composition of  claim 33 , wherein the analogue of gamma-aminobutyric acid is pregabalin. 
     
     
         36 . The pharmaceutical composition of  claim 33 , further comprising a non-opioid pain drug. 
     
     
         37 . The pharmaceutical composition of  claim 36 , wherein the non-opioid pain drug is acetaminophen. 
     
     
         38 . The pharmaceutical formulation of  claim 37 , wherein the analogue of gamma-aminobutyric acid is present in the pharmaceutical formulation at a concentration of about 1 to about 200 mg/mL and the acetaminophen is present in the pharmaceutical formulation at a concentration of about 1 to about 400 mg/mL. 
     
     
         39 . The pharmaceutical composition of  claim 33 , wherein the pharmaceutical composition has a pH of about 4 to about 8. 
     
     
         40 . The pharmaceutical composition of  claim 33 , wherein the pharmaceutical composition has a pH of about 5.5. 
     
     
         41 . The pharmaceutical composition of  claim 33 , wherein the unit dosage form is a liquid unit dosage form. 
     
     
         42 . The pharmaceutical composition of  claim 33 , wherein the aqueous carrier is water. 
     
     
         43 . The pharmaceutical composition of  claim 33 , wherein the pharmaceutical composition further comprises a buffer. 
     
     
         44 . The pharmaceutical composition of  claim 33 , wherein the pharmaceutical composition further comprises an isotonicity adjusting agent. 
     
     
         45 . The pharmaceutical composition of  claim 44 , wherein the isotonicity adjusting agent is sodium chloride. 
     
     
         46 . The pharmaceutical composition of  claim 44 , wherein the isotonicity adjusting agent is mannitol. 
     
     
         47 . The pharmaceutical composition of  claim 33 , wherein the pharmaceutical composition exhibits no more than about 5% of a lactam impurity after the sterilization as determined by HPLC assay, wherein the lactam impurity is derived from the analogue of gamma-butyric acid.