Formulations for treating pain
View Patent ↗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. An injectable pharmaceutical formulation comprising: gabapentin and acetaminophen; in an aqueous carrier, wherein the pharmaceutical formulation has a pH of about 5 to about 6.
2. The pharmaceutical formulation of claim 1 , further comprising a buffer, or a tonicity inducing agent.
3. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation has a pH of about 5.5.
4. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation is formulated for packaging in a bag.
5. The pharmaceutical formulation of claim 4 , wherein the bag is a polymer bag, and the polymer bag is further packaged in an aluminum over-pouch.
6. The pharmaceutical formulation of claim 5 , wherein the aluminum over-pouch comprises an oxygen scavenger.
7. The pharmaceutical formulation of claim 4 , wherein the bag contains from about 15 mg to about 4000 mg of gabapentin.
8. The pharmaceutical formulation of claim 4 , wherein the bag contains about 100 mg to about 4000 mg of acetaminophen.
9. The pharmaceutical formulation of claim 1 , wherein a concentration of the gabapentin in the pharmaceutical formulation is less than about 99% (w/v) and wherein a concentration of acetaminophen in the pharmaceutical formulation is less than about 99% (w/v).
10. The pharmaceutical formulation of claim 1 , wherein a concentration of the gabapentin in the pharmaceutical formulation is about 1 to 50 mg/mL and a concentration of acetaminophen in the pharmaceutical formulation is about 1 to 50 mg/mL.
11. The pharmaceutical formulation of claim 1 , wherein the aqueous carrier is selected from the group consisting of water, saline, an aqueous mannitol formulation, lactated Ringer's solution, and Ringer's acetate solution.
12. The pharmaceutical formulation of claim 1 , wherein gabapentin is present in the pharmaceutical formulation at a concentration of about 1 mg/mL to about 8 mg/mL.
13. The pharmaceutical formulation of claim 1 , wherein acetaminophen is present in the pharmaceutical formulation at a concentration of about 10 mg/mL.
14. The pharmaceutical formulation of claim 1 , wherein the concentration of the gabapentin in the pharmaceutical formulation is about 1 to 200 mg/mL and the concentration of acetaminophen in the pharmaceutical formulation is about 1 to 400 mg/mL.
15. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation further comprises a pH stabilizer, wherein gabapentin is present in the pharmaceutical formulation at a concentration of about 8 mg/mL, and acetaminophen is present in the pharmaceutical formulation at a concentration of about 10 mg/mL, wherein the pharmaceutical formulation has a pH of about 5.5.
16. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation does not comprise an antioxidant.
17. The pharmaceutical composition of claim 1 , wherein the pharmaceutical formulation exhibits no more than about 0.5% of a lactam impurity after storage at about 25° C. for about one month.