IP Library Granted Patent US 10,874,626
Granted Patent B2
US 10,874,626 · App. 16/091,614 · Granted Dec 29, 2020

Formulation for use in a method of treatment of pain

Inventors: Varun Khurana (Raritan, NJ); Vivek Yadav (Henderson, NV); Jack Martin Lipman (West Milford, NJ); Tao Zhang (Towaco, NJ); Iouri V. Ilitchev (Hillsborough, NJ); Tushar Hingorani (Bridgewater, NJ); Kumaresh Soppimath (Plainsboro, NJ); Navneet Puri (Lebanon, NJ)
Assignee: Nevakar Inc.
A61K31/195A61K9/0019A61K31/167A61K31/197A61K45/06
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Quick Facts
Patent No.
US 10,874,626
App. No.
16/091,614
Granted
Dec 29, 2020
Kind
B2
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.

Claims (16)

1. A method of treating pain in a subject in need thereof, comprising administering to the subject a pharmaceutical formulation, the pharmaceutical formulation comprising, in a unit dosage form:

a) a therapeutically-effective amount of pregabalin;

b) a therapeutically-effective amount of acetaminophen; and

c) an aqueous carrier,

wherein the pharmaceutical formulation has a pH of about 4 to about 7, wherein the pregabalin is present in the pharmaceutical formulation at a concentration of about 1 mg/mL to about 50 mg/mL, wherein the acetaminophen is present in the pharmaceutical formulation at a concentration of about 10 mg/mL to about 20 mg/mL, and wherein the administration is parenteral administration.

2. The method of claim 1 , wherein the pharmaceutical formulation has a pH of about 5 to about 6.

3. The method of claim 2 , wherein the pharmaceutical formulation has a pH of about 5.5.

4. The method of claim 1 , wherein the parenteral administration is intravenous administration.

5. The method of claim 1 , wherein the acetaminophen is present in the pharmaceutical formulation at a concentration of about 10 mg/mL.

6. The method of claim 1 , wherein the administering is once daily.

7. The method of claim 1 , wherein the administering is more than once per day.

8. The method of claim 1 , wherein the aqueous carrier is water.

9. The method of claim 1 , wherein the pharmaceutical formulation further comprises a buffer.

10. The method of claim 1 , wherein the pharmaceutical formulation further comprises an isotonicity adjusting agent.

11. The method of claim 10 , wherein the isotonicity adjusting agent is sodium chloride.

12. The method of claim 10 , wherein the isotonicity adjusting agent is mannitol.

Assignments (5)
SECURITY INTEREST Recorded May 9, 2023
From: OXFORD FINANCE LLC
To: NOVAQUEST CO-INVESTMENT FUND X, L.P.
Reel/Frame 063588/0122 →
SECURITY INTEREST Recorded Jan 18, 2023
From: NEVAKAR INJECTABLES INC
To: OXFORD FINANCE LLC
Reel/Frame 062405/0329 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 20, 2021
From: NEVAKAR INC.
To: NEVAKAR INJECTABLES INC.
Reel/Frame 057241/0504 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY NAME AND PROPPERTY NUMBER PREVIOUSLY RECORDED AT REEL: 47153 FRAME: 0050. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Oct 28, 2020
From: NEVAKAR LLC
To: NEVAKAR INC.
Reel/Frame 054243/0254 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 18, 2018
From: KHURANA, VARUN; YADAV, VIVEK; LIPMAN, JACK MARTIN; ZHANG, TAO; ILITCHEV, IOURI; HINGORANI, TUSHAR; SOPPIMATH, KUMARESH; PURI, NAVNEET
To: NEVAKAR INC.
Reel/Frame 047950/0799 →