IP Library Granted Patent US 11,850,224
Granted Patent B2
US 11,850,224 · App. 17/405,292 · Granted Dec 26, 2023

Storage stable aqueous injectable solution comprising diclofenac

Inventors: Sushilkumar Dhanaji Patil (Gujarat, IN); Nirav Ishwarlal Khatri (Gujarat, IN); Alex Kochukunju George (Gujarat, IN); Sushrut Krishnaji Kulkarni (Gujarat, IN)
Assignee: RK PHARMA INC.
A61K31/196A61K9/0019A61K9/08A61K45/06A61K47/32
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Quick Facts
Patent No.
US 11,850,224
App. No.
17/405,292
Granted
Dec 26, 2023
Kind
B2
Abstract

The present invention relates to a stable, aqueous, injectable solution comprising diclofenac and polyvinylpyrrolidone. The present invention also relates to processes for preparing the injectable solution.

Claims (2)

1. A stable aqueous solution for parenteral administration, comprising diclofenac sodium in the range of 10 mg/ml-500 mg/ml, polyvinylpyrrolidone in the range of 50 mg/ml-300 mg/ml, polysorbate 80 in the range of 1 mg/ml-100 mg/ml, and monothioglycerol in the range of 1 mg/ml-10 mg/ml, the solution having a pH in the range of 7-10, wherein the solution does not contain impurity A (1-(2,6-dichlorophenyl) indolin-2-one) more than 0.3% by weight of diclofenac, as measured by HPLC, and wherein the solution retains at least 95% of the diclofenac, after 6 months of storage at 40° C. and 75% relative humidity.

2. A method for treatment of pain comprising administering an aqueous solution via parenteral route, having a pH in the range of 7-10, comprising diclofenac sodium in the range of 10 mg/ml-500 mg/ml, polyvinylpyrrolidone in the range of 50 mg/ml-300 mg/ml, polysorbate 80 in the range of 1 mg/ml-100 mg/ml, and monothioglycerol in the range of 1 mg/ml-10 mg/ml, wherein the solution has an osmolality value between about 250 mOsm and about 400 mOsm.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 4, 2026
From: RK PHARMA INC.
To: ADVENTA PHARMA DWC LLC
Reel/Frame 075909/0846 →
SECURITY INTEREST Recorded May 8, 2024
From: RK PHARMA INC.
To: CITIBANK, N.A.
Reel/Frame 067343/0089 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSGINEE NAME PREVIOUSLY RECORDED ON REEL 063661 FRAME 0895. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jun 23, 2023
From: ZYDUS LIFESCIENCES LIMITED
To: RK PHARMA INC.
Reel/Frame 064083/0475 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 16, 2023
From: ZYDUS LIFESCIENCES LIMITED
To: R.K. PHARMA INC.
Reel/Frame 063661/0895 →
CHANGE OF NAME Recorded May 3, 2023
From: CADILA HEALTHCARE LIMITED
To: ZYDUS LIFESCIENCES LIMITED
Reel/Frame 063523/0764 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2021
From: PATIL, SUSHILKUMAR DHANAJI; KHATRI, NIRAV ISHWARLAL; GEORGE, ALEX KOCHUKUNJU; KULKARNI, SUSHRUT KRISHNAJI
To: CADILA HEALTHCARE LIMITED
Reel/Frame 057218/0433 →
Priority Claims (1)
IN 201721010402 · Mar 24, 2017 · national
Continuity (2)
Continuation 15933937 · Mar 23, 2018
Related Publication 20210369659A1 · Dec 2, 2021