	US 11,850,224 B2
	Storage stable aqueous injectable solution comprising diclofenac
Sushilkumar Dhanaji Patil, Gujarat (IN); Nirav Ishwarlal Khatri, Gujarat (IN); Alex Kochukunju George, Gujarat (IN); and Sushrut Krishnaji Kulkarni, Gujarat (IN)
Assigned to RK PHARMA INC., Pearl River, NY (US)
Filed by R K PHARMA INC, Pearl River, NY (US)
Filed on Aug. 18, 2021, as Appl. No. 17/405,292.
Application 17/405,292 is a continuation of application No. 15/933,937, filed on Mar. 23, 2018, granted, now 11,110,073.
Claims priority of application No. 201721010402 (IN), filed on Mar. 24, 2017.
Prior Publication US 2021/0369659 A1, Dec. 2, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/196 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61K 47/32 (2006.01); A61K 9/08 (2006.01)

CPC A61K 31/196 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 45/06 (2013.01); A61K 47/32 (2013.01)]

2 Claims

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.