US 12,257,219 B2
Storage stable aqueous parenteral solutions comprising diclofenac
Kannan Essakimuthu Muthaiyyan, Gujarat (IN); Debjani Manoj Singh, Gujarat (IN); Nirav Ishwarlal Khatri, Gujarat (IN); Sushrut Krishnaji Kulkarni, Maharashtra (IN); Alex Kochukunju George, Gujarat (IN); Sushilkumar Dhanaji Patil, Kolhapur (IN); and Jay Shantilal Kothari, Pennington, NJ (US)
Assigned to RK PHARMA INC., Pearl River, NY (US)
Filed by RK PHARMA INC., Pearl River, NJ (US)
Filed on Jun. 2, 2023, as Appl. No. 18/328,397.
Application 18/328,397 is a continuation of application No. 17/032,395, filed on Sep. 25, 2020, granted, now 11,707,443.
Claims priority of application No. 201921038953 (IN), filed on Sep. 26, 2019.
Prior Publication US 2023/0301952 A1, Sep. 28, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/196 (2006.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61K 47/26 (2006.01); A61K 47/32 (2006.01); A61M 5/20 (2006.01)
CPC A61K 31/196 (2013.01) [A61K 9/0019 (2013.01); A61K 47/02 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01); A61M 5/20 (2013.01)] 9 Claims
 
1. A method for the treatment of pain, the method comprising administering to a mammal, in need thereof, a solution, via subcutaneous route, comprising diclofenac composition, wherein the diclofenac sodium is present in a therapeutically effective concentration of between about 37.5 mg/mL and about 75 mg/mL, having pharmacokinetic parameters—
i. maximum diclofenac plasma concentration Cmax value not more than 9000 ng/ml,
ii. time to reach the maximum concentration Tmax of 5 minutes and
iii. area under the curve AUClast value not more than 3000 ng*h/mL,
wherein the diclofenac composition comprises polyvinylpyrrolidone, one or more pH adjusting agents, and water.