US 11,931,362 B2
Stable pharmaceutical formulations of pemetrexed
Sarabjit Singh, Navi Mumbai (IN); Alagumurugan Alagarswamy, Thane (IN); Madhusudhan Malladi, Hyderabad (IN); and Sandip Gite, Ahmednagar (IN)
Assigned to Cipla Limited, Mumbai (IN)
Filed by CIPLA LIMITED, Mumbai (IN)
Filed on Mar. 3, 2021, as Appl. No. 17/190,793.
Application 17/190,793 is a continuation of application No. 16/689,813, filed on Nov. 20, 2019, granted, now 10,966,982.
Prior Publication US 2021/0196721 A1, Jul. 1, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/519 (2006.01); A61K 33/243 (2019.01); A61K 39/395 (2006.01); A61K 47/20 (2006.01)
CPC A61K 31/519 (2013.01) [A61K 33/243 (2019.01); A61K 39/39558 (2013.01); A61K 47/20 (2013.01)] 23 Claims
 
1. A long term storage multi-dose ready-to-dilute or ready-to-use pharmaceutical liquid formulation comprising: a) pemetrexed or a pharmaceutically acceptable salt thereof, b) an antioxidant; c) a preservative; d) a buffering agent, which is present in an amount in the range of about 0.5 mg/mL to 30 mg/mL; and e) a pharmaceutically acceptable fluid, wherein the formulation when stored for six months in a sealed, sterile vial at 25° C./60% RH and 40° C./75% RH contains no more than 1.0% total impurity as measured by HPLC, wherein the antioxidant is selected from the group consisting of: monothioglycerol, L-cysteine and thioglycolic acid, acetyl cysteine, butylated hydroxy toluene, butylated hydroxy anisole, DL-tocopherol, sodium metabisulfite, sodium formaldehyde sulfoxylate, EDTA and its derivatives, ascorbic acid, citric acid and its pharmaceutically acceptable salts, sodium sulfite and its derivative, and combinations thereof.