US 12,403,070 B2
Intravenous infusion dosage form
Samarth Kumar, Baroda (IN); Prashant Kane, Baroda (IN); Subhas Balaram Bhowmick, Baroda (IN); Kirti Ganorkar, Maharashtra (IN); Nisarg Bipinchandra Mistry, Baroda (IN); and Ramaji Karshanbhai Varu, Baroda (IN)
Assigned to SUN PHARMACEUTICAL INDUSTRIES LIMITED, Mumbai (IN)
Filed by Sun Pharmaceutical Industries Limited, Mumbai (IN)
Filed on Nov. 19, 2020, as Appl. No. 16/952,565.
Application 16/952,565 is a continuation of application No. 15/550,638, granted, now 10,869,867, previously published as PCT/IN2016/050056, filed on Feb. 12, 2016.
Claims priority of application No. 473/MUM/2015 (IN), filed on Feb. 13, 2015.
Prior Publication US 2021/0128562 A1, May 6, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61J 1/10 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 31/519 (2006.01); A61K 41/10 (2020.01); A61K 47/02 (2006.01); B65B 3/00 (2006.01); B65B 7/02 (2006.01); B65B 55/06 (2006.01); A61M 5/14 (2006.01)
CPC A61J 1/10 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 31/519 (2013.01); A61K 41/10 (2020.01); A61K 47/02 (2013.01); B65B 3/003 (2013.01); B65B 7/02 (2013.01); B65B 55/06 (2013.01); A61M 5/14 (2013.01)] 16 Claims
OG exemplary drawing
 
1. An intravenous infusion dosage form comprising:
a) an aqueous composition comprising about 0.7 mg/ml to about 21 mg/ml of pemetrexed or its pharmaceutically acceptable salt, and an osmogent; and
b) a flexible infusion container containing the aqueous composition in a volume ranging from about 50 ml to about 1000 ml:
wherein the dosage form has less than 0.5% by weight of individual impurity B or impurity C after storage at 15-30° C. for at least 12 months, and
the aqueous composition is free of antioxidants.