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US 10,869,867 B2Granted
Intravenous infusion dosage form
AssigneeSun Pharmaceutical Industries Limited
InventorsSamarth Kumar, Prashant Kane, Subhas Balaram Bhowmick, Kirti Ganorkar, Nisarg Bipinchandra Mistry, Ramaji Karshanbhai Varu
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Abstract
The present invention relates to an intravenous infusion dosage form of pemetrexed or its pharmaceutically acceptable salt, having long term stability.
Claims9
An intravenous infusion dosage form comprising
- a) a composition consisting essentially of pemetrexed or its pharmaceutically acceptable salt present at a concentration ranging from about 0.7 mg/ml to about 21 mg/ml, an osmogent and an inert gas in solution in a parenteral aqueous vehicle, the solution having a volume ranging from about 50 ml to 1000 ml,
- b) a flexible infusion container containing the composition of (a) and an inert gas in a headspace of the infusion container,
- c) a second container surrounding the flexible infusion container with an inert gas or vacuum in the space between the flexible infusion container and the second container,
- wherein the total impurities are less than 2.0% by weight.
1 more element
An intravenous infusion dosage form comprising:
- a) a composition consisting essentially of pemetrexed or its pharmaceutically acceptable salt present at a concentration ranging from about 0.7 mg/ml to about 21 mg/ml, an osmogent and an inert gas in solution in a parenteral aqueous vehicle, the solution having a volume ranging from about 50 ml to 1000 ml,
- b) a rigid infusion container containing the composition of (a) and an inert gas in a headspace of the infusion container,
- wherein the dosage form is subjected to moist heat sterilization and wherein the total impurities are less than 2.0% by weight.
Dependencies are inferred from the claim text.