Infusion dosage form of norepinephrine
AssigneeSun Pharmaceutical Industries Limited
InventorsSamarth Kumar, Maheshkumar Parasmal Soni, Praveen Kumar Srivastava, Prashant Kane, Subhas Balaram Bhowmick
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Abstract
The present invention provides a ready to use stable aqueous dosage form of norepinephrine comprising an aqueous solution of norepinephrine or its pharmaceutically acceptable salt, one or more sulfite antioxidants and an ion chelator. The present invention also provides an infusion container filled with an aqueous solution of norepinephrine or its pharmaceutically acceptable salt, wherein the said solution is stable for a prolonged period of time and can be terminally sterilized by autoclaving.
Claims34
An aqueous ready to infuse stable parenteral dosage form consisting essentially of:
- a. norepinephrine or its pharmaceutically acceptable salt at a concentration ranging from 10 to 75 micrograms/ml of norepinephrine base;
- b. at least one sulfite antioxidant;
- and
- c. at least one ion chelator,
- wherein, after subjected to terminal sterilization by autoclaving and stored at 40° C. and 25% relative humidity for 6 months, contains no more than 0.2% by weight of each of 1,2,3,4-tetrahydroisoquinoline-4,6,7-triol, 1,2,3,4-tetrahydroisoquinoline-4,7,8-triol, and 3,4-dihydroxybenzaldehyde.
A method for controlling blood pressure in an acute hypotensive state, the method comprising administering an aqueous ready to infuse stable parenteral dosage form to a patient in need thereof, the ready to infuse dosage form consisting essentially of:
- a. norepinephrine or its pharmaceutically acceptable salt at a concentration ranging from 10 to 75 micrograms/ml of norepinephrine base;
- b. at least one sulfite antioxidant;
- and
- c. at least one ion chelator,
- wherein, after subjected to terminal sterilization by autoclaving and stored at 40° C. and 25% relative humidity for 6 months, contains no more than 0.2% by weight of each of 1,2,3,4-tetrahydroisoquinoline-4,6,7-triol, 1,2,3,4-tetrahydroisoquinoline-4,7,8-triol, and 3,4-dihydroxybenzaldehyde.
An infusion bag for parenteral administration of an aqueous solution consisting of:
- (A) an aqueous ready to infuse parenteral solution consisting essentially of:
- i. 10-75 micrograms/mL norepinephrine or its pharmaceutically acceptable salt;
- ii. 9000 micrograms/mL sodium chloride;
- iii. 3.2 micrograms/mL sodium metabisulfite;
- iv. 16 micrograms/mL disodium edetate;
- v. 0.1 micrograms/mL butylated hydroxyanisole;
- and
- vi. optionally, sodium hydroxide or hydrochloric acid;
- and
- (B) an inert gas which has displaced air in the infusion bag.
Dependencies are inferred from the claim text.