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US 2026/0272855 A1Published application
Norepinephrine compositions and methods therefor
AssigneeNevakar Injectables Inc.
InventorsHarshil H. Jain, Tushar Hingorani, Kumaresh Soppimath
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Abstract
The inventive subject matter is directed to compositions and methods for ready-to-inject norepinephrine compositions with improved stability. Most preferably, compositions presented herein are substantially antioxidant free and exhibit less than 10% isomerization of R-norepinephrine and exhibit less than 5% degradation of total norepinephrine.
Claims21
A sterile, ready-to-inject norepinephrine composition, comprising:
- an aqueous acidic solution comprising norepinephrine base at a concentration of between about 16 mcg/mL and about 64 mcg/mL, sodium chloride and tartrate bicarboxylic acid;
- wherein the ready-to-inject norepinephrine composition has a pH of between above 3.6 to about 4.0;
- wherein the ready-to-inject norepinephrine composition is substantially free of antioxidants;
- wherein the ready-to-inject norepinephrine composition is stored in a polymer bag that is packaged in a removable overwrap with an oxygen scavenger disposed between the polymer bag and the overwrap, and is administrable to a patient from the polymer bag;
- and
- wherein the ready-to-inject norepinephrine composition comprises at least about 90% R-isomer of norepinephrine as determined by HPLC and remains a clear, colorless solution when stored over at least three months at about 25° C.
3 more elements
A sterile, ready-to-inject norepinephrine composition, comprising:
- an aqueous acidic solution comprising norepinephrine base at a concentration of between about 16 mcg/mL and about 64 mcg/mL, dextrose and tartrate bicarboxylic acid;
- wherein the ready-to-inject norepinephrine composition has a pH of between above 3.6 to about 4.0;
- wherein the ready-to-inject norepinephrine composition is substantially free of antioxidants;
- wherein the ready-to-inject norepinephrine composition is stored in a polymer bag that is packaged in a removable overwrap with an oxygen scavenger disposed between the polymer bag and the overwrap, and is administrable to a patient from the polymer bag;
- and
- wherein the ready-to-inject norepinephrine composition comprises at least about 90% R-isomer of norepinephrine as determined by HPLC when stored over at least three months at about 25° C.
3 more elements
A sterile, ready-to-inject norepinephrine composition, comprising:
- about 250 mL of an aqueous acidic solution comprising norepinephrine base at a concentration of between about 16 mcg/mL and about 64 mcg/mL, tartrate bicarboxylic acid and a tonicity adjusting agent;
- wherein the ready-to-inject norepinephrine composition has a pH of between above 3.6 to about 4.0;
- wherein the ready-to-inject norepinephrine composition is substantially free of antioxidants;
- wherein the ready-to-inject norepinephrine composition has a dissolved oxygen concentration of equal or less than 1 ppm;
- wherein the ready-to-inject norepinephrine composition is stored in a polymer bag that is packaged in a removable, aluminum containing overwrap configured to reduce light-mediated oxidation of the norepinephrine with an oxygen scavenger disposed between the polymer bag, and is administrable to a patient from the polymer bag;
- and
- wherein the ready-to-inject norepinephrine composition comprises at least about 90% R-isomer of norepinephrine as determined by HPLC and less than 10% total norepinephrine impurities as determined by HPLC when stored over at least three months at about 25° C.
4 more elements
Dependencies are inferred from the claim text.