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US 2026/0263389 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.
Claims18
A method of treating hypotension, comprising:
- administering to a patient a sterile, ready-to-inject norepinephrine composition from a polymer bag packaged in a removable overwrap with an oxygen scavenger disposed between the polymer bag and the overwrap after removing the overwrap, the ready-to-inject norepinephrine composition comprising:
- an aqueous acidic solution comprising norepinephrine base at a concentration of about 128 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 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.;
- and
- wherein the ready-to-reject norepinephrine composition is administered at an initial dose per minute of between 8 and 12 μg/min and/or a maintenance dose per minute of between 2 and 4 μg/min.
4 more elements
A method of treating hypotension, comprising:
- administering to a patient a sterile, ready-to-inject norepinephrine composition from a polymer bag packaged in a removable overwrap with an oxygen scavenger disposed between the polymer bag and the overwrap after removing the overwrap, the ready-to-inject norepinephrine composition comprising:
- an aqueous acidic solution comprising norepinephrine base at a concentration of about 128 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;
- 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.;
- and
- wherein the ready-to-reject norepinephrine composition is administered at an initial dose per minute of between 8 and 12 μg/min and/or at a maintenance dose per minute of between 2 and 4 μg/min.
5 more elements
Dependencies are inferred from the claim text.