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US 10,420,735 B2Granted
Norepinephrine compositions and methods therefor
AssigneeNevakar Inc.
InventorsTushar Hingorani, Prem Sagar Akasapu, 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.
Claims22
A method of treating hypotension, comprising:
- administering a ready-to-administer norepinephrine composition at an initial dose per minute;
- administering the norepinephrine composition at a maintenance dose per minute, wherein the initial dose per minute is greater than the maintenance dose per minute;
- wherein the initial dose per minute is a dose of between 8 and 12 μg/min, and wherein the maintenance dose per minute is a dose of between 2 and 4 μg/min;
- wherein the norepinephrine composition comprises norepinephrine or a salt thereof at a concentration of between 10 μg/ml and 100 μg/ml in an aqueous acidic solution having a pH range of between 3.7 and 4.3, wherein the aqueous acidic solution further comprises a chelating agent at a concentration of between 1 μg/ml and 100 μg/ml and a tonicity agent;
- wherein the norepinephrine composition is substantially free of antioxidants;
- and
- wherein the norepinephrine or a salt thereof in the norepinephrine composition comprises at least about 90% R-isomer of norepinephrine after storage at 25±2° C. and 60±5% relative humidity, over at least three months as determined by HPLC.
4 more elements
A method of administering a ready-to-administer norepinephrine composition to an individual in need thereof, comprising:
- administering the norepinephrine composition at an initial rate of between 8 and 12 μg/min;
- adjusting administration of norepinephrine composition to a maintenance rate of between 2 and 4 μg/min;
- wherein the norepinephrine composition comprises norepinephrine or a salt thereof at a concentration of between 10 μg/ml and 100 μg/ml as a base and further comprises a chelating agent in an amount of between 1 μg/ml and 100 μg/ml;
- wherein the norepinephrine composition is substantially free of antioxidants;
- and
- wherein the norepinephrine composition comprises norepinephrine or a salt thereof in an aqueous acidic solution having a pH range of between 3.7 and 4.3, wherein the aqueous acidic solution further comprises a tonicity agent;
- and
- wherein the norepinephrine or a salt thereof in the norepinephrine composition comprises at least about 90% R-isomer of norepinephrine or a salt thereof after storage at 25±2° C. and 60±5% relative humidity, over at least three months as determined by HPLC.
5 more elements
Dependencies are inferred from the claim text.