Claims for Patent: 10,568,850

Summary for Patent: 10,568,850

Title:	Norepinephrine compositions and methods therefor
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.
Inventor(s):	Hingorani Tushar, Akasapu Prem Sagar, Soppimath Kumaresh
Assignee:	Nevakar Inc.
Application Number:	US16239461
Patent Claims:	1. A sterile , ready-to-administer , packaged norepinephrine composition , comprising:a container filled with a sterile, ready-to-administer norepinephrine composition and packaged in a secondary container;wherein the sterile, ready-to-administer norepinephrine composition comprises norepinephrine or a salt thereof in an amount of between 10 μg/ml and 100 μg/ml, a chelating agent in an amount of between 1 μg/ml and 100 μg/ml, a tonicity adjusting agent in an amount of between 0.6 wt % and 1.2 wt %, and an aqueous acidic solution, wherein the norepinephrine comprises at least 95% of R-isomer of norepinephrine;wherein the sterile, ready-to-administer norepinephrine composition is substantially free of antioxidants;wherein the sterile, ready-to-administer norepinephrine composition has a pH of between 3.7 and 4.3; andwherein the sterile, ready-to-administer, packaged 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.2. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the container is a large volume claim 1 , polymeric claim 1 , semi-permeable infusion container.3. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the container is a polymer bag.4. The sterile claim 3 , ready-to-administer claim 3 , packaged norepinephrine composition of claim 3 , wherein the polymer is polypropylene claim 3 , polyethylene claim 3 , or low-density polyethylene.5. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the secondary container is impervious to light.6. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the secondary container is impervious to light of a wavelength that promotes photo-initiated degradation of the norepinephrine or salt thereof in the sterile claim 1 , ready-to-administer norepinephrine composition.7. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the container and/or the secondary container includes an oxygen scavenger.8. The sterile claim 7 , ready-to-administer claim 7 , packaged norepinephrine composition of claim 7 , wherein the oxygen scavenger is a metal-free oxygen scavenger.9. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the secondary container comprises an aluminum overwrap.10. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the container is a polymer bag and the secondary container comprises an aluminum overwrap.11. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the sterile claim 1 , ready-to-administer norepinephrine composition has a pH between 3.7 and 4.0.12. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the norepinephrine is norepinephrine bitartrate.13. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the norepinephrine is present in the sterile claim 1 , ready-to-administer norepinephrine composition in an amount of about 16 μg/ml claim 1 , about 32 μg/ml claim 1 , or about 64 μg/ml.14. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the chelating agent is selected from a group consisting of a bicarboxylic acid claim 1 , a tricarboxylic acid claim 1 , and an aminopolycarboxylic acid.15. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the chelating agent is ethylenediaminetetraacetic acid (EDTA).16. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , where the tonicity adjusting agent is sodium chloride.17. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the aqueous acidic solution has dissolved oxygen at a concentration of equal or less than 1 ppm.18. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the norepinephrine or a salt thereof in the sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition comprises equal or less than about 10% S-isomer of norepinephrine or salt thereof after storage at 25±2° C. and 60±5% relative humidity claim 1 , over at least three months as determined by HPLC.19. The sterile claim 1 , ready-to-administer claim 1 , packaged norepinephrine composition of claim 1 , wherein the sterile claim 1 , ready-to-administer norepinephrine composition comprises equal or less than about 5% of total degradation of norepinephrine or salt thereof excluding S-isomer of norepinephrine after storage at 25±2° C. and 60±5% relative humidity claim 1 , over at least three months as determined by HPLC.