Claims for Patent: 10,159,657

Summary for Patent: 10,159,657

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-nor epinephrine and exhibit less than 5% degradation of total norepinephrine.
Inventor(s):	Yadav Vivek
Assignee:	NEVAKAR INC.
Application Number:	US15949736
Patent Claims:	1. A ready-to-administer norepinephrine composition , comprising:an aqueous solution comprising a chelating agent and a pharmaceutically acceptable salt;wherein the chelating agent is an aminopolycarboxylic acid present in an amount of equal or less than 100 μg/ml, and wherein the pharmaceutically acceptable salt is present in an amount of at least 0.7 wt %;norepinephrine bitartrate dissolved at a concentration of between 16 and 64 μg/ml, and wherein the norepinephrine is an R-isomer;wherein the ready-to-administer norepinephrine composition is substantially free of antioxidants; andwherein the ready-to-administer norepinephrine composition is formulated to have a pH range of between 3.8 and 4.2 and has a composition such that after storage over at least three months equal or less than 10% of the R-isomer form will isomerize to the S-isomer and such that equal or less than 5% of the total norepinephrine will degrade to degradation products.2. The composition of wherein the ready-to-administer norepinephrine composition has a pH between 3.8 and 4.1.3. The composition of wherein the ready-to-administer norepinephrine composition has a pH between 3.9 and 4.2.4. The composition of wherein the ready-to-administer norepinephrine composition has a pH of 4.0.5. The composition of wherein the aqueous solution is water.6. The composition of wherein the chelating agent is ethylenediaminetetraacetic acid (EDTA).7. The composition of wherein the chelating agent is present at a concentration of between 10 μg/ml and 100 μg/ml.8. The composition of wherein the chelating agent is 10 μg/ml.9. The composition of wherein the aqueous solution is water claim 1 , wherein the chelating agent is ethylenediaminetetraacetic acid (EDTA) at a concentration of between 10 μg/ml and 100 μg/ml.10. The composition of wherein the pharmaceutically acceptable salt is present in an amount of 0.9 wt %.11. The composition of wherein the pharmaceutically acceptable salt is present in an amount of 0.9 wt %.12. The composition of wherein the norepinephrine is present at a concentration of about 16 μg/ml claim 1 , about 32 μg/ml claim 1 , or about 64 μg/ml.13. The composition of wherein the norepinephrine is present at a concentration of about 16 μg/ml claim 9 , about 32 μg/ml claim 9 , or about 64 μg/ml.14. The composition of wherein the norepinephrine is present at a concentration of about 16 μg/ml claim 11 , about 32 μg/ml claim 11 , or about 64 μg/ml.15. The composition of wherein the storage over at least three months is at 40° C. and 75% (+/−5%) relative humidity.16. The composition of wherein equal or less than 6% of the R-isomer form will isomerize to the S-isomer.17. The composition of wherein equal or less than 6% of the R-isomer form will isomerize to the S-isomer.18. The composition of wherein equal or less than 3.5% of the total norepinephrine will degrade to degradation products.19. The composition of wherein the composition has a dissolved oxygen concentration of equal or less than 1 ppm.