Claims for Patent: 11,083,698

Summary for Patent: 11,083,698

Title:	Epinephrine compositions and containers
Abstract:	The inventive subject matter provides ready-to-administer, preferably anti-oxidant free, epinephrine compositions with improved stability, and methods for preparing the same. Contemplated compositions can be packaged using blow-fill-seal technology or packaged into flexible IV bags and maintain degradation of the epinephrine at a level of less than 5 wt % when stored over at least one months at between 2-40° C.
Inventor(s):	Akasapu Prem Sagar, Soppimath Kumaresh, Puri Reema Ajitkumar, Ilitchev Iouri V., Patel Milan, Tendulkar Pooja H.
Assignee:	NEVAKAR INC.
Application Number:	US16821689
Patent Claims:	1. A method of administering epinephrine , comprising:providing a container comprising an antioxidant-free sterile epinephrine composition that is storage stable and contains epinephrine in an aqueous pharmaceutically acceptable carrier at a concentration of equal or less than 0.07 mg/ml, wherein substantially all of the epinephrine is an R-isomer;wherein the epinephrine composition has a pH of between 3.0-4.7;wherein the epinephrine composition further comprises a metal ion chelator present in the composition at a concentration of between about 1 and 50 μg/ml, wherein the metal ion chelator is selected from the group consisting of EDTA (edetic acid), EGTA, and diethylenetriaminepentaacetic acid;wherein the epinephrine composition has a storage stability such that after storage of at least one month, the epinephrine composition comprises total impurities of equal or less than 0.7% and equal or less than 4.5% S-isomer content; andadministering the epinephrine composition via injection and without prior dilution from the container to a patient in need thereof.2. The method of claim 1 , wherein the container is a flexible infusion bag or a BFS container having a volume of between 100 mL and 1 claim 1 ,000 mL.3. The method of claim 1 , wherein the sterile epinephrine composition is an autoclaved composition.4. The method of claim 1 , wherein the composition has an epinephrine concentration of about 0.008 mg/ml claim 1 , or about 0.016 mg/ml claim 1 , or about 0.032 mg/ml claim 1 , or about 0.040 mg/ml.5. The method of claim 1 , wherein the sterile epinephrine composition is administered at a dosage rate of 0.05-2.0 mcg/kg/min.6. The method of claim 1 , wherein the patient in need thereof has acute hypotension.7. The method of claim 1 , wherein the container further comprises an overwrap and/or wherein the container further encloses an oxygen scavenger or absorber.8. The method of claim 1 , wherein the epinephrine composition has a storage stability such that after storage of at least one month claim 1 , the epinephrine composition comprises equal or less than 2% S-isomer content.9. The method of claim 1 , wherein the container was previously stored at a temperature of about 25° C. or 40° C. for at least three months.10. The method of claim 1 , wherein the epinephrine composition further comprises a buffer at a concentration of between 1 mM and 25 mM.11. The method of claim 1 , wherein the epinephrine composition further comprises a tonicity agent selected from the group consisting of sodium chloride claim 1 , glycerol claim 1 , thioglycerol claim 1 , mannitol claim 1 , lactose claim 1 , and dextrose.12. The method of claim 1 , wherein the epinephrine composition has dissolved oxygen of equal or less than 1.5 ppm O.13. A method of increasing blood pressure in a patient claim 1 , comprising:providing a container comprising an antioxidant-free sterile epinephrine composition that is storage stable and contains epinephrine in an aqueous pharmaceutically acceptable carrier at a concentration of equal or less than 0.07 mg/ml, wherein substantially all of the epinephrine is an R-isomer;wherein the epinephrine composition has a pH of between 3.0-4.7;wherein the epinephrine composition further comprises a metal ion chelator present in the composition at a concentration of between about 1 and 50 μg/ml, wherein the metal ion chelator is selected from the group consisting of EDTA (edetic acid), EGTA, and diethylenetriaminepentaacetic acid;wherein the epinephrine composition has a storage stability such that after storage of at least one month, the epinephrine composition comprises total impurities of equal or less than 0.7% and equal or less than 4.5% S-isomer content; andadministering the epinephrine composition via injection and without prior dilution from the container to the patient in need thereof.14. The method of claim 13 , wherein the container is a flexible infusion bag or a BFS container having a volume of between 100 mL and 1 claim 13 ,000 mL.15. The method of claim 13 , wherein the container was previously stored at a temperature of about 25° C. or 40° C. for at least three months.16. The method of claim 13 , wherein the composition has an epinephrine concentration of about 0.008 mg/ml claim 13 , or about 0.016 mg/ml claim 13 , or about 0.032 mg/ml claim 13 , or about 0.040 mg/ml.17. The method of claim 13 , wherein the sterile epinephrine composition is administered at a dosage rate of 0.05-2.0 mcg/kg/min.