Claims for Patent: 11,207,280

Summary for Patent: 11,207,280

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 Injectables Inc.
Application Number:	US16821785
Patent Claims:	1. A method of producing a sterile and storage stable ready-to-inject epinephrine composition , comprising:combining an aqueous pharmaceutically acceptable carrier with epinephrine and a metal ion chelator such that the epinephrine has a concentration of equal or less than 0.07 mg/ml, wherein the metal ion chelator is present in the composition at a concentration of between about 1 and 50 ug/ml, and wherein substantially all of the epinephrine is an R-isomer;adjusting the pH of the ready-to-inject epinephrine composition to a pH of between 3.5-4.7;packaging the ready-to-inject epinephrine composition into a container under an inert gas; andautoclaving the ready-to-inject epinephrine composition to sterility, wherein sterilization increases S-isomer content to no more than 4%.2. The method of wherein sterilization increases S-isomer content by no more than 1.5%.3. The method of wherein sterilization increases S-isomer content by no more than 0.5%.4. The method of wherein sterilization increases total impurities content by no more than 0.5%.5. The method of wherein sterilization increases total impurities content by no more than 0.3%.6. The method of wherein the ready-to-inject epinephrine composition has claim 1 , after sterilization and storage of at least one month at 25° C. claim 1 , total impurities of equal or less than 0.7% and equal or less than 2% S-isomer content.7. The method of wherein the ready-to-inject epinephrine composition has claim 1 , after sterilization and storage of at least one month at 25° C. claim 1 , total impurities of equal or less than 0.5% and equal or less than 1% S-isomer content.8. The method of further comprising a step of including a buffer at a concentration of between 1-25 mM into the composition.9. The method of wherein the composition comprises dissolved oxygen in an amount of equal or less than 1.5 ppm O.10. A sterile storage stable ready-to-inject epinephrine composition claim 1 , comprising:an aqueous pharmaceutically acceptable carrier containing epinephrine and a metal ion chelator;wherein the epinephrine is present at a concentration of equal or less than 0.07 mg/ml, wherein substantially all of the epinephrine is an R-isomer, and wherein the composition has a pH of between 3.5-4.7;wherein the ready-to-inject epinephrine composition is substantially antioxidant-free; andwherein the ready-to-inject epinephrine composition has, after storage of at least one month at 25° C., total impurities of equal or less than 0.7% and equal or less than 4% S-isomer content.11. The composition of claim 10 , wherein the epinephrine is present at a concentration of equal or less than 0.04 mg/ml.12. The composition of claim 11 , wherein the composition has claim 11 , after storage of at least one month at 25° C. claim 11 , total impurities of equal or less than 0.5%.13. The composition of claim 10 , wherein the epinephrine is present at a concentration of equal or less than 0.02 mg/ml.14. The composition of claim 13 , wherein the composition has claim 13 , after storage of at least one month at 25° C. claim 13 , total impurities of equal or less than 0.5%.15. The composition of claim 10 , wherein the composition is an autoclaved sterile composition claim 10 , and wherein the S-isomer content after autoclaving and after storage of at least one month at 25° C. is equal or less than 1.3%.16. The composition of claim 10 , wherein the composition is an autoclaved sterile composition claim 10 , and wherein the S-isomer content after autoclaving and after storage of at least one month at 25° C. is equal or less than 0.7%.17. The composition of claim 10 , wherein the composition comprises dissolved oxygen in an amount of equal or less than 1.5 ppm O.18. The composition of claim 10 , wherein the composition further comprises a buffer at a concentration of between 1-25 mM.19. The composition of claim 10 , wherein the composition claim 10 , after storage of at least one month at 25° C. claim 10 , changes pH no more than 0.1 pH units.20. The composition of claim 10 , wherein the composition comprises the metal ion chelator at a concentration of between about 1 and 50 μg/ml.