Claims for Patent: 12,133,837

Summary for Patent: 12,133,837

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):	Prem Sagar Akasapu, Kumaresh Soppimath, Reema Ajitkumar Puri, Iouri V. Ilitchev, Milan Patel, Pooja H. Tendulkar
Assignee:	Nevakar Injectables Inc
Application Number:	US17/526,786
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,133,837
Patent Claims:	1. A sterile storage stable ready-to-inject epinephrine composition, comprising: an aqueous pharmaceutically acceptable carrier containing epinephrine, a tonicity agent, and a metal ion chelator; wherein the epinephrine is present at a concentration of equal or less than 0.07 mg/ml, and wherein at least about 90 mol % of the epinephrine is an R-isomer; wherein the composition has a pH of between 3.0-4.7; wherein the metal ion chelator is a bicarboxylic acid, a tricarboxylic acid, or an aminopolycarboxylic acid; wherein the metal ion chelator is present in the composition at a concentration of between about 1 and 50 μg/ml; and wherein the composition has a total impurities concentration of equal to or less than 0.3% after storage of at least one month at 25° C. 2. The composition of claim 1, wherein the epinephrine is present at a concentration of equal or less than 0.04 mg/ml. 3. The composition of claim 1, wherein the epinephrine is present at a concentration of equal or less than 0.02 mg/ml. 4. The composition of claim 1, wherein the epinephrine is present as epinephrine base, and wherein bitartrate is present as a buffer. 5. The composition of claim 1, wherein the composition comprises dissolved oxygen in an amount of equal or less than 3.0 ppm O2. 6. The composition of claim 1, wherein the composition comprises a buffer at a concentration of between 1-50 mM. 7. The composition of claim 1, wherein the tonicity agent is selected from the group consisting of glycerol, mannitol, lactose, and dextrose. 8. The composition of claim 1, wherein the composition is an autoclaved sterile composition, and wherein an S-isomer content after autoclaving and after storage of at least one month at 25 ° C. is equal or less than 0.7% . 9. The composition of claim 1, wherein the composition, after storage of at least one month at 25 ° C., changes pH no more than 0.5 pH units. 10. A method of producing a sterile and storage stabile ready-to-inject epinephrine composition, comprising: combining an aqueous pharmaceutically acceptable carrier with epinephrine, a tonicity agent, and metal ion chelator such that the epinephrine has a concentration of equal or less than 0.07 mg/ml; wherein at least about 90 mol % of the epinephrine is an R-isomer; wherein the metal ion chelator is a bicarboxylic acid, a tricarboxylic acid, or an aminopolycarboxylic acid; and wherein the metal ion chelator is present in the composition at a concentration of between about 1 and 50 μg/ml; adjusting a pH of the ready-to-inject epinephrine composition to between 3.0-4.7; packaging the ready-to-inject epinephrine composition into a container under an inert gas; and autoclaving the ready-to-inject epinephrine composition to sterility, wherein the composition has a total impurities concentration of equal to or less than 0.3% after storage of at least one month at 25° C. 11. The method of claim 10, wherein the epinephrine is present at a concentration of equal or less than 0.04 mg/ml. 12. The method of claim 10, wherein the epinephrine is present at a concentration of equal or less than 0.02 mg/ml. 13. The method of claim 10, wherein the epinephrine is present as epinephrine base, and wherein as bitartrate is present as a buffer. 14. The method of claim 10, wherein the composition comprises dissolved oxygen in an amount of equal or less than 3 ppm O2. 15. The method of claim 10, wherein the composition after autoclaving and after storage of at least one month at 25 ° C. has an S-isomer content of equal or less than 0.7% . 16. The method of claim 10, further comprising a step of placing the container into a secondary light impervious container. 17. The method of claim 16, further comprising a step of placing an oxygen scavenger into a space between the container and the secondary container.