Claims for Patent: 10,653,646

Summary for Patent: 10,653,646

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:	US16360995
Patent Claims:	1. An antioxidant-free and storage stable ready-to-inject epinephrine composition , comprising:an aqueous pharmaceutically acceptable carrier containing epinephrine;wherein the epinephrine is present in the ready-to-inject epinephrine composition at a concentration of equal or less than 0.07 mg/ml;wherein substantially all of the epinephrine is an R-isomer;wherein the ready-to-inject epinephrine composition has a pH of between 3.0-4.7;wherein the ready-to-inject epinephrine composition further comprises a metal ion chelator present in the composition at a concentration of between about 1 and 50 ug/ml, wherein the metal ion chelator is selected from the group consisting of EDTA (edetic acid), EGTA, and diethylenetriaminepentaacetic acid; andwherein the ready-to-inject epinephrine composition has, after storage of at least one month, total impurities of equal or less than 0.7% and equal or less than 2% S-isomer content.2. The composition of claim 1 , wherein the epinephrine is present in the composition at a concentration of between about 0.005 mg/ml and 0.050 mg/ml.3. The composition of claim 1 , wherein the epinephrine is present in the composition at a concentration of between about 0.006-0.010 mg/ml.4. The composition of claim 1 , wherein the epinephrine is present in the composition at a concentration of between about 0.010-0.025 mg/ml.5. The composition of claim 1 , wherein the epinephrine is present in the composition at a concentration of between about 0.025-0.045 mg/ml.6. The composition of claim 1 , wherein the epinephrine is present in the composition as a pharmaceutically acceptable salt.7. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has claim 1 , after storage of at least one month claim 1 , a pH of between about 3.5-4.5.8. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has claim 1 , after storage of at least one month claim 1 , a pH of between about 3.8-4.2.9. The composition of claim 1 , wherein the aqueous pharmaceutically acceptable carrier is water for injection.10. The composition of claim 1 , wherein the aqueous pharmaceutically acceptable carrier further comprises a buffer.11. The composition of claim 10 , wherein the buffer is present in a concentration of between 1 mM and 25 mM claim 10 , and wherein the buffer is selected from the group consisting of an acetate buffer claim 10 , a citrate buffer claim 10 , a phosphate buffer claim 10 , a tartrate buffer claim 10 , and a borate buffer.12. The composition of claim 1 , further comprising 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.13. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has dissolved oxygen of equal or less than 1.5 ppm O.14. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has claim 1 , after storage of at least one month claim 1 , total impurities of equal or less than 0.5% and equal or less than 1% S-isomer content.15. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has claim 1 , after storage of at least one month claim 1 , total impurities of equal or less than 0.2% and equal or less than 1.5% S-isomer content.16. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has claim 1 , after storage of at least one month claim 1 , total impurities of equal or less than 0.5% and equal or less than 1% S-isomer content.17. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has claim 1 , after storage of at least one month claim 1 , total impurities of equal or less than 0.3% and equal or less than 0.7% S-isomer content.18. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has claim 1 , after autoclaving claim 1 , total impurities of equal or less than 0.5% and equal or less than 2.0% S-isomer content.19. The composition of claim 1 , wherein the ready-to-inject epinephrine composition has claim 1 , after autoclaving claim 1 , total impurities of equal or less than 0.2% and equal or less than 1.5% S-isomer content.20. A pharmaceutical product claim 1 , comprising:{'claim-ref': {'@idref': 'CLM-00001', 'claim 1'}, 'a polymeric container comprising the antioxidant-free and storage stable ready-to-inject epinephrine composition of , wherein the container is a blow-fill-seal (BFS) container or flexible IV bag;'}wherein the polymeric container has a volume of between 100 mL and 1,000 mL; andwherein the polymeric container is optionally enclosed in a metallized over-container that optionally further comprises an oxygen scavenger or absorber disposed between the polymeric container and the metallized over-container.