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US 2019/0290602 A1Published application
Epinephrine compositions and containers
AssigneeNevakar Inc.
InventorsPrem Sagar Akasapu, Kumaresh Soppimath, Reema Ajitkumar Puri, Iouri V. Ilitchev, Milan Patel, Pooja H. Tendulkar
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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.
Claims20
An antioxidant-free and storage stable ready-to-inject epinephrine composition, consisting essentially of:
- 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 selected from the group consisting of EDTA, edetic acid, EGTA and diethylenetriaminepentaacetic acid;
- and
- wherein 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.
4 more elements
Dependencies are inferred from the claim text.