Methods of stabilizing epinephrine
AssigneeHikma Pharmaceuticals USA Inc.
InventorsEshwaran Narayanan, Rajesh Wakaskar, Chandeshwari Chilampalli, Thrimoorthy Potta, Venkat R. Goskonda
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Abstract
The present invention is directed to methods of stabilizing a pharmaceutical composition comprising epinephrine containing the steps filling a container, capping the container, assembling the container and placing the assembled capped container (assembled device) in a secondary packaging system.
Claims16
A method of stabilizing a pharmaceutical composition comprising from about 1% to about 12% w/w epinephrine, from about 10% to about 60% w/w ethanol, from about 2% to about 20% w/w propylene glycol, from about 0.001% to about 0.02% w/w benzalkonium chloride and from about 0.01% to about 0.1% w/w edetate disodium dihydrate comprising the steps of:
- a. filling a container with the pharmaceutical composition under a vacuum or a gas overlay;
- b. closing the container;
- c. placing the closed container in a holder and actuator to create an assembled device;
- d. placing the assembled device in a secondary packaging system under one or more conditions selected from the group consisting of under a gas overlay, with an oxygen absorbing means and with oxygen indicator;
- and
- e. sealing the secondary packaging system,
- wherein the container is selected from the group consisting of a glass vial, a plastic vial, a glass bottle and a plastic bottle and the secondary packaging system is selected from the group consisting of a pouch and a blister package and wherein w/w denotes weight to total weight of the composition.
Dependencies are inferred from the claim text.