Epinephrine formulations

Abstract

Pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same. Compositions may comprise at least one of an active agent, a pH raising agent, an antioxidant, a transition metal complexing agent, a pH lowering agent, a tonicity regulating agent, optionally a preservative, and optionally a solvent.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Continuation-in-Part of U.S. patent application Ser. No. 14 / 863,112, filed Sep. 23, 2015, which is a Continuation of U.S. patent application Ser. No. 14 / 818,121, filed Aug. 4, 2015, now U.S. Pat. No. 9,295,657, Issued Mar. 29, 2016, which is a Continuation of U.S. patent application Ser. No. 14 / 657,990, filed Mar. 13, 2015, now U.S. Pat. No. 9,119,876, Issued Sep. 1, 2015. The disclosures of the prior applications are hereby incorporated in their entirety by reference.FIELD OF THE INVENTION[0002]The present invention provides pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same.BACKGROUND[0003]Epinephrine, also known as 4-[(1R)-1-Hydroxy-2-(methylamino)ethyl]-1,2-benzenediol, is the active principle of the adrenal medulla and an endogenous catecholamine which acts directly on both alpha and beta adrenergic receptors. When used in pharmaceutical compositions, ep...

AI Technical Summary

Benefits of technology

The present invention provides a pharmaceutical composition containing epinephrine that can be used for emergency treatment of various medical conditions such as allergic reactions, bronchospasm, cardiac arrhythmias, etc. The composition can be administered through various routes like subcutaneous, intracameral, intravenous, and intramuscular injection, among others. The composition has low levels of D-epinephrine, epinephrine sulfonic acid, oxidative degradants, and total impurities. It also has low levels of pH change over shelf life. The invention also provides a method for making the composition and treating medical conditions using it.

Problems solved by technology

Shelf life is limited by the formation of degradants, which mainly comprise epinephrine sulfonic acid (ESA) and D-epinephrine, an enantiomer of L-epinephrine that has insignificant therapeutic activity.

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