Phenylephrine Hydrochloride Compositions and Containers

Abstract

A ready-to-administer antioxidant free phenylephrine compositions has improved stability and is optionally free of metal chelating agents. Contemplated compositions are preferably packaged into a flexible polymer bag and maintain degradation of the phenylephrine at remarkably low levels, even over extended storage periods.

Description

[0001]This application claims priority to our co-pending US Provisional Patent Application with the Ser. No. 62 / 964,457, which was filed Jan. 22, 2020, which is incorporated by reference herein.FIELD OF THE INVENTION[0002]The field of the invention pharmaceutical compositions and methods, and particularly as they relate to stable, sterile and ready-to-administer antioxidant free phenylephrine compositions, uses, and methods of manufacturing and packaging same.BACKGROUND OF THE INVENTION[0003]The background description includes information that may be useful in understanding the present disclosure. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.[0004]All publications and patent applications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individu...

AI Technical Summary

Benefits of technology

The patent is about a new formulation of phenylephrine that is in an aqueous solution and doesn't contain any antioxidants. This formulation is stable and doesn't produce any degradation products even after being stored at room temperature for extended periods of time (e.g. up to 6 months). The formulation is also sterile and doesn't include any metal ion chelators.

Problems solved by technology

Interaction of phenylephrine with α1-adrenergic receptors on vascular smooth muscle cells causes activation of the cells and results in vasoconstriction.

As blood pressure increases following intravenous administration, vagal activity also increases, resulting in reflex bradycardia.

The concentrate must be diluted prior to use and requires personnel intervention, there is a possibility of microbial contamination or dilution error.

Thus, even though various phenylephrine hydrochloride formulations are known in the art, extended stability at low and ready-to-use concentrations is problematic.

In addition, presence of metabisulfite in known compositions may lead to undesirable side effects in at least some subjects.

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