Phenylephrine Hydrochloride Compositions and Containers

a technology of phenylephrine and compositions, applied in the field of pharmaceutical compositions and methods, can solve problems such as microbial contamination or dilution errors, extended stability at low and ready-to-use concentrations, and reflex bradycardia, so as to prolong the shelf life of products and enhance or preserve the chemical stability of phenylephrin

Pending Publication Date: 2021-07-29
ENDO VENTURES LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013]The present inventive subject matter is directed to various phenylephrine formulations in an aqueous solution that are antioxidant free and that enhance or preserve the chemical stability of phenylephrine at low (especially at ready-to-use) concentrations and consequently extend the product shelf

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 intervent

Method used

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  • Phenylephrine Hydrochloride Compositions and Containers
  • Phenylephrine Hydrochloride Compositions and Containers
  • Phenylephrine Hydrochloride Compositions and Containers

Examples

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examples

[0054]The following examples are provided for illustrative purposes only and should not be interpreted as limiting the present invention. Unless noted otherwise, all quantities indicated in % are weight percent following the general analytical protocol as indicated below.

[0055]Analytical protocol: phenylephrine hydrochloride (PEP) assay is performed using an isocratic reversed-phase HPLC-UV method. Biphenyl-modified core-shell silica particles are used as a stationary phase for chromatographic analysis using Kinetex® 2.6 μm Biphenyl LC Column, 4.6×50 mm, 2.6 μm. The mobile phase is a methanol-water mixture containing ˜0.1% o-phosphoric acid (3:97 v / v Methanol). Quantitation of PEP is accomplished by comparing corresponding peak areas from the sample solution chromatogram and the Phenylephrine Hydrochloride Reference Standard (RS) solution.

[0056]Related substances: Determination of PEP related compounds is performed using a linear-gradient reversed-phase HPLC-UV method. Biphenyl-modi...

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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...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K47/12A61K47/18A61K47/02A61K9/00B65D81/26B65D75/38B65B3/00
CPCA61K31/137A61K47/12A61K47/183B65B3/003A61K9/0019B65D81/266B65D75/38A61K47/02A61K9/08A61K47/10A61K47/26A61K47/20
Inventor PURI, REEMA AJITKUMARJAIN, HARSHIL H.HINGORANI, TUSHARSOPPIMATH, KUMARESH
Owner ENDO VENTURES LTD
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