Extract containing oleandrin and method of production thereof

Inventors

Newman, Robert A. • ADDINGTON, Otis C. • Obiso, Richard J.

Assignees

Avila Herbals LLC • Phoenix Biotechnology Inc

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Publication Number

US-12097234-B2

Patent

Publication Date

2024-09-24

Expiration Date


Abstract

A subcritical liquid extraction process for the production of oleandrin or oleandrin-containing extract is provided. The process provides improvements over other methods of preparing oleandrin-containing extract. The extract, pharmaceutical compositions, dosage forms and nutraceutical compositions comprising oleandrin or said extract are provided. Methods of treating diseases, disorders or conditions that are therapeutically responsive to oleandrin are also provided.

Core Innovation

The invention relates to producing an oleandrin-containing combination composition that includes a portion of an oleandrin-containing organic solvent extract and a portion of an oleandrin-containing subcritical liquid (SbCL) extract. The organic solvent extract is prepared by extraction with alcohol or alcohol and water, and the SbCL extract is prepared by extraction with carbon dioxide or carbon dioxide and alcohol. The combination composition is configured to include oleandrin derived from oleandrin-containing biomass while combining extract portions from two extraction modes.

The disclosure addresses prior supercritical fluid extraction methods that provide oleandrin-containing extracts with less oleandrin or with different oleandrin-to-other-component ratios than desired. The described approach uses SbCL extraction to produce an oleandrin-containing SbCL extract, and then combines it with an oleandrin-containing organic solvent extract to form an oleandrin-containing combination composition. Documented profiling compares compositions derived from ethanolic extraction and SbCL extraction and compares them to a prior supercritical extract.

The disclosure further characterizes compositional differences among extracts and the combined composition, including relative VOC/SVOC profiles and differences in oleandrin content. It also positions SbCL operation using phase-diagram based regions for SbCLE of carbon dioxide, optionally with an organic modifier, including conditions defined relative to critical pressure and critical temperature, phase lines, and triple points. The overall inventive concept is the combination of oleandrin-containing extract portions obtained from organic solvent extraction and SbCL extraction to create an oleandrin-containing combination composition with a specified compositional character.

Claims Coverage

The independent claims cover an oleandrin-containing combination composition and a method of producing that composition. Two inventive feature groupings are present: the dual extract-combination composition and the producing workflow using organic solvent extraction, SbCL extraction, and combining the extracts.

Oleandrin-containing combination composition with an organic solvent extract portion and an SbCL extract portion

An oleandrin-containing combination composition comprising a portion of oleandrin-containing organic solvent extract and a portion of oleandrin-containing SbCL extract, wherein the organic solvent extract is prepared by extraction with alcohol or alcohol and water, and the SbCL extract is prepared by extraction with carbon dioxide or carbon dioxide and alcohol.

Method of producing an oleandrin-containing combination composition by extracting first biomass with organic solvent, extracting second biomass by SbCL, and combining the extracts

A method of producing an oleandrin-containing combination composition, the method comprising subjecting oleandrin-containing first biomass to organic solvent extraction to provide an oleandrin-containing organic solvent extract; subjecting oleandrin-containing second biomass to subcritical liquid extraction to provide an oleandrin-containing SbCL extract; and combining said oleandrin-containing organic solvent extract and said oleandrin-containing SbCL extract to provide said oleandrin-containing combination composition.

The claims center on combining extract portions derived from two extraction modes: organic solvent extraction and SbCL extraction. The method claims correspond to this composition structure by extracting first biomass via organic solvent extraction, extracting second biomass via SbCL extraction, and combining the resulting oleandrin-containing extracts.

Stated Advantages

Higher oleandrin yield and higher oleandrin-to-other-component ratio versus prior supercritical fluid extraction.

The dual extract composition includes more non-oleandrin phytochemicals while maintaining substantial oleandrin.

Documented Applications

Pharmaceutical compositions and nutraceutical compositions, including sublingual and buccal dosage forms.

Cosmeceutical products.

Treatment claims described in the disclosure including cardiac glycoside/oleandrin-responsive disorders, and example-referenced antiviral, neuroprotective, and anticancer activities.

COVID-19, as referenced in the examples.

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