Compositions and methods for maintaining or enhancing homeostasis or function of female lower reproductive tract

Inventors

Ellington, Joanna E. • CLIFTON, G. Dennis

Assignees

Fairhaven Health LLC

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Publication Number

US-10357527-B2

Patent

Publication Date

2019-07-23

Expiration Date


Abstract

The present disclosure provides compositions and methods for making and using topical compositions comprised of an isotonic, biome-friendly solution containing xylose and/or a Salvia extract. The compositions are useful for, for example, maintaining or enhancing female lower reproductive tract (LRT) homeostasis and physiological function. In particular, topical compositions of this disclosure can be formulated for use as a freshening, menopausal, fertility, and/or perineal composition.

Core Innovation

The invention relates to a topical, isotonic vaginal gel composition for use in a post-menopausal female subject. The gel includes xylose and a Salvia extract, together with a non-irritating viscosity increasing agent, a pH modifying agent, a buffering agent, an osmolality adjuster, and water. The composition is defined by the listed component classes and has a pH ranging from about 4.5 to about 6.8.

The invention characterizes the isotonic vaginal gel by maintaining pH, buffering capacity, and osmolality through specific agent types. Salvia extract inclusion, together with xylose, is positioned as part of a formulation intended for compatibility with the lower reproductive tract environment. The compositions are described as biome-friendly for the female lower reproductive tract.

In disclosed embodiments, the invention frames the gel as a drug carrier base that maintains lower reproductive tract homeostasis while allowing combination with therapeutic agents. The disclosure also includes formulation categories such as perineal massage compositions, microbicide/contraceptive carriers, fertility compositions, sexual lubricant/vaginal hydration compositions, freshening compositions, vaginal tightening compositions, and drug-carrier bases.

Claims Coverage

The independent claims identify a topical, isotonic vaginal gel composition for post-menopausal female subjects, with inventive features defined by specific component classes and compositional constraints, including xylose, Salvia extract, viscosity control, pH modification, buffering, osmolality adjustment, water, and a pH range of about 4.5 to about 6.8.

Topical isotonic vaginal gel for post-menopausal use with constrained pH

A topical, isotonic vaginal gel composition for use in a post-menopausal female subject, comprising xylose, a Salvia extract, a non-irritating viscosity increasing agent, a pH modifying agent, a buffering agent, an osmolality adjuster, and water, wherein the composition has a pH ranging from about 4.5 to about 6.8.

Overall, the claim coverage centers on a post-menopausal isotonic vaginal gel defined by xylose and Salvia extract together with non-irritating viscosity control, pH modification, buffering, osmolality adjustment, and water, constrained to a pH range of about 4.5 to about 6.8.

Stated Advantages

Compositions are described as biome-friendly for the female lower reproductive tract.

The formulation is described as non-irritating via the inclusion of a non-irritating viscosity increasing agent.

The gel is described as maintaining lower reproductive tract homeostasis while allowing combination with therapeutic agents.

Documented Applications

Topical use in a post-menopausal female subject via an isotonic vaginal gel composition for the female lower reproductive tract.

Perineal massage compositions.

Microbicide/contraceptive carriers.

Fertility compositions.

Sexual lubricant/vaginal hydration compositions.

Freshening compositions.

Vaginal tightening compositions.

Drug-carrier bases.

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