Compositions and methods for maintaining or enhancing homeostasis or function of female lower reproductive tract
Inventors
Ellington, Joanna E. • CLIFTON, G. Dennis
Assignees
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Publication Number
US-9913871-B2
Publication Date
2018-03-13
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 disclosed invention relates to a topical, isotonic fertility vaginal gel composition for the female lower reproductive tract that 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 as the major component. The composition has a pH of about 6.8 to about 7.8 and is defined by total concentration ranges by weight for the listed components.
The disclosure describes compositions intended to preserve the vaginal microbiome, vaginal flora, and vaginal ecosystem while supporting lower reproductive tract-associated functions. It associates xylose with proteoglycans and glycosaminoglycans, including xylose-dependent biosynthesis, and relates these components to mucus and vaginal ecosystem preservation.
The compositions are positioned to support hydration and fertility enhancement, including sperm function and cervical mucus penetration, and also to provide contraception/microbicide effects by creating hostile mucus and reducing sperm/pathogen penetration. The disclosure further describes safety goals by minimizing mucosal irritation and reducing vaginal microbiota disruption, while also referencing freshness and perineal care, and including optional bioactives and formulation refinements such as specific Salvia extracts, buffering systems, surfactants, and paraben-free preservative systems.
Claims Coverage
The independent claim coverage centers on a topical, isotonic fertility vaginal gel composition and includes 4 inventive feature groups. The claim specifies xylose and a Salvia extract with additional formulation components, including a non-irritating viscosity increasing agent, a pH modifying agent, a buffering agent, an osmolality adjuster, and water, with a pH range of about 6.8 to about 7.8.
Topical isotonic fertility vaginal gel composition
A topical, isotonic fertility vaginal gel composition 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 of about 6.8 to about 7.8.
Defined concentration ranges for gel components
The composition has total concentration ranges by weight for xylose, Salvia extract, non-irritating viscosity increasing agent, pH modifying agent, buffering agent, osmolality adjuster, and water.
Salvia extract and formulation refinements
The composition is refined by selecting specific named Salvia extracts, specific viscosity increasing agents and buffering systems, including quantitative formulation constraints such as a hypromellose:carbomer homopolymer type B ratio and optional surfactant and paraben-free preservative systems.
Microbiota non-reduction threshold after application
Topical application of the composition to a female subject’s lower reproductive tract does not reduce the vaginal microbiota by more than 25% versus an untreated control female subject or versus prior to topical application.
The claim coverage centers on an isotonic fertility vaginal gel combining xylose and a Salvia extract with defined concentration ranges for multiple gel-forming components, constrained to a gel pH of about 6.8 to about 7.8, and includes refinements via selected ingredient systems and a microbiota non-reduction threshold after topical application.
Stated Advantages
Minimizes mucosal irritation.
Minimizes vaginal microbiota disruption while preserving the vaginal ecosystem, vaginal microbiome, and vaginal flora.
Supports hydration.
Supports fertility enhancement including sperm function and cervical mucus penetration.
Provides contraception/microbicide effects by creating hostile mucus and reducing sperm/pathogen penetration.
Provides freshness and perineal care.
Documented Applications
Topical application to a female subject’s lower reproductive tract under fertility-related objectives, while limiting vaginal microbiota reduction to no more than 25% compared to an untreated control female subject or prior to topical application.
Fertility vaginal gel use described in the disclosure context, including supporting hydration, sperm function, and cervical mucus penetration.
Contraception/microbicide use described in the disclosure context through hostile mucus and reduced sperm/pathogen penetration.
Freshness and perineal care use described in the disclosure context.
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