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-9919018-B2
Publication Date
2018-03-20
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 isotonic, topical freshening vaginal gel compositions for the female lower reproductive tract, including the vulva, vagina, and ectocervix. The compositions include xylose and a Salvia extract, together with a non-irritating viscosity increasing agent, a surfactant, a buffering agent, a pH modifying agent, and an osmolality adjuster, with water as the remainder.
The gel has a finished pH ranging from about 3.5 to about 6.8, with component concentration ranges selected to support this pH window. The formulation is described as biome-friendly and intended to be non-irritating, and it emphasizes maintenance of vaginal ecosystem homeostasis, including the vaginal microbiome and microbiota, mucus, proteoglycans and glycosaminoglycans, and immune balance.
The document also describes use cases tied to the formulation concept, including functional freshening and support for vaginal conditions across life stage and hormone-cycle physiology. Example assessment concepts include evaluating vaginal flora impact and conducting irritation and inflammation evaluation using in vitro and in vivo methods.
Claims Coverage
The provided material identifies one independent claim directed to a topical, isotonic freshening vaginal gel composition, with dependent claims refining ingredient selections and ranges and adding a vaginal microbiota preservation constraint.
Topical isotonic freshening vaginal gel composition
A topical, isotonic freshening vaginal gel composition comprising xylose, a Salvia extract, a non-irritating viscosity increasing agent, a surfactant, a buffering agent, a pH modifying agent, an osmolality adjuster, and water, wherein the composition has a pH ranging from about 3.5 to about 6.8.
Specific buffer pairing options
The buffering agent is lactic acid plus sodium lactate at a total concentration of about 0.4% to about 1% by weight, or ascorbic acid plus sodium ascorbate at a total concentration of about 0.5% to about 2% by weight.
Selected pH modifying agent list
The pH modifying agent is selected from ammonia, ammonium carbonate, diethanolamine, monoethanolamine, potassium hydroxide, potassium phosphate dibasic, sodium bicarbonate, sodium borate, sodium carbonate, sodium hydroxide, sodium lactate, sodium phosphate dibasic, trolamine, or any combination thereof.
Osmolality adjuster selection
The osmolality adjuster is sodium chloride, potassium chloride, or both.
Vaginal microbiota preservation threshold after application
Following topical application to the lower reproductive tract, vaginal microbiota of the human female subject is not reduced greater than 25% compared with an untreated control or prior to topical application.
Overall, the claim set centers on a pH-matched isotonic freshening vaginal gel defined by xylose, Salvia extract, and specified functional classes, with dependent claims narrowing to specific buffering, pH, and osmolality selections and adding a vaginal microbiota preservation constraint.
Stated Advantages
Provides isotonic, biome-friendly topical freshening compositions for the female lower reproductive tract.
Maintains vaginal ecosystem homeostasis including microbiome/microbiota, mucus, proteoglycans/glycosaminoglycans, and immune balance.
Non-irritating topical composition.
Documented Applications
Topical freshening use for the female lower reproductive tract (vulva/vagina/ectocervix).
Support of vaginal conditions across life stage and hormone-cycle physiology as described for the formulation rationale.
Functional use cases described include perineal massage and lubrication/hydration, vaginal tightening, and a drug-carrier base, as well as fertility/ovulation support and contraception/microbicide-like mucus effects.
In vitro and in vivo assessment use cases include evaluating vaginal flora impact and irritation/inflammation via a slug mucosal irritation assay.
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