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-11419909-B2
Publication Date
2022-08-23
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 composition for the female lower reproductive tract, including the vulva, vagina, and ectocervix, based on xylose and a Salvia extract. The composition includes a surfactant, a buffering agent, a pH modifying agent, an osmolality adjuster, and water, and is isotonic/iso-isoosmotic and biome-friendly. It is designed to maintain the vaginal ecosystem and vaginal microbiota while matching a desired pH range.
The composition is characterized by defined amounts of xylose and Salvia extract, together with buffering and pH modification to achieve a pH from about 3.0 to about 8.0. The document describes the roles of proteoglycans, glycosaminoglycans, mucins, and cervical mucus in this context, and presents xylose as a precursor to proteoglycans and glycosaminoglycans via xylosyltransferase. The formulation is also described as having minimal mucosal irritation and microbiota preservation concepts.
The composition is provided in semi-solid, gel, ointment, lotion, jelly, film, suspension emulsion, mucilage, foam, cream, paste or aerosol forms. The document further discusses exclusion or avoidance of certain excipients, focus on non-irritating formulation components, and evaluation concepts for irritation/inflammation and vaginal microbiota-related functional outcomes using assays described in the document.
Claims Coverage
The identified relevant independent claim is clm-00001. It contains inventive features comprising a defined topical composition with specified component concentration ranges, constrained by a target pH and a defined dosage form.
Topical composition with defined concentrations of xylose and Salvia extract
A topical composition comprising xylose at a total concentration ranging from about 0.01% to about 1% by weight and a Salvia extract at a total concentration ranging from about 0.01% to about 1% by weight.
Topical composition with defined surfactant, buffering, pH modifying, and osmolality adjuster ranges
A topical composition comprising a surfactant at a total concentration ranging from about 0.25% to about 10% by weight, a buffering agent at a total concentration ranging from about 0.05% to about 2.5% by weight, a pH modifying agent at a total concentration ranging from about 0.001% to about 2% by weight, and an osmolality adjuster at a total concentration ranging from about 0.1% to about 1% by weight, and water at a total concentration ranging from about 60% to about 99% by weight.
pH constrained topical composition for semi-solid and related dosage forms
The composition has a pH ranging from about 3.0 to about 8.0 and is in the form of a semi-solid, gel, ointment, lotion, jelly, film, suspension emulsion, mucilage, foam, cream, paste or aerosol.
Overall, the claim coverage is focused on a topical, pH-constrained composition comprising xylose and a Salvia extract together with defined ranges of surfactant, buffering agent, pH modifying agent, osmolality adjuster, and water, formulated in multiple semi-solid and topical dosage forms.
Stated Advantages
Reduced slug mucosal irritation.
Preserved sperm motility while reducing irritation markers versus controls.
Low endotoxin compared with an aloe product.
Reduced sperm DNA damage/toxicity and improved or unaltered cervical mucus penetration for fertility gels.
Vaginal microbiota protection with constraints on reduction.
Minimal mucosal irritation concepts and microbiota preservation concepts are stated in the document.
Documented Applications
Topical compositions for the female lower reproductive tract (vulva/vagina/ectocervix).
Perineal massage compositions.
Microbicide/contraceptive carrier bases.
Fertility-enhancing compositions (non-spermicidal) with pH matched to ovulation.
Sexual lubricants and vaginal hydration compositions, including menopause compositions and other pH targets.
Freshening/odor control compositions.
Vaginal tightening compositions using poly(2-oxazoline).
Drug-carrier base compositions.
Topical freshening gel compositions for freshening and mucosal interaction.
Topical vaginal tightening embodiments.
Topical application to the lower reproductive tract of a human female subject with a microbiota-preservation constraint.
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