Invented by Joanna E. Ellington, G. Dennis CLIFTON, Fairhaven Health LLC

The female reproductive system is a complex network of organs and tissues that work together to maintain a healthy balance, or homeostasis, in the lower reproductive tract. However, many women experience disruptions in this delicate balance, leading to a variety of health issues such as vaginal infections, pelvic inflammatory disease, and infertility. As a result, there is a growing market for compositions or methods that can help maintain or improve homeostasis in the female lower reproductive tract, or its function. These products and services range from over-the-counter remedies to prescription medications, as well as alternative therapies such as acupuncture and herbal supplements. One of the most common issues affecting the female reproductive system is bacterial vaginosis (BV), a condition caused by an overgrowth of harmful bacteria in the vagina. BV can cause a range of symptoms, including itching, burning, and a foul-smelling discharge. To combat this, many women turn to over-the-counter products such as vaginal suppositories and creams that contain probiotics, which help restore the natural balance of bacteria in the vagina. Prescription medications such as antibiotics and antifungal drugs are also commonly used to treat BV and other vaginal infections. However, these medications can have side effects and may not be effective for all women. In recent years, there has been growing interest in alternative therapies for maintaining or improving homeostasis in the female reproductive tract. Acupuncture, for example, has been shown to be effective in treating menstrual disorders and infertility. Herbal supplements such as chasteberry and black cohosh are also believed to help regulate hormones and improve reproductive function. Despite the growing market for these products and services, it is important for women to exercise caution when choosing treatments for their reproductive health. Many over-the-counter products are not regulated by the FDA and may not be safe or effective. It is always best to consult with a healthcare provider before trying any new treatment. In conclusion, the market for compositions or methods for maintaining or improving homeostasis in the female lower reproductive tract is growing, as more women seek out safe and effective ways to address common health issues. From over-the-counter remedies to prescription medications and alternative therapies, there are many options available to help women maintain a healthy balance in their reproductive system. However, it is important to approach these treatments with caution and seek the advice of a healthcare provider before trying anything new.

The Fairhaven Health LLC invention works as follows

The present disclosure provides methods and compositions for making and using topical formulations that contain an isotonic solution, which is biome-friendly and contains xylose or a Salvia leaf extract. These compositions can be used to maintain or enhance female lower reproductive tract homeostasis, and their physiological function. Topical compositions can be used as freshening, menopausal or fertility compositions, or perineal compositions.

Background for Compositions or methods for maintaining or improving homeostasis of the female lower reproductive tract or its function

Mounting evidence suggests that the cells that line the lower female reproductive system (LRT), which includes the vulva and vagina, along with the vaginotropic commensal microbiome, form the “vaginal eco-system”. The vaginal ecosystem is a dynamic organ which not only helps to protect against infection but also promotes tissue health. “The vaginal eco-system is composed of many factors that work together to maintain homeostasis, such as immune active cells and protective mucus coatings, antimicrobial peptides and symbiotic bacterial (e.g. Lactobacilli).

The vaginal eco-system is constantly providing a protective barrier to disease during various stages of a women’s reproductive cycle. It also lubricates the vagina to accommodate for sexual intercourse, or facilitates the passage of blood out the uterus at menses, or inhibits/optimizes sperm transport through the cervix and the vagina, while also undergoing chemical changes to promote labor and birth of a baby. For example, during various stages of a woman’s reproductive cycle, the vaginal ecosystem is continually providing a protective barrier to disease while at the same time lubricating the vagina to accommodate for sexual intercourse, or facilitating the passage of blood out of the uterus at menses, or inhibiting/optimizing sperm transport through the vagina and cervix, or undergoing chemical changes to promote labor and birth of a baby.

Throughout the woman’s lifetime, the LRT, and the vaginal eco-system, are constantly experiencing various disturbances, both acute and chronic, caused by human behavior, such as sexual activity, but also the use of contraception, and vaginal products” (Hickey and al., Translation). Res. 160:267, 2012; Ma et al., Annu. Rev. Microbiol. 66:371, 2012). When the vaginal eco-system is disturbed chronically, discomfort and disease can result. Any vaginal product which alters the mucosal ecosystem and damages the epithelial barriers can increase symptoms or disease risk (Fichorova, et. al. Toxicol). Appl. Pharmacol. 285:198, 2015; Ma et al., 2012).

The cost of women’s products that do not take into account the entire biology of the LRT, and the vaginal eco-system has been high on both an epidemiological and personal level. In clinical trials, vaginal products designed to prevent Sexually Transmitted Diseases were found to increase the rate of STDs. (Gali et. al. Antimicrob. Agents Chemother. 54:5105, 2010; Dezzutti et al., PLoS One 7:e48328, 2012). Cell toxicity (some ingredients are called?inactive carrier?) Cell toxicity of various ingredients (some are referred to as?inactive carriers?)

The need for safer LRT products to assist women’s healthcare is evident. These include products that preserve and support vaginal eco-system homeostasis, and the healthy function of this ecosystem. The embodiments disclosed herein address this need, and also provide related advantages.

The present disclosure provides compositions or methods to maintain or enhance homeostasis or function of the female lower genital tract (LRT). The present disclosure is mainly concerned with unique biome-friendly, isotonic formulations containing xylose, a Salvia-extract at different pH levels, to complement the unique hormonal cycle and life stage specific physiology of the female LRT. These biome-friendly, isotonic formulations of Salvia and xylose are useful to maintain a natural balance within the female LRT ecosystem, including the vaginal eco-system, either prophylactically, or therapeutically. The isotonic biome-friendly formulas disclosed here can be used to treat or prevent infection, enhance fertility, maintain or improve vaginal ecosystem balance, increase hydration, or do the like.

Definitions are provided throughout this disclosure. This disclosure includes additional definitions.

A ?pharmaceutical composition? “A?pharmaceutical composition? Refers to the formulations of this disclosure, and the mediums generally accepted by the industry for delivering the biologically active compound(s) into female subjects (e.g. humans). A pharmaceutical or vaginal formulation of the present disclosure can be used in any form, including as a standalone composition or as an ingredient of a prescription medicine, an OTC medicine, botanical medicine, herbal medicine, medical device, cosmetic, homeopathic agent or other health care products, which may have been reviewed and approved by an agency. “A medium generally accepted by the art includes any pharmaceutically or vaginally acceptable carriers, diluents, or excipients for it.

As used in this document, “?enriched for?” Refers to a preparation or extract of a plant that has at least a 2-fold to about 1000-fold more of an active compound than the amount found in the plant material before extraction or preparation. The weight of plant material before extraction or preparation can be either dry weight or wet weight.

As used herein, ?purified? Refers to a preparation or plant extract that has had at least one contamination removed or a desired component removed from the environment. In certain embodiments the plant extract can be purified by using any of the following methods: distillation, recrystallization or precipitation; solvent partitioning, chromatographic separation or other suitable methods.

As used herein, ?major active ingredient? or ?major active component? Refers to a compound or compounds that are active and capable of atleast one biological activity. In some embodiments, the active compound or compounds enriched in an extract are a major ingredient. In general, a major active component will confer, directly or indirect, the majority (i.e. greater than 50%), of one or several measurable biological effects or activities as compared to extract components. In some embodiments, the major active ingredient can be a minor component of an extract by weight (e.g. less than 50% or 25% of the components in the extract), but still provide the majority of the biological activity. Minor active ingredients may be present in any composition of the disclosure that contains a major ingredient. These minor actives may or may NOT contribute to the pharmaceutical activity or vaginal function of the enriched formulation, but they may or may never do so.

?Effective amount? “?Effective amount? This is the amount of a composition in this disclosure that, when administered to female mammals, such as humans, is sufficient to achieve a desired biological treatment or effect. Examples include: (1) improving perineal elasticity or promoting it to reduce trauma during childbirth; (2) maintaining or supporting vaginal homeostasis or promoting it; (3) providing contraceptive action that inhibits sperm penetration and function; (4) improving fertility by maintaining sperm survival or function; or (5) toning vulvar or vagina This disclosure specifies the amount of a particular composition that is considered to be an “effective amount”. The amount of a composition of this disclosure that constitutes an?effective amount? will vary depending upon the formulation, severity of the condition, method of administration, duration of treatment or age of the subject being treated. But can be routinely determined by a person of ordinary skill with regard to their own knowledge and the disclosure.

Compositions for the Lower Reproductive Tract (LRT), also known as “LRT compositions” refer to combinations of ingredients in this disclosure that improve, promote, increase or manage a condition associated with the female vaginal ecosystem. Refers to combinations of ingredients in this disclosure which improve, promote or increase a condition related to the female vaginal eco-system. LRT supplements can be used, for example, to improve hydration or lubrication. They may also help to maintain a healthy vaginal microbiome. Examples of LRT compositions are xylose, Salvia extract and optionally one or more other ingredients that can be used in the vaginal eco-system, such as an increaser of viscosity, a surfactant or buffering agent, pH adjuster or osmolality adjustment, solvent or preservatives (paraben-free), or any substance useful to supplement, maintain or improve LRT homeostasis.

The ?vaginal microbiome? The?vaginal microbiome? Refers to the vaginal microbial community, its products and the host LRT.

?Biome-friendly? “?Biome-friendly?

The LRT compositions disclosed in the present disclosure can be administered to mammalian male or female subjects, including humans, bovines, canines, felines, equines, porcines, ovines, avians, rodents, lagomorphs, caprines, non-human primates, or exotic species.

Female Lower Reproductive Tract

The lower reproductive tract of a woman is comprised of the vulva, the vagina and the ectocervix, which is the visible portion inside the vagina that’s covered with squamous squamous. The ectocervix and vagina that make up the birth canal have a non-keratinized stratified, squamous squamous squamous squamous squamous containing numerous epithelial-anchored mucin-producing cells. The LRT is unique in terms of its mucous membrane physiology. LRT is the part of the female reproductive system that can be touched by lotions or creams. The products may be cosmetics, drugs or medical devices that are used to treat disease, assist in reproduction, or for personal hygiene.

The vulva is made up of the labia majora and minora as well as Bartholin’s glands and clitoris. External genitals serve three main functions: they allow sperm into the body, protect the internal genitals from infection and provide sexual pleasure. Mons pubis, labia majora, and mucus-producing glands are all lined by skin. Labia minora has a mucosal layer that is moist and is maintained hydrated by mucus-secreting cells, just like the vagina. Bartholin glands secrete mucus to lubricate during sexual activity.

LRT Homeostasis and Function”.

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