Compositions comprising beta-alanine and uses thereof

Abstract

In an aspect, a method for applying beta-alanine to a tissue surface is described. The method may comprise applying a composition comprising from about 0.01 % w / w to about 5.0 % w / w beta-alanine to a tissue surface. The beta-alanine may comprise between about 0.08 % w / w to about 2 % w / w. The tissue surface may be suffering from a condition. The tissue surface may be from the group consisting of epidermis, mucosal membrane, respiratory tract lining, urinary tract lining, and reproductive tract lining. In another aspect a composition may comprise from about 0.01 % w / w to about 5.0 % w / w beta-alanine; water; an emulsifying component; and a fat. The fat may be an emollient or a moisturizing component.

Description

Compositions Comprising Beta- Alanine and Uses ThereofCROSS-REFERNCE TO RELATED APPLICATIONS

[0001] The application claims priority under 35 U.S.C. § 119(e) to United States Provisional Patent Application No. 63 / 673,856 titled “ Beta-alanine as a new aid for skin dysfunction,” filed July 22, 2024, and also claims priority under 35 U.S.C. § 119(e) to United States Provisional Patent Application No. 63 / 756,853 titled “ Kosmotrope Betain for Skincare,” filed February 11, 2025.TECHNICAL FIELD

[0002] This disclosure relates to compositions containing beta-alanine. More specifically this disclosure relates to the treatment of tissues utilizing compositions containing beta-alanine.BACKGROUND

[0003] The body’s tissue barrier layers are specialized structures that protect internal organs and regulate the exchange of substances between the body and the environment. The skin is the largest organ of the human body, acting as a dynamic barrier that protects underlying tissues from physical injury, pathogens, and harmful environmental agents. The skin supports immune defense and wound healing, hosting specialized cells that detect infections and facilitate tissue repair. Despite its resilience, the skin is susceptible to a range of ailments. Common conditions include dermatitis (inflammation causing redness and itching), eczema (chronic, itchy inflammation), psoriasis (autoimmune-driven scaling and thickening), and acne (blockage and inflammation of hair follicles). Other tissue barriers are also susceptible to damage and disease.SUMMARY

[0004] In an aspect, a method for applying beta-alanine to a tissue surface is described. The method may comprise applying a composition comprising from about 0.01 % w / w to about 5.0 % w / w beta-alanine to a tissue surface. The beta-alanine may comprise between about 0.08 % w / w to about 2 % w / w.

[0005] The tissue surface may be suffering from a condition. The tissue surface may be from the group consisting of epidermis, mucosal membrane, respiratory tract lining, urinary tract lining, and reproductive tract lining.

[0006] The method may further comprise treating the condition affecting the tissue surface. The condition may be from the group consisting of inflammation, eczema, herpes simplex virus 1 (HSV1), psoriasis, acne, aging, wound, dry skin, cracked skin, canker sores, sun damage, and / or scars. A tissue surface with a wound, treated with the composition may result in healing time faster than an identical tissue surface, with an identical wound, not treated with the composition.

[0007] The tissue surface, with the wound, treated with the composition may result in healing time faster than the identical tissue surface, with the identical wound, not treated with the composition.

[0008] In another aspect a composition may comprise from about 0.01 % w / w to about 5.0 % w / w beta-alanine; water; an emulsifying component; and a fat. The fat may be an emollient or a moisturizing component. The moisturizing component may be from the group consisting of coconut oil, colloidal oatmeal, mango butter, shea butter, cocoa butter, kukui butter, macadamia butter, and glycerin. The moisturizing component may comprise two or more of coconut oil, colloidal oatmeal, mango butter, shea butter, cocoa butter, kukui butter, macadamia butter, and / or glycerin. The emulsifying component, of embodiment fifteen, is from the list consisting of emulsifying wax, lecithin, polysorbate, cetearyl alcohol, sodium lauryl sulfate, and behentrimonium methosulfate.

[0009] Further aspects and embodiments are provided in the foregoing drawings, detailed description and claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The following drawings are provided to illustrate certain embodiments described herein. The drawings are merely illustrative and are not intended to limit the scope of claimed inventions and are not intended to show every potential feature or embodiment of the claimed inventions. The drawings are not necessarily drawn to scale; in some instances, certain elements of the drawing may be enlarged with respect to other elements of the drawing for purposes of illustration.

[0011] Figure 1 is a representation of eczema.

[0012] Figure 2 is a representation of skin and the tight junctions between cells.

[0013] Figure 3 is graph of a cell proliferation assay representing psoriasis.

[0014] Figure 4 is photos of Keratinocytes grown to confluency (filled the well), then scratched to create a “wound.” Cells were allowed to grow for 24 hours and fill the wounded space. Cells were untreated or treated with [3-ala. Time lapse of 8 h post administration of P - ala in different concentrations.

[0015] Figure 5 are photos of tests done in-vitro with primary human keratinocytes. No images are shown for the 24h state of treatment group. The Oh image is a representation of the starting state of both treatment and no treatment groups. 1% Easey (green) was a treatment with 1% beta-alanine.

[0016] Figure 6 is photos of skin treated with the composition a before treatment and after treatment photo.

[0017] Figure 7 is photos of skin treated with the composition a before treatment and after treatment photo.

[0018] Figure 8 is photos of skin suffering from dry cracked skin and treated with the composition. Day 0 is a before treatment and Day 2 is 2 days after treatment.

[0019] Figure 9 is photos of skin suffering from eczema treated with the composition a before treatment and after treatment photo. Day 0 is a before treatment and Day 10 is 10 days after treatment.

[0020] Figure 10 is a graph which represents the effect of P-alanine on the Experimental Slope according to our Flow Cytometry (FACS) protocols. E. Coli cells (BL21DE3) without any protein or overexpressing CLDN1 or CLDN5 were exposed to 1% P-alanine.Experimental Slopes (Arbitrary Units) for cells BL21DE3 and cells expressing CLDN1 or CLDN5 are shown. Statistically both CLDN1 and CLDN5 Experimental Slopes are significantly different (p<0.01). In the presence of 1% P-alanine only CLDN1 had an Experimental Slope significantly different that the untreated (None) CLDN 1. Each data point was collected 48 replicates. Graph bars represent the Experimental Slope and Standard Deviation. Experimental Slope) were analyzed using SAS software version 9 (SAS InstituteInc., Cary, NC, USA) and the Mixed Procedure method to generate p-values, standard deviation. * corresponds to p<0.01.

[0021] Figure 11 is Keratinocytes in culture exposed for 24 h to a Chaotrope or a Kosmotrope. A) untreated B) 0.05% Urea (Chaotrope), C) 0.1 % Betaine (Kosmotrope). Cell congregate and organize themselves above of that untreated and Urea treated. This indicates the ability of Betaine to induce stability in a system by favoring water network creation and stabilizing proteins and membranes (phospholipid organization).

[0022] DETAILED DESCRIPTION

[0023] The following description recites various aspects and embodiments of the inventions disclosed herein. No particular embodiment is intended to define the scope of the invention. Rather, the embodiments provide non-limiting examples of various compositions, and methods that are included within the scope of the claimed inventions. The description is to be read from the perspective of one of ordinary skill in the art. Therefore, information that is well known to the ordinarily skilled artisan is not necessarily included.Definitions

[0024] The following terms and phrases have the meanings indicated below, unless otherwise provided herein. This disclosure may employ other terms and phrases not expressly defined herein. Such other terms and phrases shall have the meanings that they would possess within the context of this disclosure to those of ordinary skill in the art. In some instances, a term or phrase may be defined in the singular or plural. In such instances, it is understood that any term in the singular may include its plural counterpart and vice versa, unless expressly indicated to the contrary.

[0025] As used herein, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. For example, reference to “a substituent” encompasses a single substituent as well as two or more substituents, and the like.

[0026] As used herein, “for example,” “for instance,” “such as,” or “including” are meant to introduce examples that further clarify more general subject matter. Unless otherwise expressly indicated, such examples are provided only as an aid for understandingembodiments illustrated in the present disclosure and are not meant to be limiting in any fashion. Nor do these phrases indicate any kind of preference for the disclosed embodiment.

[0027] The body’s tissue barrier layers are specialized structures that protect and regulate the exchange of substances between the body and the environment. The outermost and most familiar is the skin’s epidermis, composed primarily of keratinized stratified squamous epithelial cells, which forms a nearly impermeable barrier against dehydration, pathogens, and harmful chemicals. Beneath the skin, mucous membranes line internal surfaces such as the gastrointestinal, respiratory, and genitourinary tracts. These barriers, typically formed of non-keratinized stratified or simple columnar epithelium, secrete mucus that traps debris and microbes, aiding defense while allowing selective absorption and secretion.

[0028] Within blood vessels and the heart, a simple squamous epithelial layer called the endothelium provides a smooth, semi-permeable interface, regulating fluid, nutrient, and immune cell movement from the blood into surrounding tissues. Likewise, serous membranes (mesothelium) line body cavities and organs — such as the pleura around the lungs and the peritoneum in the abdomen — minimizing friction while maintaining compartmentalization and selective permeability.

[0029] Beyond these epithelial barriers, tight junctions between adjacent cells prevent unwanted molecules from passing through the cell layers, while specialized proteins — such as occludins and claudins — help maintain the integrity of the boundary.

[0030] The skin is the largest organ of the human body, acting as a dynamic barrier that protects underlying tissues from physical injury, pathogens, and harmful environmental agents. It performs several vital functions: regulating body temperature through sweat production and blood flow; preventing dehydration by limiting water loss; synthesizing vitamin D when exposed to sunlight; and enabling sensory perception via a dense network of nerve endings. Additionally, the skin supports immune defense and wound healing, hosting specialized cells that detect infections and facilitate tissue repair.

[0031] Despite its resilience, the skin is susceptible to a range of ailments. Common conditions include dermatitis (inflammation causing redness and itching), eczema (chronic, itchy inflammation), psoriasis (autoimmune-driven scaling and thickening), and acne (blockage and inflammation of hair follicles). Fungal, bacterial, and viral infections can compromise skin integrity, while allergens and irritants may provoke reactions such as hivesor contact dermatitis. The skin is also vulnerable to benign and malignant growths, from moles to various forms of skin cancer due to excessive ultraviolet exposure. Aging, genetics, and environmental stressors further influence the skin’s appearance and health, giving rise to wrinkles, pigment changes, and decreased elasticity.

[0032] Eczema, also known as atopic dermatitis, is a chronic, inflammatory skin condition marked by dry, itchy, and irritated patches of skin. It commonly begins in childhood but can affect people of all ages and is not contagious. Eczema weakens the skin’s barrier function, making it less able to retain moisture and protect against irritants, allergens, and environmental factors. Symptoms often include intense itching, redness, dryness, scaly or thickened skin, and in some cases, oozing, crusting, or blistering. The location and appearance of the rash often vary by age, but it frequently affects creases behind the knees and elbows, as well as the face, neck, wrists, and ankles.

[0033] The exact cause of eczema is not fully understood, though it is known to involve a combination of genetics, a compromised skin barrier, abnormal immune responses, and environmental triggers such as heat, stress, certain fabrics, soaps, fragrances, allergens, and weather changes. Flare-ups tend to occur when these triggers are encountered, leading to cycles of exacerbation and remission. There is a strong hereditary component — people with a family history of eczema, asthma, or hay fever are at higher risk. Scratching induced by persistent itching can worsen the condition, often resulting in thickened or lichenified skin and raising the risk of skin infections. There is no cure for eczema, however, symptoms can be managed with regular moisturizing, avoidance of known triggers, and, when necessary, treatments such as topical corticosteroids, calcineurin inhibitors, antihistamines, and, in severe cases, systemic medications or phototherapy.

[0034] Psoriasis is a chronic, noncontagious autoimmune disease characterized by the development of thick, red or discolored patches of skin covered with silvery-white or gray scales. These patches, known as plaques, often appear on the scalp, elbows, knees, trunk, hands, feet, and lower back, but they can affect almost any area of the body, including the nails, which may become pitted, discolored, or separated from the nail bed. The affected skin can be itchy, sore, and sometimes crack or bleed. Psoriasis results from an overactive immune system that speeds up the growth cycle of skin cells, causing new cells to form in days rather than weeks and to pile up on the surface of the skin. The exact cause is not fully understood, but it is believed to involve a combination of genetic predisposition andenvironmental triggers — such as infections, certain medications, skin injuries, stress, smoking, or heavy alcohol use — that set off the immune system’s inappropriate response. There are several types of psoriasis, with plaque psoriasis being the most common, but others include guttate, inverse, pustular, and erythrodermic psoriasis, each with varying symptoms and severity. Psoriasis can also be associated with joint inflammation known as psoriatic arthritis, which causes pain and swelling in the joints and, if left untreated, can lead to permanent damage. The disease course is typically relapsing and remitting, meaning people with psoriasis may experience cycles of flare-ups and periods where symptoms decrease.

[0035] Wound healing is a complex, dynamic process by which the body repairs tissue damage and restores the integrity of the skin or other organs following injury. It occurs in several overlapping phases: hemostasis, inflammation, proliferation, and remodeling. Immediately after injury, hemostasis prevents blood loss through vessel constriction and clot formation. This is quickly followed by the inflammatory phase, in which immune cells, such as neutrophils and macrophages, migrate to the wound site to remove debris, bacteria, and damaged tissue while releasing growth factors and cytokines that orchestrate subsequent healing steps. In the proliferative phase, new tissue forms as fibroblasts produce collagen and extracellular matrix components, and new blood vessels develop to bring nutrients and oxygen through a process called angiogenesis. Epithelial cells migrate and proliferate to cover the wound surface. Finally, in the remodeling phase, collagen fibers are reorganized and strengthened, and the tissue gradually regains its normal structure and function, though sometimes with residual scarring. The efficiency of wound healing can be influenced by factors such as age, nutritional status, underlying health conditions (like diabetes), infection, and the wound’s size and depth. When healing proceeds normally, this intricate sequence restores barrier function and protects the body from further harm.

[0036] Cell-cell interactions, often referred to as tight junctions, are connections between adjacent epithelial cells. (See Figure 2) Tight junctions may be composed of transmembrane proteins such as claudins, occludins, and junctional adhesion molecules (JAMs). The main function of tight junctions is to act as a regulatory barrier — preventing the unregulated passage of water, ions, and solutes through the paracellular pathway (the space between cells), thus maintaining the distinct composition of bodily compartments, such as the intestinal lumen and the bloodstream. Additionally, tight junctions work as molecular "fences," preserving cell polarity by restricting the mixing of membrane proteins and lipidsbetween the apical and basolateral surfaces of the cell. This ensures proper directional transport and organ function. Tight junctions are dynamic structures whose permeability can be modified by physiological stimuli, cytokines, pathogens, or injury. When disrupted, these barriers contribute to the development of inflammation, disease, certain skin disorders, and tissue integrity.

[0037] The skin is the largest organ in the body. The cells are organized to produce a barrier that protects the body and regulates water volume and temperature. The cell-cell interactions necessary for these properties of skin cells rely on proteins on the surface of the cells called claudins. Claudius are a family of 27 proteins but in particular claudin-1 is the main protein responsible for the proper function of the skin. We have determined that beta-alanine (a non- essential amino acid that is produced naturally in the body) can be used to strengthen the claudin-1 to claudin-1 interactions, improving skin barrier properties. Dysfunction of the skin barrier is responsible for wounds, infections through wounds, atopic dermatitis (for example, Eczema) and many other conditions. Using beta-alanine in topical applications may improve wound healing, prevent infections, fight viral infections, help treat atopic dermatitis and many other skin conditions. Additionally, for individuals with dry skin (weak skin barrier that loses too much water) beta-alanine may help alleviate the consequences of this condition and restore smooth and or youthful skin. The physical indicators of aging, such as wrinkles and dark spots may also be alleviated by the application of beta-alanine, leading to smooth and youthful skin.

[0038] Beta-alanine may strengthen claudin-1 interactions within the cell membrane and between claudin-1 proteins in neighboring cells in the skin to increase the barrier function. This may prevent invasion of microorganisms, moisturize the skin, protect against unhealthy cellular events triggered by decreased barrier as in atopic dermatitis, or even immune attacks that may increase inflammation and dry skin like Psoriasis. Beta-alanine may affect or improve certain conditions including but not limited to psoriasis, eczema, and other atopic dermatitis, pemphigus, rosacea, ichthyosis, hidradenitis suppurativa, epidermolysis bullosa, acne, and others. Beta-alanine may also affect wound healing, prevention of infection without antibiotics, moisturizing, and other problems of the skin beyond ailments and conditions, such as aging, wrinkles, scars, and dark spots.

[0039] Beta-alanine is a non-essential, naturally occurring beta amino acid with the chemical formula C3H7NO2 and the IUPAC name 3-aminopropanoic acid. Unlike the more commonalpha-alanine, beta- alanine’s amino group is attached to the beta-carbon — two carbons away from the carboxyl group — making it the only naturally occurring beta amino acid in humans, animals, and many microorganisms. It is not used directly for protein synthesis and does not have a stereocenter, so it lacks isomers. Beta- alanine is produced in the body through the breakdown of compounds like dihydrouracil and carnosine and is highly soluble in water, existing as a colorless, odorless crystalline powder.

[0040] Betaine is a nontoxic, natural substance found in plants, animals, and microorganisms. It's also known as trimethylglycine, Betaine may be a methyl group donor that functions in the normal metabolic cycle of methionine. It is a naturally occurring choline derivative commonly ingested through diet, with a role in regulating cellular hydration and maintaining cell function.

[0041] Betaine is a Kosmotrope and may act by stabilizing protein structure by organizing water molecules in the hydration radius of proteins and also enhancing water molecule networks that contribute to hydration and repel hydrophobic molecules or structures.

[0042] Betaine may enhance hydration of skin by creating extensive water molecule networks that contribute to hydration. This may create a three-dimensional network that surrounds and interacts with polar molecules like proteins, allowing them to dissolve in water. These networks may assist in maintaining protein structure and function by mediating interactions between different parts of the molecule and with its environment. Betaine may decrease the interactions of hydrophobic debris that arises from dead skin or lesions in the skin.

[0043] A moisturizing cream is a topical skincare product formulated to hydrate, protect, and restore the skin’s barrier by delivering and locking in moisture.

[0044] Cell-cell interactions, often referred to as tight junctions, are connections between adjacent epithelial cells. The tight junctions form a barrier to the passage of molecules and ions through the space between cells.

[0045] For treatment of certain conditions beta-alanine may be contained in a composition. The composition may be included in but not limited to any of the following: cream, soap, ointment, serum, soak, gel, powder, bath bomb, patch , mouthwash, toothpaste, lip balm,mist, aerosol, shampoo, conditioner, paste, sunscreen, or cosmetics including but not limited to; foundation, primer, concealer, paste, lip stick, or primer.

[0046] In some embodiments, the beta- alanine comprises from about 0.01 % w / w to about 5.0 % w / w. In some embodiments, the beta-alanine comprises from about 0.08 % to about 2 % w / w. In some embodiments, the beta-alanine comprises about 0.01, 0.02, 0.03, 0.04, 0.05,0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.20, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31, 0.32, 0.33, 0.34, 0.35, 0.36, 0.37, 0.38, 0.39, 0.40, 0.41, 0.42, 0.43, 0.44, 0.45, 0.46, 0.47, 0.48, 0.49, 0.50, 0.51, 0.52, 0.53, 0.54, 0.55, 0.56, 0.57, 0.58, 0.59, 0.60, 0.61, 0.62, 0.63, 0.64, 0.65, 0.66, 0.67, 0.68, 0.69, 0.70, 0.71, 0.72, 0.73, 0.74, 0.75, 0.76, 0.77, 0.78, 0.79, 0.80, 0.81, 0.82, 0.83, 0.84, 0.85, 0.86, 0.87, 0.88, 0.89, 0.90, 0.91, 0.92, 0.93, 0.94, 0.95, 0.96, 0.97, 0.98, 0.99, 1.00, 1.01, 1.02, 1.03, 1.04, 1.05, 1.06, 1.07, 1.08, 1.09, 1.10, 1.11, 1.12, 1.13, 1.14, 1.15, 1.16, 1.17, 1.18, 1.19, 1.20, 1.21, 1.22, 1.23, 1.24, 1.25, 1.26, 1.27, 1.28, 1.29, 1.30, 1.31, 1.32, 1.33, 1.34, 1.35, 1.36, 1.37, 1.38, 1.39, 1.40, 1.41, 1.42, 1.43, 1.44, 1.45, 1.46, 1.47, 1.48, 1.49, 1.50, 1.51, 1.52, 1.53, 1.54, 1.55, 1.56, 1.57, 1.58, 1.59, 1.60, 1.61, 1.62, 1.63, 1.64, 1.65, 1.66, 1.67, 1.68, 1.69, 1.70, 1.71, 1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, 1.80, 1.81, 1.82, 1.83, 1.84, 1.85, 1.86, 1.87, 1.88, 1.89, 1.90, 1.91, 1.92, 1.93, 1.94, 1.95, 1.96, 1.97, 1.98, 1.99, 2.00, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.10, 2.11, 2.12, 2.13, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19, 2.20, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40, 2.41, 2.42, 2.43, 2.44, 2.45, 2.46, 2.47, 2.48, 2.49, 2.50, 2.51, 2.52, 2.53, 2.54, 2.55, 2.56, 2.57, 2.58, 2.59, 2.60, 2.61, 2.62, 2.63, 2.64, 2.65, 2.66, 2.67, 2.68, 2.69, 2.70, 2.71, 2.72, 2.73, 2.74, 2.75, 2.76, 2.77, 2.78, 2.79, 2.80, 2.81, 2.82, 2.83, 2.84, 2.85, 2.86, 2.87, 2.88, 2.89, 2.90, 2.91, 2.92, 2.93, 2.94, 2.95, 2.96, 2.97, 2.98, 2.99, 3.00, 3.01, 3.02, 3.03, 3.04, 3.05, 3.06, 3.07, 3.08, 3.09, 3.10, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17, 3.18, 3.19, 3.20, 3.21, 3.22, 3.23, 3.24, 3.25, 3.26, 3.27, 3.28, 3.29, 3.30, 3.31, 3.32, 3.33, 3.34, 3.35, 3.36, 3.37, 3.38, 3.39, 3.40, 3.41, 3.42, 3.43, 3.44, 3.45, 3.46, 3.47, 3.48, 3.49, 3.50, 3.51, 3.52, 3.53, 3.54, 3.55, 3.56, 3.57, 3.58, 3.59, 3.60, 3.61, 3.62, 3.63, 3.64, 3.65, 3.66, 3.67, 3.68, 3.69, 3.70, 3.71, 3.72, 3.73, 3.74, 3.75, 3.76, 3.77, 3.78, 3.79, 3.80, 3.81, 3.82, 3.83, 3.84, 3.85, 3.86, 3.87, 3.88, 3.89, 3.90, 3.91, 3.92, 3.93, 3.94, 3.95, 3.96, 3.97, 3.98, 3.99, 4.00, 4.01, 4.02, 4.03, 4.04, 4.05, 4.06, 4.07, 4.08, 4.09, 4.10, 4.11, 4.12, 4.13, 4.14, 4.15, 4.16, 4.17, 4.18, 4.19, 4.20, 4.21, 4.22, 4.23, 4.24, 4.25, 4.26, 4.27, 4.28, 4.29, 4.30, 4.31, 4.32, 4.33, 4.34, 4.35, 4.36, 4.37,4.38, 4.39, 4.40, 4.41, 4.42, 4.43, 4.44, 4.45, 4.46, 4.47, 4.48, 4.49, 4.50, 4.51, 4.52, 4.53,4.54, 4.55, 4.56, 4.57, 4.58, 4.59, 4.60, 4.61, 4.62, 4.63, 4.64, 4.65, 4.66, 4.67, 4.68, 4.69,4.70, 4.71, 4.72, 4.73, 4.74, 4.75, 4.76, 4.77, 4.78, 4.79, 4.80, 4.81, 4.82, 4.83, 4.84, 4.85,4.86, 4.87, 4.88, 4.89, 4.90, 4.91, 4.92, 4.93, 4.94, 4.95, 4.96, 4.97, 4.98, 4.99, or 5.00 % w / w.

[0047] In some embodiments, the composition may include a fat. In some embodiments, the fat may be an oil, an emollient, or a moisturizing component. In some embodiments, the moisturizing component may be one or more of coconut oil, mango butter, shea butter, cocoa butter, kukui butter, macadamia butter, and glycerin.

[0048] In some embodiments, the moisturizing component may be colloidal oatmeal.

[0049] In some embodiments, the composition may include an emulsifying component. In some embodiments, the emulsifying component may be one or more of emulsifying wax, lecithin, polysorbate, cetearyl alcohol, sodium lauryl sulfate, and behentrimonium methosulfate.

[0050] In some embodiments, the composition may include aloe vera.

[0051] In some embodiments, the composition may include an anti-microbial component. In some embodiments, the anti-microbial component may be a preservative. In some embodiments, the preservative may be optiphen plus.

[0052] In some embodiments, the composition may include glycerin.

[0053] In some embodiments, the composition may be used to treat a condition affecting a tissue. The conditions may include inflammation, eczema, herpes simplex 1 (HSV1), psoriasis, acne, aging, wound, dry skin, cracked skin, canker sores, sun damage, and / or scars.

[0054] The composition may be applied to a tissue. The composition may be applied to the surface of the tissue. The tissue may include epidermis, mucosal membrane, respiratory tract lining, urinary tract lining, and reproductive tract lining.

[0055] In embodiments, the application of the composition may increase the growth of cells as compared to the growth of identical cells not applied the composition. In some embodiments, the application of the composition to cells may increase the growth of the cells by more than three times as compared to cells not applied the composition. In someembodiments, the application of the composition to cells may increase the growth of the cells by more than two times as compared to cells not applied the composition.

[0056] In some embodiments, the application of the composition to skin results in a reduction of redness after less than 15 days as compared to the same location before the application of the composition. In some embodiments, the application of the composition to skin results in a reduction of redness after less than 10 days as compared to the same location before the application of the composition. In some embodiments, the application of the composition to skin results in a reduction of redness after less than 2 days as compared to the same location before the application of the composition.

[0057] In some embodiments, the application of the composition to skin results in a reduction of acne pimples after less than 15 days as compared to the same location before the application of the composition. In some embodiments, the application of the composition to skin results in a reduction of acne pimples after less than 10 days as compared to the same location before the application of the composition. In some embodiments, the application of the composition to skin results in a reduction of acne pimples after less than 2 days as compared to the same location before the application of the composition.

[0058] In some embodiments, the application of the composition to skin results in a reduction of dryness as compared to skin of the same application location before the application of the composition. In some embodiments, the reduction of dryness, following the application of the composition, is increased by more than ten times. In some embodiments, the reduction of dryness, following the application of the composition, is increased by more than seven times.

[0059] In some embodiments, the application of the composition to skin, suffering from acne, results in a reduction in redness as compared to skin of the same application location prior to the application of the composition. In some embodiments, the application of the composition to skin, suffering from acne, results in a reduction of from about 35 % to about 65% in redness as compared to skin of the same application location prior to the application of the composition. In some embodiments, the application of the composition to skin, suffering from acne, results in a reduction of about 50 % in redness as compared to skin of the same application location prior to the application of the composition. In some embodiments, the application of the composition to skin, suffering from acne, results in a reduction of about 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60,61, 62, 63, 64, or 65 % in redness as compared to skin of the same application location prior to the application of the composition.

[0060] In some embodiments, application of the composition to cells results in a decrease in inflammation markers as compared to identical cells not receiving the application of the composition. In some embodiments, the cells may be keratinocytes. In some embodiments, the inflammation markers may be IL-13 and / or IL-4. In some embodiments, application of the composition to cells results in a decrease in inflammation markers from about 20 % to about 45 % as compared to identical cells not receiving the application of the composition. In some embodiments, application of the composition to cells results in a decrease in inflammation markers from about 25 % to about 38 % as compared to identical cells not receiving the application of the composition. In some embodiments, application of the composition to cells results in a decrease in inflammation markers of about 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, or 45 as compared to identical cells not receiving the application of the composition.

[0061] In some embodiments, application of the composition to cells results in an increase of CLDN1 proteins as compared to cells not receiving the application of the composition. In some embodiments, application of the composition to cells results in an increase of CLDN1 proteins of from about 5 % to about 15 % as compared to cells not receiving the application of the composition. In some embodiments, application of the composition to cells results in an increase of CLDN1 proteins of about 10 % as compared to cells not receiving the application of the composition. In some embodiments, application of the composition to cells results in an increase of CLDN1 proteins of about 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 % as compared to cells not receiving the application of the composition.

[0062] In a first embodiment, a method for applying beta-alanine to a tissue surface comprises applying a composition comprising from about 0.01 % w / w to about 5.0 % w / w beta-alanine to a tissue surface.

[0063] In a second embodiment, the beta-alanine of the method of the first embodiment comprises between about 0.08 % w / w to about 2 % w / w.

[0064] In a third embodiment, the tissue surface, of the method of the first embodiment, is suffering from a condition.

[0065] In a fourth embodiment, the tissue surface, is from the group consisting of epidermis, mucosal membrane, respiratory tract lining, urinary tract lining, and reproductive tract lining.

[0066] In a fifth embodiment, applying the composition, of the method of embodiment 1, comprises treating the condition affecting the tissue surface.

[0067] In a sixth embodiment, the condition of the fifth embodiments is from the group consisting of inflammation, eczema, herpes simplex virus 1 (HSV1), psoriasis, acne, aging, wound, dry skin, cracked skin, canker sores, sun damage, and / or scars.

[0068] In a seventh embodiment, a tissue surface of embodiment four, with a wound, treated with the composition results in healing time faster than an identical tissue surface, with an identical wound, not treated with the composition.

[0069] In an eighth embodiment, the tissue surface, with the wound, of embodiment seven, treated with the composition results in healing time faster than the identical tissue surface, with the identical wound, not treated with the composition.

[0070] In a ninth embodiment, a tissue surface of embodiment six, suffering from acne, treated with the composition results in a reduction of redness as compared to an identical tissue surface, suffering from acne, not treated with the composition.

[0071] In a tenth embodiment, a tissue surface of embodiment nine, suffering from acne, treated with the composition results in a reduction of redness, of from about 35 % to about 65 %, as compared to an identical tissue surface, suffering from acne, not treated with the composition.

[0072] In an eleventh embodiment, a tissue surface of embodiment six, suffering from dry, cracked skin treated with the composition heals faster than an identical tissue surface suffering from dry, cracked skin not treated with the composition.

[0073] In a twelfth embodiment, a tissue surface of embodiment eleven, suffering from dry, cracked skin, treated with the composition heals from about 4 times to about 12 times faster than a tissue surface suffering from dry, cracked skin not treated with the composition.

[0074] In a thirteenth embodiment, a tissue surface of embodiment six, suffering from eczema, treated with the composition results in clearing of lesions faster than a tissue surface, suffering from eczema, not treated with the composition.

[0075] In a fourteenth embodiment, a tissue surface of embodiment six, suffering from inflammation, treated with the composition results in a reduction of inflammation markers as compared to a tissue surface, suffering from inflammation, not treated with the composition.

[0076] A fifteenth embodiment is a composition comprising from about 0.01 % w / w to about 5.0 % w / w beta- alanine; water; an emulsifying component; and a fat.

[0077] In a sixteenth embodiment, the fat, of embodiment fifteen, is an emollient or a moisturizing component.

[0078] In a seventeenth embodiment, the moisturizing component, of embodiment fifteen, is from the group consisting of coconut oil, colloidal oatmeal, mango butter, shea butter, cocoa butter, kukui butter, macadamia butter, and glycerin.

[0079] In an eighteenth embodiment, the moisturizing component, of embodiment seventeen, comprises two or more of coconut oil, colloidal oatmeal, mango butter, shea butter, cocoa butter, kukui butter, macadamia butter, and / or glycerin.

[0080] In a nineteenth embodiment, the emulsifying component, of embodiment fifteen, is from the list consisting of emulsifying wax, lecithin, polysorbate, cetearyl alcohol, sodium lauryl sulfate, and behentrimonium methosulfate.

[0081] In a twentieth embodiment, the composition of embodiment 14, further comprises betaine.

[0082] Examples

[0083] Example 1

[0084] The following example is representative of one type of skin ailment, psoriasis. (Figure 3). A cell proliferation assay was performed. Keratinocytes were grown to 40 % confluency in 96 well plates. Several treatments were performed on the cells. A control. Cells treated with IL-4 and IL- 13. Cells treated with a composition comprising 1% beta- alanine. Cells treated with IL-4 and IL- 13 and a composition comprising 1% beta- alanine. The ATP in each well was measured. The ATP measured in the control was designated as 100%. The IL-4 and IL- 13 treated wells had increased levels of ATP, representing skin thickening. Treatment with the composition comprising 1% beta- alanine decreased the level of ATP. The test indicates a decrease in the factors representing psoriasis.

[0085] Example 2

[0086] Example 2 is a test to represent wound healing. (Figure 4). Keratinocytes were grown to confluency (filled the well), then scratched to create a “wound.” The cells were allowed to grow for 24 hours and fill the wounded space. Cells were untreated or treated with [3-ala. Time lapse of 8 h post administration of P -ala in different concentrations. Concentrations of 1%, 0.5%, and 0.1% were analyzed. Each of the concentrations showed reduction in the width of the “wound”. The test is a representation of skin wound healing. Concentrations of the composition from 0.1% to 1% showed similar healing.

[0087] Example 3

[0088] Example 3 is a second test to represent wound healing. (Figure 5). Keratinocytes were grown to confluency (filled the well), then scratched to create a “wound.” Cells were allowed to grow for 24 hours and fill the wounded space. Cells were untreated or treated with the composition comprising 1% beta- alanine. Untreated cells after 24 hours completed only 75% of wound closure. On the other hand, 1% bet-alanine composition promoted full closure within 12 hours. The cell growth is analogous to healing a wound in the body.

[0089] Example 4

[0090] Example 4 is an application of the composition comprising 1% beta-alanine. (Figure6). The composition was applied to the arm of a subject suffering from eczema. After six days the location where the composition was applied, showed a decrease in skin lesions.

[0091] Example 5

[0092] Example 5 is an application of the composition comprising 1% beta-alanine. (Figure7). The composition was applied to the hand of a subject suffering from eczema. After 4 days the location where the composition was applied, showed a decrease in skin lesions.

[0093] Example 6

[0094] Example 6 shows the application of the composition comprising 1% beta- alanine. (Figure 8). The composition was applied to dry cracked skin. The skin showed smoothing and healing after two days. This represented approximately a seven times increase in healing speed relative to no treatment.

[0095] Example 7

[0096] Example 7 shows the application of a composition comprising 2% beta-alanine. (Figure 9). The application of the composition to the skin of a subject suffering from eczema.The location where the composition was applied was evaluated after 10 days. The location where the composition was applied showed a reduction in redness and inflammation after 10 days. The location also showed a reduction in acne pimples after 10 days. Application of the composition therefore treats conditions affecting the skin.

[0097] Example 8

[0098] Example 8 shows a graph representing the effect of [3-alanine on the Experimental Slope according to Flow Cytometry (FACS) protocols. (Figure 10). E. Coli cells (BL21DE3) without any protein or overexpressing CLDN1 or CLDN5 were exposed to 1% [3-alanine. Experimental Slopes (Arbitrary Units) for cells BL21DE3 and cells expressing CLDN1 or CLDN5 are shown. Statistically both CLDN1 and CLDN5 Experimental Slopes are significantly different (p<0.01). In the presence of 1% [3-alanine only CLDN1 had an Experimental Slope significantly different that the untreated (None) CLDN 1. Each data point was collected 48 replicates. Graph bars represent the Experimental Slope and Standard Deviation. Experimental Slope) were analyzed using SAS software version 9 (SAS Institute Inc., Cary, NC, USA) and the Mixed Procedure method to generate p-values, standard deviation. * corresponds to p<0.01.

[0099] Example 9

[0100] Example 9 (Figure 11) shows photos of keratinocytes in culture exposed for 24 h to a Chaotrope or a Kosmotrope. A) untreated B) 0.05% Urea (Chaotrope), C) 0,1% Betaine (Kosmotrope). Cell congregate and organize themselves above of that untreated and Urea treated. This indicates the ability of Betaine to induce stability in a system by favoring water network creation and stabilizing proteins and membranes (phospholipid organization).

[0101] The invention has been described with reference to various embodiments and techniques. Nevertheless, it is understood that many variations and modifications may be made while remaining within the spirit and scope of the invention.

Claims

WHAT IS CLAIMED IS:

1. A method for applying beta-alanine to a tissue surface, the method comprising: applying a composition comprising: from about 0.01 % w / w to about 5.0 % w / w beta-alanine to a tissue surface.

2. The method according to claim 1, wherein the beta-alanine comprises between about 0.08 % w / w to about 2 % w / w.

3. The method according to claim 1, wherein the tissue surface is suffering from a condition.

4. The method according to claim 3, wherein the tissue surface is from the group consisting of epidermis, mucosal membrane, respiratory tract lining, urinary tract lining, and reproductive tract lining.

5. The method according to claim 3, wherein applying the composition comprises treating the condition affecting the tissue surface.

6. The method according to claim 5, wherein the condition is from the group consisting of inflammation, eczema, herpes simplex virus 1, psoriasis, acne, aging, wound, dry skin, cracked skin, canker sores, sun damage, and / or scars.

7. The method according to claim 6, wherein a tissue surface, with a wound, treated with the composition results in healing time faster than an identical tissue surface, with an identical wound, not treated with the composition.

8. The method according to claim 7, wherein the tissue surface, with the wound, treated with the composition results in healing time faster than the identical tissue surface, with the identical wound, not treated with the composition.

9. The method according to claim 6, wherein a tissue surface, suffering from acne, treated with the composition results in a reduction of redness as compared to an identical tissue surface, suffering from acne, not treated with the composition.

10. The method according to claim 9, wherein a tissue surface, suffering from acne, treated with the composition results in a reduction of redness, of from about 35 % to about 65 %, as compared to an identical tissue surface, suffering from acne, not treated with the composition.

11. The method according to claim 6, wherein a tissue surface, suffering from dry, cracked skin treated with the composition heals faster than an identical tissue surface suffering from dry, cracked skin not treated with the composition.

12. The method according to claim 11, wherein a tissue surface, suffering from dry, cracked skin, treated with the composition heals from about 4 times to about 12 times faster than a tissue surface suffering from dry, cracked skin not treated with the composition.

13. The method according to claim 6, wherein a tissue surface, suffering from eczema, treated with the composition results in clearing of lesions faster than a tissue surface, suffering from eczema, not treated with the composition.

14. The method according to claim 6, wherein a tissue surface, suffering from inflammation, treated with the composition results in a reduction of inflammation markers as compared to a tissue surface, suffering from inflammation, not treated with the composition.

15. A composition comprising: from about 0.01 % w / w to about 5.0 % w / w beta-alanine; water; an emulsifying component; and a fat.

16. The composition of claim 15, wherein the fat is an emollient or a moisturizing component.

17. The composition of claim 16, wherein the moisturizing component is from the group consisting of coconut oil, colloidal oatmeal, mango butter, shea butter, cocoa butter, kukui butter, macadamia butter, and glycerin.

18. The composition of claim 17, wherein the moisturizing component comprises two or more of coconut oil, colloidal oatmeal, mango butter, shea butter, cocoa butter, kukui butter, macadamia butter, and / or glycerin.

19. The composition of claim 15, wherein the emulsifying component is from the list consisting of emulsifying wax, lecithin, polysorbate, cetearyl alcohol, sodium lauryl sulfate, and behentrimonium methosulfate.

20. The composition of claim 14, further comprising betaine.

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