Topical medications

Abstract

Disclosed is a topical therapeutic product formulated for pain relief of wounded or damaged epidermis and mucosal tissue. The topical therapeutic product may comprise a pharma- ceutical effective amount of sodium pyruvate incorporated into various delivery vehicles, including sprays, soaks, emollient ointments, lotions, gels, roll-ons, and disposable products. In at least some embodiments, the topical therapeutic may be an admixture for existing skin care products. The topical therapeutic disclosed herein may alleviate symptoms of the body's inflammatory response to injury and side effects of various cancer treatments, providing patients with improved quality of life. Methods of using the topical therapeutic product to alleviate pain in affected areas are also disclosed.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority under 35 USC §119(e) to U.S. Provisional Patent Application Serial No. 63 / 301,804, filed January 21, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to topical therapeutic agents that can be applied in mammalian epidermal and mucosal tissues for the reduction and relief of pain caused by injury or the side effects of an inflammatory response, providing an improvement in the patient's quality of life. [Background technology]

[0003] Mammalian epidermis and mucosal disorders such as dermatitis, psoriasis, cheilitis, herpes, rhinitis, pharyngitis, and skin burns can result from factors including trauma, disease, and degenerative conditions caused by injury, age, genetics, and environmental exposure. Epidermal and mucosal damage typically results in symptoms including skin rashes, peeling, scaling, blisters, and open sores or ulcers that are often quite painful.

[0004] Additionally, epidermal and mucosal tissue damage can recruit reactive oxygen species as part of an immune response that results in inflammation at the site of injury. Common treatments for pain relief in these types of injuries can include steroid compounds. However, this can cause problems such as imbalances in hormone levels, which can result in cascading problems including, but not limited to, liver problems, mental / behavioral problems, sore mouths, weakened nasal passages, stomach ulcers, thinning of the skin that bruises easily, and delayed wound healing.

[0005] Furthermore, while commonly performed medical and surgical procedures such as chemotherapy and radiation therapy in cancer treatment may be effective and often life-saving, they also come with painful and adverse side effects that patients must endure. Treatments such as radiation therapy can cause radiation burns to the outer layer of the general epidermis. Additionally, chemotherapy can cause sores and ulcers in the mouth, making it painful and almost impossible to eat or drink. As a result, patients undergoing chemotherapy often suffer from nutritional deficiencies and poor health.

[0006] In another application, hormone therapy may be used to treat or alleviate symptoms associated with breast and prostate cancer. Although hormone therapy may be effective in suppressing the growth of cancer, it comes with side effects including, but not limited to, increased risk of injury, bone loss; vaginal dryness, inflammation, itching; and scalp scaly and itchy. Furthermore, excess hormones may be excreted from the body in urine and feces, which can aggravate the rectal, urethral, ​​and vaginal areas, causing severe pain when urine or feces are passed.

[0007] Although prior therapies have attempted to alleviate these epidermal and mucosal damage, there is a need for topical treatments that provide rapid, immediate pain relief and that do not adversely affect or antagonize current treatment regimens. Thus, there is a need for therapeutic products that are readily available, effectively reduce and even temporarily relieve pain, promote cell and tissue repair at the site of injury, and improve the quality of life for patients with short-term and long-term epidermal and mucosal pain and injury. Summary of the Invention [Problem to be solved by the invention]

[0008] Various embodiments provide a topical therapeutic system with multifaceted benefits for relieving pain, promoting cell and tissue repair, and improving quality of life in patients suffering from epidermal and mucosal damage and inflammatory responses due to reactive oxygen species production in the body. [Means for solving the problem]

[0009] In one aspect, the present disclosure provides a topical therapeutic product formulated to deliver a pharma- ceutically effective amount of sodium pyruvate to a target area of ​​injury or inflammation. In various embodiments, the delivery vehicle may include a spray, a soak, an emollient ointment, a lotion, a gel, a roll-on, or an impregnated disposable. In some embodiments, the topical therapeutic impregnated disposable may include a panty liner, a wipe, an eye patch, a diaper, an adhesive bandage, and a transepidermal patch. In various embodiments, the topical therapeutic spray may include a nasal spray, a throat spray, or a body spray. In at least some embodiments, the topical therapeutic product may be an admixture for a skin care product. Exemplary skin care products may include sunscreens, moisturizers, facial creams, facial masks, hand and body lotions, and scalp moisturizers.

[0010] In another aspect, the present disclosure provides a treatment method for alleviating epidermal and mucosal damage in a patient.In various embodiments, the method can include administering a topical therapeutic agent to the damaged area, and then delivering a pharmacologic effective amount of the topical therapeutic agent to the surface of the damaged area to provide pain relief.In some embodiments, the method can further include re-administering the topical therapeutic agent to the damaged area to provide continued pain relief.

[0011] In another aspect, the present disclosure provides a pharma- ceutically effective aqueous solution of sodium pyruvate. In some embodiments, the effective concentration of sodium pyruvate may be between about 100 mg / L and about 500 mg / L, about 150 mg / L and about 350 mg / L, and about 200 mg / L and about 250 mg / L. In some embodiments, the sodium pyruvate solution may be administered in saline. In other embodiments, the sodium pyruvate solution may be administered in saline and may further include about 5 wt% to about 10 wt% glycerin.

[0012] The details of one or more aspects of the disclosure are set forth in the following description. Other features, objects, and advantages of the techniques described in the present disclosure will become apparent from the specification and claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Various embodiments herein provide therapeutic products for treating damaged mammalian epidermal and mucosal tissue cells involving inflammatory responses resulting from the production of reactive oxygen species and tissue damage. The inflammatory response mediators and various therapeutic products disclosed herein reduce the undesirable cascading effects of the body's inflammatory response, provide direct pain relief in the damaged area, and improve the quality of life for patients suffering from naturally occurring symptoms or undergoing various treatments and therapies.

[0014] The following text may refer to or exemplify specific formulations and delivery systems, but is not intended to limit the scope of the present invention to such specific references or examples. For example, other delivery vehicles for topical therapeutic products are contemplated. The resulting product will achieve the same objective by reducing pain and promoting cell and tissue repair in the administration area where epidermal or mucosal damage has occurred.

[0015] Various modifications may be made by those skilled in the art based on practical and economic considerations, such as, for example, compatibility of materials used in the source and delivery medium, and damage characteristics of various epidermal and mucosal tissues. In order to more clearly and concisely describe the subject matter of the claims, the following definitions are intended to provide guidance as to the meaning of terms used in this application.

[0016] definition As used herein, the articles "a" and "an" mean "one or more" or "at least one," unless otherwise indicated. That is, the reference to any element of the invention by the indefinite article "a" or "an" does not exclude the possibility that more than one of the element is present.

[0017] "About" means plus or minus 10% of the referenced numerical indication.

[0018] "Admix" means that the disclosed sodium pyruvate is mixed into an existing product to provide added functionality.

[0019] "Antagonism" refers to an interaction between two or more drugs or therapies that have opposing effects on the body that may inhibit or reduce the effectiveness of one or more drugs or therapies.

[0020] "Antioxidants" refer to substances that help protect the surface of the skin from oxidative damage.

[0021] "Apply," "applying," "administering," or "administration" refers to applying a topical therapeutic agent to affected and adjacent areas of epidermal and mucosal tissue cells by spreading, gently rubbing, spraying, or by prolonged contact with the affected and adjacent areas.

[0022] The term "aqueous solution" refers to a solution in which a solute is dissolved in water.

[0023] "Cascading effect" refers to a series of unseen or unanticipated events that can lead to further adverse effects.

[0024] A "colloid bath" is a bath prepared by adding a soothing agent to the bath water to relieve skin irritation.

[0025] "Delivery vehicle" or "delivery system" refers to the manner in which topical therapeutic compounds are administered to affected areas of epidermal and mucosal tissue cells.

[0026] "General epidermis" refers to the outermost layer of the skin of the body.

[0027] "Micelle" refers to a mediator that allows for epidermal penetration of the sodium pyruvate formulation in the delivery vehicle.

[0028] A "patient" or "subject" refers to both human and non-human mammals receiving therapy or treatment.

[0029] "Pharmaceutically acceptable salt" refers to salt compounds that possess the desired pharmacological or therapeutic activity.

[0030] "Pharmaceutically effective" or "effective amount" refers to a nontoxic but sufficient amount of sodium pyruvate to provide the desired therapeutic effect.

[0031] "Reactive oxygen species" refers to a type of unstable molecule that contains oxygen and reacts with other molecules within cells during the body's immune response to injury.

[0032] "Superoxide" refers to a type of reactive oxygen species that reacts with other molecules within cells during the body's immune response to injury.

[0033] "Surfactant" refers to an additive to aqueous solutions to facilitate incorporation into oily or non-polar products.

[0034] Unless otherwise noted, all percentages are by weight.

[0035] Before discussing the details of the relevant disclosed embodiments, it is useful to understand the mechanisms of the body's inflammatory response.

[0036] In mammals, when disease or injury induces destruction of epidermal or mucosal tissue cells, activated macrophages release inflammatory mediators, including nitric oxide and other reactive oxygen species, inducing vasodilation, which widens blood vessels and thus increases blood volume while slowing blood flow. This reduced blood flow allows immune cells in the blood to leave the circulation and enter the injured tissue. In addition, nitric oxide and other reactive oxygen species also increase vascular permeability, resulting in blood leakage into the infected tissue. Localized concentration of fluid and plasma proteins aids in the concentration of proteins in the infected tissue. Thus, this influx of fluid is associated with symptoms of inflammation, such as swelling, redness, and fever in the injured area.

[0037] Additionally, during inflammatory responses, large amounts of superoxide can be produced, which is involved in blood vessel constriction and in the body's immune response to kill pathogens, but in excess also has negative side effects, such as oxidative breakdown in cells and tissue damage.

[0038] Antioxidant molecules such as pyruvate-based compounds that may act as a remedy against the undesirable effects of inflammatory responses due to reactive oxygen species are being explored. Sodium pyruvate, also known as pyruvate sodium salt, α-ketopropionic acid sodium salt, or 2-oxopropanoic acid sodium salt, is a potential candidate due to its commercial availability, therapeutic properties, and being naturally produced in the body during glycolysis. Moreover, the antioxidant properties of sodium pyruvate may interact favorably with injured cells and tissues to counteract excess superoxide production, thus promoting cell and tissue repair.

[0039] The acid form of pyruvate, also known as pyruvic acid, is widely used in skin peeling and superficial skin repair treatments. This treatment iteration utilizes millimolar concentrations of pyruvate compounds, which correspond to the concentrations the body uses for de novo skin repair. Various embodiments of the present disclosure describe products formulated from sodium pyruvate solutions ranging from about 100 mg / L to about 500 mg / L, about 150 mg / L to about 350 mg / L, and about 200 mg / L to about 250 mg / L. The time-dependent relief effect correlates to the molar concentration, depending on the specific topical application and co-ingredient design.

[0040] The following discussion includes a description of localized treatments to reduce pain in the area of ​​injury, alleviate inflammatory symptoms, and promote cell and tissue repair in accordance with the principles of the present disclosure. Alternative embodiments are also disclosed.

[0041] Topical therapeutic products for the relief of pain in epidermal and mucosal tissues One aspect of the present specification provides topical therapeutic products and methods for relieving pain in epidermis and mucosal tissues of mammals.Various topical therapeutic embodiments disclosed herein may include pharma- ceutically acceptable pyruvate sodium salt formulations that are solubilized and incorporated into various delivery vehicles or products that can be applied locally to damaged areas.Modes of locally administering the disclosed topical therapeutic agents include, but are not limited to, oral and nasal inhalation via spray, application of topical therapeutic agent to general epidermal damaged areas, and targeted application via disposable products that are saturated with therapeutic agent.

[0042] In some embodiments, the sodium pyruvate salt may first be solubilized in a preformulated product as the aqueous fraction of the product formulation to maintain the water percentage of the product formulation, and then further mixed with the product. In various embodiments, the topical therapeutic product may be water-based or oil-based, depending on the dosage or delivery vehicle. In some embodiments, the sodium pyruvate salt may be dissolved in water or a pharma- ceutically acceptable polar solvent for incorporation into an aqueous product. In another embodiment, the sodium pyruvate salt may first be dissolved in water or a polar solvent, and then incorporated into an emulsion, dispersion, gel, or hydrogel for incorporation into an oil-based product. In various embodiments, the topical therapeutic product may be primarily lipid. In this case, the sodium pyruvate solution may be combined with a surfactant to form micelles for incorporation into the lipid product environment. In an exemplary embodiment, about 5 wt% to about 10 wt% glycerin may be combined with sodium pyruvate as an emollient. In some embodiments, the sodium pyruvate salt may be incorporated into the aqueous or polar phase of a topical treatment product having both polar and non-polar phases.

[0043] In some embodiments, a concentrate of the sodium pyruvate formulation dosed in saline or saline and glycerin can be produced. This embodiment is a concentrated master batch sodium pyruvate formulation, where a pharma- ceutical effective amount of the master batch can be incorporated into various delivery vehicles or products for commercial production. According to one master batch embodiment, the sodium pyruvate may be a dry salt product for dissolving in solution to provide an in situ topical therapeutic product.

[0044] In various embodiments, the disclosed topical therapeutic agent can be delivered to the epidermis. In some embodiments, the topical therapeutic agent is applied directly to the skin as a lotion, an emollient ointment, a gel, or a roll-on. In some embodiments, the topical therapeutic agent can be delivered via a mucosal route. In an exemplary embodiment, the topical therapeutic agent can be delivered via a nasal spray or an oral spray.

[0045] In at least some embodiments, the topical therapeutic agent is an impregnated disposable item such as a transepidermal patch, an eye patch, a disposable tissue (wipe), a diaper, an adhesive bandage, or a panty liner.

[0046] In some embodiments, the topical therapeutic agent is an admixture for existing skin care products such as sunscreens, moisturizers, facial creams, disposable facial masks, hand and body lotions, and scalp moisturizers.

[0047] In some embodiments, the topical therapeutic agent is a soak. In some embodiments, a kit is provided that includes dry pyruvate, a solvent, and optionally saline or glycerin, for mixing the ingredients in situ for an immediate topical therapeutic soak to the injury site.

[0048] The exact dosage will be determined on a treatment basis, but in most cases some generalizations regarding dosage can be made. The present disclosure describes products formulated with sodium pyruvate in solutions ranging from about 100 mg / L to about 500 mg / L, from about 150 mg / L to about 350 mg / L, and preferably from about 200 mg / L to about 250 mg / L in millimolar concentrations.

[0049] When administering a pharma- ceutically acceptable salt, the dosage can be calculated as the free acid. The time-dependent relief effect correlates to the molar concentration, depending on the specific topical application and co-ingredient design. In some embodiments, the disclosed topical therapeutics can be administered 1-4 times a day, or as needed, depending on the severity and frequency of injury or inflammation.

[0050] In some embodiments, multiple concentrations of the same delivery vehicle may be provided depending on the severity of the injury or inflammation. In some embodiments, low dose topical therapeutics may be available over the counter, while higher dose topical therapeutics would require physician approval.

[0051] Products for Treatment One aspect of the present specification provides topical therapeutic products and methods for alleviating the surface damage of epidermis and mucosal tissue.The various topical therapeutic aspects disclosed herein may include pharma- ceutically acceptable pyruvate formulations that are mixed into various administration or delivery vehicles that can be applied locally to the damaged area.The multiple methods of locally administering the disclosed therapeutic agent include, but are not limited to, inhalation via aerosol, application of therapeutic product to the general epidermis damaged area, and targeted application via disposables that are impregnated with at least therapeutic agent.

[0052] The destruction of epidermal and mucosal tissues by injury recruits reactive oxygen species as part of the immune response. Such responses to the body's inflammatory response can be caused by, but are not limited to, impact; contusion; chemical, radiation, electrical, and thermal burns; diseases such as dermatitis, psoriasis, ulcers, and herpes; exposure of surface tissues to bodily fluids; environmental exposure such as UV radiation, and phytochemical hypersensitivity. In various embodiments, the dermatitis can be atopic dermatitis, contact dermatitis, or seborrheic dermatitis. In at least some embodiments, the surface burn can be a first-degree burn or a second-degree burn.

[0053] These lesions may be present anywhere on the body surface, including, but not limited to, the general epidermis, scalp, nasal cavities, mouth, throat, eyes, sites of semen discharge, urinary discharge, fecal discharge, and vaginal areas.

[0054] One aspect of the specification discloses a method for the relief of pain caused by these injuries and similar inflammatory responses, according to the invention of the present disclosure.

[0055] In various embodiments, damage to the epidermis and mucosal regions may be due to side effects of various medical treatments, including, but not limited to, hormone therapy, monoclonal antibody therapy, chemotherapy, and radiation therapy. In some embodiments, patients undergoing radiation cancer therapy may exhibit skin side effects such as itching, pain, peeling, and radiation burns. In various embodiments, damage to the skin may be due to chemical sensitivity to plant oils, such as, but not limited to, poison ivy, poison oak, and other poisonous or allergenic plants. In at least some embodiments, the damage may be sunburn due to prolonged exposure to the sun.

[0056] Patients undergoing hormone therapy are administered high concentrations of hormones that can be excreted in bodily fluids such as sweat, semen, vaginal secretions, urine, and feces. The presence of excess hormones in the excreted bodily fluids damages excretory sites such as sweat glands, urethra, vagina, rectum, and anus. Additionally, hormone therapy is associated with increased dryness and irritation in the eye area. Furthermore, damaged excretory sites can become further inflamed, causing further pain and medical problems. Topical therapeutic agents provide targeted relief and pain relief to these vulnerable areas.

[0057] In some embodiments, a broad spectrum topical therapeutic agent in the form of a lotion, gel, or body spray can be applied to the general epidermis to provide pain relief in the sweat glands. In other embodiments, a topical therapeutic agent impregnated disposable patch or transepidermal patch can be applied to targeted areas such as, but not limited to, the anal or vaginal area and areas near the eyes. In some embodiments, a therapeutic agent impregnated tissue can be used on the affected area as part of the cleansing process after the patient has voided urine or feces.

[0058] In various embodiments, patients undergoing radiation therapy may have radiation burns in irradiated areas of the skin and may exhibit dryness, itching, peeling, swelling, and open sores. Various embodiments of topical therapeutics may provide relief to these areas, providing both pain relief and protection from further infection. In some embodiments, broad spectrum topical therapeutics in the form of lotions or gels may be applied to the general epidermis, providing pain relief at the skin surface. In other embodiments, disposable or transepidermal patches saturated with topical therapeutics may be applied to the target area. In at least some embodiments, topical therapeutic impregnated tissues may be utilized as an alternative to colloid baths.

[0059] In addition, patients undergoing cancer treatment may develop sores in the oral cavity and throat, which may inhibit the intake of food and other nutrients due to a weakened immune system. In this case, the patient may not be able to consume the nutrients necessary to sustain themselves throughout cancer treatment, and as a result, may lose a lot of weight. As a result, the patient's vitality may be significantly reduced and cancer treatment may become less effective. To prevent such an undesirable chain reaction, oral sprays can be administered to relieve pain in the damaged areas of the oral cavity and pharynx, allowing the patient to painlessly consume the necessary foods and nutrients without discomfort, improving the quality of life of patients undergoing cancer treatment. In another embodiment, nasal sprays can be used to relieve pain in patients with sores or sores in the nasal cavity, providing a clear nasal passage for breathing.

[0060] In various embodiments, the topical treatment can be incorporated into a daily regimen, such as skin care. In some embodiments, the topical treatment can be an admixture for existing skin care products, such as sunscreens, moisturizers, facial creams, disposable facial masks, hand and body lotions, and scalp moisturizers, to provide relief from damage induced by environmental exposures, such as ultraviolet radiation that causes sunburn, and poisonous or allergenic plants that induce an inflammatory response in the contact area.

[0061] The topical therapeutic agent disclosed above may be administered before, after, or simultaneously with other treatments and therapies. The topical therapeutic agent disclosed above provides beneficial pain relief, promotes cell and tissue repair, and improves the quality of life of patients suffering from various skin injuries and disorders. Thus, the topical therapeutic agent disclosed above may be administered together with drugs or therapeutic agents without adding antagonistic effects.

[0062] Various embodiments of the present disclosure may be applied to non-human mammalian subjects. In some embodiments, the subject is a domestic pet, including but not limited to dogs, cats, hamsters, and non-human primates. In various embodiments, the subject is a large livestock animal, including but not limited to cows, horses, pigs, goats, and sheep. Common diseases, including but not limited to pruritus, inflammatory bowel disease, disc disease, and other skin conditions from ragweed pollen and non-toxic insect bites, induce inflammatory responses in non-human mammalian cells that manifest as irritation, dryness, warty, lumpy skin, and general pain and discomfort in at least animals. Currently, the only available treatments to alleviate these symptoms are steroid-based oral and topical products, which are associated with adverse side effects, including but not limited to frequent urination, diarrhea, constipation, increased agitation, aggressive behavior, and drug-induced illness. Various embodiments and methods discussed in this application may be used in veterinary medicine as an alternative to steroid-based treatments.

[0063] In various embodiments, topical treatments may be administered to injured or inflamed areas of the undercarriage, ears, nose, mouth, gums, and anal and rectal areas to reduce irritation, swelling, and pain. In some embodiments, topical treatments may be sprays to cover larger affected areas. In other embodiments, topical treatments may be soaks or wipes that may be applied as part of a bathing or washing process. EXAMPLES

[0064] Example 1: Patient A Setting: The study consisted of administering a topical therapeutic spray to patients with rhinitis and burning nose and throat as a result of persistent, long-term exposure to secondhand tobacco smoke. The spray was formulated with sodium pyruvate at a concentration of approximately 250 mg / L, administered to the nasal passages and throat in approximately 1 ml per spray, with 2-3 sprays per administration.

[0065] Summary: Patient A noted a reduction in burning or itching in the affected nose and throat areas within 15 minutes of the first dose. The spray treatment was reapplied two hours later. The second treatment resulted in complete relief of the burning sensation in both the nose and throat. The spray was applied prophylactically before bedtime. The pain and burning did not return.

[0066] Example 2: Patient B Setting: The study consisted of administering topical treatment tissues to patients suffering from epidermal lesions with psoriatic plaques. Patient B presented with psoriatic plaques on his back. Sodium pyruvate at a concentration of approximately 250 mg / L, combined with glycerin emollient, was administered to the affected areas via the impregnated tissue. Treatment was administered twice daily, once in the morning and once in the evening.

[0067] Summary: Patient B noted a reduction in burning or itching within 15 minutes of administration. With continued administration, the itching or burning did not recur and the skin surface returned to normal morphology. When topical therapy was discontinued, the plaques recurred along with the itching and burning.

[0068] Example 3: Patient C Setting: The study consisted of administering a topical therapeutic spray to patients suffering from epidermal lesions due to psoriatic plaques. Patient C presented with psoriatic plaques behind the ears and in the scalp area. Sodium pyruvate in a concentration of approximately 250 mg / L formulated with glycerin emollient was administered to the affected areas via an impregnated roll-on. Treatment was administered twice daily, once in the morning and once in the evening.

[0069] Summary: Patient C showed relief from burning and itching within 15 minutes of administration. With continued administration, the itching and burning did not recur and the skin surface returned to normal morphology. When administration was discontinued, the plaques recurred along with the itching and burning.

[0070] Example 4: Patient D Setting: The study consisted of administering topical therapeutic sprays and wipes to breast cancer patients suffering from generalized redness and burning of the epidermis and deep muscle pain following radiation therapy treatments. The patients received 30 daily radiation treatments over the course of just over a month. Medical staff encouraged the patients to moisturize the skin with petrolatum products, but the pain, burning, and redness were not alleviated. Sodium pyruvate in a concentration of approximately 250 mg / L with glycerin emollient was administered to the affected areas via impregnated wipes and sprays.

[0071] Summary: Patient D showed a reduction in the burning sensation without any blistering of the skin within 30 minutes after the first application of the impregnated cloth tissue. The topical treatment spray was used each time thereafter. After the topical treatment procedure and follow-up observation, the radiation oncologist remarked how unusual and unexpected it was that the usual browning of the affected area disappeared more rapidly than usual.

[0072] Example 5: Patient E Setting: This study consisted of administering topical therapeutic impregnated tissues to patients receiving concurrent chemotherapy, Taxotere and Carboplatin, along with monoclonal antibody infusion therapy. Side effects of cancer treatment included patients experiencing intense burning, itching and peeling in the urethra, vagina and anal areas due to the excretion of chemicals through urine and stool. Sodium pyruvate in a glycerin emollient tissue at a concentration of approximately 250 mg / L was used during discomfort as well as for washing the affected areas after excretion.

[0073] Summary: Patient E noted a reduction in burning and itching within an hour of the first dose. Sloughing of damaged skin stopped within a few days of continued doses. Patient E continued to use this topical treatment concurrently with and for approximately one month after cancer treatment.

[0074] Example 6: Patient F Setting: The study consisted of administering a topical therapeutic spray to a 5-year-old Jack Russell terrier suffering from red, itchy patches on the hairless areas of the underside of the body and around the ears due to ragweed pollen hypersensitivity. The dog exhibited visible discomfort and scratching due to the sores. After washing with water and drying the area, sodium pyruvate spray with glycerin was applied to the undercarriage and ears at a concentration of approximately 250 mg / L.

[0075] Summary: After the first dose, the redness subsided within 15 minutes and the dog became relaxed. Dosing continued every time the dog went outside during the ragweed pollen season. If dosing was discontinued during the pollen season, the itching, redness and scratching recurred.

[0076] Example 7: Patient G SETTING: The study consisted of administering a topical therapeutic spray to cancer patients undergoing chemotherapy with Taxotere and Carboplatin. Due to side effects of the cancer treatment, the patient presented with severe mouth sores, sores, and skin rashes that prevented regular chewing and intake of food and some beverages. Patient G's taste buds were also severely affected, making his sense of taste unreliable. Cancer industry experts recommended applying baking soda to the affected areas, but this did little to alleviate the problem, and the patient remained unrelieved for 18 to 20 weeks. Sodium pyruvate oral spray at a concentration of approximately 250 mg / L was administered into the mouth and throat, 1 ml per spray, 2-3 sprays per administration.

[0077] Summary: Patient G experienced near complete relief of pain and burning within 30 minutes of the first dose. As saliva reintroduces the chemicals that cause discomfort, the product was used ad hoc to provide ongoing comfort. With the use of the topical therapeutic spray, the sores resolved and the pain and discomfort was managed. Patient G was able to consume food and drink regularly without discomfort; however, the taste issues were not improved with the topical therapeutic spray.

[0078] Example 8: Patient H Setting: The study consisted of administering a topical therapeutic spray to patients who had sustained moderate sunburns on their face, shoulders, and arms while working on a field project at the beginning of the summer season. Although the patients had used sunscreen, the effects of sunburn were visible due to prolonged exposure. The face was especially reddened because it was directly exposed to ultraviolet (UV) radiation and was not covered by clothing. Sodium pyruvate spray at a concentration of approximately 250 mg / L formulated with glycerin emollient was applied to the affected areas.

[0079] Summary: Patient H experienced relief from sunburn within 15 minutes of first application. She continued to apply the spray on another day until the redness subsided. The product helped prevent the blistering and peeling of the skin caused by sunburn, which did not occur as usual.

[0080] Example 9: Patient I Setting: The study consisted of administering a topical therapeutic spray to patients exhibiting redness, burning, and skin irritation after exposure to an irritating plant, e.g., poison ivy. The affected area was washed with cold water without soap to remove any oils or waxes transferred from the plant. Sodium pyruvate spray at a concentration of approximately 250 mg / L formulated with glycerin emollient was applied to the affected area over the entire epidermis.

[0081] Summary: Patient I experienced relief from burning and itching within 15 minutes of the first dose. The topical therapeutic spray was re-administered for that purpose depending on the severity of exposure.

[0082] Example 10: Patient J Setting: The study consisted of administering a topical therapeutic spray to patients suffering from a burning throat caused by dry air, an allergic reaction, or a disease state reaction. Sodium pyruvate oral spray was administered into the mouth and throat at a concentration of approximately 250 mg / L, 1 ml per spray, 2-3 sprays per administration.

[0083] Summary: Patient J experienced relief from burning, itching, and general discomfort within 15 minutes of the first dose. The product was used for that purpose to provide continued comfort.

[0084] The foregoing is merely illustrative of the principles of the present disclosure and is not intended to be limiting, merely illustrating some of the many possible embodiments for the appended claims. Those skilled in the art will readily recognize various modifications and changes that may be made without following the embodiments described herein and without departing from the spirit and scope of the following claims.

Claims

1. A topical therapeutic product formulated for pain relief in mammalian epidermal and mucosal tissues comprising a pharma- ceutical effective amount of sodium pyruvate incorporated in a delivery vehicle.

2. 10. The topical therapeutic product of claim 1, wherein the delivery vehicle is selected from the group consisting of a spray, a soak, an emollient ointment, a lotion, a gel, a roll-on, and an impregnated disposable.

3. 3. The topical therapeutic product of claim 2, wherein the impregnated disposable item is selected from the group consisting of panty liners, tissues, eye patches, diapers, adhesive bandages, and transepidermal patches.

4. 3. The topical therapeutic product of claim 2, wherein the spray is a nose spray, a throat spray, or a body spray.

5. 10. The topical therapeutic product of claim 1, wherein the topical therapeutic product is an admixture for a skin care product.

6. 6. The topical treatment product of claim 5, wherein the skin care product is selected from the group consisting of sunscreens, moisturizers, facial creams, facial masks, body lotions, hand lotions, and scalp moisturizers.

7. Methods for relieving pain and promoting cell and tissue repair from epidermal and mucosal injuries and disorders, including: a. administering the topical therapeutic product of claim 1 to the area of ​​injury; b. Relieving pain from epidermal and mucosal injury by delivering a pharmacologic effective amount of a topical therapeutic agent to the surface of the injured area; and optionally c) Re-administering the topical treatment to the damaged area.

8. 8. The method of claim 7, wherein the damaged area is selected from the group consisting of the general epidermis, the scalp, the nasal passages, the mouth, the throat, the eyes, the areas of semen discharge, the areas of urinary discharge, the areas of fecal discharge, the vaginal areas, and combinations thereof.

9. 8. The method of claim 7, wherein the injury is selected from the group consisting of dermatitis, psoriasis, stomatitis, cold sores, burns, inflammation, and combinations thereof.

10. 10. The method of claim 9, wherein the dermatitis is selected from the group consisting of atopic dermatitis, contact dermatitis, seborrheic dermatitis, and combinations thereof.

11. 10. The method of claim 9, wherein the burn injury is selected from the group consisting of a sunburn, a thermal burn, a radiation burn, a chemical burn, an electrical burn, and combinations thereof.

12. 12. The method of claim 11, wherein the radiation burn further comprises damage from cancer radiation therapy.

13. 12. The method of claim 11, wherein the chemical burn further comprises damage caused by excreted chemicals in bodily fluids from cancer treatments.

14. 14. The method of claim 13, wherein the cancer treatment is selected from the group consisting of hormonal therapy, chemotherapy, monoclonal antibody therapy, and combinations thereof.

15. 14. The method of claim 13, wherein the bodily fluid is selected from the group consisting of sweat, tears, semen, vaginal secretions, urine, feces, and combinations thereof.

16. 12. The method of claim 11, wherein the degree of burn injury is selected from the group consisting of first degree burns or second degree burns.

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