Kit comprising multivitamin am-pm antiseptic mouthwash that regulates circadian rhythm and is safe for sensitive groups

Abstract

The invention relates to a kit comprising an AM-PM antiseptic mouthwash that is absorbed sublingually, comprises natural and biocompatible ingredients, is multivitamin, regulates circadian rhythm and is safe for sensitive groups. The use of the kit improved sleep in a sample of 25 patients. A total improvement in sleep quality was achieved, on a qualitative scale based on patient criteria, ranging from improved to excellent, in the following proportion: Improvement in sleep quality Sample percentage Improved 16% Good 40% Very good 32% Excellent 12%.

Description

[0001] AM-PM Multivitamin Antiseptic Mouthwash Kit, Circadian Rhythm Regulator and Safe for Sensitive Groups.

[0002] Field of invention

[0003] Food grade mouthwash composition

[0004] The invention relates to the field of mouthwash compositions, particularly mouth rinses. This rinse has antiseptic and nourishing properties, taking advantage of the absorption efficiency of the oral mucosa to strengthen the oral microbiota and nourish the neurotransmitters that regulate the circadian rhythm.

[0005] Background of the Invention

[0006] Oral hygiene is a fundamental component for maintaining not only oral health but also overall health. The mouth is the gateway to the digestive system and plays a crucial role in the first stage of food processing. Proper oral care prevents diseases such as tooth decay, gingivitis, and periodontitis, which, if left untreated, can lead to more serious complications, affecting not only the oral cavity but also systemic health.

[0007] However, most toothpaste and mouthwash products available on the market focus solely on eliminating bacteria and maintaining oral hygiene, but they overlook an essential aspect: the protection and balance of the oral microbiota.

[0008] This microbiota, composed of a community of beneficial microorganisms, plays a vital role in immune protection, regulating oral pH, and preventing the growth of pathogens.

[0009] Continued use of products containing synthetic ingredients, such as Sodium Lauhl Sulfate (SLS) and triclosan, can disrupt this balance, reducing beneficial bacteria and allowing chemical compounds to enter the body, acting as endocrine disruptors and contributing to chronic inflammation.

[0010] Over the years, numerous patented solutions have been developed to address oral hygiene challenges. However, most of these solutions simply replace one synthetic ingredient with another or modify the dosages of existing compounds. For example, patent Z968870 offers a formulation with zinc salts, which, while potentially effective in reducing bad breath, still relies on components that do not address oral microbiota issues or systemic health.

[0011] Similarly, patent CN1 12022791 uses menthol and glycine, two common ingredients that offer limited benefits and do not eliminate long-term adverse effects on the oral microbiota. Patent 2932551 is notable for its use of chlorhexidine, a potent antiseptic, but one with known side effects, such as mucosal irritation and disruption of the bacterial balance in the mouth. Finally, patent W09416674 introduces propylene glycol and glycine in doses different from those used in traditional mouthwashes, but still does not offer a solution that avoids disruption of the oral microbiota or the potential systemic effects of these compounds.

[0012] Given the growing concern about the negative effects of these synthetic ingredients on oral and systemic health, the need to develop products that not only maintain oral hygiene but also protect and nourish the oral microbiota and, consequently, the individual's overall health is evident. It is crucial that future oral hygiene products offer a safe and natural alternative that avoids exposure to harmful synthetic compounds while actively promoting the user's overall well-being.

[0013] This invention arises precisely to satisfy this need, offering an innovative solution that combines natural and biocompatible ingredients with the ability to regulate the circadian rhythm, protect the oral microbiota, and improve the individual's overall health. Description of the invention

[0014] This invention relates to advanced oral care compositions that replace traditional chemical ingredients with environmentally friendly and biocompatible ingredients. Unlike conventional products, these compositions not only effectively cleanse the oral cavity but also promote a balanced oral microbiota, supporting overall health and preventing adverse systemic effects.

[0015] The key innovative aspect lies in the ingredients' ability to be absorbed through the oral mucosa, especially the sublingual mucosa, allowing for the rapid and efficient delivery of essential minerals that regulate the circadian rhythm. This formula addresses health issues such as insomnia, chronic adrenal fatigue, and chronic inflammation, improving sleep quality, metabolic balance, and contributing to a better quality of life.

[0016] The oral cavity is a critical region not only for its role in digestion but also as an efficient channel for the direct absorption of substances. Among the absorption routes that do not require intestinal intervention, sublingual absorption stands out in medicine for its use in the rapid and effective administration of medications and nutrients through the mucosa located under the tongue. This area has a rich network of blood vessels and a thin layer of epithelial tissue that allows for direct absorption into the bloodstream. Unlike conventional oral administration, which involves passage through the digestive system and hepatic metabolism, sublingual absorption bypasses this "first-pass effect," providing greater bioavailability and rapid action.

[0017] This process is especially useful in situations requiring immediate action, such as the administration of nitroglycerin for angina, which provides rapid relief by improving blood flow to the heart. Furthermore, it offers opportunities for the efficient delivery of nutrients and other bioactive compounds, enabling rapid therapeutic effects.

[0018] The invention takes advantage of the oral cavity's unique ability to absorb minerals and other essential compounds. This maximizes the efficacy of the natural ingredients in the formulation, allowing for direct intervention in the regulation of key physiological processes such as neurotransmitter production and circadian rhythm synchronization. The absorption of minerals like iron, crucial for the production of tyrosine, which generates morning dopamine, and magnesium, essential for melatonin synthesis, underscores the importance of sublingual administration in this invention for improving overall health.

[0019] The oral cavity, and specifically sublingual absorption, represents a valuable and underutilized channel for the efficient delivery of nutrients and medications. This absorption route optimizes the bioavailability of compounds and allows for rapid influence on critical physiological functions, such as central nervous system balance and circadian rhythm regulation. Utilizing this mechanism in oral care products offers an innovation with the potential to profoundly improve overall health and well-being.

[0020] Faced with current challenges in oral hygiene and general health, especially the adverse effects of synthetic ingredients in traditional toothpaste products, this invention offers an innovative solution. It not only avoids disrupting the oral microbiota and overall health, but also provides a sanitizing and protective action that actively promotes a balanced oral microbiota.

[0021] The key to this invention lies in the integration of natural, food-grade ingredients, selected for their compatibility with the oral ecosystem and their ability to promote overall health. Unlike conventional products that can disrupt the natural microbiota, these ingredients support and strengthen it, contributing to a healthier and more balanced oral environment.

[0022] Furthermore, this formulation leverages sublingual absorption to efficiently deliver essential minerals and nutrients directly to the central nervous system. This enables effective intervention in the regulation of neurotransmitters such as dopamine, serotonin, and melatonin, crucial for maintaining a healthy circadian rhythm. By designing a toothpaste that not only cleans and protects teeth but also actively supports the production of morning dopamine and nighttime melatonin, this invention offers a holistic solution for improving both oral and overall health.

[0023] Our toothpaste is formulated with ingredients that, while they can be ingested as nutrients, are designed to be efficiently absorbed through the oral cavity. This approach maximizes the benefits of the ingredients without having to wait for the digestive system to metabolize them, providing a safe, fast, and effective alternative to conventional toothpastes.

[0024] This mouthwash formulation is specially tailored for use in sensitive groups, such as pregnant women, children, and convalescent individuals, and comprises natural and biocompatible ingredients for its safety and efficacy.

[0025] In summary, this invention redefines the concept of oral hygiene by protecting and nourishing the oral microbiota, and adds a new dimension to personal care by supporting systemic health through the oral absorption of essential nutrients. Thus, it addresses key modern health challenges, such as chronic inflammation, insomnia, and circadian rhythm dysregulation, offering a comprehensive solution for improving quality of life.

[0026] Details of the Proposed Innovation

[0027] The proposed invention differs fundamentally from conventional toothpastes by using natural and biocompatible ingredients. These ingredients not only effectively cleanse the oral cavity but also support the balance and health of the oral microbiota. Unlike synthetic ingredients, which can be harsh on the oral mucosa, disrupt the microbiota, and be endocrine disruptors, the ingredients in this invention are designed to work in harmony with the oral ecosystem.

[0028] Thanks to the expertise of the inventor, an orthomolecular scientist and master in evidence-based nutritional supplementation, this invention leverages the unique characteristics of the sublingual cavity. The sublingual mucosa, located beneath the tongue, is known for its ability to rapidly absorb certain nutrients and medications, allowing their direct entry into the bloodstream and bypassing initial hepatic metabolism. This is traditionally used in the sublingual administration of medications such as nitroglycerin and vitamin B12. However, current toothpastes have ignored this pathway, representing a missed opportunity to nourish the body directly through a routine process like oral hygiene.

[0029] The inventor acknowledges that, just as nitroglycerin rapidly reaches the bloodstream when administered sublingually, the synthetic ingredients in current toothpastes are also quickly absorbed. This makes these toothpastes potential toxins that, with continued use, can cause serious health problems by acting as endocrine disruptors and negatively affecting metabolic systems.

[0030] Based on this understanding, the question arises: "Why not use this same absorption mechanism to deliver essential nutrients to the body?" For example, magnesium is a mineral involved in more than 300 enzymatic reactions in the body, and its deficiency, according to the World Health Organization (WHO), affects approximately 90% of the population. The proposed invention allows for the absorption of magnesium and other nutrients directly through the sublingual mucosa, leveraging tooth brushing as a daily opportunity to improve systemic health.

[0031] The inventor has taken into account renowned research, such as that conducted by the doctors awarded the Nobel Prize in Medicine in 2017, which demonstrates how disruption of the circadian rhythm can influence the onset of degenerative diseases, cancer, and autoimmune diseases. This invention aims to optimize the circadian rhythm by delivering essential nutrients through daily oral hygiene, supporting the regulation of internal biological rhythms.

[0032] Furthermore, the inventor has considered the global prevalence of insomnia and poor sleep quality, conditions that have been linked to magnesium deficiencies. This mineral is essential for the production of melatonin, a key neurotransmitter in inducing sleep. By administering magnesium sublingually through mouthwash, this invention not only improves oral health but also contributes to better sleep quality and, consequently, a more balanced overall state of health.

[0033] The inventor has identified chronic low-grade inflammation as an epidemic condition in modern society, exacerbated by the intake of endocrine disruptors and poor sleep quality. This chronic inflammation particularly affects areas of the body with microbiota, such as the gut and oral cavity. Conditions like chronic gingivitis, stomatitis, cheilitis, and tongue inflammation are common manifestations of this low-grade oral inflammation, which can have a significant long-term impact on health if not properly addressed.

[0034] Finally, the inventor has considered that iron intake during the first hours of the day can facilitate the production of dopamine, a neurotransmitter essential for regulating biorhythms and daily activity. This invention proposes an innovative approach to iron administration, using sublingual absorption during the daily oral hygiene routine to optimize dopamine levels and support a healthy biorhythm.

[0035] The present invention offers a significant advance in oral care by differentiating itself from conventional toothpaste products in several key aspects, effectively addressing modern health problems such as sleep deprivation, depression, and anxiety. The innovative elements of the proposal are highlighted below:

[0036] Unlike traditional toothpastes that often contain potentially harmful synthetic ingredients, this formula uses only natural and biocompatible ingredients. These components not only cleanse the oral cavity but also actively promote the balance and health of the oral microbiota, an essential factor for overall well-being. By avoiding harsh chemical agents, the formula protects the integrity of the oral microbiota, crucial for immune health and the prevention of oral and systemic diseases.

[0037] The product is presented as an innovative kit, consisting of two different mouthwashes for use in the morning (AM) and at night (PM), each designed to fulfill specific functions that optimize systemic health:

[0038] • AM Rinse: Formulated for use at the start of the day, this rinse optimizes the production of dopamine, a neurotransmitter essential for energy, motivation, and alertness. Including key nutrients that are efficiently absorbed through the sublingual mucosa, this rinse helps improve mental clarity and focus during daytime activities. Ingredients such as vitamin B12, iron, and stimulating natural extracts enhance the body's ability to generate energy and face daily challenges with vigor.

[0039] • PM Rinse: Designed for nighttime use, this rinse promotes the absorption of magnesium, a critical mineral in the production of melatonin, the neurotransmitter responsible for inducing and regulating sleep. This rinse contributes to restful, high-quality sleep, helping to alleviate insomnia and reduce anxiety and depression associated with inadequate rest. The inclusion of ascorbic acid and other nutrients that facilitate relaxation and rest ensures a smooth transition to sleep. Furthermore, its PM function is linked to AM, because the production of quality dopamine in the morning guarantees quality melatonin at night.

[0040] One of the most innovative features of this invention is the use of sublingual absorption, a process that takes advantage of the unique properties of the oral mucosa to allow for the rapid and effective absorption of nutrients and active compounds directly into the bloodstream. This method, which has been largely ignored by conventional toothpaste manufacturers, offers significantly greater bioavailability by bypassing first-pass metabolism in the liver, ensuring that nutrients such as magnesium, vitamin B12, and other essential compounds are optimally utilized by the body.

[0041] The dual approach of this mouthwash kit not only focuses on oral hygiene but also significantly contributes to overall well-being by synchronizing daily physiological processes. The AM rinse is designed to boost energy and daily activity, while the PM rinse promotes deep, restorative sleep. This synergy between the AM and PM rinses helps regulate the circadian rhythm, which is essential for combating sleep deprivation, reducing chronic inflammation, and alleviating symptoms of depression and anxiety. Furthermore, supporting the oral microbiota and efficiently delivering nutrients can also contribute to improved metabolic health, reducing the risk of chronic diseases.

[0042] In summary, this invention not only redefines oral hygiene by combining natural, microbiota-supporting ingredients with a sublingual delivery system for essential nutrients, but also offers a holistic solution for optimizing mental and physical health. By effectively addressing common health issues such as sleep deprivation, depression, anxiety, and chronic inflammation, this innovation has the potential to significantly improve users' quality of life.

[0043] The present invention is distinguished not only by its innovative formulation that addresses modern health problems, but also by its differentiation in terms of the ingredients used compared to traditional products, such as Amway's Glister mouthwash.

[0044] Ingredient Comparison:

[0045] • Coconut Oil (Our Product) vs. Glycine (Glister): o Benefits of Coconut Oil: It is a natural ingredient with antibacterial and anti-inflammatory properties, in addition to strengthening gums and fighting plaque. It also acts as an emollient base, providing a pleasant texture without synthetic agents. o Potential Harms of Glycine: Although it is a humectant that retains moisture, ingesting large quantities can cause gastrointestinal discomfort. Furthermore, it can form a film on teeth that inhibits remineralization, affecting long-term dental health.

[0046] • Sunflower Lecithin (Our Product) vs. Poloxamer 407 (Glister): o Benefits of Sunflower Lecithin: Natural and biocompatible, it acts as an emulsifier, improving the product's texture without harmful side effects. It also contains phospholipids that benefit brain health. o Potential Harms of Poloxamer 407: This synthetic copolymer, used as a stabilizer and foaming agent, has been associated with alterations in cholesterol and triglyceride levels, as well as liver damage with prolonged use. Its presence in oral products could contribute to chronic inflammation and affect metabolic health.

[0047] • Oregano Distilled Water (Our Product) vs. Benzyl Alcohol (Glister): o Benefits of Oregano Distilled Water: Provides a gentle antiseptic action thanks to the antimicrobial properties of oregano, without the irritating effects of pure essential oil. Helps maintain oral freshness and hygiene naturally. o Potential Harms of Benzyl Alcohol: Used as a preservative and solvent, it can cause allergic reactions and irritation of the oral mucosa in sensitive individuals, in addition to being a disruptor of the oral microbiota.

[0048] • Eucalyptus Extract (Our Product) vs. Cetylpyridinium Chloride (CPC) (Glister): o Benefits of Eucalyptus Extract: Known for its antibacterial and anti-inflammatory properties, it helps maintain oral health and offers a refreshing flavor without the need for synthetic compounds. o Potential Harms of CPC: Although effective against plaque, it can cause irritation of the oral mucosa and tooth discoloration. Its absorption may have unwanted systemic effects, such as disruption of the gut microbiota.

[0049] • Guava Extract (Our Product) vs. Sodium Fluoride (Glister): o Benefits of Guava Extract: Rich in antioxidants and anti-inflammatory compounds, it contributes to gum health and offers natural protection against bacteria that cause periodontal disease. o Potential Harms of Sodium Fluoride: Although effective in preventing cavities, excess sodium fluoride can lead to dental fluorosis, especially in children, and has been the subject of debate due to its impact on bone and neurological health.

[0050] Bitter Orange Seed Oil and Sesame Oil (Our Product) vs. Artificial Flavorings (Glister):

[0051] • Benefits of Natural Oils: Both oils have antioxidant, anti-inflammatory, and antibacterial properties, in addition to providing a pleasant flavor naturally. These oils also contribute to a healthy oral microbiota and promote overall health.

[0052] • Potential Harmful Effects of Artificial Flavorings: Synthetic flavorings may contain chemical compounds that, although approved for use, can cause irritation in some people and offer no additional oral health benefits.

[0053] Benefits of the AM and PM Formulation:

[0054] • AM Rinse: o Ingredients: Ginger, Cinnamon Extract, Clove Extract, Vitamin B12, Coconut Oil, Sunflower Lecithin, Oregano Distilled Water, Eucalyptus Extract, Guava Extract, Bitter Orange Seed Oil, Sesame Oil, Saponins. o Benefits: Optimizes dopamine production, improving energy and alertness throughout the day. Ingredients such as vitamin B12 and ginger stimulate metabolism and brain activity, providing a natural and healthy boost.

[0055] • PM Rinse: o Ingredients: Magnesium Citrate, Ascorbic Acid, Coconut Oil, Sunflower Lecithin, Oregano Distilled Water, Eucalyptus Extract, Guava Extract, Bitter Orange Seed Oil, Sesame Oil, Saponins. o Benefits: Promotes restful sleep by supporting melatonin production, thanks to magnesium and other relaxing ingredients. It also combats chronic inflammation, helping to reduce anxiety and improve sleep quality.

[0056] Compared to products like Amway's Glister, the present invention offers a safer, more natural, and more effective alternative. By avoiding potentially harmful synthetic ingredients and opting for natural components that support both oral and overall health, this mouthwash not only fulfills its primary function of oral hygiene but also contributes to improved systemic health, circadian rhythm regulation, and quality of life.

[0057] The proposed invention is distinguished by its comprehensive approach to oral and general health, using natural ingredients that not only cleanse but also provide essential nutrients that promote systemic well-being. The nutrients provided by each ingredient in the formulation are detailed below, along with their benefits for the circadian rhythm, cognitive and cardiovascular health, and how these contribute to a safe and effective solution for diverse population groups.

[0058] Coconut oil:

[0059] • Safety and Use: Safe for ingestion, suitable for pregnant women, children, and convalescent individuals. Its antimicrobial and anti-inflammatory action makes it an excellent component for oral health without risk of adverse effects. • Nutrients and Benefits: Rich in medium-chain fatty acids (MCFAs), especially lauchoic acid, with antibacterial and anti-inflammatory properties. Contains antioxidants that protect cells from oxidative damage.

[0060] • Circadian Rhythm: MCFAs are rapidly metabolized by the liver, providing an immediate source of energy that supports brain function and improves daytime alertness.

[0061] • Cognitive Health: Supports brain function by providing an alternative energy source to the brain in the form of ketone bodies, which are beneficial for mental clarity and focus.

[0062] • Cardiovascular Health: Improves HDL ("good") cholesterol levels, promoting cardiovascular health.

[0063] Sunflower Lecithin:

[0064] • Safety and Use: Natural and safe for all groups, including pregnant women and children. Its ability to emulsify fats also aids in the absorption of other fat-soluble nutrients in the formulation.

[0065] • Nutrients and Benefits: Contains phospholipids, especially phosphatidylcholine, essential for cell membrane formation and brain health.

[0066] • Circadian Cycle: Phospholipids maintain the integrity of nerve cells, crucial for the transmission of brain signals related to circadian rhythms.

[0067] • Cognitive Health: Phosphatidylcholine is a precursor to acetylcholine, a key neurotransmitter for memory and learning.

[0068] • Cardiovascular Health: Helps reduce cholesterol levels and improves cardiovascular function.

[0069] Distilled Oregano Water:

[0070] • Safety and Use: Gentle and safe for ingestion, ideal for sensitive groups such as pregnant women, children, and convalescent individuals. • Nutrients and Benefits: Contains phenolic compounds such as carvacrol and thymol, with antimicrobial and antioxidant properties.

[0071] • Circadian Cycle: Antioxidants can reduce oxidative stress, a factor that can disrupt circadian rhythms.

[0072] • Cognitive Health: Protects brain cells from damage and supports cognitive function.

[0073] • Cardiovascular Health: Phenolic compounds reduce inflammation and protect the cardiovascular system from oxidative damage.

[0074] Eucalyptus extract:

[0075] • Safety and Use: Natural and non-irritating at the concentrations used, safe for pregnant women, children, and convalescents. Effective for maintaining oral health by combating bacteria that cause bad breath and periodontal disease.

[0076] • Nutrients and Benefits: Rich in cineole, with anti-inflammatory, analgesic and decongestant properties.

[0077] • Circadian Cycle: Opens the airways, improving sleep quality and contributing to a regular circadian cycle.

[0078] • Cognitive Health: Improves breathing, increasing brain oxygenation and promoting mental clarity and concentration.

[0079] • Cardiovascular Health: Reduces systemic inflammation, protecting cardiovascular health.

[0080] Guava Extract:

[0081] • Safety and Use: Safe for ingestion and beneficial for pregnant women and people in recovery due to its high content of vitamin C and other antioxidants.

[0082] • Nutrients and Benefits: Rich in vitamin C, tannins and flavonoids, with antioxidant and anti-inflammatory properties.

[0083] • Circadian Rhythm: Vitamin C is essential for collagen synthesis and acts as an antioxidant that protects the brain and other organs from oxidative damage, maintaining healthy circadian rhythms. • Cognitive Health: It improves immune function and protects neurons from oxidative stress, supporting mental and cognitive health.

[0084] • Cardiovascular Health: Flavonoids and vitamin C improve circulation and reduce the risk of cardiovascular disease by fighting inflammation.

[0085] Bitter Orange Seed Oil and Sesame Oil:

[0086] • Safety and Use: Safe for ingestion and provide additional benefits such as improved skin health and reduced systemic inflammation.

[0087] • Nutrients and Benefits: Bitter orange seed oil is rich in vitamin C and antioxidants, while sesame oil contains unsaturated fatty acids, sesamin, and vitamin E.

[0088] • Circadian Rhythm: Both oils combat oxidative stress and inflammation, supporting a balanced circadian rhythm.

[0089] • Cognitive Health: The antioxidants in these oils protect brain cells from damage, promoting healthy cognitive function.

[0090] • Cardiovascular Health: Unsaturated fatty acids and antioxidants improve heart health by reducing inflammation and protecting against oxidative damage.

[0091] Saponins (as a natural foaming agent):

[0092] • Safety and Use: Natural and safe for ingestion, ideal for inclusion in a mouthwash intended for various groups, including sensitive individuals.

[0093] • Nutrients and Benefits: Saponins have antibacterial and anti-inflammatory properties, and are known to reduce cholesterol.

[0094] • Circadian Cycle: They regulate cholesterol levels and maintain overall health, important for optimal body functioning during the circadian cycle.

[0095] • Cognitive Health: By reducing inflammation and improving circulation, saponins support brain health and mental clarity. • Cardiovascular Health: They help lower LDL ("bad") cholesterol levels, improving cardiovascular health.

[0096] Ginger, Cinnamon Extract and Clove (AM Rinse):

[0097] • Safety and Use: Although they are stimulants, at the concentrations used they are safe for most people. It is recommended to use them in the morning to avoid potential sleep disruptions.

[0098] • Nutrients and Benefits: Rich in antioxidants and anti-inflammatory compounds, they have stimulating properties that promote circulation and digestion.

[0099] • Circadian Rhythm: They help to start the day with more energy and mental clarity by stimulating the production of dopamine and noradrenaline.

[0100] • Cognitive Health: They improve brain function by increasing circulation and reducing inflammation in the brain.

[0101] • Cardiovascular Health: They help reduce blood pressure and improve circulation, protecting cardiovascular health.

[0102] Magnesium Citrate and Ascorbic Acid (PM Rinse):

[0103] • Safety and Use: Safe for all groups, including pregnant women and convalescents. Ideal for nighttime, promoting relaxation and deep sleep.

[0104] • Nutrients and Benefits: Magnesium citrate is crucial for melatonin production, while ascorbic acid (vitamin C) enhances magnesium absorption and acts as a powerful antioxidant.

[0105] • Circadian Cycle: Magnesium is essential for muscle relaxation and melatonin synthesis, improving sleep quality and regulating the circadian cycle.

[0106] • Cognitive Health: Magnesium and vitamin C help reduce stress and anxiety, promoting restful sleep and mental health.

[0107] • Cardiovascular Health: They help maintain blood pressure at healthy levels and protect against oxidative stress.

[0108] Vitamin B12 (AM Rinse): • Safety and Use: Safe for ingestion, especially important for people on vegan or vegetarian diets, pregnant women and the elderly.

[0109] • Nutrients and Benefits: Essential for energy production and red blood cell formation, also crucial for neurotransmitter synthesis.

[0110] • Circadian Rhythm: Helps regulate energy levels and improves mental clarity during the day by supporting the production of dopamine and other neurotransmitters.

[0111] • Cognitive Health: Essential for brain health, improving memory and concentration.

[0112] • Cardiovascular Health: Helps maintain low levels of homocysteine, a risk factor for cardiovascular disease.

[0113] Conclusion: This formulation not only effectively cleanses the mouth but also acts as a broad-spectrum multivitamin supplement. Each ingredient has been selected not only for its ability to maintain oral health but also for its systemic benefits, including circadian rhythm regulation, improved cognitive and cardiovascular health, and safety for all groups, including pregnant women, children, and convalescents. This invention represents a significant advancement in personal care, offering a holistic approach to improving quality of life through a simple oral hygiene routine.

[0114] Technical Formula of AM Mouthwash

[0115] Formula Composition (percentage by weight):

[0116] • Coconut Oil: 10%

[0117] • Sunflower Lecithin: 5%

[0118] • Oregano Distilled Water: 20%

[0119] • Eucalyptus Extract: 2%

[0120] • Guava Extract: 3%

[0121] • Bitter Orange Seed Oil: 2%

[0122] • Sesame Oil: 2% • Saponins: 0.5%

[0123] • Vitamin B12 (Cyanocobalamin): 0.1%

[0124] • Ginger Extract: 5%

[0125] • Cinnamon Extract: 3%

[0126] • Sweet Clove Extract: 2%

[0127] • Purified Water: 45.4% (enough to complete 100%)

[0128] 2. Technical Formula of PM Mouthwash

[0129] Formula Composition (percentage by weight):

[0130] • Magnesium Citrate: 5%

[0131] • Ascorbic Acid (Vitamin C): 3%

[0132] • Coconut Oil: 10%

[0133] • Sunflower Lecithin: 5%

[0134] • Oregano Distilled Water: 20%

[0135] • Eucalyptus Extract: 2%

[0136] • Guava Extract: 3%

[0137] • Bitter Orange Seed Oil: 2%

[0138] • Sesame Oil: 2%

[0139] • Saponins: 0.5%

[0140] • Purified Water: 47.5% (enough to complete 100%)

[0141] 3. Molecular Interaction of the Ingredients

[0142] Coconut Oil (10%):

[0143] Coconut oil is primarily a mixture of medium-chain triglycerides, with a high concentration of lauhcotic acid. At the molecular level, lauhcotic acid (C12H24O2) has antimicrobial properties by inserting itself into the lipid membranes of bacteria, causing destabilization and cell lysis. This is particularly effective against Streptococcus mutans, a common bacterium in the oral cavity.

[0144] Sunflower Lecithin (5%): Lecithin is a mixture of phospholipids, primarily phosphatidylcholine (C8H18NO8P). These phospholipids act as emulsifiers, stabilizing oil-and-water mixtures. At the molecular level, phosphatidylcholine binds to the micelles formed by coconut oil and water, creating a stable emulsion that facilitates the penetration of the active ingredients into the oral mucosa.

[0145] Distilled Oregano Water (20%):

[0146] Distilled oregano water contains phenolic compounds such as carvacrol (C10H14O) and thymol (C10H14O), which have potent antimicrobial and antioxidant properties. These compounds interact with the lipid membranes of microbial cells, altering their permeability and causing cell death. In addition, carvacrol acts as a chelating agent, neutralizing free radicals that can cause oxidative damage to the oral mucosa.

[0147] Eucalyptus extract (2%):

[0148] Cineole (C10H18O), the main component of eucalyptus extract, possesses anti-inflammatory and decongestant properties. At the molecular level, cineole acts by inhibiting the production of pro-inflammatory cytokines, such as interleukin-1 (IL-1) and tumor necrosis factor alpha (TNF-α), through the modulation of NF-κB signaling pathways.

[0149] Guava Extract (3%):

[0150] Guava is rich in vitamin C (ascorbic acid, C6H8O6) and flavonoids, which act as powerful antioxidants. Vitamin C acts as a cofactor in collagen synthesis, essential for the integrity of the gums and oral mucosa. At the molecular level, vitamin C donates electrons to neutralize free radicals, while flavonoids stabilize reactive oxygen species (ROS), protecting cells from oxidative damage.

[0151] Bitter Orange Seed Oil and Sesame Oil (2% each): These oils are composed primarily of unsaturated fatty acids (such as oleic acid, C18H34O2) and antioxidants. Unsaturated fatty acids interact with cell membranes, improving membrane fluidity and facilitating the absorption of other nutrients. In addition, the antioxidants present in these oils help protect oral cells from oxidative stress.

[0152] Saponins (0.5%):

[0153] Saponins are terpenoid glycosides that reduce the surface tension of water, creating foam. At the molecular level, saponins interact with the lipids in the cell membranes of microorganisms, increasing cell permeability and facilitating the removal of debris and bacteria from the tooth surface.

[0154] Vitamin B12 (0.1% - AM Rinse):

[0155] Vitamin B12 (C63H88CoN14014P) is a cobalamin that acts as a coenzyme in DNA synthesis and red blood cell formation. In the oral mucosa, vitamin B12 can be efficiently absorbed sublingually, where it participates in the synthesis of neurotransmitters such as dopamine, crucial for energy and alertness during the day.

[0156] Magnesium Citrate (5% - PM Rinse):

[0157] Magnesium citrate (C12H10Mg3O14) is a highly bioavailable form of magnesium, an essential mineral involved in more than 300 enzymatic reactions, including the synthesis of melatonin, the neurotransmitter that regulates sleep. At the molecular level, magnesium acts as a cofactor in the transfer of phosphate groups, essential for ATP production and muscle relaxation.

[0158] Ascorbic Acid (3% - PM Rinse):

[0159] Ascorbic acid (C6H8O6) is not only a powerful antioxidant, but it also facilitates magnesium absorption by maintaining it in its ionic form (Mg2+), thus improving its bioavailability. Furthermore, ascorbic acid participates in collagen synthesis, which strengthens the gums and oral mucosa.

[0160] 4. Molecular Interaction and Synergy of Ingredients

[0161] The molecular interaction between the ingredients in both mouthwashes is key to maximizing their efficacy and safety. The base of natural oils and lecithin allows for the formation of a stable emulsion that facilitates the even distribution of the active ingredients in the oral cavity. The sublingual mucosa, rich in capillaries, acts as a direct channel for the absorption of nutrients and bioactive compounds, bypassing initial hepatic metabolism and ensuring high bioavailability.

[0162] In the AM rinse, the combination of vitamin B12, ginger, and cinnamon stimulates metabolism and the production of neurotransmitters like dopamine, increasing energy and focus. The synergy between antioxidants and anti-inflammatories (coconut oil, guava, eucalyptus) strengthens the mouth's natural defenses, maintaining a healthy and balanced environment.

[0163] In the PM rinse, magnesium citrate and ascorbic acid work together to promote muscle relaxation and melatonin synthesis, improving sleep quality. Essential oils and antioxidants work to reduce chronic inflammation and protect the oral microbiota, ensuring restful sleep and supporting cell regeneration overnight.

[0164] 5. Formation of the Final Product

[0165] To form the final product, a cold emulsification process is used to preserve the integrity of the active compounds. The oils and lecithin are first combined to form a base emulsion, to which the extracts and nutrients are gradually added under constant agitation to ensure even distribution. The AM and PM mouthwashes are packaged in opaque bottles to protect photosensitive ingredients, such as vitamin B12 and ascorbic acid, from light degradation. The result is a biphasic (AM and PM) mouthwash that not only cleanses and protects the oral cavity but also acts as a multivitamin supplement, providing key nutrients that improve systemic health, cognitive function, and sleep quality—all through a highly effective sublingual delivery mechanism.

[0166] Formulation Process Flowchart

[0167] This diagram shows the steps in the formulation process, from the initial mixing of ingredients to the final packaging.

[0168] Stage Description

[0169] Start The formulation process begins

[0170] Oil and Lecithin Blend Coconut oil and lecithin blend Active Ingredients Blend of extracts, vitamins, magnesium Emulsion Base Formation Creation of a base emulsion Solution Preparation Dissolving of active ingredients Combination with Agitation Combining both mixtures with constant agitation

[0171] Product Homogenization: Mixing until a uniform texture is obtained. Quality and Stability Control: Review of quality parameters. Packaging in Opaque Bottles: Packaging of the final product in opaque bottles. End of Process: Completion of the process

[0172] 2. Bar Chart of the Concentration of Active Ingredients in AM and PM Rinses i -

[0173] | Ingredient | AM (%) | PM (%) | Difference

[0174] (AM - PM) I

[0175] Vitamin B12 | 5 | 0 | +5

[0176] Ginger | 5 | 0 | +5

[0177] Cinnamon Extract | 4 | 0 | +4

[0178] Sweet Clove Extract | 4 | 0 | +4

[0179] Sunflower Lecithin | 3 | 3 | 0

[0180] Guava Extract | 3 | 4 | - 1 _ _ _ _

[0181] _ YO

[0182] This comparative chart allows you to visualize the concentration of the main active ingredients in both rinses.

[0183] Pie Chart of Ingredient Ratios (Total Percentages)

[0184] This pie chart shows the relative proportion of each ingredient group in the formula, in both the AM and PM rinses.

[0185] - [ AM Proportion Pie Chart ] -

[0186] Yo

[0187] | Purified Water 45.4% |

[0188] | Coconut Oil 10% |

[0189] | Oregano Distilled Water 20%

[0190] | Sunflower Lecithin 5% |

[0191] | Ginger, Cinnamon, Clove 10%

[0192] | Other (Saponins, Vitamins) 9.6%

[0193] [PM Proportion Pie Chart]

[0194] | Purified Water 47.5% |

[0195] | Coconut Oil 10%

[0196] | Oregano Distilled Water 20%

[0197] | Sunflower Lecithin 5% | Magnesium Citrate 5% |

[0198] | Other (Saponins, Vitamins) 12.5% ​​|

[0199] II

[0200] Description of the Graphics:

[0201] 1. Formulation Process Flowchart: This diagram is useful for showing the manufacturing process, ensuring that all key stages are understood and that the workflow is clear.

[0202] 2. Active Ingredient Concentration Bar Chart: This chart clearly shows the differences in formulation between AM and PM rinses, highlighting the relative concentrations of the main active ingredients.

[0203] 3. Ingredient Proportion Pie Chart: This chart allows you to quickly visualize the proportion of different ingredient groups in the formulation, helping you understand the relative importance of each group in the final product.

[0204] Coconut Oil (Lauhco Acid, C12H24O2)

[0205] Chemical Justification:

[0206] Lauhco acid is a medium-chain saturated fatty acid found in coconut oil. Its chemical structure, CH3(CH2)10COOH, gives it antimicrobial and anti-inflammatory properties by disrupting the lipid membranes of bacteria and fungi, destabilizing them and leading to their destruction.

[0207] Chemical Formula:

[0208] Lauric Acid: C12H24O2oCH3(CH2)10COOH

[0209] \text{C}_{12}\text{H}_{24}\text{0}_{2} \quad \text{o} \quad \text{CH}_3(\text{CH}_2)_{10}\text{COQH}La'uric acid: C12H24Q2oCH3 (CH2)10COQH

[0210] Function in the Formulation: • Antimicrobial: The medium chain of lauhco acid facilitates its incorporation into the lipid membrane of microorganisms, causing a structural and functional disruption.

[0211] • Formula Stabilization: Its lipophilic structure helps emulsify other lipid ingredients in the formulation.

[0212] 2. Sunflower Lecithin (Phosphatidylcholine, C42H80NO8P)

[0213] Chemical Justification:

[0214] Phosphatidylcholine, the main component of sunflower lecithin, is a phospholipid with a polar head (choline and phosphate) and nonpolar tails (fatty acids). This amphipathic molecule is key in the formation of micelles, which are essential for emulsification in liquid products such as mouthwash.

[0215] Chemical Formula:

[0216] Phosphatidylcholine: C42H80NO8P\text{Phosphatidylcholine:}

[0217] \text{C}_{42}\text{H}_{80}\text{NO}_{8}\text{P}Phosphatidylcholine: C42H80NQ8P

[0218] Function in the Formulation:

[0219] • Emulsification: Facilitates the homogeneous mixing of lipophilic (oils) and hydrophilic (water and plant extracts) ingredients.

[0220] • Improves Bioavailability: By forming micelles, lecithin improves the absorption of lipophilic compounds through the sublingual mucosa.

[0221] 3. Magnesium Citrate (MgC6H6O7)

[0222] Chemical Justification:

[0223] Magnesium citrate is a highly bioavailable form of magnesium, where the Mg ion 2+ It is chelated by citrate, a conjugate base of citric acid. The magnesium ion is crucial in melatonin synthesis, and the chelated form (citrate) facilitates its absorption in the body.

[0224] Chemical Formula: Magnesium Citrate: MgC6H607\text{Magnesium Citrate:}

[0225] \text{MgC}_{6}\text{H}_{6}\text{0}_{7}Magnesium Citrate: MgC6H6O7

[0226] Function in the Formulation:

[0227] • Muscle Relaxation and Melatonin Production: Mg 2+ It is an essential cofactor for the enzyme N-acetylserotonin O-methyltransferase, which converts serotonin into melatonin.

[0228] • Rapid Absorption: The citrate chelated structure promotes sublingual absorption.

[0229] 4. Ascorbic Acid (Vitamin C, C6H8O6)

[0230] Chemical Justification:

[0231] Ascorbic acid is an organic compound with antioxidant properties. Its ability to donate electrons allows it to reduce reactive oxygen species (ROS), protecting cells from oxidative damage. It is also essential for the synthesis of collagen, an important structural protein in gums and blood vessels.

[0232] Chemical Formula:

[0233] Ascorbic Acid: C6H8O6

[0234] \text{C}_{6}\text{H}_{8}\text{O}_{6}AscoTbic Acid: C6H8O6

[0235] Function in the Formulation:

[0236] • Antioxidant: Protects other active ingredients from oxidation and improves product stability.

[0237] • Synergy with Magnesium: Improves magnesium absorption and enhances collagen synthesis in oral tissues.

[0238] 5. Saponins (e.g., Escin, C55H86O24)

[0239] Chemical Justification: Saponins are triterpenic or steroidal glycosides that possess a hydrophilic part (sugars) and a hydrophobic part (aglycone). This amphipathic structure allows them to reduce surface tension, acting as natural foaming agents. They also have anti-inflammatory and antimicrobial properties.

[0240] Chemical Formula (Example of Escin):

[0241] Escin: C55H86O24\text{Escin:}

[0242] \text{C}_{55}\text{H}_{86}\text{O}_{24}Escin: C55H86O24

[0243] Function in the Formulation:

[0244] • Natural Foaming Agent: Facilitates foam formation during use, which improves the distribution of the rinse in the oral cavity.

[0245] • Anti-inflammatory properties: Helps reduce inflammation in the gums.

[0246] 6. Vitamin B12 (Cobalamin, C63H88CoN14014P)

[0247] Chemical Justification:

[0248] Cobalamin is a complex molecule containing a cobalt ion at its center, coordinated by a corrin ring. It is essential in DNA synthesis and cellular energy production, acting as a coenzyme in the conversion of homocysteine ​​to methionine.

[0249] Chemical Formula:

[0250] Vitamin B12: C63H88CoN14014P\text{Vitamin B12:}

[0251] \text{C}_{63}\text{H}_{88}\text{CoN}_{14}\text{0}_{ 14}\text{P} Vitamin B12: C63 H88CoN14014P

[0252] Function in the Formulation:

[0253] • Energy and Cognitive Function: Supports the production of neurotransmitters, including dopamine, improving alertness and energy. • Efficient Sublingual Absorption: Cobalamin is well absorbed sublingually, avoiding degradation in the digestive tract.

[0254] Molecular Interactions and Synergy in Formulation:

[0255] When these ingredients are combined in the mouthwash formulation, the molecular interactions are optimized to create a synergistic product:

[0256] • Emulsion Stability: Sunflower lecithin acts as an emulsifying agent, ensuring that oils (such as coconut oil) and water remain in uniform suspension, allowing for an even distribution of the active ingredients.

[0257] • Rapid and Efficient Absorption: The combination of the amphipathic structure of lecithin with the small molecular size of ascorbic acid and magnesium ions allows for rapid absorption through the sublingual mucosa.

[0258] • Antioxidant Protection: Ascorbic acid not only stabilizes the formulation by preventing the oxidation of other ingredients, but also enhances overall antioxidant activity, which is critical to counteract oxidative stress and inflammation in the oral cavity.

[0259] • Circadian Cycle Regulation: Magnesium and vitamin B12 play complementary roles in regulating the circadian cycle, with magnesium promoting nighttime sleep and B12 optimizing daytime energy.

[0260] Conclusion:

[0261] The formulation of the AM and PM mouthwashes is not only based on a combination of natural and biocompatible ingredients, but is also supported by sound chemical principles that ensure their efficacy, stability, and safety. The synergy between the ingredients allows for a holistic approach to oral care and systemic health, addressing issues such as chronic inflammation, oxidative stress, and circadian rhythm dysregulation. These factors make this invention a robust and innovative offering in the field of personal care.

Claims

Independent Claims 1. A sublingually absorbed mouthwash kit comprising natural and biocompatible ingredients, in which eucalyptus extract is present at a concentration of 0.1% to 0.5% by weight and provides anti-inflammatory and antimicrobial effects. It is further composed of coconut oil, sunflower lecithin, oregano distilled water, eucalyptus extract, guava extract, sour orange seed oil, sesame oil, saponins, ginger, cinnamon extract, clove extract, vitamin B12, magnesium citrate, and ascorbic acid. This composition is designed for sublingual absorption to optimize oral and systemic health.

2. A mouthwash kit comprising: • an AM mouthwash formulated for morning use, designed to improve energy and alertness, and • a PM mouthwash formulated for nighttime use, designed to promote relaxation and improve sleep quality, wherein both mouthwashes contain ingredients selected from the composition described in claim 1. Dependent Claims:

3. The composition of the Mouthwash Kit according to claim 1, wherein the AM mouthwash contains vitamin B12 in a concentration of 0.01% to 0.05% by weight, ginger in a concentration of 0.5% to 2.0% by weight, cinnamon extract in a concentration of 0.1% to 0.5% by weight, and clove extract in a concentration of 0.05% to 0.2% by weight.

4. The composition of the Mouthwash Kit according to claim 1, wherein the PM mouthwash contains magnesium citrate at a concentration of 0.5% 2.0% by weight and ascorbic acid at a concentration of 0.5% to 1.5% by weight.

5. The composition of the Mouthwash Kit according to claim 1, wherein coconut oil is present in a concentration of 1% to 5% by weight and acts as a natural emollient with antimicrobial properties.

6. The composition of the Mouthwash Kit according to claim 1, wherein the saponins act as natural foaming agents at a concentration of 0.1% to 0.5% by weight, contributing to oral cleaning without irritation.

7. The mouthwash kit according to claim 2, wherein the AM mouthwash further includes guava extract to improve gum health and eucalyptus extract to provide freshness and protection against bacteria.

8. The mouthwash kit according to claim 2, wherein the PM mouthwash further includes sunflower lecithin to enhance nutrient absorption and sour orange seed oil to reduce inflammation. Multiparty Claims:

9. The use of a mouthwash composition according to claim 1 for the prevention of periodontal diseases and the improvement of the circadian rhythm by means of daily sublingual administration of bioactive ingredients. Additional Claims:

10. A method for reducing chronic inflammation in the oral cavity, comprising the daily administration of a mouthwash composition according to any of claims 1 to 6, designed to be sublingually absorbed.

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