Respiratory aqueous solution composition containing molecular iodine

Abstract

The present invention provides an aqueous solution composition capable of rapidly preventing, alleviating or eliminating symptoms of acute respiratory diseases by applying a hypertonic aqueous solution composition containing molecular iodine to all parts of the eyes, oral cavity, nasal cavity, and respiratory tract. The present invention provides a hypertonic aqueous solution composition containing molecular iodine, which can prevent and eliminate acute respiratory infectious diseases such as cold, flu, and COVID-19, and can rapidly alleviate or eliminate runny nose and nasal congestion caused by allergic and non-allergic rhinitis.

Description

Molecular iodine-containing respiratory aqueous solution composition

[0001] The present invention relates to a hypertonic aqueous solution composition containing high-concentration molecular iodine that can be applied to all parts of the eyes, nasal cavity, oral cavity and upper and lower respiratory tracts, and a composition for combating the source of infection of acute respiratory infectious diseases and preventing, alleviating, or eliminating the manifestation of symptoms of acute respiratory infectious or non-infectious diseases.

[0002] Although the common cold and the flu are caused by different viruses, both diseases can present with a runny nose, nasal congestion, congestion, cough, and sore throat; in particular, the flu may be accompanied by a fever, headache, fatigue, and general body aches. Since these symptoms do not appear strongly from the start but are very mild in the early stages, it is difficult to determine what the infection is. It is hard to make a diagnosis without professional testing. It is very difficult to visit a hospital for professional testing when only mild symptoms are present. Therefore, there is a need for a method to prevent or treat symptoms of all acute respiratory diseases, regardless of the pathogen.

[0003] In particular, since parainfluenza viruses, influenza viruses, human metapneumovirus, RSV, SARS viruses, and SARS-CoV-2 viruses cause infection not only in the upper respiratory tract but also in the lower respiratory tract, in order to control them, there must be means to neutralize them in all parts of the respiratory tract from the upper to the lower respiratory tract. All acute respiratory infections (ARI) cause infection in the epithelial cells of the respiratory tract and initiate the onset of symptoms.

[0004] Major bacteria causing acute respiratory infections include Streptococcus pneumoniae and Haemophilus influenzae; Mycoplasma pneumoniae and Chlamydia pneumoniae can also act as causative agents, and infections can occur in combination with viruses (such as adenovirus and influenza viruses). Particular caution is required for immunocompromised patients, such as young children and the elderly, as these infections can lead to bacterial pneumonia or severe complications.

[0005] Allergies are non-infectious but are an overreaction of the respiratory immune system to common allergens such as pollen or dust, causing inflammation and excessive mucus. This can create a respiratory environment that makes one more vulnerable to other infections, and sometimes allergy symptoms are similar to those of a cold.

[0006] Non-infectious, non-allergic respiratory symptoms are not caused by a reaction to allergens such as pollen or dust, but present with acute symptoms similar to those of a cold. It is rhinitis, or inflammation of the nasal cavity. It is characterized by symptoms such as sneezing, nasal congestion, nasal itching, and a runny nose. In the United States, the prevalence of non-allergic rhinitis (NAR) affects approximately 7% of the population, or about 22 million people. About 50% of patients visiting an otolaryngologist are diagnosed with NAR. The most common form of NAR is vasomotor rhinitis, which accounts for about 71% of all NAR cases. Like nasal allergies, NAR also initiates symptom development in respiratory epithelial cells.

[0007] In addition to these, endemic viruses emerging annually all initiate infection and symptom onset in respiratory epithelial cells. Although there are many types of acute respiratory infections (ARI) that cause great suffering to countless people worldwide, there is no easy way to prevent or overcome them.

[0008] Acute respiratory infections (ARTIs) occur very frequently because the respiratory system is continuously exposed to massive amounts of airborne pathogens, such as viruses and bacteria, through respiration, overwhelming or impairing the efficiency of immune defenses. Common causes of ARIs include rhinovirus, influenza, human respiratory syncytial virus (RSV), adenovirus, and parainfluenza virus; additionally, numerous viruses and bacteria, such as Streptococcus pneumoniae, Mycoplasma pneumoniae, and Chlamydia pneumoniae, can cause respiratory infections. As such, ARIs have posed a serious threat to human health for thousands of years, and effective prevention and treatment technologies remain lacking to this day.

[0009] All acute respiratory diseases manifest symptoms resulting from a combination of direct tissue destruction by pathogens and inflammation caused by an immune response. The immune response releases numerous types of inflammatory cytokines to control pathogens. These cytokines induce runny nose, nasal congestion, redness, swelling, and mucus production, leading to various symptoms such as coughing, sneezing, congestion, and muscle pain. Therefore, the prevention, alleviation, or eradication of acute respiratory diseases is possible only by simultaneously controlling both pathogens and cytokines.

[0010] Even in cases of non-infectious or non-allergic allergies where no pathogens are present, symptoms occur due to the release of numerous types of inflammatory cytokines as an immune response to external substances. Therefore, suppressing cytokines can also suppress allergies.

[0011] Cytokines are part of the normal immune response, but in some infections, particularly severe ones, they are overproduced, causing a "cytokine storm." This storm can lead to widespread inflammation and severe damage to various organs. Cytokine storms exacerbate infections and can cause serious complications, such as lung damage or even death. COVID-19 is closely associated with cytokine storms. The severity of COVID-19 is often correlated with the extent of the cytokine storm, and this storm is a significant factor in the mortality rate associated with severe cases.

[0012] The critical parts of pathogens and cytokines are proteins. Therefore, controlling these proteins allows for the control of infection and symptoms. The problem lies in their types. While there are many types of pathogens, they frequently mutate to develop resistance. Consequently, vaccines cannot be developed for the common cold virus, which undergoes frequent mutations. In the case of influenza, a vaccine that does not match the mutations is ineffective. Therefore, a new vaccine tailored to the virus circulating that year must be administered every year.

[0013] There are numerous types of symptom-inducing cytokines, and since each plays a role in inducing inflammation, it is virtually impossible to attack and eliminate them individually. Therefore, to respond to acute respiratory diseases, there must be a universal means capable of simultaneously neutralizing all mutated and modified pathogens and countless cytokines.

[0014] Fortunately, the critical parts of all pathogens and their cytokines are all protein substances that are highly vulnerable to oxidation. Furthermore, since they all originate in the infected respiratory epithelium, administering an oxidizing agent to this epithelial layer can simultaneously destroy all of these pathogens and cytokines. In the case of allergic and non-allergic diseases, an overreaction of the immune system causes IgE antibodies to generate inflammatory cytokines in epithelial cells, thereby triggering symptoms. Consequently, allergic and non-allergic diseases can also be controlled with oxidizing agents. By destroying these pathogens and symptom-inducing cytokine proteins, both the source of infection and the symptoms can be eliminated simultaneously.

[0015] However, because oxidizers are toxic, not just any oxidizer can be administered into the respiratory system. The only oxidizer that can be safely administered into the respiratory system is iodine. Iodine is widely used for biological disinfection due to its broad-spectrum activity as an oxidizer (activity against aerobic and anaerobic bacteria, as well as viruses, Chlamydia, and fungi) and safety. Despite having been used as a disinfectant for a long time, iodine does not exhibit resistance.

[0016] Iodine has been used as a safe disinfectant for nearly 100 years. The antimicrobial activity of iodine comes from free molecular iodine (I2), which damages pathogens and induces their death. Free molecular iodine (I2) rapidly penetrates and oxidizes several major proteins and major groups of nucleotides and fatty acids, thereby causing infectious agents and cytokines to lose their function. In this way, iodine molecules (I2) exhibit multiple modes of action, showing broad activity without resistance or cross-resistance. It also acts on various proteins that cause symptoms, causing infection symptoms to disappear quickly. Furthermore, immunity can be acquired by killing antigens that have entered the body. In other words, molecular iodine (I2) can simultaneously block infection and symptoms by oxidizing pathogens that cause disease in respiratory epithelial cells and cytokine and chemokine proteins that cause infection symptoms, thereby causing them to lose their function.

[0017] Due to the broad activity of iodine, it was thought that PVP-I could be applied to all symptoms of infection occurring in the upper respiratory tract. Thus, the nasal and oral use of PVP-I was recommended during the COVID-19 pandemic. However, Zarabanda et al. reported in Laryngoscope. 2022 Nov;132(11):2089 that administering a 0.5% diluted PVP-I nasal spray to COVID-19 positive outpatients up to day 30 had no effect. They reported that while there was a slight effect when 2.0% PVP-I was administered, there was severe burning irritation inside the nose.

[0018] Povidone iodine (PVP-I) is a substance formed by the combination of an iodine molecule and a water-soluble polymer polyvinylpyrrolidone; while it makes insoluble iodine (I2) soluble in water, the strong bond releases very little of the active ingredient, molecular iodine (I2). A 10% PVP-I solution contains 1% effective iodine, but the true active species, free molecular iodine (I2), is only about 1 to 2.54 ppm. Although a 10% PVP-I solution contains about 1% iodine, it releases very little of the active free molecular iodine (I2). For this reason, PVP-I was ineffective against COVID-19. To destroy acute respiratory infection viruses, spores, or certain bacteria more quickly, a concentration of free iodine (I2) of 20 to 175 ppm is required.

[0019] Although PVP-I is known for its bactericidal and disinfectant effects, it has not been used for respiratory infections due to toxicity and skin irritation issues. While using diluted PVP-I is safe, the high molecular weight PVP binds to iodine, hindering molecular iodine (I2) from entering cells and thus rendering it ineffective. To date, no iodine preparation has been known that can be applied to all parts of the upper and lower respiratory tracts to prevent or treat acute respiratory infections.

[0020] Recently, it was discovered that the toxicity and irritation of PVP-I are caused not by free molecular iodine (I2), but by triiodide contained in PVP-I or Lugol solution. Triiodide is an iodide anion added to molecular iodine to dissolve iodine in water, which allows iodine to dissolve easily in water. Therefore, it is effective to dissolve iodine in water without iodide ions. However, it is difficult to dissolve molecular iodine (I2) in water without iodide ions.

[0021] The means employed to dissolve molecular iodine (I2) was to add solvents such as PVP or KI, but unfortunately, these added for dissolution caused I3 anions to form, which caused toxicity. Therefore, an aqueous solution containing a high concentration of molecular iodine without iodide ions is required.

[0022] Furthermore, even if a high-concentration molecular iodine (I2) solution is obtained, applying it to the respiratory system presents another challenge. That is, it must be applicable to all parts of the respiratory system, including the eyes, nasal cavity, sinuses, oral cavity, and upper and lower respiratory tracts. However, the respiratory system is highly sensitive to the tonicity of the solution. For a high-concentration aqueous iodine solution to be applied to the respiratory system, it must possess tonicity suitable for the respiratory organs. If the tonicity is not suitable, it triggers a strong cough reflex that makes inhalation impossible and causes significant irritation to the nasal cavity. Therefore, the high-concentration aqueous iodine solution composition sprayed into the respiratory system must possess hypertonicity suitable for the respiratory organs. To date, no hypertonic aqueous iodine solution composition for application to the respiratory system has been known.

[0023] Furthermore, this solution must be capable of treating all infected sites of the respiratory tract. In the case of viral infections, applying it to only certain infected areas is ineffective because the virus replicates in the untreated areas and continues to re-infect the entire area. Therefore, a composition and method capable of simultaneously neutralizing infectious agents and cytokines in all infected sites of the respiratory tract must be available.

[0024] In the case of respiratory viral infections, the asymptomatic incubation period is long, allowing transmission to occur and spread to others even during this time. Therefore, controlling the pathogen during the asymptomatic incubation period can eliminate one's own infection and prevent transmission to others. Consequently, such preventive measures are essential. Furthermore, even with very dangerous infections, symptoms are often very mild in the early stages, leading many to believe they will recover quickly and miss the optimal time for treatment. Therefore, medication must be easily applicable during the incubation period or when symptoms are mild. In other words, the administration of the medication must be very simple.

[0025] Therefore, there is a need for a high-concentration, hypertonic aqueous molecular iodine solution formulation with broad-spectrum activity capable of treating all acute respiratory diseases, and a method that can be applied very conveniently to all respiratory organs.

[0026] The present invention is derived from the above-mentioned needs and aims to provide a molecular iodine (I2) containing hypertonic aqueous solution composition that can be widely applied to all parts of the respiratory system, including the eyes, nasal cavity, oral cavity, larynx, and lower respiratory tract, for the prevention, alleviation, or treatment of various infectious or non-infectious acute respiratory diseases, and a method for the prevention, alleviation, and treatment of acute respiratory diseases using the same.

[0027] One preferred embodiment of the present invention provides a hypertonic aqueous solution composition containing molecular iodine (I2) that can be used for the prevention and treatment of acute respiratory infection (ARI) disease, and a method for prevention, alleviation, or treatment using the same.

[0028] Acute respiratory diseases are sudden infections that affect the respiratory system, including the nose, throat, airways, and lungs. Common causes include the common cold, influenza, RSV, and COVID-19, as well as viruses, allergens, or bacteria such as dust, pollen, or bacteria. Major types include the common cold, pneumonia, bronchitis, sinusitis, and acute respiratory distress syndrome (ARDS). Acute bacterial respiratory infections include Mycoplasma pneumonia and Veterinary Disease, while acute respiratory distress syndrome (ARDS) is a severe acute respiratory disease that causes lung damage and is life-threatening.

[0029] The symptoms of acute respiratory infections (ARI) are primarily caused by the body's immune response to invading pathogens rather than the pathogens themselves. The mechanism is as follows: Viruses or bacteria generally enter the respiratory tract through inhalation or contact with contaminated surfaces. These pathogens attach to respiratory epithelial cells, form colonies, and replicate within the host's epithelial cells. Respiratory epithelial cells are located throughout the respiratory tract, from the nasal cavity to the deepest parts of the lungs, and they play an essential role in the body's defense against pathogens. The upper respiratory tract acts as the primary physical barrier.

[0030] When infection occurs in respiratory epithelial cells, the innate immune system is activated, triggering a local immune response that releases pro-inflammatory cytokines (IL-1β, IL-6, IL-8, TNF-α, etc.), chemokines (CCL2, etc.), reactive oxygen species (ROS), and bioactive lipids (prostaglandins, leukotrienes, etc.). These mediators, triggered by innate immune receptors, recruit and activate immune cells, coordinate the immune response, and cause tissue damage and airway inflammation. While these inflammatory mediators play a crucial role in eliminating pathogens, they also trigger various characteristic symptoms of respiratory infection. Pathogens and inflammatory mediators also activate neural pathways, further inducing symptoms such as coughing or sneezing.

[0031] Synthesizing the mechanisms of acute respiratory infections and symptom induction, it can be seen that infection and symptoms can be blocked by simultaneously destroying pathogens and inflammatory mediators in the epithelial layer of the respiratory tract. The substance capable of simultaneously destroying these infectious agents and immune inflammatory mediators is an oxidizing agent. Among numerous oxidizing agents, molecular iodine is an oxidizing agent that is safe for the human body. To achieve this, the present invention provides a hypertonic aqueous solution composition containing molecular iodine (I2) and a method of application. A preferred embodiment of the present invention provides a high-concentration molecular iodine-containing aqueous solution composition and a method that can be administered to all respiratory tracts, including the eyes, nasal cavity, oral cavity, and upper respiratory tract, while containing high concentrations of molecular iodine (I2), for the prevention or treatment of acute respiratory infectious diseases.

[0032] Since iodine (I2) is insoluble in water, it cannot be directly dissolved in water. An aqueous iodine solution can be obtained by first dissolving solid iodine in a water-soluble solvent and then adding it to water. In this case, an aqueous iodine solution can be obtained by using an amphoteric solvent that has both a hydrophilic polar part and a nonpolar part capable of dissolving nonpolar substances within its molecule.

[0033] In one embodiment of the present invention, a high-concentration molecular iodine aqueous solution can be prepared by first dissolving solid iodine in a solvent with a fast dissolution rate, such as ethanol, isopropanol, acetic acid, or DMSO, then diluting the solution with a solvent, such as liquid polyhydric alcohols (polyols) (e.g., glycerol, propylene glycol, dipropylene glycol, tripropylene glycol, butanediols, pentanediols, hexanetriols, PEG-200, 300, 400, 600, or water-soluble polypropylene glycol, e.g., PPG-200, PPG-400, or PPG-600), and then adding the solution to water. In addition to these, low molecular weight water-soluble polyvinyl alcohol (PVA), polyacrylic acid (PAA), or polylactic acid (PLA) with a molecular weight of, for example, 3000 or less, may be used.

[0034] In this way, an aqueous solution containing 0.001 to 1.0 w / v% of molecular iodine (I2, cas no. 7553-56-2) can be prepared at room temperature without the addition of pvp, KI, or NaI. At this time, the solvent is 0.1 v / v% to 50 v / v%. Preferably 1.0 to 20 v / v%, more preferably 1.0 to 10 v / v%.

[0035] Even though iodine possesses excellent antiviral, anti-allergic, or antibacterial effects, iodine-containing compositions cannot be administered to the respiratory tract. The respiratory tract is highly sensitive to the inhalation of foreign substances other than air. If water is sprayed into the nasal cavity, it causes severe irritation. If water is sprayed into the throat and inhaled into the airway, it triggers a severe cough reflex, making inhalation impossible. To prevent this, a hypertonic aqueous solution must be used. The iodine-containing hypertonic aqueous solution composition of the present invention can prevent irritation and cough reflex reactions in the nasal cavity, larynx, and airway, allowing it to be administered to all parts of the respiratory tract.

[0036] In a preferred embodiment of the present invention, the osmotic agent may consist of one or more salts selected from a salt of a cation selected from the group consisting of lithium, sodium, potassium, magnesium, calcium, or zinc, and an anion selected from the group consisting of chloride, sulfate, phosphate, acetate, carbonate, lactate, gluconate, succinate, tartarate, or citrate. For example, 1.0 w / v% to 5.0 w / v% of sodium chloride, potassium chloride, calcium gluconate, or magnesium sulfate may be added. In a preferred embodiment of the present invention, a hypertonic aqueous solution composition may be prepared containing 1.0 w / v% to 5.0 w / v% of NaCl, preferably 1.0 to 3 wt / v% of NaCl, as a hypertonic osmotic agent.

[0037] In addition, to administer drugs to the respiratory system, they must be passed through the nose and mouth, and the nose and mouth are highly sensitive to taste and smell. Iodine, in particular, causes aversion due to its taste and smell. Therefore, the aversion to the taste and smell of iodine must be masked to prevent user aversion. In a preferred embodiment of the present invention, a sweetener may be included to enhance the masking effect of the unpleasant smell and taste of iodine. It is preferable that the sweetener be contained in an amount of 0.0001 w / v% to 1.0 w / v%, more preferably 0.001 w / v% to 0.1 w / v%, of one or more selected from saccharin, aspartame, acesulfame potassium, sucralose, neotame, advancem, or stevia.

[0038] In a preferred embodiment of the present invention, a flavoring agent may be added to enhance the masking effect of the unpleasant odor and taste of iodine. In a preferred embodiment of the present invention, the flavoring agent may be a substance selected from among the flavoring agents listed in the International Fragrance Association (IFRA), and it is preferable to use a substance that can be used simultaneously as a flavoring agent and a flavoring agent, and it is preferable to use a stable substance that does not react with iodine, and it is preferable to use a compound having functional groups such as saturated alkyl, acid, alcohol, ester, ether, lactone, ketone, or aromatic.

[0039] In a preferred embodiment of the present invention, the fragrance may contain 0.0001% to 1.0 wt / v% of one or more compounds. Preferably, the fragrance may contain 0.001% to 0.1 wt / v%. The fragrance contained in the composition of the present invention may be added in the following manner. The fragrance to be contained may be dissolved in a solvent and then added to a molecular iodine (I2) solution to be added dropwise to an aqueous solution. In this way, a fragrance-containing molecular iodine (I2) aqueous solution composition may be prepared.

[0040] In a preferred embodiment of the present invention, this composition can mask the unpleasant or repulsive smell and taste of iodine, and the hypertonic aqueous solution composition of the present invention can be applied to the upper and lower respiratory tracts, eyes, nasal cavity, oral cavity, and lower respiratory tract without repulsion caused by iodine.

[0041] The molecular iodine-containing hypertonic aqueous solution composition of the present invention can prevent, alleviate, or eliminate infectious agents and symptoms of acute respiratory diseases by inactivating proteins on the surface of viruses, bacteria, or allergic or non-allergic antigens or pathogens that cause acute respiratory diseases, as well as mediator protein substances that cause symptoms.

[0042] When infected with an acute respiratory disease, symptoms such as runny nose, nasal congestion, sore throat, cough, mild fever, headache, sneezing, tearing, muscle pain, fatigue, and chest congestion appear. In a preferred embodiment of the present invention, a high-concentration molecular iodine-containing aqueous solution composition can rapidly prevent, alleviate, or eliminate symptoms of infection of acute respiratory diseases such as the common cold, influenza, COVID-19, allergies, and non-allergics, namely, sneezing, runny nose, nasal congestion, difficulty breathing, itching or tearing of the eyes, facial pressure, cough, inflammation, pains such as sore throat, muscle pain, and joint pain, fever, chills, headache, discomfort, fatigue, lethargy, loss of appetite, drowsiness, and malaise.

[0043] These symptoms are triggered by cytokines such as interferon, interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α). Major pro-inflammatory cytokines secreted during acute respiratory infections cause symptoms such as fever, muscle pain, fatigue, and shortness of breath, which are closely related to viral replication and inflammatory responses.

[0044] The relationship between the major cytokines secreted during acute respiratory infections and the resulting symptoms is as follows. Interleukin-1 beta (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α) are key mediators of the acute inflammatory response and can cause fever, malaise and fatigue, muscle pain and headache, as well as chemokines (e.g., IL-8, CCL3, etc.) and cough and shortness of breath. These cytokines and chemokines are all functional proteins. When they are inactivated by molecular iodine, the associated symptoms disappear.

[0045] Generally, viruses that cause acute respiratory infections include rhinovirus (common cold), influenza virus (flu), coronavirus (SARS-CoV, SARS-CoV-2, MERS-CoV, etc.), respiratory syncytial virus (RSV), parainfluenza virus, human metapneumovirus and adenovirus, and enteroviruses. These viruses are widespread, and influenza, RSV, and coronavirus often cause more severe diseases, posing a greater risk, particularly in infants and the elderly. The molecular iodine-containing aqueous solution composition of the present invention can prevent or rapidly treat these acute respiratory infectious diseases.

[0046] Bacteria that cause acute respiratory infections, such as Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, and Chlamydia pneumoniae, can act as causative agents and cause infection; they may also cause infection in combination with viruses (such as adenovirus and influenza viruses). In particular, it can induce bacterial pneumonia or severe infection in immunocompromised patients, such as young children and the elderly. The molecular iodine-containing aqueous solution composition of the present invention can prevent or rapidly treat these acute respiratory infectious diseases.

[0047] In a preferred embodiment of the present invention, the high-concentration molecular iodine-containing hypertonic aqueous solution composition of the present invention can be applied by spraying and inhaling into the eyes, nasal cavity, nasopharynx, oral cavity, larynx, and trachea. It can be applied to the oral cavity by spraying and can also be used as a mouthwash. Through this, viruses and cytokines generated in the respiratory epithelium can be inactivated, thereby eliminating infections and symptoms.

[0048] During periods when acute respiratory infections such as the common cold, influenza, or COVID-19 are prevalent, anyone is susceptible to infection. Even if one is exposed and infected during these times, the fact of infection is often unknown because no symptoms appear during the incubation period. However, the absence of symptoms does not mean that the virus is not being released, for example, in the case of the flu. If infected with influenza, the virus can be replicated and released even without symptoms, potentially infecting those around you. Thus, there is a risk of infection even when meeting someone who is asymptomatic, and it is possible that viruses are already actively replicating and being released within one's own body.

[0049] Thus, preventive measures are essential during periods when respiratory infectious diseases are prevalent. That is, if you have entered a crowded gathering or place, or if there is a possibility of contact with an infected person, or if you feel that you may have been exposed to infection, you can prevent infection by lightly spraying the iodine-containing hypertonic aqueous solution of the present invention into each nostril 1 to 2 times for disinfection, even if you do not feel any symptoms. In addition, during periods when acute respiratory infectious diseases are prevalent, you can prevent infection by spraying and inhaling the solution into the nasal cavity 1 to 2 times every 2 to 3 days.

[0050] Even the most dangerous acute respiratory infections present with very mild symptoms in the early stages. Symptoms may include a slight runny nose, a mild cough, or a slight fever; because the symptoms are so mild, it feels as though the condition will improve quickly. However, this is a very dangerous misconception. Often, symptoms suddenly worsen after just one day. If left untreated, it can be life-threatening. It is difficult to visit a hospital and see a doctor for treatment when symptoms are absent or extremely mild. In such cases, prompt treatment is crucial. It is vital to treat quickly when there is a risk of infection or when one is already infected. Delaying treatment is the most dangerous aspect. To avoid missing this window of opportunity, the treatment must be convenient. Sprays are the best option.

[0051] The hypertonic molecular iodine composition of the present invention is inhaled into the nasal cavity by spraying 1 to 3 times. If symptoms are severe, in addition to the nasal spray, spray into the mouth and throat 2 to 3 times and inhale the spray into the airway 2 to 3 times. In this way, the onset of symptoms can be suppressed or alleviated. If symptoms persist after 3 to 4 hours, the symptoms can be eradicated within 24 hours by spraying the same treatment into the eyes, nasal cavity, mouth, and throat at intervals of 3 to 4 hours.

[0052] If symptoms persist thereafter, the above method may be applied up to 3 to 4 times a day until the symptoms disappear. When there is a sore throat, it is recommended to spray 3 to 4 times into the larynx. It is also recommended to gargle with the aqueous solution of the present invention for 1 to 2 minutes.

[0053] Even when symptoms are mild, do not take them lightly; if you quickly inhale the solution into the nose while spraying the composition of the present invention 1 to 3 times, you can experience the symptoms being alleviated or disappearing within one hour.

[0054] If you have severe cold or flu symptoms, such as a high fever, sore throat, severe nasal symptoms, severe cough, or body aches, it may be because the infection has already spread to the entire respiratory system. Therefore, if you repeat the spray inhalation 2 to 5 times at intervals of 3 to 4 hours to all respiratory organs from the eyes to the lower respiratory tract, the symptoms will gradually disappear.

[0055] In particular, the tear ducts can be disinfected by spraying one or two times into each eye, gently rubbing the eyeballs and snowflakes with a clean finger, spraying one or two times into each eye again, blocking both nostrils, and sucking the solution into the nose. When administering the composition of the present invention to the eyes, one drop at a time can be instilled using an ophthalmic dropper, and the eyelids can be disinfected by rubbing with a clean finger. Alternatively, one drop can be placed in each eye, allowing the liquid to accumulate in the eyes, and then the tear ducts can be disinfected by blocking the nose with a hand and sucking the solution into the nose.

[0056] For the lower respiratory tract, spray into the throat 2 to 5 times while inhaling the spray into the lungs. If you repeat this entire process 2 to 4 times at intervals of 3 to 4 hours, you will feel a significant improvement in lower respiratory tract and systemic symptoms.

[0057] In addition, if symptoms of acute respiratory infection are severe, applying the spray to the entire respiratory system, including the eyes, nasal cavity, nasopharynx, oral cavity, tonsils, trachea, bronchi, bronchioles, and lungs, can significantly alleviate the symptoms within 24 hours.

[0058] If more than three days pass after the onset of symptoms, acute respiratory diseases can transition from viral to bacterial infections, making treatment difficult and potentially worsening symptoms. Therefore, it is advisable to treat the condition before symptoms appear if possible, or to treat it promptly at the onset of symptoms.

[0059] In one embodiment of the present invention, when applied to patients with acute respiratory infections, particularly those with a cold, flu, COVID-19, and allergic rhinitis, symptoms such as headache, runny nose, nasal congestion, and fever are significantly alleviated or disappear within 1 to 2 hours after administration, so there is no hindrance to daily activities, and there is no recurrence or worsening thereafter.

[0060] In one embodiment of the present invention, the composition and method of the present invention can rapidly prevent, alleviate, or treat symptoms of the common cold, influenza, COVID-19, RSV, hMPV, allergic rhinitis, non-allergic rhinitis, runny nose, nasal congestion, or cough of unknown cause.

[0061] Major bacteria causing acute respiratory infections include Streptococcus pneumoniae and Haemophilus influenzae, while Mycoplasma pneumoniae and Chlamydia pneumoniae are also causative agents, and infections can occur in combination with viruses (such as adenovirus and influenza viruses). In particular, if left untreated without prompt care in immunocompromised patients, such as young children and the elderly, it can lead to bacterial pneumonia or severe infection.

[0062] To prevent, alleviate, or overcome acute respiratory diseases, the dosage and frequency of administration may vary depending on the patient's age, gender, weight, the specific disease or pathological condition to be treated, and the severity of the disease or pathological condition. The determination of the dosage based on these factors is within the level of a person skilled in the art, and administration may be performed once or several times a day. The above dosage does not limit the scope of the present invention in any way.

[0063] The present invention is a hypertonic aqueous solution composition containing molecular iodine as an active ingredient, which can rapidly prevent, alleviate, or eliminate symptoms caused by acute respiratory infectious diseases such as the common cold, influenza, COVID-19, and RSV, or non-infectious diseases, such as cough, runny nose, nasal congestion, mild fever, fever, chills, muscle pain, headache, fatigue, body aches, chills, sore throat, cough, sneezing, itchy eyes, watery eyes, sinus congestion, chest congestion, respiratory distress, facial pressure, joint pain, discomfort, lethargy, loss of appetite, drowsiness, malaise, or wheezing.

[0064] Preferred embodiments of the present invention will be described in detail below. However, the present invention is not limited to the embodiments described herein and may be embodied in other forms. Rather, the content introduced herein is provided to be thorough and complete and to sufficiently convey the concept of the present invention to those skilled in the art.

[0065] <Example 1>

[0066] Method for preparing a hypertonic aqueous solution containing molecular iodine

[0067] 0.040 g of iodine (I2) was added to 1 ml of DMSO at room temperature and dissolved, and then 6 ml of propylene glycol was added to dilute it. This solution was added dropwise under stirring to 93 ml of a solution in which 1.5 g of NaCl was dissolved in distilled water to prepare a 100 ml hypertonic aqueous solution composition containing 0.04 w / v% of molecular iodine.

[0068] <Example 2-63>

[0069] According to the method of Example 1, iodine is first dissolved in ethanol, isopropanol, or dimethyl sulfoxide, then dissolved again in glycerol, propylene glycol, or dipropylene glycol, and added dropwise to distilled water to prepare a high-concentration molecular iodine-containing hypertonic aqueous solution composition. The prepared composition is shown in Table 1.

[0070] List of compositions for hypertonic aqueous solutions containing molecular iodine Examples iodineNaClEtOHIPAdmsoglclpgdpgtpg20.0252.25530.0102.20.240.0251.10.52.550.0302.20.5160.0302.20.50.570.0301.80.50.5280.0401.80.50.52.090.0351.80.51.5100.1002.20.513.5110.0501.80.541120.0701.50.59130.1502.00.514140 .0502.00.56150.0401.50.21160.0501.150.25170.0451.20.24180.0301.50.5190.0401.20.23200.0501.30.34210.0502.32220.0501.812230.0301.50.53240.0301.50.3250.0501.50.14260.0301.30.13270.0501.40.34280.0601.40.44.5290.0501.40.2543 00.0502.00.254310.0552.00.54320.0402.00.254330.0402.20.23340.0602.20.354350.0301.50.13360.0301.50.13370.0302.00.14380.0252.00.14390.0251.80.13400.0252.00.52410.0251.40.12420.0251.80.10.5431.01.050440.11.015450.10.910460 .061.28470.051.56480.11.095490.071.573500.071.59510.152.014520.12.012530.052.06540.042.32550.042.31560.041.01 2570.051.150.25580.0451.20.24590.041.20.23600.042.21610.051.40.254620.052.00.254630.0552.00.54640.041.51Peg400 10

[0071] iodine; w / v%, nacl; NaCl w / v%, solvent; v / v%, etoh; ethanol, dmso; dimethyl sulfoxide, glcl; glycerol, pg; propylene glycol dpg; dipropylene glycol, tpg; tripropylene glycol, Peg400; polyethylene glycol-400

[0072] <Example 65>

[0073] After preparing the solutions of Examples 1 to 64 above, 0.001 g to 0.5 g of one or more substances selected from the sweeteners saccharin, aspartame, acesulfame potassium, or sucralose is added to prepare a 100 ml aqueous solution composition.

[0074] <Example 66>

[0075] A 100ml aqueous solution composition was prepared by adding 0.02g of sucralose as a sweetener and 0.004g of menthol as a flavoring to the solutions of Examples 1 to 64 above.

[0076] <Example 67>

[0077] A 100 ml aqueous solution composition was prepared containing 0.02 g of sucralose, 0.004 g of menthol, 0.0002 g of exaltolide, and 0.0004 g of ambroxide in the solution of Example 1.

[0078] < Test Example 1 >

[0079] A 56-year-old male, who was experiencing significant disruption to his work due to severe runny nose caused by allergic rhinitis of unknown cause, blocked the nostril opposite to the one with the runny nose by pressing it with his finger, sprayed the composition of Example 1 contained in a nasal spray bottle into the nostril with the runny nose twice, and inhaled strongly. One hour after spraying, the runny nose symptoms disappeared.

[0080] <Test Example 2>

[0081] During an influenza epidemic, a 48-year-old woman commuted by subway, and because there were infected individuals at her workplace, she had no symptoms but was concerned about infection. Upon returning home, she immediately sprayed the composition of Example 1 contained in a nasal spray bottle into each nostril twice and inhaled it. She repeated this once every three days. Subsequently, no symptoms of infection appeared until the end of the influenza season.

[0082] < Test Example 3 >

[0083] A 35-year-old woman began to experience cold symptoms accompanied by a runny nose. She sprayed the composition of Example 67 into each nostril twice and inhaled it. One hour after the nasal spray, the runny nose significantly decreased, and the cold symptoms also significantly decreased. The procedure was repeated after three hours. After 24 hours, the cold symptoms disappeared.

[0084] < Test Example 4 >

[0085] A 45-year-old male with cold symptoms including a cough and slight fever placed the composition of Example 67 into a nasal spray bottle, blocked one nostril with a finger, sprayed it into the opposite nostril twice, and inhaled strongly to prevent the solution from dripping out. He then sprayed the composition into his eyes once using the spray bottle and gently rubbed his eyelids and eyeballs with the liquid that had accumulated in his eyes using a clean finger. He did the same for both eyes. Next, he sprayed an additional time into the outer corner of his eye, blocked both nostrils with his fingers, and sucked the liquid accumulated in his eyes into his nose. This was repeated two more times at 2-hour intervals. Afterward, his symptoms disappeared.

[0086] <Test Example 5>

[0087] A 55-year-old male with influenza, including cough, fever, and headache. The composition of Example 67 was placed in a nasal spray bottle, one nostril was blocked by pressing with a finger, and the solution was sprayed twice into the opposite nostril, followed by strong inhalation to prevent the liquid from dripping out. Two sprays were inhaled into each nostril. Next, the composition of Example 67 was placed in a nasal spray bottle, and the eyelids and eyeballs were gently rubbed with clean fingers using the liquid that had accumulated in the eyes. This was done for both eyes. An additional spray was applied to the outer corner of the eye to allow the liquid to accumulate, after which the patient held both nostrils with two fingers and sucked the liquid accumulated in the eyes into the nose. Next, the composition was sprayed evenly into the mouth. Then, while opening the mouth and inhaling, the spray was inhaled into the lower respiratory tract by spraying 3 to 4 times toward the throat. This was repeated two more times at 2-hour intervals. Subsequently, the cough disappeared, the fever subsided, and the headache vanished, with all symptoms resolving without recurrence.

[0088] <Test Example 6>

[0089] A 45-year-old male infected with COVID-19 was treated in the same way as the influenza patient in <Test Example 5>. Afterward, symptoms disappeared and did not recur.

[0090] <Test Example 7>

[0091] A 50-year-old male with a sore throat. The composition of Example 67 was placed in a spray bottle, and the mouth was opened wide and sprayed into the throat 3 to 4 times. This was repeated 3 times at 3-hour intervals. Afterward, the symptoms of the sore throat disappeared.

[0092] < Test Example 8 >

[0093] A 79-year-old male had a tickling sensation inside his nose and continuous sneezing. He sprayed the composition of Example 67 into each nostril twice and inhaled it while breathing deeply to prevent the solution from flowing out. He did the same for each nostril. One hour after spraying, the nasal itching disappeared and the sneezing also stopped, and did not recur thereafter.

[0094] As seen above, it has been confirmed that the molecular iodine-containing hypertonic aqueous solution composition of the present invention is highly effective in the prevention and treatment of various acute respiratory disease symptoms.

[0095] As such, the molecular iodine-containing hypertonic aqueous solution composition of the present invention can prevent or rapidly treat infectious diseases caused by rhinovirus (common cold), influenza virus (flu), Avian influenza, coronavirus (SARS-CoV, SARS-CoV-2, MERS-CoV), respiratory syncytial virus (RSV), parainfluenza virus, human metapneumovirus and adenovirus, and enteroviruses that cause acute respiratory infections.

[0096] In addition, the composition and method of the present invention can prevent or rapidly treat infections caused by bacteria that cause acute respiratory infections, such as Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, and Chlamydia pneumoniae, or infections caused by these bacteria and viruses (adenovirus, influenza virus, etc.).

[0097] In addition, the composition and method of the present invention can prevent or rapidly treat respiratory allergies, respiratory non-allergics, runny nose of unknown cause, headache, fever, sore throat, or cough symptoms.

Claims

An antiviral, anti-allergic, and antibacterial composition characterized by being a hypertonic aqueous solution comprising 0.001 to 1 w / v% of molecular iodine (I2 cas no. 7553-56-2); 0.1 to 50 v / v% of a solvent; and 1 to 5 w / v% of an osmotic agent; Here, the solvent is one or more selected from the group consisting of ethanol, isopropyl alcohol, acetate, DMSO, glycerol, propylene glycol, butanediol, pentanediol, hexanetriol, dipropylene glycol, tripropylene glycol, PEG-200, PEG-300, PEG-400, PEG-600, PPG-200, or PPG-400; and the osmotic agent represents one or more salts selected from salts consisting of a cation selected from the group consisting of lithium, sodium, potassium, magnesium, calcium, or zinc and an anion selected from the group consisting of chloride, sulfate, phosphate, acetate, carbonate, gluconate, lactate, succinate, tartarate, or citrate. An antiviral, anti-allergic, and antimicrobial composition characterized by being a hypertonic aqueous solution comprising 0.001 to 1 w / v% of molecular iodine (I2 cas no. 7553-56-2); 0.1 to 50 v / v% of a solvent; and 1 to 5 w / v% of an osmotic agent; 0.0001 w / v% to 0.1 w / v% of a flavoring agent; and / or 0.001 w / v% to 0.1 w / v% of a sweetener; Herein, the solvent is one or more selected from the group consisting of ethanol, isopropyl alcohol, acetate, DMSO, glycerol, propylene glycol, butanediol, pentanediol, hexanetriol, dipropylene glycol, tripropylene glycol, PEG-200, PEG-300, PEG-400, PEG-600, PPG-200, or PPG-400; and the osmotic agent represents one or more salts selected from salts consisting of a cation selected from the group consisting of lithium, sodium, potassium, magnesium, calcium, or zinc and an anion selected from the group consisting of chloride, sulfate, phosphate, acetate, carbonate, gluconate, lactate, succinate, tartarate, or citrate; and the fragrance is one or more selected from the group consisting of menthol, ambroside, or exaltolide; The sweetener represents one or more selected from the group consisting of saccharin, aspartame, acesulfame potassium, sucralose, neotame, advancem, or stevia. In paragraph 1 or 2, The above composition is an antiviral, anti-allergic, and antibacterial composition characterized by being applied to the eyes, nasal cavity, oral cavity, larynx, or lower respiratory tract to prevent or treat acute respiratory diseases. An antiviral, anti-allergic, and antimicrobial composition characterized by preventing or treating acute respiratory diseases by applying an aqueous solution comprising 0.001 to 1 w / v% molecular iodine (I2 cas no. 7553-56-2); 0.1 to 50 v / v% solvent; and 1 to 5 w / v% osmotic agent as a spray to the eyes, nasal cavity, oral cavity, larynx, or lower respiratory tract. Here, the solvent is one or more selected from the group consisting of ethanol, isopropyl alcohol, acetate, DMSO, glycerol, propylene glycol, butanediol, pentanediol, hexanetriol, dipropylene glycol, tripropylene glycol, PEG-200, PEG-300, PEG-400, PEG-600, PPG-200, or PPG-400; and the osmotic agent is one or more salts selected from salts consisting of a cation selected from the group consisting of lithium, sodium, potassium, magnesium, calcium, or zinc and an anion selected from the group consisting of chloride, sulfate, phosphate, acetate, carbonate, gluconate, lactate, succinate, tartarate, or citrate. An antiviral, anti-allergic, and antimicrobial composition characterized by preventing or treating acute respiratory diseases by applying a hypertonic aqueous solution comprising 0.001 to 1 w / v% molecular iodine (I2 cas no. 7553-56-2); 0.1 to 50 v / v% solvent; and 1 to 5 w / v% osmotic agent; 0.0001 w / v% to 0.1 w / v% flavoring; and / or 0.001 w / v% to 0.1 w / v% sweetener as a spray to the eyes, nasal cavity, oral cavity, larynx, or lower respiratory tract. Herein, the solvent is one or more selected from the group consisting of ethanol, isopropyl alcohol, acetate, DMSO, glycerol, propylene glycol, butanediol, pentanediol, hexanetriol, dipropylene glycol, tripropylene glycol, PEG-200, PEG-300, PEG-400, PEG-600, PPG-200, or PPG-400; and the osmotic agent represents one or more salts selected from salts consisting of a cation selected from the group consisting of lithium, sodium, potassium, magnesium, calcium, or zinc and an anion selected from the group consisting of chloride, sulfate, phosphate, acetate, carbonate, gluconate, lactate, succinate, tartarate, or citrate; and the fragrance is one or more selected from the group consisting of menthol, ambroside, or exaltolide; The sweetener represents one or more selected from the group consisting of saccharin, aspartame, acesulfame potassium, sucralose, neotame, advancem, or stevia. In paragraph 4 or 5, The above composition is an antiviral and anti-allergic composition characterized by being a cold, influenza, coronavirus (SARS-CoV, SARS-CoV-2, MERS-CoV), syncytial virus (RSV), Avian influenza, parainfluenza virus, human metapneumovirus, adenovirus, enteroviruses, or respiratory allergic disease. In paragraph 4 or 5, The above composition is a composition for treating symptoms of runny nose, cough, headache, fever, nasal congestion, sore throat, sneezing, or watery eyes by applying it as a spray to the eyes, nasal cavity, oral cavity, larynx, or lower respiratory tract. A composition comprising 0.001 to 0.1 w / v% molecular iodine (I2 cas no. 7553-56-2); 0.1 to 30 v / v% solvent; and 1 to 3.0 w / v% osmotic agent; and a flavoring agent and a sweetener, applied by spray to the eyes, nasal cavity, oral cavity, larynx, or lower respiratory tract to prevent or treat symptoms of acute respiratory disease such as runny nose, cough, headache, fever, nasal congestion, sore throat, sneezing, or watery eyes. Here, the solvent is one selected from the group consisting of ethanol, isopropyl alcohol, acetylglycol, and DMSO, and one selected from the group consisting of glycerol, propylene glycol, butanediol, pentanediol, hexanetriol, dipropylene glycol, or tripropylene glycol; and the osmotic agent is one or more selected from salts selected from the group consisting of sodium chloride or potassium chloride; the flavoring agent contains menthol; the sweetener contains sucralose; and the acute respiratory disease refers to the common cold, influenza, coronavirus (SARS-CoV, SARS-CoV-2, MERS-CoV), syncytial virus (RSV), African influenza, parainfluenza virus, metapneumovirus, adenovirus, enteroviruses, or respiratory allergic disease.