HYDROGEN PEROXIDE-BASED THERAPEUTIC SPRAY FOR PROTECTION AND TREATMENT OF MUCOSAL MUCOSA CROSS-REFERENCE TO PROVISIONAL APPLICATION This application claims the benefit of U.S. Provisional Application No. 6,331,09710, filed in March 2022.
Patent Information
- Application Number
- JP2024552333
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-03-02
- Filing Date
- 2023-03-01
- Publication Date
- 2025-03-13
AI Technical Summary
【0024】 本発明のエアロゾル化した鼻スプレーまたは粘膜スプレーは、ネティポットやシンクのようなかさばる装置を必要とせずに、3 分未満で洗浄、消毒および治療を可能にし、鼻腔内または粘膜上に便利に投与することができる。本発明の鼻スプレーボトルとは、実質的に、感染した粘液を鼻腔から除去し、3 分以内に治療の緩和をもたらす装置である。開示されたシステムと方法は治療用化合物を粘膜に送達しながら、ウイルス感染を防ぐために感染した粘液を鼻から出すことを可能にする。開示された粘膜スプレーは様々な病状を治療するために、治療の緩和を提供し、酸化還元反応のエネルギーによって粘膜を介した薬剤送達を強化することを可能にする。本発明の利用は、家畜にも同様に適用できる。
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Figure 2025506999000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention is a therapeutic spray for the protection and treatment of mucous membranes, particularly nasal mucosa from infections and allergies, and a spray for protecting against oxidative damage caused by the use of hydrogen peroxide-based nasal sprays. Hydrogen peroxide-based sprays work by a redox reaction between hydrogen peroxide and mucus and body fluids of the mucosa, which in the long term leads to damage of the mucosa. The present invention reduces this damage while providing therapeutic relief to users with suspected infections and allergies. The present invention uses a hydrogen peroxide-based nasal spray to oxidize the mucus in the nasal cavity, thereby loosening the mucus in the nasal cavity, while at the same time facilitating the delivery of at least one or more pharma- ceutically acceptable compounds to the nasal mucosa with the energy of the redox reaction, allowing for irrigation, disinfection and treatment of the nasal cavity. The present invention minimizes the discomfort associated with administration of hydrogen peroxide by gradually oxidizing the mucus and body fluids over a period of 10 to 180 seconds. The disclosed therapeutic compounds penetrate the mucosa through the skin moisturizer and the energy of the redox reaction, protecting the mucosa from the harsh effects of hydrogen peroxide. The present invention is capable of using the energy of redox reactions to deliver drug samples within 3 minutes for use in treating various diseases, and is capable of locally treating mucous membranes.
[0002] A directional spray bottle equipped with a metering pump is configured to deliver a drug compound in the form of aerosolized droplets <100 micron sized droplets from a drug composition having a viscosity of 1.1-1000 centipoise containing a plurality of or at least one therapeutic compound and hydrogen peroxide, the drug composition consisting essentially of hydrogen peroxide, 5%-3% w / w, a therapeutic compound, and deionized water. When administered onto the mucosa, the aerosolized droplets essentially form a self-adhesive coating <0.5 mm thick (2') (Fig. 1a), which loosens the mucus or fluid from the mucosa by oxidizing it over a period of 10-180 seconds, while at the same time allowing the delivery of deionized water and therapeutic compounds to the mucosa in less than 3 minutes via the energy of the redox reaction between hydrogen peroxide and the mucus or fluid.
[0003] One embodiment of the present invention is a method for disinfecting the nasal mucosa while protecting it from oxidative damage caused by hydrogen peroxide, using a pharmaceutical compound provided with hydrogen peroxide.One embodiment of the present invention is a nasal spray system that disinfects the nasal mucosa while protecting it from oxidative damage through its redox reaction, and simultaneously provides therapeutic relief to a subject exposed to an infection or allergy.One embodiment of the present invention is a nasal spray system that disinfects the mucosa of a subject exposed to an infection or allergy through the energy of the redox reaction, while simultaneously protecting the mucosa from damage caused by the redox reaction, and simultaneously provides therapeutic relief. [Background technology]
[0004] Cleansing and disinfection of the nasal passages and respiratory tract are essential for the prevention and treatment of many allergies and viral infections, and it is also important to deliver therapeutic compounds and antibacterial agents to the mucous membranes. A conventional method that allows for cleaning and disinfection of the nasal passages is saline nasal irrigation using a neti pot, as disclosed in the existing technology described in Patent Documents 1 and 2 below. Such methods are cumbersome because they require equipment, large amounts of water, and a sink. If a viral infection is suspected, it must be treated immediately. People who are away from home may not have access to such methods. Many pharmacologic acceptable antibacterial and therapeutic compounds are known, but even if they are applied directly to the nasal passages, sufficient penetration is not achieved because the mucous membrane is often covered with mucus and body fluids.
[0005] It is known that viral infections can become trapped in mucus in the nasal passages, but it is not known how to clear the infected mucus. The focus of existing technology has often been to kill the virus on the spot, which harms the mucous membrane. The present invention takes a different approach to viral infections. It discloses a nasal spray that simultaneously clears the infected mucus from the nose and delivers a medicinal compound to the mucous membrane, allowing for sterilization and treatment in about 3 minutes. The present invention uses 100 micron aerosolized droplets containing hydrogen peroxide as an active agent to loosen and clear the mucus in the nasal passages, exposing the surface of the mucous membrane and facilitating delivery of the disclosed medicinal compound to the mucous membrane. The inventor personally demonstrates an embodiment of the invention as a nasal spray in a video clip posted at www.gunkex.com / video1. Several hydrogen peroxide-based compositions are known, including U.S. Patent Nos. 5,233,663 to 5,311,622, but none of them disclose a drug delivery method for disinfecting or treating the nasal cavity or mucous membranes, or a nasal spray or mucosal spray for cleaning. Despite the urgent need during the pandemic, government agencies, medical institutions, and manufacturers have not come up with a system or method for removing infected mucus from deep within the nasal cavity and simultaneously delivering antibacterial compounds to the mucous membranes. The closest existing technology may be the applicant's own previous application (patented) described in U.S. Patent No. 5,233,663, which is limited only to certain compositions. Note that the provisional application of the present invention was filed prior to U.S. Patent Application Publication No. 2022 / 0061320, published on March 3, 2022. Hydrogen peroxide in liquid form is known to be harmful to the mucous membranes of the nasal passages, and the U.S. Food and Drug Administration discourages its use. Administration of nasal irrigation with a 3% hydrogen peroxide solution using traditional methods such as a neti pot, as described in Non-Patent Document 2, can be cumbersome, harmful, and even fatal. The New Jersey state government website lists hydrogen peroxide as a hazardous substance, as described in Non-Patent Document 3, and has several official warnings against its use in the nose and throat.
[0006] There is no data available on the safety of long-term use of hydrogen peroxide on the nasal mucosa. Informal studies have confirmed that hydrogen peroxide nasal sprays are not only harmful to the nasal mucosa after several days of use, but also cause discomfort when used and provide no therapeutic relief to the user. Figure 0x (Fig. 0x) shows an example of the oxidative (redox) damage caused to the mucosa when hydrogen peroxide is used alone. The present invention discloses a means to protect the mucosa from oxidative damage caused by topical administration of hydrogen peroxide to the mucosa, particularly the nasal mucosa, while at the same time providing therapeutic relief through the mucosa. Despite the urgent need during the pandemic, no major manufacturer has developed a hydrogen peroxide-based nasal spray, and the Food and Drug Administration (FDA) has not recommended the use of hydrogen peroxide. The present invention has taken several ingenious steps to overcome the aforementioned problems and has demonstrated that hydrogen peroxide can be safely used when mixed with the disclosed therapeutic compounds and administered as a fine mist aerosol. The inventor of the present invention personally demonstrates the unexpected results in a video clip posted at www.gunkex.com / video1. [Prior art documents] [Patent documents]
[0007] [Patent Document 1] US Patent Publication No. 20130041329 [Patent Document 2] US Patent Publication No. 20130039950 [Patent Document 3] U.S. Pat. No. 4,927,627 [Patent Document 4] U.S. Pat. No. 4,900,721 [Patent Document 5] U.S. Patent No. 6,348,187 [Patent Document 6] US Patent Application Publication No. 2022 / 0061320 [Patent Document 7] European Patent No. 2680818 [Patent Document 8] Australian Patent Application Publication No. 2005 / 244462 [Patent Document 9] U.S. Patent No. 8,637,085 [Patent Document 10] Canadian Patent No. 2564763 [Patent Document 11] Canadian Patent No. 1277899 [Patent Document 12] U.S. Pat. No. 5,665,332 [Patent Document 13] U.S. Patent No. 7,060,253 [Patent Document 14] US Patent Application Publication No. 2006 / 0293320 [Patent Document 15] U.S. Patent No. 8,729,077 [Patent Document 16] U.S. Pat. No. 8,394,968 [Patent Document 17] U.S. Patent No. 8,143,414 [Non-patent literature]
[0008] [Non-Patent Document 1] Duggal,Vijay Gunk Ex, www.gunkex.com / video1, (accessed 2024-10-23). [Non-Patent Document 2] Duggal,Vijay Dangers of hydrogen peroxide, https / / youtu.be / 5OowL-JuF1o, (accessed 2024-10-23). [Non-Patent Document 3] State of New Jersey Hazardous Substance Fact Sheet, https / / tinyurl.com / 2p8jcyra, (accessed 2024-10-23). [Non-Patent Document 4] FDA USFood & Drug Administration Inactive Ingredients Database Download, https / / tinyurl.com / 57yxyxjw(July.2022), (accessed 2024-10-23). Summary of the Invention [Problem to be solved by the invention]
[0009] The present invention provides a method for protecting the nasal mucosa from oxidative damage caused by topical administration of hydrogen peroxide to the mucosa, particularly the nasal mucosa, and for enhancing the delivery of energy from an oxidation-reduction reaction to one or more pharma- ceutically acceptable compounds to the mucosa in less than three minutes for the treatment of a medical condition, thereby enabling irrigation, disinfection and treatment of the nasal passages. [Means for solving the problem]
[0010] Hydrogen peroxide is a hazardous substance, which is uncomfortable to use and harmful to mucous membranes, but the present invention has been found to mitigate these harmful effects while being useful for cleaning, disinfecting and treating nasal passages and mucous membranes, and to enhance drug delivery through mucous membranes for the treatment of various medical conditions. At least one or more pharma- ceutically acceptable compounds can be dispersed into mucous membranes for the treatment of nasal disinfection, loosening and removing mucus from the nasal passages, enabling nasal cleaning, and for the treatment of medical conditions. Compositions and methods for nasal or mucosal spray devices using hydrogen peroxide are disclosed. The present invention discloses a number of means and methods for protecting the nasal mucosa from damage caused by the redox reaction of hydrogen peroxide with mucus or bodily fluids while providing therapeutic relief to subjects exposed to infection or allergies. These means include droplet sizes of 100 microns or less, viscosity of drug compounds, and the use of skin conditioners and the disclosed therapeutic compounds that reduce this damage and provide relief from discomfort and therapeutic relief. The nasal mucosa is often covered with mucus, which prevents efficient penetration of topical medications when administered as a nasal spray. The present invention discloses compositions, methods and devices that can loosen mucus by oxidation of hydrogen peroxide in approximately 10-180 seconds, while facilitating delivery of drugs and therapeutic compounds to the mucosa through the energy of a redox reaction between hydrogen peroxide and the mucus and bodily fluids. The loosened mucus can be expelled or wiped away by the user. The system and method allows for cleaning, disinfection, treatment and enhanced drug delivery through the mucosa to treat a variety of medical conditions in less than three minutes.
[0011] The fine mist spray bottle is configured to generate aerosolized droplets <100 micron in size from at least one pharma- ceutically acceptable deliverable drug compound with hydrogen peroxide as an active delivery agent. When the aerosolized droplets are administered intranasally or onto a mucous membrane, they oxidize mucus and fluids to loosen them from the mucous membrane and simultaneously disperse the deliverable compound(s) to the mucous membrane by the energy of the redox reaction within 3 minutes. This process allows for topical mucosal cleansing, disinfection, and treatment, as well as being able to deliver drug samples into the body to treat various medical conditions.
[0012] The objective of the present invention is to protect mucous membranes from oxidative damage caused by hydrogen peroxide and to reduce the pain and discomfort associated with administration of hydrogen peroxide. The present invention has discovered that the amount of hydrogen peroxide in contact with a mucous membrane over a period of time is directly proportional to the pain and discomfort it causes. The present invention has discovered that the harmful and uncomfortable effects of hydrogen peroxide on the nasal mucosa can be mitigated by administering it as aerosolized droplets <100 microns in size along with the disclosed skin moisturizers, drug polymers, and other therapeutic agents disclosed below. Increasing the viscosity of the solution of skin moisturizers and polymers minimizes the amount of hydrogen peroxide that comes into contact with the mucous membrane at one time, allowing the mucus to be oxidized gradually, reducing pain and discomfort while preventing damage to the nasal mucosa.
[0013] The predetermined viscosity of the disclosed drug compounds allows for a gradual oxidation-reduction reaction. The predetermined viscosity of 1.1-1,000 centipoise allows for a controlled rate of electron transfer between hydrogen peroxide and body fluids to allow for a gradual oxidation / reduction reaction. The released energy is distributed over a longer period of time, e.g., 10-180 seconds. The controlled release of energy over time reduces pain and the controlled delivery of the disclosed compounds to the mucosa prolongs the therapeutic effect and protects the mucosa from damage caused by sudden energy release. Protection against the harmful effects of hydrogen peroxide is further enhanced by the disclosed skin moisturizers, such as glycerin, aloe vera gel, and drug polymers, which increase the viscosity and provide adhesion to form a self-adhering reactive coating 2' (Fig. 1a).
[0014] In one embodiment of the invention, the spray bottle utilized in the present invention is configured with a metering pump configured to deliver approximately 0.05 ml to 0.2 ml of solution per pump. The objective is to deliver a predetermined amount of hydrogen peroxide to the nasal cavity with each pump to minimize discomfort. For young healthy adults, approximately 0.15 milligrams of hydrogen peroxide per pump is generally suitable for each nostril. The word "approximately" means a variability of 20% (±). For both cavities, this amount is approximately 0.3 milligrams per pump. To relieve pain or discomfort, two to three sprays spaced 10 to 30 seconds apart are generally used, resulting in a dose of 0.6 to 1.2 milligrams of hydrogen peroxide per spray. Half this dose is recommended for children, and double this dose for livestock animals. The above doses are administered intranasally. For mucous membranes of other body parts, this dose is preferably doubled. The above dosages are calculated based on 0.15% hydrogen peroxide using a 0.1 ml metering pump.
[0015] The present invention has discovered that aerosolized droplets <100 microns in size forming a thin, self-adhesive, reactive coating of hydrogen peroxide <0.5 millimeters thick (2') (FIG. 1a) are sufficient to loosen mucus and fluids in the nasal passages and mucous membranes, allowing the disclosed pharmaceutical compounds to diffuse to the mucous membranes. The present invention has further discovered that rapid oxidation of mucus in the nasal passages with hydrogen peroxide, e.g., for less than 10 seconds, is uncomfortable, whereas controlled, gradual oxidation, e.g., for 10-180 seconds, is reasonably acceptable to most young healthy adults.
[0016] The present invention uses glycerin, aloe vera gel, mucoadhesive polymers, surfactants, emulsifiers, and thickeners that allow aerosolized droplets to adhere to the mucosa for 10-180 seconds without substantial dripping to form a reactive coating (2') <0.5 millimeter thick for controlling and slowing down the oxidation of nasal mucus. In one embodiment of the present invention, a solution viscosity of 1.1-1000 centipoise is utilized as a means to minimize dripping and allow for a controlled and slow redox reaction. The thickness of the reactive coating (2') and the size of the droplets used will vary depending on the mucoadhesive polymers, surfactants, emulsifiers, alcohols, astringents, or thickening stabilizers used. For example, a reactive coating (2') based on hydrogen peroxide, monoterpenoids, alcohols, and astringents can be 0.1 millimeter thick and have droplet sizes of 1-30 microns. When using aloe vera gel, mucoadhesive polymers and / or thickening stabilizers to increase the viscosity, the droplet size can be 20-100 microns (VMD) to ensure a smooth flow of the spray, and the thickness of the reactive coating (2') can be 0.01-1 millimeter. The thickness of 0.5 millimeters claimed is the average thickness of the coating. It varies between about 0.01-1 millimeter. The aforementioned measurements are not intended to limit the scope of the invention, since they depend on several other factors, such as the number of sprays, the dryness of the individual's nasal passages, and environmental factors such as temperature and humidity. The administered droplets move according to gravity, so they collect in every nook and cranny of the mucous membrane, thickening the reactive coating (2') in certain places. The measurements of the coating here are average values. These measurements begin to change as soon as the reactive coating (2') is applied due to the redox reaction. Also, the measurement times mentioned here are only examples, since the discomfort level is subjective to the subject and the invention is equally applicable to livestock.Solutions with droplet sizes of <100 microns and viscosities of 1.1 to 1000 centipoise, methods of mucoadhesion such as electrostatic deposition, spreading, adsorption and / or hydrogen bonding of fine mist droplets with mucosa, and methods using the disclosed surfactants, alcohols, astringents, solubilizers, mucoadhesives, polymers and thickening stabilizers all contribute to the formation of a self-adhesive reactive coating (2') <0.5 millimeters thick that allows for a gradual redox reaction between hydrogen peroxide and the mucus or body fluids.
[0017] To prevent the discomfort associated with administration of hydrogen peroxide to the nasal and oral cavities, the present invention utilizes aroma and flavor compounds that also provide therapeutic relief. To reduce the harmful effects of hydrogen peroxide on mucous membranes, the present invention utilizes skin moisturizers and humectants such as glycerin (glycerol) or its derivatives, aloe vera gel, and pharma- ceutically acceptable polymers. In one embodiment of the present invention, therapeutic compounds such as baking soda and citric acid are utilized to allow for controlled, gradual oxidation by the hydrogen peroxide droplets, which provides therapeutic relief. The use of aroma and flavor compounds is omitted for livestock.
[0018] The objective of the present invention is to enable enhanced drug delivery of pharmaceutical compounds through mucosa to treat various medical conditions such as treating localized pathologies associated with mucosa and drug delivery to the central nervous system (CNS). In one embodiment of the present invention, aerosolized droplets of <100 microns size comprising hydrogen peroxide are utilized to deliver therapeutic salts, topical steroids, antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesic compounds, antibiotic compounds and local anesthetic compounds through mucosa in the form of nasal and throat sprays. In one embodiment of the present invention, gum sprays, ear sprays or specialized medicines for treating urinary system diseases are delivered by the energy of redox reactions. Many of these drugs are anchored by chemical structures that comprise at least one or more 5-membered rings, 6-membered heterocyclic rings, or combinations thereof. The present invention has discovered that hydrogen peroxide as an active agent is compatible with delivering compounds anchored by the aforementioned chemical structures when the compounds comprise oxygen, nitrogen, sulfur, phosphorus, or combinations thereof within the chemical structure.
[0019] When <100 micron aerosolized droplets containing hydrogen peroxide are administered onto the mucosa, miniature clusters of active microscopic oxygen bubbles1 (Fig. 1b) are formed, which act as vehicles to disperse the disclosed drug compounds into the mucosa by mechanical action. These vehicles can be moved by the energy of redox reactions, allowing the disclosed compounds to penetrate deeper into the mucosa.
[0020] The disclosed nasal and oral spray devices provide a convenient and rapid means for cleaning, disinfecting and treating nasal passages and mucous membranes without the need for bulky equipment, thereby minimizing the risk of viral infection soon after it is suspected. The devices and methods provide a preventative measure against viral infection, a first aid system for viral infection, and drug delivery to mucous membranes to treat a variety of medical conditions. The method comprises the steps of: (1) Aerosolized sub-100 micron sized droplets comprising 0.25%-3% w / w hydrogen peroxide, at least one or more pharma- ceutically acceptable deliverable compounds, and deionized water, sprayed into the nasal passages or onto mucous membranes. (2) The aerosolized droplets form a reactive coating (2') <0.5 millimeters thick in the nasal cavity or on the mucous membrane. (3) Aerosolized water droplets react with mucus in the nasal cavity and mucous membranes for 10 to 180 seconds. As a result, the aerosolized droplets oxidize mucus in the nasal cavity, loosening the mucus for clearance and simultaneously dispersing the pharma- ceutically acceptable deliverable compound(s) to the mucosa via redox energy(s) within three minutes.
[0021] The term "self-adhering reactive coating (2')" refers to the property of aerosolized droplets such that at least 50% of the administered droplets adhere to the inner surface of the nasal cavity without dripping for 10 seconds. As disclosed therein, this is made possible by glycerin, aloe vera gel, mucoadhesives, polymeric surfactants or astringents. Glycerin, aloe vera gel, mucoadhesives, and drug polymers are used to achieve a viscosity of 1.1 to 1000 centipoise, which gradually oxidizes the mucus over a period of 10 to 180 seconds, minimizing discomfort. This is in contrast to hydrogen peroxide alone as a nasal spray, which oxidizes suddenly and causes significant discomfort and damage to the nasal mucosa.
[0022] It is an object of the present invention to minimize the decomposition of hydrogen peroxide and to facilitate economical utilization of the disclosed materials for use as nasal or mucosal sprays. To achieve these objectives, the present invention discloses retail packaging options for nasal or mucosal sprays as shown in Figs. 2a and 2b and described below.
[0023] The objective of the present invention is to minimize the harmful effects of antimicrobial agents by enabling targeted drug delivery. For example, one embodiment of the present invention is a dental spray containing 2%-3% hydrogen peroxide, 0.01-0.2% chlorhexidine gluconate, and an aromatic compound or flavoring. This dental spray can target only the specific gingiva of the user who needs treatment with just one or two sprays of 0.1-0.2 ml of liquid. Furthermore, the chlorhexidine gluconate is delivered deeper into the mucosa by the energy of the redox reaction. Effect of the Invention
[0024] The aerosolized nasal or mucosal spray of the present invention allows for cleaning, disinfection and treatment in less than three minutes and can be conveniently administered into the nasal cavity or onto the mucosa without the need for bulky devices such as neti pots or sinks. The nasal spray bottle of the present invention is essentially a device that clears infected mucus from the nasal cavity and provides therapeutic relief within three minutes. The disclosed system and method allows for the delivery of therapeutic compounds to the mucosa while clearing infected mucus from the nose to prevent viral infection. The disclosed mucosal spray provides therapeutic relief and allows for enhanced drug delivery through the mucosa by the energy of redox reactions to treat a variety of medical conditions. The use of the present invention can be applied to livestock as well. [Brief description of the drawings]
[0025] [Figure 1]Figure legend: Fig. 0x shows an example of oxidative damage caused by hydrogen peroxide to the mucosa. Fig. 1a shows a schematic cross-section of the mucosa. Administration of aerosolized droplets onto the mucosa shows the formation of a self-adhesive reactive coating 2'. This results in the formation of miniature clusters of active microscopic oxygen bubbles (1'). The active oxygen bubbles 1' move by mechanical transport, driven by the energy generated during the oxidation / reaction of hydrogen peroxide with mucus and fluids in the mucosa (Fig. 1b). Mechanical transport refers to the movement of active oxygen bubbles (1') on the mucosa, as shown in Fig. 1b. This movement is driven by the energy generated during the redox reaction of hydrogen peroxide with mucus and fluids in the mucosa. The active oxygen bubbles (1') facilitate drug delivery of the deliverable compound by mechanical movement. This movement is the result of the energy released during the redox reaction of hydrogen peroxide with mucus, which provides the energetic driving force for the bubble movement. In addition, the movement of the active oxygen bubbles (1') by the energy (not only singular but plural) of the redox reaction also enables the active transport (ATP) of the deliverable compound into the proteins of the cell membrane, further facilitating the delivery of the compound. A non-limiting example of the movement of active oxygen bubbles (1') can be seen at www.gunkex.com / video1 Fig. 1b shows a micrograph snapshot of a miniature cluster of active microscopic oxygen bubbles (1'). [Diagram 2] FIGURE LEGENDS Figs. 2a and 2b show retail packaging options for nasal and mucosal sprays for irrigation, disinfection and treatment of the nasal passages or mucous membranes. [Diagram 3] FIG. 3a and FIG. 3b show examples of heterocyclic compounds.
[0026] The present invention utilizes hydrogen peroxide in various ways to achieve nasal disinfection, nasal irrigation, and drug delivery of various therapeutic compounds and drugs to the mucosa with the energy of redox reactions (including not only singular but also plural) that occur by oxidizing impurities present in the mucosa of mucus, enzymes, and body fluids. Several means and methods are disclosed to protect the nasal mucosa from the harmful effects caused by redox reactions while providing therapeutic relief to subjects suspected of being exposed to infections and allergies. The present invention provides that only a thin coating (2') with a thickness of <0.5 millimeters formed by droplets of fine mist of hydrogen peroxide with a size of <100 microns, consisting of 0.5% to 3% w / w hydrogen peroxide and deionized water, delivered using a directional spray bottle, is sufficient to loosen and remove mucus in the nasal cavity while mitigating the harmful effects of redox reactions, and at the same time disperse droplets of hydrogen peroxide and deionized water to the mucosa for disinfection and irrigation of the nasal cavity. In different embodiments of the present invention, additional therapeutic compounds are added to the aqueous solution to further enhance the therapeutic value, usability, and therapeutic effect of various diseases. The unexpected results achieved by the present invention are demonstrated by the inventors in a video clip posted at www.gunkex.com / video1.
[0027] In one embodiment, the present invention is a pharmaceutical composition consisting essentially of hydrogen peroxide and glycerin or a moisturizer for use as a medicament for protecting mucous membranes from oxidative damage when administered as aerosolized droplets <100 microns in size to treat a medical condition. In one embodiment, the present invention is directed to an aerosolized composition consisting essentially of hydrogen peroxide, glycerin or a skin moisturizer, a therapeutic compound, and deionized water for use in a method for protecting nasal mucous membranes from oxidative damage while allowing for the treatment of a medical condition. One embodiment of the present invention is hydrogen peroxide for use in dispersing at least one or more pharma- ceutically acceptable compounds to mucous membranes. One embodiment of the present invention is hydrogen peroxide for use in a method for allowing relief of nasal congestion. In one embodiment of the present invention, hydrogen peroxide is a compound or method for dispersing at least one or more pharma-ceutically acceptable compounds to mucous membranes for use in nasal or mucosal spray devices for use in nasal disinfection, treatment to loosen mucus membranes to allow for removal of mucus from the nasal passages and nasal irrigation, or treatment of a medical condition. The fine mist spray bottle is configured to generate aerosolized droplets <100 microns in size from a pharmaceutical compound that includes a reactive oxygen species (ROS), such as hydrogen peroxide, as an active delivery agent and at least one pharma- ceutically acceptable deliverable compound. When administered intranasally or onto a mucous membrane, the aerosolized droplets oxidize the mucus or fluid therein, thereby loosening the mucus or fluid from the mucous membrane and simultaneously dispersing the deliverable compound(s) to the mucous membrane by the energy of the oxidation-reduction reaction within 3 minutes.
[0028] The present invention discloses a nasal or mucosal spray for irrigating, disinfecting and treating the nasal passages or mucous membranes, and for delivering various pharmaceutical compounds to the mucous membranes in less than 3 minutes. The system essentially consists of a fine mist spray bottle configured to generate aerosolized droplets <100 microns in size and pharma- ceutical acceptable peroxide with an oxygen oxidation state of O-1. At least one or more pharma-ceutical acceptable deliverable compounds are delivered to the mucous membranes in less than 3 minutes. and deionized water. When administered as a nasal or mucosal spray, the aerosolized droplets form a reactive coating (2') <0.5 millimeters thick on the mucosa, oxidizing mucus or enzymes for 10 to 180 seconds, loosening mucus or fluids from the mucosa and thereby allowing the energy of the redox reaction to disperse the deliverable compound to the mucosa. Microscopic oxygen bubbles form during the redox reaction. 1' (Figs. 1a and 1b) is formed, allowing the dispersion of the deliverable compound(s) and deionized water to the mucosa.
[0029] In one embodiment of the present invention, the fine mist spray bottle is configured to generate a directed spray of aerosolized droplets <100 micron size from a liquid consisting of 0.5%-3% w / w hydrogen peroxide and deionized water. When the aerosolized droplets are administered to the nasal cavity, a reactive coating (2') of <0.5 millimeters thickness is formed that loosens and removes mucus from the nasal cavity by oxidation of the mucus within 10-180 seconds, while simultaneously allowing deionized water to disperse to the mucus by the energy of the redox reaction, thereby allowing disinfection and cleansing of the nasal cavity in less than 3 minutes. Various additional substances are added to further minimize discomfort and enhance therapeutic value and options, as disclosed below.
[0030] In one embodiment of the invention, the nasal spray or mucosal system consists essentially of a fine mist directional spray bottle configured to produce aerosolized droplets <100 microns in size from a liquid having a viscosity of about 1.1 to 1000 centipoise. Substantially at least one or more pharma- ceutically acceptable peroxides 0.25% to 5% w / w The liquid comprises at least one or more aromatic compounds 0.005%-5% w / w, at least one or more skin moisturizers, humectants or mucoadhesive polymers, emulsifiers, solvents or surfactants 0.1%-30% w / w, and deionized water. Upon administration, the aerosolized droplets adhere substantially to the inner wall of the nasal cavity or mucosa without dripping for at least 10 seconds, forming a <0.5 millimeter thick reactive coating (2') therein. The aerosolized droplets oxidize the mucus or body fluids for 10-180 seconds, loosening the mucus or body fluids from the mucosa and simultaneously dispersing the aromatic compounds, skin moisturizers, humectants, and mucoadhesive polymers into the mucosa to allow for cleaning, disinfection, and treatment. In one embodiment of the present invention, the liquid further comprises substantially 0.0.01%-1% w / w of benzalkonium chloride, benzoic acid, boric acid, chlorhexidine gluconate, cetylpyridinium chloride (CPC), or a pharma- ceutically acceptable cationic surfactant.
[0031] In one embodiment of the invention, the liquid further consists essentially of 0.01%-5% w / w of sodium bicarbonate, magnesium sulfate, aluminum sulfate, sodium borate, sodium benzoate, sodium phosphate, sodium salicylate, sodium carbonate perhydrogenate, sodium percarbonate, sodium citrate, or sodium carboxymethylcellulose. In one embodiment of the invention, the liquid further consists essentially of 0.01%-5% w / w of a preservative, topical steroid, antihistamine, nonsteroidal anti-inflammatory drug (NSAID), analgesic compound, antibiotic compound, antipruritic compound, local anesthetic compound, or central nervous system (CNC) drug. In one embodiment of the invention, the liquid further consists essentially of 5%-50% v / v alcohol. All formulations contain pharma- ceutically acceptable preservatives, stabilizers chelating agents, or buffers to ensure the desired shelf life of the formulation.
[0032] In one embodiment of the present invention, a nasal spray includes a nasal spray bottle configured to generate aerosolized <100 micron sized droplets from a liquid consisting of hydrogen peroxide 0.25%-3% w / w, at least one or more aromatic or fragrance compounds 0.005%-5% w / w, at least one or more skin moisturizers, humectants, mucoadhesive polymers, emulsifiers, solvents or surfactants 0.1%-30% w / w, and deionized water. The aerosolized droplets administered to the nasal cavity form a thin coating <1000 microns thick (2') on the mucosa where they oxidize the mucus for 10-180 seconds, loosening and removing the mucus while simultaneously dispersing the aromatic or fragrance compounds, skin moisturizers, humectants, mucoadhesive polymers, emulsifiers, solvents or surfactants into the mucosa. Dispersion of the deliverable compounds is enabled by energy or redox reactions, resulting in the formation of miniature clusters of active fine oxygen bubbles 1' (Figs. 1a, 1b) on the mucosa during the oxidation process. In one embodiment of the solution, it further comprises an effective amount of an antiseptic, a topical steroid, an antihistamine, a nonsteroidal anti-inflammatory drug (NSAID), an analgesic compound, an antibiotic compound, an antipruritic compound, a local anesthetic compound, or a central nervous system drug (CNC).
[0033] One embodiment of the present invention is a nasal or mucosal spray, which is a fine mist spray consisting of aerosolized droplets <100 micron size, containing 0.25% to 3% w / w hydrogen peroxide. 0.005% to 2.5% w / w of one or more aromatic compounds; about 0.1% to 30% glycerin or derivatives of glycerin; It consists of aloe vera gel or a mucoadhesive polymer and deionized water. In one embodiment of the invention, the aerosolized droplets further contain ethanol 5%-50% v / v.
[0034] One embodiment of the present invention is a nasal spray comprising a fine mist spray comprising aerosolized droplets of <100 micron size consisting of hydrogen peroxide 0.25%-5% w / w, chlorhexidine gluconate 0.01%-1%, at least one or more aromatic or flavor compounds 0.005%-5% w / w, and deionized water. Upon administration, the aerosolized droplets oxidize and loosen mucus or fluids in the mucosa while dispersing the chlorhexidine gluconate and aromatic or flavor compounds to the mucosa through the energy of the redox reaction.
[0035] One embodiment of the present invention is a mucosal spray, comprising a fine mist spray of aerosolized droplets <100 micron size, comprising 0.25%-5% w / w hydrogen peroxide, 0.1%-5% borax, from about 0.1%-30% glycerin, glycerin derivatives or mucoadhesive polymers and deionized water. When administered, the aerosolized droplets oxidize and loosen mucus or fluids in the mucosa while dispersing the borax, glycerin, glycerin derivatives or mucoadhesive polymers to the mucosa through the energy of the redox reaction.
[0036] In one embodiment of the present invention, the method for cleaning, disinfecting and treating the nasal cavity or mucous membranes comprises the following steps. (1) A spray of <100 micron aerosolized droplets containing 0.25%-3% w / w hydrogen peroxide, one or more pharma- ceutically acceptable deliverable compounds selected from Group 1 and deionized water is administered to the nasal passages or mucosa. Group 1 includes: At least one aromatic or flavoring compound 0.005%-5% w / w At least one skin moisturizer or humectant 0.1%-30% w / w 0.1%-10% w / w of at least one pharma- ceutically acceptable mucoadhesive polymer, surfactant, emulsifier or thickener (2) forming a reactive coating of said aerosolized droplets (2') in the nasal cavity or on the mucosa, and allowing the aerosolized droplets to react with mucus in the nasal cavity or on the mucosa for at least 10 seconds, where the aerosolized droplets oxidize the mucus, loosening it for removal and simultaneously dispersing the pharma- ceutically acceptable deliverable compound(s) from group 1 to the mucosa in less than 3 minutes.
[0037] The present invention primarily utilizes stabilized hydrogen peroxide or food grade hydrogen peroxide 0.25%-5% w / w as the active delivery agent. The use of other pharma- ceutically acceptable peroxides or oxidizing agents such as urea hydrogen peroxide, benzoyl peroxide, and sodium percarbonate is also within the scope of the present invention. In one embodiment of the present invention, the aerosolized droplets consist of a combination of hydrogen peroxide and urea hydrogen peroxide or benzoyl peroxide as the active delivery agent. The active delivery agent is used to deliver one or more pharma-ceutically acceptable deliverable compounds. The oxidation state of the active delivery agent when administered as aerosolized droplets is O-1, meaning that the peroxide will not decompose when mixed with the liquid deliverable agent and is still active to carry out the intended oxidation of mucus or body fluids. The peroxides and / or hydrogen peroxides utilized in the present invention are generally formulated with a combination of chemical stabilizers, buffers, chelating compounds and catalytic inhibitors, such as sodium phosphate, sodium phytate, phosphoric acid, phosphorous acid, acetanilide, Sodium stannate, a stannous derivative, and / or edetate disodium (EDTA).
[0038] In one embodiment of the invention, the disclosed drug compound is pre-filled into the fine mist spray bottle, while in another embodiment, the drug compound is contained in a separate container, allowing the user to fill or refill the fine mist spray bottle as needed. In one embodiment of the invention, the hydrogen peroxide and the pharma- ceutically acceptable deliverable compound are packaged in separate containers to extend the shelf life of the compounds. The user can combine these materials as needed. The spray bottles and liquid containers can be packaged as one retail package or in separate retail packages. The above configurations allow for economical utilization of the components of the nasal, respiratory and mucosal treatment system. Figs. 2a, 2b show diagrams of embodiments of the invention in the form of nasal cleaning and disinfection systems 101 and 102. The system 101 comprises a retail package 101a comprising a nasal spray bottle 101b and a liquid container 101c. The nasal spray bottle 101b can be pre-filled with a liquid comprising hydrogen peroxide and a pharma- ceutically acceptable deliverable compound. It can also be left empty so that the user can fill it with the above liquid from the container 101c when needed. The system 102 comprises a retail package 102a comprising a nasal spray bottle 102b, a liquid container 100b, and a liquid container 102d. Liquid container 102c is filled with stable hydrogen peroxide 0.210%-10% w / w, or a combination of pharma- ceutically acceptable peroxide 0.210%-10% w / w and deionized water. Liquid container 102d is filled with at least one or more pharma- ceutically acceptable deliverable compounds. A method of utilizing system 102 comprises mixing the formulations from containers 102c and 102d in a pre-determined ratio and filling the mixture into nasal spray bottle 102b as needed.
[0039] One of the challenges of compounds containing peroxide is maintaining their integrity when mixed with a deliverable drug, since peroxides tend to oxidize most substances and degrade in the process. The present invention has discovered that drug compounds containing 5- or 6-membered heterocyclic rings in their chemical structure are generally compatible with hydrogen peroxide and can facilitate delivery to mucosa. The compounds used in the present invention generally do not contain transition metals (groups 3-12) since they have been found to decompose peroxides. The present invention utilizes chemical buffers, inhibitors, and chelators, even if not specifically claimed, to maintain the integrity of hydrogen peroxide. The following are non-limiting examples of pharma-ceutical acceptable therapeutic compounds and drug materials. As references to the claims, they are classified into the following groups. However, these groups do not represent scientific or chemical classifications. Compounds that are incorrectly defined or classified in this application may be omitted without affecting the scope of the invention. Group (a) Pharmaceutically acceptable heterocyclic compounds. Some examples of such compounds are shown in Figures 3a and 3b. In one embodiment of the present invention, the heterocyclic compounds are identified by a chemical structure that comprises at least one or more 5-membered heterocyclic rings, at least one or more 6-membered heterocyclic rings, or a combination thereof.
[0040] The heterocyclic compounds utilized in the present invention contain at least one heteroatom in their chemical structure, either nitrogen (N), oxygen (O), sulfur (S) or phosphorus (P). For example, furans, indoles and purines are the scaffolds and drug building blocks of many pharmaceutical drugs. Many heterocyclic derivatives and substituted heterocyclics combining various heteroatoms are known in the art, as identified by patents (US Pat. Nos. 5,993,133, 5,993,142, 5,993,151, 5,993,161, 5,993,171, 5,993,182, 5,993,191, and 6,000,000). Examples include aromatic compounds, monoterpenoids, alcohols, phenols and their derivatives. Drugs and substances such as acetaminophen, aspirin, benzocaine, hydroxyzine, cloxylenol, cloflucarban, bacitracin, salicylic acid, chlorhexidine gluconate, niacinamide, cannabis, caffeine, nicotine, and the like. Central nervous system (CNS) stimulants such as armodafinil and modafinil. Nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen, antipruritics, analgesic compounds, antihistamines, antibiotics, antiseptics, local anesthetics, steroids, antifungals such as azoles and azole derivatives, nucleic acids, vitamins, and vaccines consisting of the aforementioned chemical structures or substructures. Group (b) Pharmaceutically acceptable aromatic compounds, monoterpenes, and terpenoids: Aromatic and therapeutic substances contained in essential oils, such as: Phenolic monoterpenoids, such as thymol, carvacrol, and eugenol; and an effective amount of methyl salicylate, cineole, geraniol, menthol, raspberry ketone, p-cymene, cinnamaldehyde, salicylic acid, nootkatone, terpineol, alpha-terpineol, limonene, borneol, terpinen-4-ol, camphor, cannabidiol (CBD), cresol, phenol, or derivatives of the aforementioned compounds. Although some substances, such as camphor, do not meet the chemical classification of aromatic, in the context of the present invention, such substances are considered aromatic because they are part of monoterpenes. Pharmaceutically acceptable fragrance compounds such as geranyl acetate, methyl formate, ethyl acetate, jasmone, benzaldehyde, vanillin, anethole and benzenediol, germinane and germine, 0.1% to 10% w / w. Synthetic fragrances. Aromatic compounds are dissolved in pharma-ceutically acceptable solvents, ethanol, dimethylsulfoxide (DMSO), solubilizers, emulsifiers and / or surfactants and are uniformly distributed by the disclosed aerosolized droplets. Examples include sugar alcohols such as sorbitol mannitol, erythritol, maltitol, xylitol. See Non-Patent Document 4. Group (c) Pharmaceutically acceptable skin moisturizers or humectants 0.1% to 30% w / w such as aloe vera gel, glycerin (glycerol) or its derivatives such as polyglycerins, monoglycerides, diglycerides. Hydrophilic polymers, pharma- ceutically acceptable polymers or polycols such as polyethylene glycol (PEG) or its derivatives (PPGs) such as PEG-40, propylene glycol (PG) or its derivatives and copolymers. Hydrophilic silicone polymers such as alpha-hydroxy acids (AHA, BHA), silica aerogels. Hyaluronic acid, salicylic acid, sodium lactate, sodium PCA or lactic acid. Urea and its derivatives such as urea hyaluronate, allantoin (10-ureidohydantoin), imidazlidynyl urea. Dimethicone Vitamin A, vitamin B3, D-panthenol, pantothenic acid, vitamin E, peptides, amino acids Hydrogenated castor oil, lanolin oil, hydrogenated lanolin, paraffin (including both singular and plural), paraffin oil Ceramides, collagen. Glycolic acid, ascorbic acid, citric acid Pharmaceutically acceptable polymer 0.1%-30% w / w. Skin care additives such as emollients and occlusives. https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC410010343 / Group (d) Pharmaceutically acceptable polymers Adhesives, gelling agents, thickeners or polycols. Polyethylene glycols (PEGs) such as PEG-40 or their derivatives (PPGs). Derivatives of cellulose with carboxymethyl groups (-CH2-COOH), carboxymethylcellulose (CMC), cellulose gum, xanthan gum, Emulthix™, disodium EDTA, carbomer, sodium carboxymethylcellulose (SCMC), hydrogels, polysaccharide polymers and their derivatives, acrylates, carrageenan, gellan, polyacrylic acid, glycerin (glycerol) and its derivatives, aloe vera gel, hyaluronic acid, poly(acrylic acid) polymers, poly(hydroxyethyl methylacrylate), poly(ethylene oxide), poly(vinylpyrrolidone), poly(vinyl alcohol), chitosan and its derivatives. Mucoactive agents such as poloxamers, poloxamer 407 hydrophilic polymer mucolytics. http: / / tinyurl.com / 2fwptvpz Group (e) Alcohols Ethanol, isopropyl alcohol, cetyl alcohol, aromatic alcohols, sugar alcohols, benzyl alcohol. Group (f) Pharmaceutically acceptable surfactants, emulsifiers, solubilizers or astringents 0.01% - 1% Such as nonionic, anionic, cationic or amphoteric surfactants such as hexadecyltrimethylammonium (cetrimide), chlorhexidine and its derivatives such as chlorhexidine gluconate, chlorhexidine acetate, xylenol, chloroxylenol, benzalkonium chloride, hexadecylpyridinium chloride, cetylpyridinium chloride (CPC), polysorbate-20, polysorbate-80, polyoxyethylene, glycosides, cremophor RH 40, and derivatives of oxygen-containing quaternary ammonium compounds. Bile acids. Lipids and phospholipids Palmitic acid, stearic acid, oleic acid, linoleic acid. Self-emulsifying drug delivery systems (SEDDS). Mucoactive agents such as alum and derivatives, witch-hazels, dimethylsulfoxide (DMSO) mucolytics. Group (g) Pharmaceutically acceptable therapeutic salts Organic salts: Sodium bicarbonate, sodium borate, sodium benzoate, sodium fluoride, sodium phosphate, Pharmaceutically acceptable sodium salts such as sodium salicylate, sodium percarbonate, sodium percarbonate, sodium citrate, sodium carboxymethylcellulose, sodium phytate, etc. Alum and its derivatives Magnesium sulfate, zinc gluconate, carboxylates, benzethonium chloride. https / / en.wikipedia.org / wiki / Oxyanion | https / / tinyurl.com / 2p8kpvny Different combinations of substances from groups (a)-(g) can be combined with therapeutic compounds as pharmaceutical compounds or emulsions as pharmaceutical products used to generate aerosolized compositions using the directional spray bottle of the present invention. The pharmaceutical compositions can be in the form of microemulsions or nanoemulsions with at least one or more components from the aforementioned groups. A combination of measures such as viscosity 1.1-1,000, droplet size <100 microns, use of adhesives and polymers that also function as skin moisturizers, use of surfactants and alcohols allows the formation of a self-adhesive reactive coating with a thickness of <0.25 microns that can gradually oxidize mucus in 10-180 seconds, further loosening mucus or body fluids from the mucosa and simultaneously delivering the disclosed drug compound to the mucosa by the energy of the redox reaction between hydrogen peroxide and body fluids in less than 3 minutes. The term "consisting essentially of" in the context of the present invention excludes all prior art materials that do not play an active role as disclosed by the present invention. However, the term "consisting essentially of" in the context of the present invention includes materials such as preservatives, stabilizers, and chemical buffers that extend the shelf life of the disclosed pharmaceutical compounds. "Miniature Clusters of Activated Oxygen Bubbles" The term "miniature clusters of active microscopic oxygen bubbles" is used as a means to describe random clusters of active oxygen bubbles in any formation. The term "sufficient amount" refers to an amount that is pharma- tically acceptable to provide therapeutic relief to treat a medical condition, or an amount suitable as a prophylactic or therapeutic measure. The systems and methods disclosed herein are applicable to the treatment of mucous membranes of any body site, such as the pharynx, oral cavity, respiratory tract, gums, ears, genitals, etc. In one embodiment of the present invention, the aforementioned systems and methods are used to treat hair follicles, open wounds, disinfection of body parts during surgical procedures, damaged skin, etc. Droplet size in microns refers to the volume mean diameter (VMD). Viscosity measurements were performed at room temperature of 21°C.
[0041] This application includes some exemplary hyperlinks that provide additional information. However, these external hyperlinks are provided for reference only, as they may change. They are not part of this application. The embodiments of the present invention described herein are examples and should not be used in a limiting sense to interpret the scope of the present invention. Different embodiments of the present invention can be combined to develop other embodiments. Embodiments developed by extrapolation or combination of the compositions, drug delivery methods, devices and systems disclosed herein are within the scope of the present invention.
Claims
1. A nasal spray system for dispersing one or more aerosolized therapeutic compound(s) to the nasal mucosa, having a predetermined viscosity, Hydrogen peroxide about 0.1% to 5% w / w; About 0.1% to 4% w / w of one or more skin moisturizers; at least one aromatic compound; and water, 1. A nasal spray device comprising a metering pump configured to deliver aerosolized droplets of 100 microns or less produced from a pharmaceutical composition comprising: The aerosolized droplets are characterized in that, when administered intranasally, they form a self-adhering reactive coating less than 0.5 millimeters thick on at least a portion of the nasal mucosa, thereby oxidizing at least a portion of the mucus of the nasal mucosa in less than 3 minutes and loosening at least a portion of the mucus for removal from the nasal cavity, while dispersing at least a portion of the skin moisturizer(s), at least a portion of the aromatic compound(s), and at least a portion of the water to the nasal mucosa of the nasal cavity by the energy of redox reaction between the hydrogen peroxide and at least a portion of the mucus.
2. A nasal spray system for dispersing one or more aerosolized therapeutic compounds to the nasal mucosa, comprising:
1. A directional spray device comprising a metered pump configured to deliver aerosolized droplets of 100 microns or less having a predetermined viscosity and generated from a pharmaceutical composition, the device comprising: Hydrogen peroxide: about 0.1% to 5% w / w at least one or more skin moisturizer(s) from about 0.1% to 30% w / w; About 0.005% to 2.5% w / w of an aromatic compound(s) and a pharma- ceutically acceptable surfactant. And water When the aerosolized droplets are administered intranasally, they form a self-adhesive reactive coating substantially less than 0.5 millimeters thick on at least a portion of the nasal mucosa, thereby oxidizing at least a portion of the mucus of the nasal mucosa in less than three minutes, loosening at least a portion of the mucus, and simultaneously dispersing at least a portion of the skin moisturizer(s), at least a portion of the aromatic compound(s), and at least a portion of the water to the nasal mucosa of the nasal cavity by energy of an oxidation-reduction reaction between the hydrogen peroxide and at least a portion of the mucus.
3. 1. A method for dispersing at least one or more aerosolized therapeutic compound(s) to the nasal mucosa, comprising: A nasal spray system with a metering pump that delivers aerosolized droplets of a drug compound at or below 100 microns in size is constructed. Said pharmaceutical composition comprises: Hydrogen peroxide approx. 0.1% to 5% w / w About 0.1% to 30% w / w of at least one or more skin moisturizers At least one or more of the following pharma- ceutically acceptable heterocyclic compounds: Heterocyclic compounds (including both the singular and the plural) and heterocyclic derivatives (singular and plural) from about 0.005% to 2.5% w / w and water administering said aerosolized droplets to the nasal cavity. The aerosolized droplets are characterized in that when administered to the nose, and forming a substantially self-adhesive reactive coating less than 0.5 millimeters thick on at least a portion of said nasal mucosa of said nasal cavity and gradually oxidizing at least a portion of said mucus in said nasal mucosa in less than three minutes, thereby loosening at least a portion of said mucus in said nasal mucosa of said nasal cavity for removal. At the same time, the skin moisturizer(s), the heterocyclic compound(s), the heterocyclic derivative(s), and the water are delivered into the nasal mucosa at least in part by energy of an oxidation-reduction reaction between the hydrogen peroxide and the mucus.
4. 1. A drug delivery system for dispersing at least one or more aerosolized therapeutic compound(s) to a mucosal membrane, comprising:
1. A directional spray device comprising a metering pump configured to deliver aerosolized droplets of 100 microns or less having a predetermined viscosity and generated from a pharmaceutical composition, comprising: Approximately 0.1% to 5% w / w hydrogen peroxide A sufficient amount of at least one or more of the following: aromatic compound(s), pharma- ceutically acceptable heterocyclic compound(s), heterocyclic derivative(s), or heterocyclic group(s) At least one or more pharma- ceutically acceptable surfactants; and water When the aerosolized droplets are administered onto a mucosa, they form a substantially self-adhesive reactive coating on at least a portion of the mucosa less than 0.5 millimeters thick, and oxidize at least a portion of the body fluid of the mucosa in less than 3 minutes, thereby loosening at least a portion of the body fluid from the mucosa, and simultaneously deliver at least a portion of the aromatic compound(s), the heterocyclic compound(s), the heterocyclic derivative, the pharma- ceutical acceptable compound(s) with heterocyclic group(s) substitution, the surfactant(s), and the water to the mucosa by energy of an oxidation-reduction reaction between the hydrogen peroxide and the body fluid.
5. 1. A drug delivery system for dispersing at least one or more aerosolized therapeutic compound(s) to a mucosal membrane, comprising:
1. A directional spray device having a metering pump configured to deliver aerosolized droplets of 100 microns or less having a predetermined viscosity and produced from a pharmaceutical composition, comprising: Approximately 0.1% to 5% w / w hydrogen peroxide A sufficient amount of at least one of the following: chlorhexidine gluconate (CHG), cetylpyridinium chloride, borax, boric acid, magnesium sulfate, alum, and pharma- ceutically acceptable sodium salts; and water When the aerosolized droplets are administered onto a mucosa, they form a substantially self-adhesive reactive coating on at least a portion of the mucosa less than 0.5 millimeters thick, oxidize at least a portion of the body fluid of the mucosa in less than 3 minutes, thereby loosening at least a portion of the body fluid from the mucosa, and simultaneously deliver at least a portion of the chlorhexidine gluconate (CHG), at least a portion of the cetylpyridinium chloride, at least a portion of the borax, at least a portion of the boric acid, at least a portion of the magnesium sulfate, at least a portion of the alum, at least a portion of the pharma- ceutically acceptable sodium salt, and at least a portion of the water to the mucosa by energy of an oxidation-reduction reaction between the hydrogen peroxide and the body fluid.
6. A nasal spray system as claimed in claims 1 and 2, a method for dispersing one or more aerosolized therapeutic compounds (including not only singular but also plural) to the nasal mucosa as claimed in claim 3, and the aforementioned water-deionized drug delivery system as claimed in claims 4 and 5.
7. The nasal spray system of claims 1 and 2. The drug delivery system of claims 4 and 5, wherein said viscosity is 0.8 to 1000 centipoise.
8. A nasal spray system as described in claims 1 and 2, a method of dispersing one or more aerosolized therapeutic compounds (including not only singular but also plural) to the nasal mucosa as described in claim 3, and a drug delivery system as described in claims 4 and 5, wherein said metering pump is configured to deliver a set amount of said hydrogen peroxide per pump.
9. A nasal spray system as described in claims 1 and 2, a method of dispersing one or more aerosolized therapeutic compounds (including not only singular but also plural) to the mucous membranes of the nasal cavity as described in claim 3, and a drug delivery system as described in claims 4 and 5, wherein the directional spray device is part of a retail package that includes the pharmaceutical compound contained in a bottle separate from the directional spray device.
10. The nasal spray system of claims 1 and 2, the method of dispersing one or more aerosolized therapeutic compound(s) to the nasal mucosa of claim 3, and the drug delivery system of claims 4 and 5, which is a metered pump configured to deliver about 0.05 ml to 0.2 ml per pump of said liquid composition to allow for a defined amount of said dose(s) of hydrogen peroxide.
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