MX2007005165A - Methods of entrapping, inactivating, and removing viral infections by the administration of respiratory tract compositions - Google Patents

Abstract

The present invention is directed to methods of preventing and treating respiratory tract viral infections by administering compositions to areas of the respiratory tract such as the nasal cavity, wherein the compositions provide for the encapsulation, inactivation, and/or removal of viruses and/or viral strains associated with the common cold and influenza. The methods of encapsulation, inactivation, and removal of cold and influenza viruses have been shown to create and maintain environments that are hostile to the viruses to result in effective prevention and treatment of cold and influenza-like symptoms.

Description

METHODS TO TRAP, INACTIVATE AND ELIMINATE INFECTIONS VIRALS THROUGH THE ADMINISTRATION OF COMPOSITIONS FOR THE RESPIRATORY TRACT FIELD OF THE INVENTION The present invention is directed to methods for trapping, inactivating or eliminating viral infections by administration of compositions for the respiratory tract. In particular, the present invention is directed to methods for trapping, inactivating or eliminating viral infections of the upper respiratory tract by administering compositions for the respiratory tract, in the nasal cavity.

BACKGROUND OF THE INVENTION It is known that many viruses and different viral strains cause symptoms associated with viral infections of the respiratory tract. The common cold is a complex syndrome caused by about 200 antigenically distinct viruses found in five families of viruses. These families include rhinovirus, myxovirus, paramyxovirus, respiratory syncytial virus, adenovirus and coronavirus. The most important group is rhinovirus, Gwaltney J.M., Common Cold, pgs. 489-493, Mandell G.L., Douglas, R.G. Jr., Bennett, J.E., Principles and Practice of Infectious Diseases (Principles and practice of infectious diseases), 3a. ed., Churchill Livingstone, New York, 1990. It is not easy, or sometimes feasible, to determine precisely the specific cause of the disease because there are also a number of predisposing factors whose contribution to the manifestation of symptoms is not yet fully understood. . These factors are, among others, physical fatigue, psychological stress and the general state of physical health. Regardless of the virus and the associated factors that lead to the onset of cold and flu symptoms, several medications have been suggested to relieve the symptoms of the common cold and the flu. In an attempt to improve the existing medicines for the cold, specialists in the area have suggested various pharmacotherapeutic alternatives and, subsequently, they have carried out clinical trials to verify the efficacy of these; see, for example, the therapy described in The New England Journal of Medicine, published in 1986 and the therapy described in The Journal of Infectious Diseases, published in 1992. Treatment for influenza includes vaccines and the use of specific antiviral drugs, such as the treatments considered by A. Elliot and J. Ellis, 2000, in Pharmaceutical Journal (Pharmaceutical Journal), 265, 446-451. Various patents have also been granted which describe compositions for preventing and treating the common cold or the flu, as well as their methods of use. For example, U.S. Pat. num. 5,240,694, 5,422,097, and 5,492,689, issued to Gwaltney, describe treatments using combinations of antiviral compounds and anti-inflammatories; US patents num. 33,465 and 5,409,905, both given to Eby describe treatments using zinc salts; the U.S. patent 5,626,831 issued to Van Moerkerken describes a treatment using orally administered aminocarboxylic acid compounds; US patents num. 4,619,934 and 4,552,899, both issued to Sunshine, describe treatments for cough and colds using compositions comprising non-steroidal anti-inflammatory drugs such as NSAIDS with antihistaminic-effective materials such as chlorpheniramine; and EP 310317 issued to Bordt et al., assigned to Beecham, discloses a method for inactivating viruses and bacteria (e.g., vaccines) with pharmaceutical compositions wherein the method involves inactivating viruses or bacteria with ascorbic acid or its salts in the presence of oxygen and heavy metal ions. Other descriptions of compositions and their methods of use include publications that describe the administration of pharmaceutical compositions to the nasal membrane. For example, U.S. Pat. no. 4,689,223, granted on August 25, 1987, assigned to T & amp;R Chemicals discloses nasal aerosol compositions for treating the symptoms of, or preventing common cold, wherein the compositions comprise sulfites or bisulfites having a low pH, but not specifically described. U.S. Pat. no. 6,080,783, issued June 27, 2000, to Gum Tech International, Inc., discloses viscous gels to deliver a less effective homeopathic amount of zinc or other metal to the nasal membrane. The U.S. patent no. 4,767,788 awarded to Diana, assigned to Sterling Drug Inc., describes processes to destroy viruses such as the rhinovirus with glutaric acid in the nasal mucosa. U.S. Pat. no. 5,622,724 issued to Bryce-Smith discloses aerosol preparations such as nasal sprays to treat symptoms of the common cold wherein the preparations comprise non-chelated zinc compounds. Although it is well documented that there are numerous products and medicines for cough and cold, suitable to treat or prevent symptoms associated with the common cold and influenza, has not been addressed or found yet a more effective method to treat the symptoms of the cold and influenza that includes the encapsulation, inactivation and elimination of viruses or viral strains of the respiratory tract. It has been proven that at the onset of cold and flu symptoms, these can be effectively alleviated by using methodologies that involve the encapsulation, inactivation and elimination of viruses or viral strains. It has been shown that these methodologies are not only effective in treating cold and flu symptoms, but also in treating or preventing the recurrence of cold and flu symptoms.

BRIEF DESCRIPTION OF THE INVENTION The present invention is directed to methods for preventing and treating infections of the upper respiratory tract by administering a composition in the nasal cavity, wherein the The composition comprises combinations of encapsulating, inactivating and secreting or eliminating agents, such that combinations are selected from (A) a rheological agent that gives the composition a viscosity ranging from about 1 cps (0.001 Pa.s) to about 2000 cps (2 Pa.s) in combination with a virus inactivating agent; (B) a rheological agent that gives the composition a viscosity ranging from about 1 cps (0.001 Pa.s) to about 2000 cps (2 Pa.s) in combination with a nasal secretion agent; (C) a virus inactivating agent in combination with a nasal secretion agent, and (D) a rheological agent that gives the composition a viscosity ranging from about 1 cps (0.001 Pa.s) to about 2000 cps (2). Pa.s), a virus inactivation agent and a nasal secretion agent. The present invention is also directed to a method for preventing and treating viral infections of the upper respiratory tract that allows the encapsulation, inactivation and elimination of viruses and / or infectious viral strains of the respiratory system; the method comprises the administration of a composition in the nasal cavity, characterized in that said composition comprises (a) a rheological agent that provides a composition viscosity of about 1 cps (0.001 Pa.s) at 2000 cps (2 Pa.s) and (b) a buffer solution having a pH of from about 3.0 to about 5.5.

It has been found that the administration of selective compositions in the nasal cavity can achieve the encapsulation, inactivation or elimination of viruses or viral strains that cause viral respiratory infections associated with the common cold or influenza. The methodologies defined herein provide for the administration of compositions to effectively treat viruses or viral strains employing the encapsulation, inactivation and elimination procedure, thereby achieving highly effective methods for reducing or eliminating the symptoms associated with the common cold. and the flu.

DETAILED DESCRIPTION OF THE INVENTION The methods of the present invention provide for the encapsulation, inactivation or elimination of viruses or viral strains associated with the common cold and influenza. The methods involve administering compositions for the respiratory tract, especially the administration of compositions in the nasal cavity of the respiratory tract. These methods are highly efficient to provide prevention and treatment of the symptoms associated with the common cold and the flu. As used in this, the term "encapsulation" refers to enveloping the infectious virus or viral strains within the matrix of the compositions defined herein and inhibiting the contact of viruses or viral strains with cellular receptors. As used herein, the term "inactivation" refers to blocking the infectivity of viral particles. In other words, "inactivate" means that the viral particles are no longer infectious. The inactivation materials defined herein may provide a temporary or permanent blockage of the infectivity of the viral particles, where temporary blocking means that the inactivation material must be present for such inactivation to occur, and permanent blocking means that the inactivation material causes damage to the viral particles of such a nature that the virus or the viral strains can not be recovered.

As used herein, the term "secretion agent" refers to the physical removal of the viral particles from the proximity of their infection targets. The secretion agents defined herein stimulate a mild rhinorrhea, such that viral particles and inflammatory mediators are eliminated from the adjacent area of cells susceptible to cold or flu infections. As used herein, the term "respiratory tract" refers to the regions of the nose, mouth, tongue and throat, including the mucous membrane of the nose, mouth, tongue and throat. The compositions defined herein are administered in the respiratory tract to prevent and treat "flu-like and cold-like symptoms." As used herein, the phrase "flu-like symptoms and the cold" refers to symptoms that are normally associated with viral infections of the respiratory tract. These symptoms are, among others, nasal congestion, chest congestion, sneezing, runny nose, fatigue or discomfort, cough, fever, chills, sore body, sore throat, headache and other known symptoms similar to the flu and the cold. The terms "respiratory virus", "respiratory virus", the "virus" and "viral strains" are used interchangeably herein to refer to a virus or more that are the agents that cause flu-like symptoms. and the cold. These viruses include rhinovirus, myxovirus (influenza virus), paramyxovirus (parainfluenza virus), respiratory syncytial virus, adenovirus and coronavirus.

The method of the present invention includes the administration of compositions that can essentially comprise, consist of or be composed of the elements and limitations inherent to the invention described herein, as well as any of the additional or optional ingredients, components or limitations described herein. . All percentages, parts and proportions are expressed by weight of the compositions, unless otherwise indicated. All these weights, insofar as they correspond to the ingredients listed, are based on the level of the specific ingredient and, therefore, do not include carriers or by-products that can be included in commercially available materials, unless otherwise specified. All relevant parts of the documents cited herein, including the publications, patent applications and patents issued herein, are considered incorporated herein by reference. The citation of any of the documents does not imply admitting the possibility of being considered as a prior industry of the present invention. Encapsulating agent The methods of the present invention include the administration of compositions comprising an encapsulating agent that surrounds viruses or viral strains present in the region of the respiratory tract and physically inhibits viruses or viral strains to reach the cells receptors, targets of the respiratory tract. The encapsulation agent includes Theological agents that are responsible for retaining viruses or viral strains in regions of the respiratory tract such as the nasal cavity. The rheological agent can be used in combination with a virus inactivating agent or with a secretion agent, or the compositions can comprise a rheological agent, a virus inactivating agent and a nasal secretion agent. Without being restricted by theory, it is believed that the rheological agent achieves the retention of viruses and / or viral strains for further treatment by the virus inactivating agent or the nasal secretion agent in order to maintain an environment hostile to the viruses. virus and improve the prevention and treatment of symptoms similar to the flu and the cold. It has been found that the methods of the present invention are highly effective for the prevention and treatment of flu-like and cold-like symptoms when the methods involve the administration of compositions that create a hostile environment to the viruses. Such an environment allows to encapsulate, inactivate or eliminate viruses in addition to preventing them from continuing to infect the region of the respiratory tract, especially the nasal cavity. The rheological agent can be included in the compositions of the present invention as an individual rheological agent or as a combination of mucoadhesives, provided that the total concentration of rheological agent varies from about 0.01% to about 30%, preferably from about 0.1% to about 20%, more preferably from about 1% to about 15%, by weight of the composition.

The incorporation of a rheological agent in the compositions of the present invention generally results in a composition with a viscosity ranging from about 1 cps (0.001 Pa.s) to about 2000 cps (2 Pa.s), preferably about 1 cps. (0.001 Pa.s) at about 1000 cps (1 Pa.s), more preferably from about 5 cps (0.005 Pa.s) to about 500 cps (0.5 Pa.s), most preferably about 5 cps ( 0.005 Pa.s) at approximately 300 cps (0.3 Pa.s). The viscosity of the compositions can be measured by any known technique or any other effective way that is used to determine the viscosity. Generally, the viscosity of the compositions of the present invention is determined using known methods, such as those described in ASTM D1824-87, ASTM D1084-88, and ASTM D2196-86. Viscometers generally used to measure viscosity include the Brookfield Syncho-Lectric viscosimeter and the Haake. For example, when the Brookfield Syncho-Lectric viscosimeter is used to perform viscosity measurements, it is generally equipped with a spindle 4 to measure viscosities below 8000 cps (8 Pa.s) at low shear rates at certain rotational speeds. Similarly, when the Haake viscometer is used, the Rheostress 1 model is suitable, which is equipped with a probe (ie spindle), which can be a C35 / 2T probe, where the viscosity measurement is It is carried out at a temperature in the range of 5 ° C to 40 ° C and 5.2 rad / s (50 revolutions per minute (rpm)) / second (sec).

Known theological agents suitable for use herein are selected from the group consisting of carboxypolymethylenes, carboxyvinyl polymers, homopolymers of acrylic acid crosslinked with an allyl ether of pentaerythritol, homopolymers of acrylic acid crosslinked with an allyl ether of sucrose, homopolymers of acrylic acid crosslinked with divinyl glycol and mixtures thereof. Non-limiting examples of homopolymers of acrylic acid crosslinked with a suitable phenylethritol allyl ether or a suitable allyl ether of sucrose are distributed by B. F. Goodrich Company under the tradename "Carbopol". The specific carbopols are, among others, Carbopol 934, 940, 941, 956, 980, and mixtures thereof. Carbopol 980 is preferred among Carbopol rheological agents. Polymers of this type have slightly acidic carboxyl group substituents. Polymers of this type generally have a pH of about 3 in water and are used by neutralization during the preparation of compositions to form gels or viscous films which can trap viruses. When the compositions of the present invention comprise one or more Carbopol rheological agents, generally these polymers are used in concentrations ranging from about 0.01% to about 2.5% by weight of the composition. Non-limiting examples of homopolymers of acrylic acid crosslinked with suitable divinyl glycol are distributed by B. F. Goodrich Company as polycarbophils under the tradename "Noveon".

Other non-limiting examples of a suitable rheological agent for use herein include natural polymers, polymeric cellulose derivatives, polyvinyl pyrrolidones (PVP), dextran polymers, polyethylene oxide polymers, including Polyox-600, heat-reversible polymers, sensitive polymers to ions, copolymers of polymethylvinylether and maleic anhydride and mixtures thereof. Thermoreversible polymers and polymeric cellulose derivatives are preferred. Specific non-restrictive examples of natural polymers suitable for use as a rheological agent herein include arabic gums, tragacanth gums, agar polymers, xanthan gums, alginic acid and sodium alginate copolymers, chitosan polymers, pectins, carrageenans, pullulan polymers, modified starches and mixtures of these. Specific non-limiting examples of polymeric cellulose derivatives suitable for use as the preferred rheological agent in the present invention include hydroxyalkyl cellulose polymers, including hydroxypropylmethylcellulose (HPMC) and hydroxypropylcellulose (HPC), methylcellulose polymers, carboxymethylcellulose (CMC) polymers, salts of carboxymethylcellulose, including the sodium salt of carboxymethylcellulose, as well as mixtures of these. Specific non-limiting examples of thermoreversible polymers suitable for use as the preferred rheological agent in the present invention comprise poloxamers, among which are included those poloxamers sold under the tradenames Lutrol F-127 and Lutrol F-68, ethylhydroxyethylcellulose (EHEC), and mixtures thereof. Specific non-restrictive examples of ion-sensitive polymers suitable for use herein as the rheological agent include gelrite, gellan gum, Kelcogel F and mixtures thereof. Specific non-restrictive examples of polymethyl vinyl ether and maleic anhydride copolymers suitable for use as the rheological agent in the present invention include the copolymers sold under the tradename Gantrez, which, in turn, include the copolymers of the Gantrez S and Gantrez type. MS. The rheological agent suitable for use herein is described in greater depth in the Journal Pharmacy Pharmacology 53, pages 3-22, (2001 Edition); the International Journal of Pharmaceutics (Ediciones 1988, 1996 and 1998), and the Journal Controlled Relay 62, pages 101-107, (1999 Edition); said descriptions are incorporated herein by reference. Inactivation Agent The methods of the present invention include the administration of compositions comprising a virus inactivating agent that allows to reduce or eliminate the infectivity of viral particles. The inactivation agent can temporarily or permanently prevent the infectious capacity of the virus or viral strains to achieve the prevention and treatment of symptoms similar to the flu and the cold.

The compositions of the present invention may comprise one or more inactivating agents, provided that the total concentration of the inactivating agent varies from about 0.01% to about 20%, preferably from 0.05% to about 10%, more preferably about 0.10% to about 5%, by weight of the composition. The inactivating agent may be included in the composition in combination with the rheological agent or nasal secretion agent defined herein. Suitable inactivating agents for use in the present invention include metal compounds, surfactants, chelating agents, pyroglutamic acid, and mixtures thereof. Examples of non-restrictive metal compounds for use as inactivation agents herein include the metal compounds commonly referred to as "metal salts", which comprise metal ion substituents selected from the group consisting of manganese (Mn), silver (Ag), zinc ( Zn), tin (Sn), iron (Fe), copper (Cu), aluminum (Al), nickel (Ni), cobalt (Co) and mixtures thereof. Preferred metal compounds include those metal compounds containing Cu, Fe or Zn metal ions, or combinations thereof. Examples of such metal compounds include the metal compounds known as salicylates, fumarates, benzoates, glutarates, lactates, citrates, malonates, acetates, glycolates, thiosalicylates, adipates, succinates, gluconates, aspartates, glycinates, tartrates, maleates, maleates, ascorbates, chlorides, sulfates, nitrates, phosphates, fluorides, iodides, pidolates, and mixtures of these. Acetates, ascorbates, chlorides, benzoates, citrates, gluconates, glutarates, lactates, maleates, malonates, salicylates, succinates, sulfates and mixtures of these are the preferred metal compounds. Specific examples of a metal compound suitable for use herein include zinc acetate, zinc chloride, zinc ascorbate, zinc gluconate, zinc pidolate, zinc succinate, zinc sulfate, zinc chloride, and mixtures thereof. . Zinc acetate is the most preferred metallic compound. It is believed that when the compositions of the present invention comprise a metal compound containing zinc ions, the zinc ion provides antiviral properties that cause the inactivation of viruses or viral strains. Moreover, it is known that metal ions such as iron, silver, copper and zinc can provide antiviral properties for the prevention and treatment of symptoms similar to the flu or the cold. In particular, zinc and its possible effects on common colds have been widely documented in George A. Eby's The Handbook for Curinq the Common Cold, published in 1994 by George Eby Research, in Texas, USA It is believed that its mechanism of action is multifactorial. It has been shown that zinc ions are antiviral and antibacterial. It is believed that these inhibit the cleavage of rhinovirus polypeptides and that they prevent the replication and formation of infectious virions. Zinc ions reduce the ability of rhinoviruses to penetrate cell membranes and decrease the expression of the intercellular adhesion molecule (intercellular adhesion molecule or ICAM). It has also been shown that zinc ions stimulate T cell lymphocytes, including the production of the natural antiviral, interferon gamma. They also stabilize cell plasma membranes and protect cells against cytotoxic agents, which prevents cell leakage. Non-limiting examples of surfactants suitable for use as the inactivation agent herein include nonionic, anionic, cationic, amphoteric, zwitterionic surfactants and mixtures thereof. Nonionic and anionic surfactants are preferred. Specific non-limiting examples of nonionic surfactants include amine oxides such as N, N-dimethyldodecylamine-N-oxide, available from Procter & Gamble Chemical, USA Nonoxynol-9, available from Shanghai Longsheng Corporation, China; Span, available from Dewolf Chemical Inc. East Province, R102914; the class of Brij surfactants, such as Brij 76 (esteareth-10) and Brij 56 (Ceteth-10), available from Sigma-Aldrich; sorbitan esters, known as Tweens, for example, Tween 80, available from Sigma-Aldrich; and mixtures of these. Specific non-limiting examples of anionic surfactants include alkyl lauryl sulfate and alkyl ether sulfate or their sodium salts, available from Surfachem Limited, Leeds, United Kingdom; ammonium lauryl sulfate, known as Genapol LSA, available from Clariant Limited, Leeds, United Kingdom; sodium of C14-C17 alkylsulfonate, known as Hostapur, available from Clariant Limited, Leeds, United Kingdom, and mixtures thereof.

Non-limiting examples of chelating agents suitable for use as inactivation agents herein include phytic acid; alkaline salts of tetraacetic acid ethylenediamine (EDTA), including disodium, calcium and zinc salts of EDTA; tetrasodium EDTA; sodium hexametaphosphate (SHMP); di (hydroxyethyl) glycine; 8-hydroxyquinoline, and mixtures thereof. Non-limiting examples of pyroglutamic acid suitable for use as an inactivating agent in the present invention include those pyroglutamic acid compounds which, collectively, are termed stereoisomers and tautomers of pyroglutamic acid. Pyroglutamic acid, which is also known as pyrrolidone carboxylic acid, has two stereoisomers (D and L) and both are preferred for use herein. The pharmaceutically acceptable pyroglutamic acid salts are also suitable for use herein. The stereoisomer D of pyroglutamic acid is also known by the following names: D-proline, 5-oxo - (+) - 2-pyrrolidone-5-carboxylic acid, (+) - pyroglutamic acid, (R) -2-pyrrolidone acid -5-carboxylic acid, 5-oxo-D-proline, D-2-pyrrolidone-5-carboxylic acid, D-pyroglutamic acid, D-pyrrolidinonecarboxylic acid and D-pyrrolidonecarboxylic acid. The stereoisomer L of pyroglutamic acid is also known by the following names: L-proline, 5-oxo - (-) - 2-pyrrolidone-5-carboxylic acid, (-) - pyroglutamic acid, (5S) -2-oxopyrrolidone acid -5-carboxylic acid, (S) - (-) - 2-pyrrolidone-5-carboxylic acid, (S) -2-pyrrolidone-5-carboxylic acid, (S) -5-oxo-2-pyrrolidinecarboxylic acid, acid ( S) -pyroglutamate, 2-L-pyrrolidone-5-carboxylic acid, 2-pyrrolidinone-5-carboxylic acid, 5-carboxy-2-pyrrolidinone, 5-oxo-L-proline, 5-oxoproline, 5-pyrrolidinone-2-carboxylic acid, glutamic acid, glutamic acid, L-2-pyrrolidone acid -5-carboxylic acid, L-5-carboxy-2-pyrrolidinone, L-5-oxo-2-pyrrolidinecarboxylic acid, L-5-oxoproline, L-glutamic acid, gamma-lactam, L-glutamic acid, L-glutamic acid , L-pyroglutamic acid, L-pyrrolidinonecarboxylic acid, L-pyrrolidonecarboxylic acid, oxoproline, PCA, pidolic acid, pyroglutamic acid, pyrrolidinonecarboxylic acid, pyrrolidone-5-carboxylic acid and pyrrolidonecarboxylic acid. The DL form of pyroglutamic acid (a mixture of D and L stereoisomers) is known by the following names: DL-proline, 5-oxo - (. + -.) - 2-pyrrolidone-5-carboxylic acid, (. + -.) - pyroglutamic acid, 5-oxo-DL-proline, DL-2-pyrrolidinone-5-carboxylic acid, DL-2-pyrrolidone-5-carboxylic acid, DL-pyroglutamate, DL-pyroglutamic acid, DL-pyrrolidonecarboxylic acid and oxoproline. The DL form is also on the market under the trade names Ajidew A 100 and Ajidew N 50 (nonilaminodperoxycaproic acid or Na-PCA), from Ajinomoto. Some of the stereoisomers listed above are commercially distributed by UCIB, France, via Barnet Products Corp., of New Jersey. These compounds are sold under commercial names such as Cuivridone (Cu-PCA), L-FER Pidolate (Fe-PCA) and Pidolidone. It has been shown that when the compositions of the present invention comprise pyroglutamic acid in combination with an organic acid secreting agent with a pKa value of about 3.0 to about 5.5, this combination provides a surface pH of the tissue of the nasal cavity of about 3.0 to 5.5 pH. , Nasal secretion agent The methods of the present invention include the administration of compositions comprising a nasal secretion agent that allows virus or virus strains to be eliminated from the respiratory tract, especially, from the nasal cavity. The nasal secretion agent stimulates a mild rhinorrhea, in such a way that the viral particles and inflammatory mediators are eliminated from cellular receptors affected by regions of the respiratory tract, such as the nasal cavity. The compositions of the present invention may comprise one or more nasal secretion agents, provided that the total concentration of the nasal secretion agent varies from about 0.001% to about 10%, preferably from about 0.005% to about 5%, most preferably from about 0.01% to about 1%, by weight of the composition. The nasal secretion agent may be included in the composition in combination with the rheological agent or inactivating agent defined herein. Nasal secretion agents suitable for use herein include organic acids, aromatic plant extracts, hypertonic solutions and mixtures thereof. Non-limiting examples of organic acids suitable for use herein as nasal secretion agents include acid ascorbic acid, monocarboxylic acids, dicarboxylic acids, tricarboxylic acids and mixtures thereof. Specific non-limiting examples of suitable monocarboxylic, dicarboxylic or tricarboxylic acids include salicylic, fumaric, benzoic, glutaric, lactic, citric, malonic, acetic, glycolic, malic, adipic, succinic, aspartic, italic, tartaric, glutamic, gluconic, and mixtures of these. Non-limiting examples of extracts of aromatic plants suitable for use herein as a nasal secretion agent include pepper extracts, garlic extracts, onion extracts, mustard extracts and mixtures thereof. Specific non-restrictive examples of pepper extracts include capsaicin, capsicum and mixtures thereof. Non-limiting examples of hypertonic solutions suitable for use herein as a nasal secretion agent include sodium chloride in concentrations with an osmolarity ranging from about 280 millimoles to about 450 millimoles, and mixtures thereof. Buffering Solution The methods of the present invention include the administration of compositions comprising an encapsulating agent in combination with a buffer solution having a pH of from about 3.0 to about 5.5. It has also been found that combining an encapsulating agent and a buffer solution makes the compositions that are effective to encapsulate, inactivate and eliminate viruses or infectious respiratory viral strains also achieve the prevention and treatment of viral infections of the respiratory tract. Non-limiting examples of buffering agents which constitute suitable buffers for use herein include fumarates, benzoates, lactates, citrates, succinates, tartrates, chlorides, sulfates, phosphates and mixtures thereof. Pharmaceutically acceptable vehicle The methods of the present invention include the administration of compositions for the regions of the respiratory tract, particularly the nasal cavity. The compositions are generally administered in regions of the respiratory tract as formulations comprising a pharmaceutically acceptable carrier or vehicle system. Any pharmaceutically acceptable carrier in the form of liquid, solid or gas is suitable for delivering the compositions for the respiratory tract in order to prevent and treat flu-like and cold-like symptoms. The compositions of the present invention can be administered in product forms such as droppers, pumping sprinklers, pressurized sprinklers, atomizers, air inhalation devices and the like. Depending on the desired shape and the delivery device to be used, the compositions of the present invention can be combined with pharmaceutically acceptable carriers, such as water, water miscible solvents, including ethanol, propylene glycol, polyethylene glycol , transcutol, glycerol and other known miscible solvents in water, or effective in some other way, liquid aerosol propellants and mixtures of these. Preferably, these vehicles are isotonic with human plasma. When the compositions are administered using water as the pharmaceutically acceptable carrier, preferably, the water is purified or deionized and free of organic impurities. The concentration of water used to formulate the compositions in the form of a final product for delivery in the areas of the respiratory tract ranges from about 40% to about 99.98%, preferably from about 80% to about 99.95%, by weight of the formulation of the final product. When the compositions of the present invention are administered using a pharmaceutically acceptable solid carrier, the carrier can be applied in the powder form. In other words, the compositions of the present invention can be applied as a solid powder containing the essential ingredients and any of the optional components described herein, with or without any of the solidification aids known or effective in any other way. However, solid pharmaceutically acceptable carriers can be added to contribute to the processing of the compositions, improve the consistency of the compositions, provide greater stability, facilitate handling, obtain hygroscopicity benefits, as well as for other similar purposes. Materials for pharmaceutically acceptable solid carriers include ingredients such as powder and particulate sealants, for example, lactose powder. For the compositions for the respiratory tract in the form of nasal compositions that are administered using a solid pharmaceutically acceptable powder carrier, the particle size of the powder is generally greater than 10 microns, especially when the nasal composition is a nasal inhalant. Optional components The compositions of the present invention may further comprise one or more known optional components, or in any other effective form, for use in pharmaceutical compositions, provided that the optional components are physically and chemically compatible with the essential components described above, or that do not unduly affect the stability, aesthetics or performance of the product in any other way. Optional components suitable for use herein include materials such as pH adjusting agents, preservatives, percipients, sweeteners, flavors, volatile oils, mucilages and the like. The optional components can be included in the pharmaceutical compositions in concentrations ranging from about 0.001% to about 20%, preferably from about 0.01% to about 10%, by weight of the composition. The compositions of the present invention may optionally comprise homeopathic ingredients. A detailed, but not necessarily complete, list of homeopathic ingredients is found in The Homeopathic Pharmacopoeia of the United States, 1999 edition, published by The Homeopathic Pharmacopeia of the United States.

Pharmacopoeia Convention of the American Institute of Homeopathy, © 1982, Vol. 1 -4, whose descriptions are incorporated herein by reference. Specific non-restrictive examples of known homeopathic optional components, or effective in some other way, suitable for use in the present invention, are described in more detail below. A specific non-restrictive example of an optional component, suitable for use in the present invention includes optional pH adjusting agents. Optional pH adjusting agents can be included in the compositions of the present invention to adjust the pH of the compositions to values less than about 4.5. Therefore, when the compositions are applied to the areas of the respiratory tract such as the nasal tissues, the pH of the composition in the nasal tissues remains at a level of about 3.0 to about 5.5, but it is not so low as to cause irritation of the nasal tissues. Optional pH adjusting agents include those agents normally associated with the use of nasal compositions, including compounds such as sodium bicarbonate, sodium phosphate, sodium hydroxide, ammonium hydroxide, sodium stannate, triethanolamine, sodium citrate, succinate. deodoric and mixtures of these. When present, optional pH adjusting agents are generally included in concentrations ranging from about 0.01% to about 5.0% by weight of the composition.

Another specific non-limiting example of an optional component suitable for use in the present invention includes optional preservatives. Preservatives may be optionally included to prevent microbial contamination, which can be attributed to the dosing devices or to the application of the composition in the nose. Optional preservatives include those which are generally associated with use in nasal compositions, including benzalkonium chloride, chlorhexidine gluconate, phenylethyl alcohol, phenoxyethanol, benzyl alcohol, sorbic acid, thimerosal, phenylmercuric acetate and mixtures thereof. Manufacturing Method The compositions of the present invention can be prepared by any known technique or in some other effective form, suitable for providing a pharmaceutical composition that provides a therapeutic benefit to prevent and treat flu-like or cold-like symptoms. The methods of the present invention include the administration of compositions for the respiratory tract, wherein the compositions are processed as final products in the form of liquid, dew, powder, inhalants, pumps, drops, etc., for administration in regions of the tract. Respiratory to prevent and treat symptoms caused by viral infections of the respiratory tract. When the compositions are administered using a pharmaceutically acceptable carrier, such as a liquid, to deliver the compositions in spray product forms, pumps, drops and the like, the compositions are generally prepared by solubilizing a rheological agent. in a liquid vehicle such as water. While stirring, a virus inactivating agent or a nasal secretion agent is added to the rheological agent solution. Then, a mixture of percipient is added while the solution is maintained in continuous agitation. The permeation agent mixture is generally added as a premix solution which may contain a combination of ingredients such as a combination of ethanol, menthol, peppermint oil and peppermint oil. The pH of the resulting product should be between about 3.0 and about 5.5, however, a pH adjusting agent such as sodium hydroxide and / or disodium succinate can be added to maintain the pH of the resulting product at values below 4.5. These compositions are administered as compositions for the respiratory tract in their liquid forms of final product, wherein the liquid is suitable for incorporation into drip bottles in order to spray regions of the respiratory tract such as the nostrils or turbinates to achieve prevention and treatment effective symptoms similar to the flu and the cold. Generally, about 1 microliter (μ?) To about 500 microliters (pls) of the composition are sprayed into each nostril or turbinate. When the compositions of the present invention are administered using a pharmaceutically acceptable carrier, such as a powder, the compositions are generally prepared by dry mixing a rheological agent or a virus inactivating agent or a nasal secretion agent using a V-mixer. add a pH adjusting agent, like sodium citrate, to the dry mix. The dry mix is then micronised using a fluid energy mill. The resulting micronized dry mix is then dry blended with a powder sealer, such as a lactose powder. This final powder composition for the respiratory tract can optionally be coated with a sensation premix using spray coating techniques. The final powder composition for the respiratory tract can be filled in a nasal inhalation measuring pump to prevent and treat cold and influenza symptoms, where approximately 10 milligrams (mgs) of the final powder can be administered in an area of the respiratory tract such as a nasal concha or grave As set forth in this, the compositions of the present invention are suitable for administration in the respiratory tract in the final liquid product forms, sprays, pumps, inhalants, powders, etc. Suitable devices used in the administration of these final compositions for the respiratory tract include containers for liquids that are used in general or that are effective in some other way, drippers, spray vessels, including pressurized sprayers, recipients with pumps, devices for inhalation, powder containers, atomizers and the like. METHOD OF TREATMENT The present invention is directed to preventing and treating viral infections of the respiratory tract by administering the compositions described herein in regions of the respiratory tract such as the nasal cavity. Generally, a safe and effective amount of the compositions is applied in the region of the respiratory tract, particularly the nasal cavity. In this context, the term "safe and effective amount" refers to an amount that provides a therapeutic benefit with minimal or no adverse reactions. As mentioned herein, methods for preventing and treating viral infections of the respiratory tract include any other method known or otherwise effective in preventing and treating viruses or viral strains that can affect the respiratory tract and cause symptoms associated with the common cold and the flu. In order to prevent and treat viral infections of the respiratory tract, a safe and effective amount of compositions of the present invention is administered to the respiratory tract. The safe and effective amount depends on factors such as the type of composition administered, for example, the compositions of the present invention can be administered using product forms such as liquids, sprays, powders, inhalants, pumps, drops, and the like. A preferred method for treating and preventing viral infections of the respiratory tract consists in spraying the compositions of the present invention in the nasal cavity. In the case of compositions for the respiratory tract in the form of nasal sprays, effective amounts ranging from about 1 microliter to about 500 microliters, preferably from about 1 microliter to about 150 microliters, in each nostril or turbinate of the nasal cavity, one or more times, to provide an effective method intended to prevent and treat viral infections of the respiratory tract. Generally, approximately 50 microliters of nasal spray are administered two or three times in each nostril or committed as an effective method intended to prevent and treat viral infections of the respiratory tract. For compositions for the respiratory tract in the form of diluted nasal sprays, they are sprayed from about 0.1 milliliters (μ? _) To about 50 milliliters in each pit or turbinate one or more times. It has been found that by spraying the compositions in the nasal cavity, viruses or infectious viral strains are encapsulated, inactivated or eliminated from the nasal cavity and flu-like and cold-like symptoms contributing to viruses or strains are alleviated. viral EXAMPLES The following examples further describe and demonstrate the embodiments that are within the scope of the present invention. The examples are provided for illustrative purposes only and should not be construed as limiting the present invention since many variations are possible without deviating from their spirit and scope. All concentrations exemplified are given in percentage by weight, unless otherwise specified. The illustrative compositions for the respiratory tract of the present invention are exemplified in Table II which is presented to continuation. These compositions for the respiratory tract preferably comprise a premix of sensation that is illustrated in Table I below. The feel premixes illustrated in Table I provide compositions for the respiratory tract that are aesthetically pleasing in taste, taste, freshness, smell and the like. The compositions for the respiratory tract illustrated in Table II below are suitable for spraying regions of the respiratory tract such as the nostrils or turbinates in order to achieve the prevention and treatment of symptoms similar to influenza and the cold. Generally, about 1 microliter to about 500 microliters of the composition is sprayed into each nostril or turbinate.

Table I Table II % by weight - percentage by weight 1 - Hydroxypropylmethylcellulose available from Colorcon Ltd, Kent, United Kingdom 2 - . 2 - Lutrol F-127 distributed by BASF Specialty Chemicals, Mount Oliver, NJ, USA. 3 - . 3 - Zinc acetate dihydrate available from Verdugt B.V., Belgium 4 - Amine oxide available from Procter & Gamble Chemicals, USA 5 - Nonoxynol-9 available from Shanghai Langsheng Corporation 6 - Succinic acid available from DSM Fine Chemicals, United Kingdom 7 - Acetic acid available from Post Apple Scientific, PA, USA. 8 - Capsaicin available from Steve Weiss & Co, New York, USA 9 - Sodium Chloride available from Alfa AESAR, MA, USA While particular embodiments suitable for use in the method of the present invention have been illustrated and described, it will be apparent to those with knowledge in the industry that various changes and modifications can be made to the present, without deviating from the spirit and scope of the invention. . It is intended to cover, in the following claims, all modifications that are within the scope of this invention.

Claims (10)

1. Using a composition in the manufacture of a medicament useful for preventing or treating viral infections of the upper respiratory tract, the composition is characterized by: (a) From 0.01% to 30% by weight of a Theological agent; and (b) from 0.01% to 20% by weight of a virus inactivating agent; characterized in that the composition has a viscosity ranging from about 1 cps (0.001 Pa.s) to about 2000 cps (2 Pa.s).

2. Use of a composition in the manufacture of a medicament useful for preventing or treating viral infections of the upper respiratory tract, the composition is characterized by: (a) A Theological agent; and (b) a buffer solution with a pH of from about 3.0 to about 5.5; characterized in that the composition has a viscosity ranging from about 1 cps (0.001 Pa.s) to about 2000 cps (2 Pa.s).

3. The use according to claim 1 or 2, further characterized in that the composition has a viscosity from about 5 cps (0.005 Pa.s) to about 500 cps (0.5 Pa.s).

4. The use according to any of the preceding claims, further characterized in that the rheological agent is selected from the group consisting of carboxypolymethylenes, carboxyvinyl polymers, homopolymers of acrylic acid crosslinked with an allyl ether of pentaerythritol, homopolymers of acrylic acid crosslinked with an allyl ether of sucrose, homopolymers of acrylic acid crosslinked with divinyl glycol, natural polymers, cellulose-derived polymers, polyvinylpyrrolidones (PVP), dextran polymers, polyethylene oxide polymers, thermoreversible polymers, ion sensitive polymers, copolymers of polymethyl vinyl ether and maleic anhydride, and mixtures thereof.

5. The use according to any of the preceding claims, further characterized in that the rheological agent is a cellulose derivative selected from the group comprising hydroxypropylmethylcelluloses, hydroxypropylcelluloses, methylcellulose polymers, carboxymethylcellulose polymers, carboxymethylcellulose salts, and mixtures thereof.

6. The use according to any of the preceding claims, further characterized in that the rheological agent is a thermoreversible polymer selected from the group comprising poloxamers, ethylhydroxy ethylcelluloses, and mixtures thereof. The use according to any of claims 1, 3, 4, 5 or 6, further characterized in that the virus inactivating agent is selected from the group comprising a metal compound, a surfactant, a chelating agent, pyroglutamic acid, and mixtures of them. 8. The use according to claim 7, further characterized in that the metal compound is selected from the group comprising Salicylates, fumarates, benzoates, glutarates, lactates, citrates, malonates, acetates, glycolates, thiosalicylates, adipates, succinates, gluconates, aspartates, glycinates, tartrates, maleates, maleates, ascorbates, chlorides, sulfates, nitrates, phosphates, fluorides, iodides, pyrolates, and mixtures of them. 9. The use according to any of the preceding claims, further characterized in that the composition has a pH ranging from 3 to 5.5. The use according to any of the preceding claims, further characterized in that the composition comprises from 0.001% to 10% by weight of a nasal secretion agent selected from the group comprising organic acid, an extract of an aromatic plant, a solution hypertonic, and mixtures of them.