Title:  Nasal solution containing a broad spectrum microbicide and a method for its use

United States Patent:  6,664,289

Issued:  December 16, 2003

Inventors:  Hansen; Richard L. (9607 Troy Ct., Mentor, OH 44060)

Appl. No.:  139522

Filed:  May 6, 2002

Abstract

The invention provides for a nasal spray which is an aqueous solution containing a broad spectrum microbicide which may be applied in nasal passages in the manner of a decongestant type nose spray in the event of known or suspected exposure of the individual to common cold virus, flu, or other infective microbial agents. The solution contains active agents which are based on a chlorine or hypochlorite solution, or a solution of chlorine or hypochlorite plus a salt of chloride, bromide or iodide. Alternatively, the solution may contain a bromine solution, or a solution of bromine plus a salt of chloride, bromide or iodide such as sodium chloride, zinc chloride, sodium bromide, zinc bromide, sodium iodide or zinc iodide. The chlorine, hypochlorite, bromine, chloride, bromide, and iodide may originally come from inorganic compounds or organic compounds, which are then dissolved in the water. Further, the solution may contain glycerin or another moisturizing or wetting agent for the nasal mucosa. Zinc gluconate or a zinc halide such as zinc chloride, zinc bromide or zinc iodide may also be included.

SUMMARY OF THE INVENTION

The invention relates generally to aqueous solution which contains a broad spectrum microbicide which may be applied in nasal passages in the manner of a decongestant type nose spray. The spray is intended particularly for human use. It is to be applied in the event of known or suspected exposure of the individual to common cold virus, flu, or other infective microbial agents including for example, bacteria, rickettsia, viruses and even mold and fungus. It may also be applied when there is a pre-existing infection caused by the previously mentioned agents. The solution contains an active agent which is based on a chlorine or hypochlorite solution, or a solution of chlorine or hypochlorite plus a salt of chloride, bromide or iodide. Alternatively, the solution may contain a bromine solution, or a solution of bromine plus a salt of chloride, bromide or iodide such as sodium chloride, zinc chloride, sodium bromide, zinc bromide, sodium iodide or zinc iodide. The chlorine, hypochlorite, bromine, chloride, bromide, and iodide may originally come from inorganic compounds or organic compounds, which are then dissolved in the water. Further, the solution may contain glycerin or another moisturizing or wetting agent for the nasal mucosa since the halogens or halides may be dehydrating or drying. Zinc gluconate or a zinc halide such as zinc chloride, zinc bromide or zinc iodide may also be included to further render the nasal mucosa more slippery and thus more difficult for invading microbes to colonize the area.

BACKGROUND OF THE INVENTION

Cold viruses or other microbes are sometimes transmitted by aerosol such as by a water droplet that is dispersed by coughing or sneezing, or by personal contact including, for example, hand to hand contact where a handshake transfers the microbes from one person to another and then the contaminated hand is brought into the vicinity of the individual's nose. (As when touching the nose or scratching it or rubbing it.) It is generally believed that infective agents will grow and multiply in regions where they have the proper temperature, nutrients, and other conditions conducive to growth or multiplication such as in the nasal mucosa. Thus, an object of the present invention is to apply a broad-spectrum microbicide to the area where infective viruses may be transmitted or transported and would ordinarily multiply.

A number of explanations could be proposed for the effectiveness of the microbicide in reducing the risk of full-blown infection. For example, the composition may act to kill the microbe, or to render it ineffective. Further, the microbicide may act to slow diffusion into a cell by tagging it with a heavy ion. This slowing of diffusion may slow the microbe's multiplication and allow the body's natural defenses to catch up and eliminate the microbes. Further, the nasal solution may dilute the attacking organism and wash it out away from the optimum area for growth so as to weaken the statistical probability of success of the infection.

It is thus an object of the invention to apply a medical agent to the area of entry, namely the nose, and specifically the inside of the nose, the nasal fossae and the sinus areas within the nose. This treatment can be remedial so as to inhibit an existing infection, or prophylactic so as to prevent spread into the respiratory system by affecting the microbe in the nose. Thus, in accordance with a method of using the nasal spray, it could be applied as soon as the person has determined he or she has "caught" a cold. It could also be applied after the person first begins to feel the initial symptoms of catching a cold, such as stuffiness or muscular aches or fever. Or it could be applied prophylactically as soon as a person has been exposed to others who have colds and has real reason to be concerned about catching a cold after such an exposure. Moreover, it could be applied in a similar manner for cases of influenza or other infections for minimizing symptoms and extent of "infection".

DETAILED DESCRIPTION OF THE INVENTION

One preferred embodiment of the invention is an aqueous solution of sodium hypochlorite with a halogen salt such as sodium chloride, sodium bromide, sodium iodide, zinc chloride, zinc bromide or zinc iodide. It may also include more than one of the aforementioned salts. In addition, it may also include zinc gluconate.

Another embodiment of the invention would be an aqueous solution of chlorine with a halogen salt such as sodium chloride, sodium bromide, sodium iodide, zinc chloride, zinc bromide or zinc iodide. It may also include more than one of the aforementioned salts. In addition, it may also include zinc gluconate.

Another preferred embodiment of the invention is an aqueous solution of bromine with a halogen salt, i.e. chloride, bromide or iodide. The salt may constitute a chloride, a bromide or iodide with a specific example being sodium bromide, or zinc bromide.

Another embodiment of this invention is the use of organic compounds of chlorine, bromine or iodine, or organic compounds that are chlorides, bromides or iodides. These compounds are such that they decompose in solution or chemically react in order to provide the necessary halogen components for making the aqueous mixture that will be used to spray into the nose onto the nasal mucosa.

There may be particular advantages of using mixed halogens since they sometimes combine in stable but reactive trimers like Br₂ Cl--, Br₂ I--, I₂ Cl--, I₂ Br--, etc. Having stabilized the reactive halogen, there will likely be more of the halogen present in the solution for reaction with sensitive areas of the microbes existing on the nasal mucosa.

It is postulated that these ionic species will react chemically with organic or biological chemicals on or in the virus so as to kill it or render it ineffective. Further, the solutions can contain glycerin or some other additive to act as a moisturizer since the halogen species tend to have a dehydrating, drying effect on the nasal mucosa. The pH could be adjusted, if necessary, to match the pH of mucous membranes or to optimize the activity without being harmful to the nasal mucosa. It can be adjusted up or down using sodium hydroxide, chlorine, sodium hypochlorite, hydrogen chloride, bromine, or hydrogen bromide. Thus, an appropriate pH for the final solution would be from about pH 5.5 to about pH 8.5, and preferably from about pH 6 to pH 8 and more preferably from about pH 6.5 to pH 7.5.

Sodium hypochiorite would be present in a concentration of about 0.5 ppmw to about 50,000 ppmw, and preferably from about 5 ppmw to about 5000 ppmw and more preferably from about 50 ppmw to 500 ppmw. It may also be potassium, calcium, or other bypochlorites.

Sodium or potassium chloride would be present in a concentration of about 55 ppmw to 75,000 ppmw, and preferably from 250 ppmw to 50,000 ppmw and more preferably from about 2500 ppmw to 25,000 ppmw. This could also be magnesium or calcium chloride or other chlorides.

Sodium or potassium bromide would be present in a concentration of about 0.7 ppmw to about 140,000 ppmw, more preferably from about 140 ppmw to about 55,000 ppmw, and more preferably from about 1,400 ppmw to about 28,000 ppmw. This could also be magnesium or calcium bromide or other bromides.

Sodium or potassium iodide would be present in a concentration of about 0.1 ppmw to about 160,000 ppmw, more preferably from about 200 ppmw to about 80,000 ppmw, and more preferably from about 2,000 ppmw to about 40,000 ppmw.

This could also be magnesium or calcium iodide or other iodides. Chlorine would be present at a concentration of about 0.4 ppmw to about 50,000 ppmw, more preferably from about 2 ppmw to about 5000 ppmw, and more preferably from about 10 ppmw to about 500 ppmw.

Bromine would be present at a concentration of about 1 ppmw to about 75,000 ppmw, more preferably from about 4 ppmw to about 8,000 ppmw, and more preferably from about 20 ppmw to about 1000 ppmw.

Zinc chloride would be present at a concentration of about 0.4 ppmw to about 50,000 ppmw, more preferably from about 40 ppmw to about 15,000 ppmw, and more preferably from about 400 ppmw to about 5,000 ppmw.

Zinc bromide would be present at a concentration of about 0.7 ppmw to about 80,000 ppmw, more preferably from about 75 ppmw to about 33,000 ppmw, and more preferably from about 750 ppmw to about 10,000 ppmw.

Zinc iodide would be present at a concentration of about 1 ppmw to about 120,000 ppmw, more preferably from about 100 ppmw to about 80,000 ppmw, and more preferably from about 1,000 ppmw to about 20,000 ppmw.

Zinc gluconate would be present at a concentration of about 1.7 ppmw to about 60,000 ppmw, more preferably from about 17 ppmw to about 6,000 ppmw, and more preferably from about 170 ppmw to about 1800 ppmw.

Glycerine would be present at a concentration of about 0.01 wt % to about 5 wt %, more preferably from about 0.04 wt % to about 2 wt %, and more preferably from about 0.1 wt % to about 1 wt %. Propylene glycol could be used as a substitute for glycerine.

Claim 1 of 25 Claims

What is claimed is:

1. A method of reducing the risk of microbial infection or of combating a microbial infection which is established first in the nasal mucosa area comprising:

the application of a nasal spray solution within the nose, said nasal spray solution comprising an aqueous solution having the following components:

a) sodium hypochlorite, potassium hypochlorite, or calcium hypochlorite in a concentration of about 0.5 ppmw to about 50,000 ppmw;

b) sodium chloride, magnesium chloride, calcium chloride or potassium chloride in a concentration of about 55 ppmw to 75,000 ppmw;

c) sodium bromide, magnesium bromide, calcium bromide or potassium bromide in a concentration of about 0.7 ppmw to about 140,000 ppmw;

d) sodium iodide, magnesium iodide, calcium iodide or potassium iodide in a concentration of about 0.1 ppmw to about 160,000 ppmw;

e) chlorine in a concentration of about 0.4 ppmw to about 50,000 ppmw;

f) bromine in a concentration of about 1 ppmw to about 75,000 ppmw;

g) zinc chloride in a concentration of about 0.4 ppmw to about 50,000 ppmw;

h) zinc bromide in a concentration of about 0.7 ppmw to about 80,000 ppmw; and

i) zinc iodide in a concentration of about 1 ppmw to about 120,000 ppmw;

and optionally one or more of zinc gluconate in a concentration of about 1.7 ppmw to about 60,000 ppmw, and glycerine or propylene glycol in a concentration of about 0.01 wt % to about 5 wt %.

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