Gargle method to reduce the duration of common cold symptoms

Drug – bio-affecting and body treating compositions – Dentifrices

Reexamination Certificate

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C424S434000, C424S435000, C424S725000, C424S059000, C514S724000

Reexamination Certificate

active

06641801

ABSTRACT:

OTHER REFERENCES
Eby et al. Antimicrobrial Agents and Chemother 1984;25:20-24.
Garland M L, O Hagmeyer K. Ann Pharmacother 1998;32:63-69.
Godfrey J C et al. J Intl Med Res 1992;20:234-246.
Godfrey J C. Antimicrobrial Agents and Chemother 1988;32:605.
Korant B D et al. Nature 1974;248:588-590.
Macknin M L et al. JAMA 1998;279:1962-1967.
Mossad S B et al. Ann Intem Med 1996;125:81-88.
Turner R B. Ann Alergy Asthma Immunol 1997:78:531-540.
van kempen M et al.
Rhinology
1999;37(3):97-103 . . .
BACKGROUND OF THE INVENTION
1. Field of Invention
This invention relates to methods and preparations for reducing the duration of common colds and reducing the severity of common cold symptoms. More particularly, this invention relates to the remedies comprising medicaments, which shorten the duration of common colds, reduce the severity of symptoms, and/or otherwise beneficially treat common colds. These ingredients are believed to be antiviral agents. Such ingredients are combined with a pharmaceutically acceptable carrier suitable for the chosen method and form of administration. The most preferred method of administration is exposure of the oral and oral pharyngeal tissues to the agents for a period of time sufficient for the remedy to be exposed to the oral and oral pharyngeal mucous membranes. The preferred forms of the remedy for administration therefore include mouthwashes and lozenges. In these embodiments, the preparation preferably includes a suitable carrier, and other ingredients such as flavors, stabilizers, lubricants, and additional natural or artificial sweeteners.
2. General Background
The “common cold” and, simply, “cold” are time-honored phrases used by both physicians and lay persons alike for the identification of upper respiratory illness caused by viral infection. Colds are most often acute, minor illnesses which eventually subside without treatment for the infection itself. However, common colds are still a major public health problem.
Colds are the most common acute illness in the United States and account for about one-half of all absences from school and work. Viruses that cause the common cold are easily transmitted from host to host. For example, such viruses may be spread in aerosols, so they may be spread through the air by, e.g., sneezing. Additionally, the viruses can survive out of a host's body for extended periods of time, and so can be transmitted by hands and objects. Further, a virus that causes only a minor cold in one host may threaten the life of another host by causing influenza, a much more serious upper respiratory infection that may be fatal. P. R. Murray et al.,
Medical Microbiology,
2
nd
ed., Mosby-Year Book, Inc., p. 723,616-7 (1994).
Since the discovery of rhinovirus in 1956, a considerable body of knowledge has been acquired on the etiology and epidemiology of common colds. It is known that the common cold is not a single entity, but rather is a group of diseases caused by members of several families of viruses including adenoviruses, influenza viruses, parainfluenza viruses, rhinoviruses, respiratory syncytial viruses, enteroviruses, echoviruses, coxsackieviruses, and coronaviruses. Much work has been performed in characterizing viruses which cause the common cold. For instance, the molecular biology of rhinoviruses, which causes at least 50% of all upper respiratory tract infections, is understood in great detail. Murray, pp. 723,616
In contrast, progress on the treatment of common colds has been slow despite these advances. Indeed, it has been believed that the only current cure for the common cold is the body's natural defenses and the passage of time.
Many over-the-counter remedies for the common cold only treat symptoms. There are over 200 different virus serotypes that can cause the common cold. For example, there are at least 100 serotypes of rhinoviruses alone. Murray p. 616, Rhinology 37(3):97-103, 1999. It is therefore not possible to build immunity to this many causes of the common cold. It is also difficult to develop remedies that are effective against such a large number of viruses. Therefore, symptomatic relief has been the traditional recourse.
These prescription or over-the-counter products which treat symptoms of the common cold usually contain one or more of the following drugs: antihistamines, decongestants, pain relievers (aspirin, acetaminophen, ibuprofen), cough suppressants, expectorants, and analgesics. These remedies do not reduce the duration of the common cold, are of limited effectiveness in relieving the symptoms of the cold, and are often accompanied by unwelcomed side effects.
The duration of the average cold varies greatly among individuals. Twenty-five percent of all colds last 14 days, but the average duration of a cold is 7 days, with or without treatment.
Treatment with interferon has been somewhat successful in limiting the progression of infection in common colds. However, interferon has many negative effects and cannot be administered for any length of time. Murray pp. 616-619.
Zinc ions have been reported to inhibit the replication of rhinoviruses. See, Korant B D et al., Nature 248:588-590 (1974). Recently, soluble and ionizable zinc compounds applied to the oral and oralpharyngeal mucosa have been used to treat common colds and have had some success in shortening the duration of the common cold. See, for example, U.S. Pat. Nos. 5,409,905; 5,286,748; 5,286,748; RE033465; and 4,956,385; to Eby Ill. See also U.S. Pat. No. 5,622,724 to Bryce-Smith and U.S. Pat. No. 4,684,528 to Godfrey. Eby claims that after seven days, 86% of 37 zinc-treated subjects were asymptomatic, compared with only 46% of 28 placebo-treated subjects. (Antimicrob. Agents Chemother. 25(1):20-4, 1984). Mossad's double-blind, placebo controlled study on zinc lozenges revealed that patients treated with zinc lozenges had colds averaging 4.4 days compared to 7.6 days for those on the placebo. (Ann Intem Med 125::81-88, 1996). However, treatment also causes side effects, such as nausea and bad-taste reactions. Mossad. The cold duration thus appears reduced by zinc treatment, but the reduction is not dramatic, especially given the average cold duration of 7 days.
Given the very limited success of current cold remedies, some people say that cold remedies today come no closer to curing the common cold than they did thousands of years ago. Thus there can be no question as to the need for an improved remedy that will shorten the duration of common colds.
SUMMARY OF THE INVENTION
This invention provides methods and compounds for reducing the presence, duration, and severity of a common cold and of its symptoms by the administration of ethanol with or without homeopathic and/or herbal medicaments.
It is an object of this invention to provide effective treatments for the treatment of the common cold and its symptoms. Specifically, it is an object of this invention to provide remedies which reduce the duration of the cold, which reduce the severity or duration of one or more symptoms of the cold, and/or which prevent the common cold.
It is another object of this invention to overcome the problems and disadvantages associated with currently known approaches to treating the common cold and its symptoms.
Prior treatments for the cold have focused on alleviation of its symptoms. Very few remedies have had any success in reducing the duration of the cold. Further, prior treatments almost always contain drugs which cause side effects, which can be as debilitating as the cold itself. Unexpectedly, the present inventor has discovered that certain medicaments (ethanol with or without homeopathic and/or herb ingredients) can reduce the duration of the cold itself, as well as reducing the severity of the symptoms of the cold, and may also prevent infection by cold viruses. The remedy's active ingredient is ethanol with or without homeopathic and/or herb ingredients that are without known side effects and/or are given at homeopathic dosages, which appear to produce no side effects. The remedies of this invention therefore represe

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