Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2000-01-06
2002-03-26
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C424S043000, C424S046000, C424S464000, C514S958000, C514S959000
Reexamination Certificate
active
06362225
ABSTRACT:
FIELD OF THE INVENTION
The instant invention relates to therapies and compositions for treating a variety of viral infections, most specifically viral infections that affect mucous membranes.
BACKGROUND OF THE INVENTION
Most people, at one time or another, are at risk for a variety of viral infections, some resulting in running nose, cough, sinus inflamation, sore throat, and ear fullness. These symptoms are often a part of what is usually called “the common cold” and are also associated with many forms of influenza. A variety of digestive problems or stomach upsets may also be associated with influenza or may be associated with other viral infections. We are told that colds, flus and intestinal viral infections must run their course and that other than rest and fluids there is not much to be done to speed the healing process. The various symptoms can be treated indiviually with a plethora of prescription and over-the-counter remedies. The cold itself has not yielded to any medication. Additionally, many of the over-the-counter medications given to treat cold and other flu symptoms may cause drowsiness and other side effects which make them undesirable for many potential users.
Vitamin C has been widely used to prevent and treat colds, but recent studies have shown that its effects are questionable at best. The time-worn remedy of chicken soup has been found to actually provide some benefits to cold and flu sufferers.
Other common viral infections include some sore throats and eye inflammations as well as cold sores, canker sores, genital herpes, some lung inflammations and intestinal upsets as noted above. Antibiotics are ineffective against these viral infections and anti-viral medications are often slow acting and may produce unwanted side effects.
Tulin-Silver et al. in U.S. Pat. No. 5,508,282 teaches the application of ascorbic acid in a spray used directly on nasal membranes to shorten the duration of colds. The nasal sprays contain ascorbic acid, caffeine, and other water soluble vitamins and minerals in an aqueous carrier at a pH range of 5.5 to 6.5. These preparations are designed to help repair cell membranes, stimulate the immune system and improve the sense of smell, though the combination taught by Tulin Silver et al. has no effect on the virus itself.
Nasal sprays have also been found effective in delivering large protein molecules such as insulin directly into the body through mucous membranes. The absorption of such polypeptides has been enhanced by the addition of a chelating agent to the nasal spray composition. (U.S. Pat. No. 4,476,116 to Anik) The nasal membrane was chosen as a direct route into the blood stream without resorting to injection and without entering the digestive system where the large protein molecules are broken down by the digestive process. A combination of the nucleoside inosine, lysine ororate and a vitamin, administered orally, has been found to have an anti-inflammatory effect on a variety of mucous membrane diseases such as gastric ulcer, periodontitis, and mouth ulcers. The combination can be administered in aqueous solution or as a gel, capsule or tablet. (U.S. Pat. No. 4,405,610 to Krnjevic') The aqueous solution and gel are examples of the therapeutic agent being delivered to the site of the infection, or close to that site. The particular combinations taught by Krnjevic' do not act on the cause of the inflammation, but on the inflammation itself.
Amino acids such as alanine, glycine, serine, lysine and arginine when added to the gluconate salt solutions of minerals such as zinc resulted in the mineral being absorbed more readily and acting more efficiently on the cellular tissue level in the target organ than when the minerals were administered alone. (U.S. Pat. No. 4,937,234 to Fahim) It appears that these amino acids are being readily absorbed into the cells through interaction with the mineral which assist in its passage through cell membranes.
Lysine has been found very effective in treating and preventing cold sores which are caused by herpes viruses and has also been used to treat genital herpes. The lysine was administered in tablet form. Lysine was also administered intravenously to successfully treat encephalitis. (Saturday Evening Post, November-December 1995 v267 p 54 and p 56) See also “The Metabolic Roles, Pharmacology, and Toxiclolgy of Lysine”, N. W. Flodin, J. Am. Coll. of Nutrition, Feb. 1997, pp 7-21. When used in the treatment of cold sores, the tablets were swallowed, not dissolved in the mouth. They had to be taken over long time periods, weeks or months, to be effective. Diets low in arginine and high in lysine also showed promise in treating herpes infections, but again, this regimen was a long term solution.
The administration of a variety of drugs by nasal spray is increasing as a means to introduce such drugs into the bloodstream without having to resort to injection.
Since different viral infections manifest themselves with symptoms in different parts of the body it is believed that there may be a higher concentration of the virus in those specific areas. It makes sense therefore, to concentrate the antiviral therapy in those infected areas. Infections of the mucous membranes caused by non-regenerative viruses may respond readily to such therapies. Combining the nasal spray delivery system with additional applications to the specific areas of infection may provide an even more effective therapy.
The use of lozenges that slowly dissolve in the mouth are well known. Such lozenges when used for a sore throat are usually taken to moisten the throat and to administer a topical anaesthetic to ease the pain. The usual medicaments for a sore throat, antibiotics, are swallowed, not taken in lozenge form. The most common topical administration of a medicament is to treat skin problems such as rashes and allergic reactions, though even these treatments are given more to alleviate the symptoms than to treat the cause. Topical means to treat other types of medical problems are not widespread.
None of the patents or articles described above specifically discuss treatments of viral infections by administration of lysine through nasal sprays, throat sprays, topical drops, lozenges, gums, suppositories, as a microcrystalline powder, or other topical and localized means of application and such applications directly to mucous membranes, nor do they describe combinations of such delivery systems. There is a need for a medicament that can easily be administered directly to the area where the viral infection is concentrated. There is a need for such a medicament that has no inflammatory effect on the body, specifically on mucous membranes, no known toxicity levels and minimal, if any, side effects.
BRIEF SUMMARY OF THE INVENTION
The present invention may provide safe and effective therapies for treating common viral infections such as colds, flu, sore throat, lung congestion, eye inflammations, herpes outbreaks and intestinal disturbances. A solution or suspension of L-lysine monohydrochloride in an aqueous medium or water soluble medium may be administered in a variety of delivery systems such as a spray, inhalant, lozenge, chewing gum, drops, suppository, or enema, or as a topical application such as in a gel or in a combination of two or more of these delivery systems. Lysine in the form of a microcrystalline powder may also be applied to certain target areas. The application of L-lysine monohydrochloride may be made directly to the target areas at regular intervals during the duration of the viral infection.
It is an object of the present invention to provide easily administered preparations that can be used by adults and children to effectively shorten the duration of common viral infections.
It is another object of the present invention to provide preparations with minimal side effects.
It is a further object of the present invention to provide preparations that can prevent or lessen the symptoms of common viral infections if taken at the very onset of such symptoms.
Another object of the present invention i
Kotin Sandra M.
Travers Russell
Wang Shengjun
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