Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2002-04-15
2003-07-22
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S439000, C424S756000
Reexamination Certificate
active
06596313
ABSTRACT:
BACKGROUND OF THE INVENTION
A. Field of the Invention
The present invention relates to a nutritional supplement and methods of using it. More particularly, the present invention relates to a nutritional supplement useful for promoting the health of salivary glands and/or to support normal or healthy swallowing, and to methods for administering the nutritional supplement for at least these purposes.
B. Description of the Prior Art
Treatment of Sialorrhea
Sialorrhea, a symptom related to amyotrophic lateral sclerosis (ALS), and other causes such as achalasia, acoustic neuroma, Bell's palsy, cerebral palsy, cerebrovascular accident (stroke), glossopharyngeal neuralgia, Guillain-Barre syndrome, hypocalcemia, Ludwig's angina, mental retardation, motor-neuron disease, muscular dystrophy, myasthenia gravis, myotonic dystrophy, paralytic poliomyelitis, polymyositis, Parkinson's disease, Radical Cancer surgery, Seventh-nerve palsy, Shy-Drager syndrome, and Wilson's disease, is the excessive drooling due to salivary gland dysfunction such as overproduction of saliva from the salivary glands. Sometimes, sialorrhea may also be induced by drugs such as clonazepam, ethionamide, haloperidol, and transdermal nicotine among others. People have made much effort to treat Sialorrhea. Newall et al reported using beta antagonists to control the excessive secretions of the oral salivary glands and achieve 75% success rates (J. Neurol. Sci., 1996, 139, 43-4). Mier et al have found that ingestion of glycopyrrolate is effective in treating sialorrhea in children. However, 20% of the children being treated with glycopyrrolate experienced substantial adverse effects, enough to require discontinuation of medication (Arch. Pediatr. Adolese. Med., 2000, 154, 1214-1218). Sialorrhea may also be caused by abnormal or unhealthy swallowing by a patient suffering from diseases such as ALS.
According to a recent study by Rettori et al. (Ann. N.Y. Acad. Sci., 2000; 917; 258-67), inhibitors of nitric oxide synthase (NOS) decrease stimulated salivary secretions whereas donors of NOS potentiate stimulated salivary secretions. This indicates that nitric oxide exerts a stimulatory role on salivary secretion.
Treatment of Inflammation
In modem non-herbal medicine, there are two major categories of anti-inflammatory medicines: steroidal and non-steroidal. Steroidal anti-inflammatory medicines are powerful medications, which are based on hormonal substances, such as cortisone. These medications have a stronger anti-inflammatory response than the non-steroidal medicines. They can be taken as pills, injected into the bloodstream, or injected directly into a joint space. There are many non-steroidal anti-inflammatory medications. Acetaminophen, aspirin, ibuprofen, and naproxen are the most common ones.
There are side effects to both of these groups of medicines. They include stomach upset, stomach bleeding or ulcers, kidney problems, hearing problems and ankle swelling. Additionally, the steroidal anti-inflammatory medications can have more serious side effects including: loss of bone mass, cataracts, reduced ability to fight infection, swelling and weight gain, mood changes, high blood pressure, and problems with the bone marrow where blood cells are produced.
Turmeric (
Curcuma longa
)
Turmeric or Haldi in Hindi is used very widely as medicine as well as a common ingredient in Indian cooking. The rhizome of turmeric is used in medicine and food as a fine powder.
The anti-inflammatory effects of curcumin isolated from
Curcuma longa
were reported in Srimal and Dhawan, Pharmacology of Diferuloyl Methane, a Non-steroidal Anti-inflammatory Agent, J. Pharm. Pharmac. 25:447-452 (1973). Significant anti-inflammatory activity comparable with phenylbutazone and hydrocortisone was observed by Arora et al. (Indian Journal of Medical Research 1971, 59, 1289-1291). Curcumin, an alkaloid (diferuloyl methane) isolated from the alcoholic extract of turmeric has been shown to be a potent anti-inflammatory agent and is considered to be its active ingredient. Further work on anti-inflammatory and anti-arthritic activity has also been carried out by Thatte et al (Indian Journal of Pharmacology 1986, 18 (1), 19-21). Turmeric has been found to have significant anti-inflammatory activity both in acute and chronic models. The therapeutic dose for optimal activity if used alone is reported to be in the range of 5 to 10 grams of dry powder daily (Patwardhan, U.S. Pat. No. 5,494,668). This dosage level, however, can produce a feeling of nausea.
Curcumin not only has anti-inflammatory properties but also has anti-oxidant anti-tumor and other valuable properties. When used in low concentrations, curcumin can inhibit nitric oxide synthase (NOS) and, therefore, inhibit nitric oxide production. For example Brouet et al. (Biochem. Biophys. Res. Commmun., Jan. 17, 1995; 206 (2); 533-40) have reported that NOS activity in soluble extracts of macrophages activated for 6-24 hours in the presence of curcumin (10 microM) was significantly lower than that of macrophages activated without curcumin. Northern-blot and immunoblotting analyses demonstrated that significantly reduced levels of the mRNA and 130-kDa protein of inducible NOS were expressed in macrophages activated with curcumin, compared to those with curcumin. Inhibition of NOS induction was maximal when curcumin was added together with lipopolysaccharide (LPS) and interferon-gamma (IFN-gamma) and decreased progressively as the interval between curcumin and LPS/IFN-gamma was increased to 18 hours. Therefore, curcumin, when used in an effective amount, may be used to effectively control overproduction of saliva by virtue of its property of acting as a NOS inhibitor.
Ginger (
Zingiber officinale
)
Native to southern Asia, ginger is a 2- to 4-foot perennial that produces grass-like leaves up to a foot long and almost an inch wide. Ginger root, as it is called in the grocery store, actually consists of the underground stem of the plant, with its bark-like outer covering scraped off.
Chinese medical texts from the fourth century B.C. suggest that ginger is effective in treating nausea, diarrhea, stomachaches, cholera, toothaches, bleeding, and rheumatism. Ginger was later used by Chinese herbalists to treat a variety of respiratory conditions, including coughs and the early stages of colds.
Ginger's modern use dates back to the early 1880s, when a scientist named D. Mowrey noticed that ginger-filled capsules reduced his nausea during an episode of flu. Inspired by this, he performed the first double-blind study of ginger. Germany's Commission E subsequently approved ginger as a treatment for indigestion and motion sickness. Ginger has become widely accepted as a treatment for nausea. Even some conventional medical texts suggest ginger for the treatment of the nausea and vomiting of pregnancy, although others are more cautious.
Ginger gives relief from muscular discomfort and pain. It inhibits prostaglandin and leukotriene biosynthesis and histamine release. Thus it acts as an anti-inflammatory as well as an antacid agent. It is a dual-inhibitor of the lipoxigenase and cycloxigenase system Ginger contains 1-4% essential oil (oleoresin). Used alone fresh Ginger is required to be used in substantially high doses (50 grams daily), which is not only inconvenient but can act as an irritant to the gastric mucosa. In dry form for any significant results 7 to 10 grams of dry ginger powder has to be taken daily. These therapeutic doses of ginger are extremely inconvenient for the patient and affect patient compliance on a daily basis. (See Potwardhan, U.S. Pat. No. 5,494,668.)
Horseradish (
Armoracia rusticana
)
Horseradish, a perennial herb (
Armoracia rusticana
, but sometimes classified in other genera) of the family Cruciferae (mustard family), is native to Central and Southern Europe (where it has long been cultivated in gardens) and naturalized in many parts of North America. It is grown mainly for its roots, which formerly were used medicinally, particularly as an antiscorbutic. H
Knoble & Yoshida LLC
Spear James M.
The Quigley Corporation
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