(12) Patent Application Publication (10) Pub. No.: US 2003/0031737 A1 Rosenbloom (43) Pub
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US 2003OO31737A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2003/0031737 A1 ROSenbloom (43) Pub. Date: Feb. 13, 2003 (54) MEDICINAL COMPOSITION AND METHOD (57) ABSTRACT OF USING IT A novel composition for treating Symptoms Such as Symp toms of a common cold, a Sore throat, congestion, laryngitis, (76) Inventor: Richard Allen Rosenbloom, Elkins mucous membrane inflammation and Sialorrhea is disclosed. Park, PA (US) The composition includes ingredients to obtainable from turmeric extract, ginger root powder, and horseradish root Correspondence Address: powder. This composition can be orally administered a KNOBLE & YOSHIDA, LLC patient. The composition may further include ingredients Eight Penn Center, Suite 1350 obtainable from Slippery elm bark powder and green tea. 1628 John F. Kennedy Blvd. This composition may further include a pharmaceutically Philadelphia, PA 19103 (US) acceptable carrier for oral administration. (21) Appl. No.: 09/923,090 A method of administering this composition orally to a patient to treat Symptoms of a common cold, a Sore throat, (22) Filed: Aug. 6, 2001 congestion, laryngitis, mucositis, Sialorrhea and mucous membrane inflammation is also disclosed. To treat these Publication Classification Symptoms, the composition is administered to a patient Suffering one to fifteen times daily, as needed. To achieve the (51) Int. Cl. ................................................ A61K 35/78 best effect, the composition should be held in the mouth of (52) U.S. Cl. ............................................ 424/755; 424/756 a patient for 5 to 60 minutes. US 2003/0031737 A1 Feb. 13, 2003 MEDICINAL COMPOSITION AND METHOD OF nylbutaZone and hydrocortisone was observed by Arora et USING IT al. (Indian Journal of Medical Research 1971, 59, 1289 1291). Curcumin, an alkaloid (diferuloyl methane) isolated BACKGROUND OF THE INVENTION from the alcoholic extract of turmeric has been shown to be a potent anti-inflammatory agent and is considered to be its 0001 A. Field of the Invention active ingredient. Further work on anti-inflammatory and 0002 The present invention relates to a medicinal com anti-arthritic activity has also been carried out by Thatte et position and method of using it. all (Indian Journal of Pharmacology 1986, 18 (1), 19-21). Turmeric has been found to have significant anti-inflamma 0003) B. Description of the Prior Art tory activity both in acute and chronic models. The thera peutic dose for optimal activity if used alone is reported to 0004 Treatment of Inflammation be in the range of 5 to 10 grams of dry powder daily 0005. In modern non-herbal medicine, there are two (Patwardhan, U.S. Pat. No. 5,494.668). This dosage level, major categories of anti-inflammatory medicines: Steroidal however, can produce a feeling of nausea. and non-Steroidal. Steroidal anti-inflammatory medicines are powerful medications, which are based on hormonal 0013 Curcumin not only has anti-inflammatory proper Substances, Such as cortisone. These medications have a ties but also has anti-oxidant, anti-tumor and other valuable Stronger anti-inflammatory response than the non-Steroidal properties. When used in low concentrations, curcumin can medicines. They can be taken as pills, injected into the inhibit nitric oxide synthase (NOS) and, therefore, inhibit bloodstream, or injected directly into a joint Space. There are nitric oxide production. For example, Brouet et al. (Bio many non-Steroidal anti-inflammatory medications. chem. Biophys. Res. Commun., Jan. 17, 1995; 206 (2); Acetaminophen, aspirin, ibuprofen, and naproxen are the 533-40) have reported that NOS activity in soluble extracts moSt COmmOn OneS. of macrophages activated for 6-24 hours in the presence of curcumin (10 microM) was significantly lower that that of 0006 There are side effects to both of these groups of macrophages activated without curcumin. Northern-blot and medicines. They include Stomach upset, Stomach bleeding or immunoblotting analyses demonstrated that significantly ulcers, kidney problems, hearing problems and ankle Swell reduced levels of the mRNA and 130-k Da protein of ing. Additionally, the Steroidal anti-inflammatory medica inducible NOS were expressed in macrophages activated tions can have more Serious Side effects including: loSS of with curcumin, compared to those with curcumin. Inhibition bone mass, cataracts, reduced ability to fight infection, of NOS induction was maximal when curcumin was added Swelling and weight gain, mood changes, high blood pres together with lipopolysaccharide (LPS) and interferon Sure, and problems with the bone marrow where blood cells gamma (IFN-gamma) and decreased progressively as the are produced. interval between curcumin and LPS/IFN-gamma was 0007 Treatment of Sialorrhea increased to 18 hours. Therefore, curcumin, when used in an effective amount, may be used to effectively control over 0008 Sialorrhea, a symptom related to amyotrophic lat production of Saliva by Virtue of its property of acting as a eral Sclerosis (ALS), is the excessive drooling due to over NOS inhibitor. production of Saliva from the Salivary glands. People have made much effort to treat Sialorrhea. Newall et al reported 0014) Ginger (Zingiber officinale) using beta antagonists to control the excessive Secretions of 0015 Native to Southern Asia, ginger is a 2- to 4-foot the oral Salivary glands and achieve 75%. Success rates (J. perennial that produces grass-like leaves up to a foot long Neurol. Sci., 1996, 139, 43-4). Mier et all have found that and almost an inch wide. Ginger root, as it is called in the ingestion of glycopyrrolate is effective in treating Sialorrhea grocery Store, actually consists of the underground stem of in children. However, 20% of the children being treated with glycopyrrolate experienced Substantial adverse effects, the plant, with its bark-like outer covering Scraped off. enough to require discontinuation of medication (Arch. 0016 Chinese medical texts from the fourth century B.C. Pediatr. Adolese. Med., 2000, 154, 1214-1218). Suggest that ginger is effective in treating nausea, diarrhea, 0009 According to a recent study by Rettori et al. (Ann. Stomachaches, cholera, toothaches, bleeding, and rheuma N.Y. Acad. Sci., 2000; 917; 258-67), inhibitors of nitric tism. Ginger was later used by Chinese herbalists to treat a oxide synthase (NOS) decrease stimulated salivary secre variety of respiratory conditions, including coughs and the tions whereas donors of NOS potentiate stimulated salivary early Stages of colds. Secretions. This indicates that nitric oxide exerts a Stimula 0017 Ginger's modern use dates back to the early 1880s, tory role on Salivary Secretion. when a Scientist named D. Mowrey noticed that ginger-filled capsules reduced his nausea during an episode of flu. 0010 Turmeric (Curcuma longa) Inspired by this, he performed the first double-blind study of 0.011 Turmeric or Haldi in Hindi is used very widely as ginger. Germany's Commission E Subsequently approved medicine as well as a common ingredient in Indian cooking. ginger as a treatment for indigestion and motion Sickness. The rhizome of turmeric is used in medicine and food as a Ginger has become widely accepted as a treatment for fine powder. nausea. Even Some conventional medical texts Suggest gin ger for the treatment of the nausea and Vomiting of preg 0012. The anti-inflammatory effects of curcumin isolated nancy, although others are more cautious. from Curcuma longa were reported in Srimal and Dhawan, Pharmacology of Diferuloyl Methane, a Non-steroidal Anti 0018 Ginger gives relief from muscular discomfort and inflammatory Agent, J. Pharm. Pharmac. 25:447-452 (1973). pain. It inhibits prostaglandin and leukotriene biosynthesis Significant anti-inflammatory activity comparable with phe and histamine release. Thus it acts as an anti-inflammatory US 2003/0031737 A1 Feb. 13, 2003 as well as an antacid agent. It is a dual inhibitor of the 0026. It is an object of certain embodiments of the lipoxigenase and cycloxigenase System. Ginger contains present invention to provide a composition, which has a 1-4% essential oil (oleoresin). Used alone fresh Ginger is Strong anti-inflammatory effect while avoiding or reducing required to be used in Substantially high doses (50 grams the adverse side effects of Some of the foregoing anti daily), which is not only inconvenient but can act as an inflammatory medications Such as nausea and gastric irritant to the gastric mucosa. In dry form for any significant mucosa irritation. results 7 to 10 grams of dry ginger powder has to be taken 0027. It is another object of certain embodiments of the daily. These therapeutic doses of ginger are extremely present invention to provide a composition for treating Some inconvenient for the patient and affect patient compliance on common types of inflammations Such as a Sore throat, a daily basis. (See Potwardhan, U.S. Pat. No. 5,494,668.) congestion, laryngitis and mucous membrane inflammation. 0019 Horseradish (Armoracia rusticana) 0028. It is a further object of certain embodiments of the 0020 Horseradish, a perennial herb (Armoracia rusti present invention to provide a composition for treating cana, but Sometimes classified in other genera) of the family Sialorrhea. Cruciferae (mustard family), is native to Central and South 0029. It is still a further object of certain embodiments of ern Europe (where it has long been cultivated in gardens) the present invention to provide a method to treat a Sore and naturalized in many parts of North America. It is grown throat, congestion, laryngitis and mucous membrane inflam mainly for its roots, which formerly were used medicinally, mation by administering a composition made from natural particularly as an antiscorbutic. Horseradish is also an herbs. excellent diuretic, and is good for digestion problems. Herbalists combine horseradish and honey for coughs and 0030. It is still a further object of certain embodiments of asthma treatments. Externally, it is Sometimes used to alle the present invention to provide a method to treat Sialorrhea Viate the pain and Stiffness caused by rheumatism. by administering a composition made from natural herbs.