Use of antifungal compositions to treat upper gastrointestinal conditions

Abstract

The present invention provides a novel method for treating oral conditions and upper gastrointestinal conditions in a subject by providing an inventive oral dosage form of a pharmaceutical composition comprising an effective amount of at least one antifungal and optionally a flavor modifier and/or salivation component such as an herbal component. In the present invention, the subjects have either not been diagnosed or do not have active or recurrent fungal infections. Specifically, the present invention is directed to chewable dosage forms.

1 . A method for treating upper gastrointestinal conditions in a subject, which comprises administering to the subject in need thereof a solid oral dosage form of a pharmaceutical composition comprising an effective amount of at least one antifungal. 
     
     
         2 . The method of  claim 1 , wherein the pharmaceutical composition further comprises an effective amount of a flavor modifier. 
     
     
         3 . The method of  claim 1 , wherein the pharmaceutical composition further comprises an effective amount of at least one herbal component. 
     
     
         4 . The method of  claim 1 , wherein the subject has not been found to have a fungal infection. 
     
     
         5 . The method of  claim 1 , wherein the antifungal is selected from the group consisting of nystatin and nystatin dehydrate. 
     
     
         6 . The method of  claim 5 , wherein the antifungal is nystatin. 
     
     
         7 . The method of  claim 6 , wherein the effective dosage amount of nystatin ranges from about 5,000 units to 1,000,000 units per day. 
     
     
         8 . The method of  claim 7 , wherein the effective amount of nystatin ranges from about 50,000 units to about 500,000 units per day. 
     
     
         9 . The method of  claim 8 , wherein the effective amount of nystatin ranges from about 80,000 units to about 200,000 units per day. 
     
     
         10 . The method of  claim 1 , wherein the upper gastrointestinal condition is selected from the group consisting of active benign gastric ulcer, gastroesophageal reflux disease, Zollinger-Ellison syndrome, erosive esophagitis, indigestion gastric reflux, dyspepsia, and reflux disease. 
     
     
         11 . The method of  claim 1 , wherein the flavor modifier is selected from the group consisting of fruit flavorings, mint flavorings, salt, and sweeteners. 
     
     
         12 . The method of  claim 11 , wherein the flavor modifier is present in amounts ranging from about 5 mg to about 100 mg. 
     
     
         13 . The method of  claim 12 , wherein the flavor modifier is present in amounts ranging from about 20 mg to about 50 mg. 
     
     
         14 . The method of  claim 1 , wherein said oral dosage form is selected from the group consisting of a pastille, lozenge, chewing gum, chewable candy, pouch, and plugs. 
     
     
         15 . The method of  claim 1 , wherein the solid oral dosage form is administered for at least one day. 
     
     
         16 . The method of  claim 1 , wherein the oral dosage form comprises a component that induces salivation. 
     
     
         17 . The method of  claim 16 , wherein the salivation enhancer is an herbal component selected from the group consisting of ginger, senega root, gentian, motherwort, hops, dandelion, papaya, dock or sorrel, sunflower, calendula, nasturtium, mallow, chicory, corn silk, clover and mixtures thereof. 
     
     
         18 . The method of  claim 1 , further comprising an additive selected from the group consisting of betaine hydrochloride, betaine beta carotene, vitamin E, selenium, vitamin B-6, folic acid, vitamin C, magnesium, vitamin B-1, vitamin B-2, niacinamide, vitamin B-12, zinc, copper, biotin, pantothenic acid, dandelion root, acidophilus dairy free, bifidus dairy free, FOS powder, chromium polynicotinate, betaine HCl, pancreatin, papain, and pepsin. 
     
     
         19 . A dosage form comprising an oral pharmaceutical composition comprising:
 (a) an effective amount of at least one antifungal;   (b) a component that induces salivation; and   (c) a carrier.   
     
     
         20 . The dosage form of  claim 19 , further comprising a flavor modifier. 
     
     
         21 . The dosage form of  claim 19 , wherein the antifungal is selected from the group consisting of nystatin and nystatin dehydrate. 
     
     
         22 . The dosage form of  claim 21 , wherein the antifungal is nystatin. 
     
     
         23 . The dosage form of  claim 22 , wherein the effective dosage amount of nystatin ranges from about 10,000 units to 1,000,000 units per day. 
     
     
         24 . The dosage form of  claim 23 , wherein the effective amount of nystatin ranges from about 50,000 units to about 500,000 units per day. 
     
     
         25 . The dosage form of  claim 24 , wherein the effective amount of nystatin ranges from about 80,000 units to about 200,000 units per day. 
     
     
         26 . The dosage form of  claim 19 , wherein the pharmaceutical composition provides daily effective therapy for upper gastrointestinal symptoms. 
     
     
         27 . The dosage form of  claim 26 , wherein the upper gastrointestinal symptoms are caused by an active benign gastric ulcer, gastroesophageal reflux disease, Zollinger-Ellison syndrome, erosive esophagitis, indigestion gastric reflux, dyspepsia or reflux disease. 
     
     
         28 . The dosage form of  claim 19 , wherein the pharmaceutical composition provides daily effective therapy for nausea associated with morning sickness. 
     
     
         29 . The dosage form of  claim 20 , wherein the flavor modifier is selected from the group consisting of fruit flavorings, mint flavorings, salt, and sweeteners. 
     
     
         30 . The dosage form of  claim 29 , wherein the flavor modifier is present in amounts ranging from about 10 mg to about 100 mg per dosage form. 
     
     
         31 . The dosage form of  claim 30 , wherein the flavor modifier is present in amounts ranging from about 20 mg to about 50 mg per dosage form. 
     
     
         32 . The dosage form of  claim 19 , wherein the salivation component is an herbal component selected from the group consisting of ginger, senega root, gentian, motherwort, hops, dandelion, papaya, dock or sorrel, sunflower, calendula, nasturtium, mallow, chicory, corn silk, clover and mixtures thereof. 
     
     
         33 . The dosage form of  claim 19 , further comprising at least one additive selected from the group consisting of: an excipient, a diluent, a disintegrant, a lubricant, a plasticizer, a colorant, a dosing vehicle, and any combination thereof 
     
     
         34 . The dosage form of  claim 19 , wherein the chewable dosage form is a form selected from the group consisting of chewing gum and chewable candy. 
     
     
         35 . The dosage form of  claim 19 , further comprising an additive selected from the group consisting of betaine hydrochloride, betaine beta carotene, vitamin E, selenium, vitamin B-6, folic acid, vitamin C, magnesium, vitamin B-1, vitamin B-2, niacinamide, vitamin B-12, zinc, copper, biotin, pantothenic acid, dandelion root, acidophilus dairy free, bifidus dairy free, FOS powder, chromium polynicotinate, betaine HCl, pancreatin, papain, and pepsin. 
     
     
         36 . A method for treating nausea associated with morning sickness in a subject in need thereof, which method comprises administering to the subject in need thereof a solid oral dosage form of a pharmaceutical composition comprising an effective amount of at least one antifungal. 
     
     
         37 . A method for treating oral conditions in a subject in need thereof, which method comprises administering to the subject in need thereof a solid oral dosage form of a pharmaceutical composition comprising an effective amount of at least one antifungal. 
     
     
         38 . The method of  claim 36 , wherein the oral condition is selected from the diseases selected from halitosis, dental plaque, gingivitis, xerostomia, dry mouth, oral malodor and combinations thereof.