Film-coated tablet for improved upper gastrointestinal tract safety

Abstract

A novel oral dosage to be delivered to the stomach comprising a safe and effective amount of an active ingredient selected from the group consisting of emepronium bromidebromide, doxycycline, and other tetracyclines/antibiotics, iron preparations, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine (AZT), bisphosphonates and mixtures thereof and pharmaceutically-acceptable excipients, wherein said oral dosage form is a generally oval form and film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus.

What is claimed is:  
     
         1 . A novel oral dosage form to be delivered to the stomach said dsoage form comprising a safe and effective amount of an active ingredient selected from the group consisting tetracycline antibiotics, iron preparations, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine, bisphosphonates or mixtures thereof and pharmaceutically-acceptable excipients, wherein said oral dosage form is a generally oval form and film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus.  
     
     
         2 . A dosage form according to  claim 1  wherein the film coating is soluble at pH from about 1.2 to about 5.  
     
     
         3 . A dosage form according to  claim 2  wherein said film coating is selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, methylcellulose, ethylcellulose, acrylic resins, polyvinylpyrrolidone or gelatin or mixtures thereof.  
     
     
         4 . A dosage form according to  claim 3  wherein said dosage form comprises dimensions of from about 0.23 to about 0.85 inches for length, from about 0.11 to about 0.4 inches for width and from about 0.075 to about 0.3 inches for thickness.  
     
     
         5 . A dosage form according to  claim 4  wherein said dosage form is a modified oval or caplet shape.  
     
     
         6 . A dosage form according to  claim 5  wherein said active ingredient is selected from the group consisting of emperonium bromide, doxycycline, iron preparations, potassium chloride, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine, risedronate, alendronate or pamidronate, or mixtures thereof.  
     
     
         7 . A dosage form according to  claim 6  wherein said film coating is selected from the group consisting of hydroxypropylmethylcellulose and hydroxypropylcellulose.  
     
     
         8 . A dosage form according to  claim 7  wherein said active ingredient is selected from the group consisting of risedronate, alendronate or pamidronate.  
     
     
         9 . A dosage form according to  claim 8  wherein said active ingredient is risedronate.  
     
     
         10 . A dosage form according to  claim 9  wherein said risedronate is form about 0.25% to about 40% of the composition.  
     
     
         11 . A dosage form according to  claim 10  wherein said dosage form is a modified oval.  
     
     
         12 . A novel oral dosage form according to  claim 1  wherein said dosage form is a compressed tablet comprising particles of the active ingredient and pharmaceutically-acceptable excipients.  
     
     
         13 . A novel oral dosage form according to  claim 12  wherein said dosage form is a modified oval.  
     
     
         14 . A novel oral dosage form according to  claim 13  wherein said dosage form is itself film coated.  
     
     
         15 . A novel oral dosage form according to  claim 12  wherein said particles of active ingredients are themselves film coated.