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.

1 . A oral dosage form to be delivered to the stomach said dosage form comprising a safe and effective amount of a active ingredient tetracycline antibiotic, wherein said oral dosage form is a oval shaped with dimensions 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 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 5.  
   
   
       3 . A dosage form according to  claim 2  wherein said film coating is selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylcellulose, carboxymethylecellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, methylcellulose, ethylcellulose, acrylic resins, polyvinylpyrrolidone or gelatin or mixtures thereof.  
   
   
       4 . A dosage form according to  claim 3  wherein said film coating is selected from the group consisting of hydroxypropylmethylcellulose and hydroxypropylcellulose.  
   
   
       5 . A novel oral dosage form according to  claim 1  wherein said dosage form is a compressed tablet comprising particles of tetracycline antibiotics and pharmaceutically-acceptable excipients.  
   
   
       6 . A novel oral dosage form according to  claim 5  wherein said dosage form is itself film coated.  
   
   
       7 . A novel oral dosage form according to  claim 5  wherein said particles of active ingredients are themselves film coated.  
   
   
       8 . An oral dosage form according to  claim 4  wherein the length is about 0.455 inches, the width about 0.255 inches and the thickness about 0.157 inches.