Controlled Release Azithromycin Solid Dosage Forms

Abstract

A solid dosage form for oral administration comprising azithromycin in an amount below that which causes gastrointestinal side effects, which dosage form is a controlled release dosage form.

1 . A controlled release solid oral dosage form comprising azithromycin in an amount that is less than 250 mg. 
     
     
         2 . The oral dosage form of  claim 1  wherein the amount of azithromycin is higher than 150 mg. 
     
     
         3 . The oral dosage form of  claim 1  which is a tablet. 
     
     
         4 . The oral dosage form of  claim 1  which is a capsule. 
     
     
         5 . The oral dosage form of  claim 1  wherein the dosage form is coated with an enteric coating. 
     
     
         6 . The oral dosage form of  claim 1  wherein the dosage form comprises a multiplicity of particles that are individually coated. 
     
     
         7 . The oral dosage form of  claim 6  wherein the coated particles have been formed into a solid that forms a part of or all of a tablet. 
     
     
         8 . The oral dosage form of  claim 6  wherein the coated particles are contained within a capsule shell. 
     
     
         9 . A controlled release solid oral dosage form comprising azithromycin in an amount that is less than 250 mg from which dosage form not more than 50% of the azithromycin is released at pH 1 within one hour. 
     
     
         10 . The controlled release solid dosage form of  claim 9  wherein the amount of azithromycin is higher than 150 mg. 
     
     
         11 . The solid oral dosage form of  claim 9  from which not more than 25% of the azithromycin is released at pH 1 within one hour. 
     
     
         12 . The solid oral dosage form of  claim 9  from which not more than 10% of the azithromycin is released at pH 1 within one hour. 
     
     
         13 . The solid dosage form of  claim 9  which is a tablet. 
     
     
         14 . The solid dosage form of  claim 9  which is a capsule. 
     
     
         15 . A method for making a solid dosage form for oral administration containing azithromycin comprising combining azithromycin in an amount less than 250 mg and one or more pharmaceutically acceptable excipients in a solid form and applying an enteric coating to the dosage form. 
     
     
         16 . The method of  claim 15  wherein the amount of azithromycin is higher than 150 mg. 
     
     
         17 . The method of  claim 15  wherein the enteric coating is applied to the outer surface of the solid dosage form. 
     
     
         18 . The method of  claim 15  wherein the enteric coating is applied to individual particles containing azithromycin and the one or more pharmaceutically acceptable excipients within the solid oral dosage form. 
     
     
         19 . The method of  claim 15  wherein the solid dosage form is a tablet. 
     
     
         20 . The method of  claim 15  wherein the solid dosage form is a capsule. 
     
     
         21 . A method for increasing the bioavailability of azithromycin from an oral solid dosage form containing azithromycin in an amount less than 250 mg comprising providing said oral dosage form as a controlled release form. 
     
     
         22 . The method of  claim 21  wherein the amount of azithromycin is higher than 150 mg. 
     
     
         23 . The method of  claim 21  wherein the oral dosage form is a tablet. 
     
     
         24 . The method of  claim 21  wherein the oral dosage form is a capsule. 
     
     
         25 . The method of  claim 21  wherein the dosage form is coated with an enteric coating. 
     
     
         26 . The method of  claim 21  wherein the dosage form comprises a multiplicity of particles that are individually coated. 
     
     
         27 . The method of  claim 26  wherein the coated particles have been formed into a solid that forms a part of or all of a tablet. 
     
     
         28 . The method of  claim 26  wherein the coated particles arc contained within a capsule shell.