Azithromycin dosage forms with reduced side effects

Abstract

The present invention is related to an oral dosage form comprising an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a glyceride which comprises glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate, or a mixture thereof and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule.

1 - 107 . (canceled)  
   
   
       108 . Azithromycin multiparticulates comprising: 
 (a) azithromycin;    (b) a surfactant; and    (b) a pharmaceutically acceptable carrier,    wherein at least 70% of the azithromycin is crystalline.    
   
   
       109 . A multiparticulate of  claim 108  wherein said surfactant is selected from the group consisting of poloxamers, docusate salts, polyoxyethylene alkyl ethers, hylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, sorbitan esters, alkyl sulfates, polysorbates and polyoxyethylene alkyl esters.  
   
   
       110 . A multiparticulate of  claim 109  wherein said surfactant comprises a poloxamer.  
   
   
       111 . A multiparticulate of claims  108 - 110  wherein said carrier is a wax, a glyceride, or a mixture thereof.  
   
   
       112 . A multiparticulate of  claim 111  wherein said wax is a synthetic wax, microcrystalline wax, paraffin wax, Carnauba wax, beeswax, or a mixture thereof.  
   
   
       113 . A multiparticulate of  claim 111  wherein said glyceride is a glyceryl monooleate, glyceryl monostearate, glyceryl palmitostearate, polyethoxylated castor oil derivatives, hydrogenated vegetable oils, glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate, glyceryl tristearate, glyceryl tripalmitate, or a mixture thereof.  
   
   
       114 . A multiparticulate of  claim 113  wherein said glyceride comprises a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate.