Stable compositions of famotidine and ibuprofen

Abstract

Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. The compositions comprise a famotidine core having a reduced or minimal surface area surrounded by a layer of ibuprofen. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.

1 .- 16 . (canceled) 
     
     
         17 . A method for manufacturing a unit dosage form comprising ibuprofen and famotidine, wherein the method comprises the steps of:
 providing a first layer comprising from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient,   applying to the first layer, a second layer comprising from 750 mg to 850 mg ibuprofen as an active pharmaceutical ingredient to form said unit dosage form,
 wherein the unit dosage form is formulated for immediate release, 
 wherein none of the unit dosage form, the first layer, the second layer, the famotidine active pharmaceutical ingredient or the ibuprofen active pharmaceutical ingredient is enterically coated or formulated for sustained or delayed release, 
 wherein the pharmaceutical composition is formulated so that release of the ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient begins to occur at about the same time, and 
 wherein no more than about 1% of a sulfamide is present when the composition is stored at 40° C. and 75% relative humidity for a period of one month or at least 90% of the amount of ibuprofen initially present and at least 90% of the amount of famotidine initially present remains after the composition is stored at 40° C. and 75% relative humidity for a period of one month, 
 provided that the unit dosage form is not a tablet-in-tablet formulation having a famotidine shell completely surrounding an ibuprofen core. 
   
     
     
         18 . The method of  claim 17 , wherein the second layer completely surrounds the first layer. 
     
     
         19 . The method of  claim 17 , wherein the first layer comprises a plurality of famotidine beads. 
     
     
         20 . The method of  claim 17 , wherein the first layer is substantially spherical in shape. 
     
     
         21 . The method of  claim 17 , wherein the first layer is substantially cylindrical in shape. 
     
     
         22 . The method of  claim 17 , further comprising the step of: coating said unit dosage form with one or more over-coating layers. 
     
     
         23 . The method of  claim 17 , wherein the second layer is applied using compression. 
     
     
         24 . The method of  claim 17 , wherein the first layer is prepared by mixing famotidine and at least one pharmaceutically acceptable excipient and compressing the resulting mixture to form the first layer. 
     
     
         25 . The method of  claim 17 , wherein the second layer is applied by compressing onto said first layer, a mixture comprising ibuprofen and at least one pharmaceutically acceptable excipient.