Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione

Abstract

Pharmaceutical compositions and single unit dosage forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate, are provided herein. Also provided are methods of treating, managing, or preventing various disorders, such as cancer or an inflammatory disease.

1 - 60 . (canceled) 
     
     
         61 . An oral dosage form in the form of a capsule which comprises: 1) pomalidomide at an amount of 0.1 to 3 weight percent of the total weight of the composition; 2) a binder or filler at an amount of 90 to 99 weight percent of total weight of the composition, wherein the binder or filler is starch, mannitol or a mixture thereof. 
     
     
         62 . The oral dosage form of  claim 61 , wherein pomalidomide is present at an amount of 0.5 to 2 weight percent of total weight of the composition. 
     
     
         63 . The oral dosage form of  claim 61 , wherein the binder or filler is present at an amount of 95 to 99 weight percent of total weight of the composition. 
     
     
         64 . The oral dosage form of  claim 61 , wherein the binder or filler is a mixture of starch and mannitol. 
     
     
         65 . The oral dosage form of  claim 64 , wherein the starch is pregelatinized starch. 
     
     
         66 . The oral dosage form of  claim 64 , wherein the mannitol is spray dried mannitol. 
     
     
         67 . The oral dosage form of  claim 61  further comprising a lubricant at an amount of 0.01 to 1 weight percent of total weight of the composition. 
     
     
         68 . The oral dosage form of  claim 67 , wherein the lubricant is present at an amount of 0.1 to 0.5 weight percent of total weight of the composition. 
     
     
         69 . The oral dosage form of  claim 67  or  68 , wherein the lubricant is sodium stearyl fumarate.