Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol

Abstract

A solid pharmaceutical composition suitable for oral administration, comprising: (a) a SI P receptor modulator; (b) a filler, and (c) a cyclodextrin.

1 . A solid pharmaceutical composition suitable for oral administration, comprising
 a) a first compound selected from 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, a pharmaceutically acceptable salt thereof, and a phosphate derivative thereof,   b) a filler, and   c) a stabilizer comprising a cyclodextrin or a derivative thereof.   
     
     
         2 . A composition according to  claim 1 , comprising less than 1.5% or 1% by weight, e.g. 0.25% by weight or less, of the first compound, based on the total weight of the composition. 
     
     
         3 . A composition according to  claim 1 , comprising 0.5 mg or less, of the first compound, 
     
     
         4 . A composition according to  claim 1 , wherein the filler comprises a sugar alcohol, for example mannitol. 
     
     
         5 . A composition according to  claim 1 , further comprising a binder, for example a binder comprising hydroxypropyl cellulose. 
     
     
         6 . A composition according to  claim 1 , further comprising a lubricant, for example a lubricant comprising magnesium stearate. 
     
     
         7 . A composition according to  claim 1 , wherein the stabilizer comprises hydroxypropyl-beta-cyclodextrin. 
     
     
         8 . A composition according to  claim 1 , wherein the first compound is 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol or a pharmaceutically acceptable salt thereof. 
     
     
         9 . A composition according to  claim 1  for treating an autoimmune disease. 
     
     
         10 . A method of treating an autoimmune disease in a patient in need thereof, comprising administering a therapeutically effective amount of a compound selected from 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, a pharmaceutically acceptable salt thereof, and a phosphate derivative thereof, with a pharmaceutical composition as defined in  claim 1 .