Fingolimod containing stable composition

摘要

The present invention relates to a pharmaceutical composition comprising fingolimod and a weak acid cation exchange resin in the form of an ion-exchange complex and pharmaceutically acceptable excipients.

主权项

1. A pharmaceutical composition comprising fingolimod and a weak acid cation exchange resin in the form of an ion-exchange complex and pharmaceutically acceptable excipients;
wherein the weak acid cation exchange resin is a copolymer of methacrylic acid and divinylbenzene as depicted by Formula I; wherein X is hydrogen and the weak acid cation exchange resin have an ion exchange capacity of not less than 10.0 meq/g on dried basis, wherein the mean particle size of the resin particles lies in the range of 150 micron to 45 micron and wherein the particle size distribution of the resin is such that not more than 70% of particles have a particle size greater than 50 micron; 15% to 30% of the particles have a particle size of greater than 75 micron and not more than 1% of the particles have a particle size of greater than 150 micron.