Process for making compositions comprising sphingosine 1 phosphate (S1P) receptor modulators

摘要

The present invention relates to stable compositions comprising a sphingosine 1 phosphate (S1P) receptor modulator, suitable for use as a dosage form. The S1P receptor modulators are typically sphingosine analogues, such as 2-substituted 2-amino-propane-1,3-diol or 2-amino-propanol derivatives, e.g. a compound comprising a group of formula Y.

主权项

1. A process for making a pharmaceutical composition in a final dosage form, comprising the steps of:
a) preparing a blend consisting of:
(i) 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol in free form or a pharmaceutically acceptable salt thereof; and(ii) one excipient selected from the group consisting of Sorbitol, dicalcium phosphate, Lactose, Hydroxypropyl methylcellulose (HPMC), Hydroxypropylcellulose (HPC), Crospovidone, croscarmellose sodium, starch, calcium silicate, colloidal silicone dioxide, talc, and calcium stearate; and b) mixing the blend of step a) with additional excipients to prepare the final form wherein the final form is an oral formulation in form of a tablet, a granular, multiparticulate pellets, a soluble tablet or a capsule.