Pharmaceutical formulation of odevixibat

A process for the preparation of a pharmaceutical formulation of odevixibat, or a pharmaceutically acceptable salt thereof, the process comprising the steps of:

• a) wetting odevixibat in water using a homogenizer;
• b) dispersing the wetted odevixibat in water by wet milling, thereby obtaining a homogeneous aqueous suspension of odevixibat;
• and
• c) spraying the homogeneous aqueous suspension of odevixibat onto a plurality of cores, thereby forming a plurality of particles;
• wherein each particle is between about 0.1 and about 1.5 mm in size and contains odevixibat, or pharmaceutically acceptable salt thereof, in an amount of from about 0.1% w/w to about 5.0% w/w based on the total weight of the particle, and
• wherein each particle comprises odevixibat agglomerates having a d90 particle size distribution of less than 15 μm.