EuPFI 2021: Taste Assessment Study of Belumosudil to Inform an Integrated Pediatric Formulation Development Program

Presented at the 2021 EuPFI event, the poster documents the project of a ROCK2 selective inhibitor in development for the treatment of immune disorders.

Belumosudil, a ROCK2 selective inhibitor, is currently in development for the treatment of immune disorders. An oral suspension formulation is being investigated as a possible pediatric formulation for patients aged between three months and twelve years. This study aimed to select and identify a suitable, novel belumosudil oral suspension formulation, with an optimal flavor and/or sweetener combination to improve palatability in the target population.

The study comprises a taste assessment and relative bioavailability in a two-part protocol. The initial study part (Part 1) involves a ‘sip and spit’ taste assessment to profile the taste characteristics of the API and identify a suitable flavor system which can be taken into Part 2 for a relative bioavailability assessment of the novel oral suspension compared to the reference adult oral tablet formulation.