(386d) Improved Spray Drying Capability with Affinisol™ High Productivity Polymers

An increasing number of new drug entities suffer from low solubility making the development of a viable deliverable dose challenging. Hypromellose 2910 (HPMC) and hypromellose acetate succinate (HPMCAS) have proven effective at producing stable amorphous solid dispersions for poorly soluble active pharmaceutical ingredients (APIs) that demonstrate enhanced free drug levels in solution and inhibit recrystallization. Currently, there is a variety of HPMC 2910 viscosities available allowing a degree of control over solution viscosity and spray drying throughput; however, there is only a single viscosity of HPMCAS available. The limited viscosity ranges of these polymers impede the ability to maximize spray drying throughput when forming spray dried dispersions.

The present study examines the in vitro drug release rate and crystallization inhibition of amorphous spray dried dispersions formed with poorly soluble model APIs and AFFINISOL™ High Productivity polymers. Novel AFFINISOL™ HPMC High Productivity 2910 and AFFINISOL™ High Productivity HPMCAS are evaluated for physical properties including glass transition temperature and solution viscosity as a function of solids loading. In addition, performance of spray dried dispersions with model APIs will be assessed.