(724e) Transition from Spray Drying to Hot Melt Extrusion with Affinisol™ HPMC HME

Formulation of new drug entities is increasingly challenging due to poor solubility of the drug and limited polymers that can produce amorphous solid dispersions. AFFINISOL™ HPMC HME has proven effective at producing stable amorphous solid dispersions with poorly soluble compounds that inhibit recrystallization and provide enhanced drug levels in solution. AFFINISOL™ HPMC HME is unique among cellulosic excipients in that it can be readily processed by both spray drying and hot melt extrusion techniques.

The present study examines small scale formulation optimization via spray drying and subsequent transfer to hot melt extrusion (HME) for production. The physical characterization and in vitro drug release rate and crystallization inhibition of amorphous spray dried dispersions will be used to maximize formulation drug load with several model APIs. Optimized formulations with each drug will be transferred to HME and the physicochemical properties and in vitro dissolution of the extrudates will be compared to that of the spray dried dispersions. The utility of AFFINISOL™ HPMC HME across the two technologies will be demonstrated.