(458) Alternative Reconstitution Soft Foods Vehicles for Sodium Oxybate Extended-Release Drug Product

Introduction: Sodium Oxybate for Extended-Release (ER) Oral Suspension Drug Product (LUMRYZ) is a once-nightly formulation of sodium oxybate containing both immediate release (IR) beads and pH-dependent controlled-release (CR) beads, designed to be reconstituted in water and administered orally. A study was conducted to determine the dissolution profile and pH of LUMRYZ at prescribed doses after mixing with soft food vehicles like pudding, applesauce and yogurt.