(T0930-07-40) Soft Foods as Alternative Reconstitution Vehicles for Sodium Oxybate Extended-Release Drug Product (LUMRYZ^TM)

Purpose: Studying the effect of soft foods on dissolution of LUMRYZ™ (Sodium oxybate (SO) for extended-release oral suspension) and pH after reconstitution. 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.

Methods: The dissolution and the pH testing were conducted using 4.5 g and 9 g single-dose drug packs reconstituted in Milli-Q water (control (CL)), Lemon Pudding (LP), Applesauce (AS), and Vanilla Lowfat Yogurt (YO). Dissolution was measured at 15 minutes and 2, 2.5, 3, 4, 5 hours after mixing by shaking and 5-minute rest period. The pH of each mixture was measured prior to and after addition of the drug product.

Results: The 4.5 g dose released 50% of its SO after 15 minutes in the control, 48% in LP, 49% in AS and 50% in YO; at 5 hours, 101% was released in control, 98% in LP, 99% in AS and 100% in YO. The 9.0 g dose released 51% of its SO after 15 minutes in the control, 45% in LP, 48% in AS and 50% in YO; at 5 hours, 100% was dissolved in control, 97% in LP, 99% in AS and 100% in YO. The pH of LP, AS and YO, before the addition of the LUMRYZ™ was 3.6, 3.6 and 4.1, respectively. For the 4.5 g dose reconstituted in control, LP, AS, and YO, the pH was 5.7, 5.3, 5.3, and 5.3 at 5 minutes respectively. For the 9.0 g reconstituted in control, LP, AS, and YO, the pH was 5.8, 5.5, 5.5, and 5.5 at 5 minutes, respectively.

Conclusion: The dissolution and the pH testing study demonstrated consistent and acceptable dissolution and pH results of the sodium oxybate extended-release drug product (LUMRYZ™) in various soft foods, which enables patients to safely and effectively use these alternative soft food vehicles for their preparation.