In Vitro Stability and Recovery Studies of Pimavanserin in Water and in Different Vehicles Orally Administered.

BACKGROUND AND

objectiveSwallowing difficulties (i.e., dysphagia) occur in up to 40% of the adult general population, particularly among the elderly prescribed solid oral dosage forms. Pimavanserin is approved for the treatment of hallucinations and delusions in patients with Parkinson's disease psychosis (PDP) as a 34-mg capsule formulation. Patients with PDP may be at-risk for dysphagia that could affect administration of intact pimavanserin capsules. The stability of oral pimavanserin was evaluated in different liquid/soft food vehicles.

methodsThe stability of pimavanserin intended for oral administration was assessed by sprinkling the contents of 1 pimavanserin 34-mg capsule into water (40 mL), applesauce (40 g), vanilla Ensure (60 mL), or non-pulp orange juice (60 mL).

resultsThe stability study demonstrated >95% recovery within 24 hours after contents of a 34-mg pimavanserin capsule were dispersed in applesauce, vanilla Ensure®, orange juice, or water. Assay values at 24 h for individual capsules were within 5% of time zero, and no significant change in the impurity profile was observed in any vehicle. Pimavanserin degradation products recovered from various food vehicles for individual and total degradation products were < 0.5% at all time points. In addition, the impurity profile of compatibility samples matched that obtained for a control sample.

conclusionThese results support the ability of pimavanserin to be given orally by emptying the capsule contents into soft foods or liquids in accordance with the product label.