Objective: To evaluate the suitability of mixing crushed contents from valbenazine capsules with soft foods/liquids or adding them to water for delivery through a gastrostomy tube (G-tube).

Background: Once-daily valbenazine is FDA-approved for tardive dyskinesia, with potential additional indications for chorea associated with Huntington disease and dyskinetic cerebral palsy. Dysphagia can occur with these disorders, making it difficult to swallow whole medications.

Method: Three studies were conducted on two doses of valbenazine capsules (40 and 80 mg). In Study 1, whole valbenazine capsules and crushed capsule contents were dissolved in a warm solution. Samples were collected serially over 1 hour (from 10 to 60 min) for analysis. In Study 2, the crushed contents of valbenazine capsules (both doses) were mixed into applesauce, yogurt, and pudding; crushed contents (40 mg) were also added to buffer solutions (pH 1.2, 4.5, 6.8) and fed-state simulated gastric fluid (FeSSGF). In Study 3, crushed valbenazine capsule contents (both doses) were dispersed in tap water (approximately 0° to 50°C) and added to a G-tube via a syringe, with and without a cup rinse. In Studies 2 and 3, conditions that yielded 90-110% valbenazine recovery were considered acceptable for administration.

Results: In Study 1, valbenazine capsules could be opened manually, with the contents easily crushed between spoons. Rapid and complete drug release (>98% in 15 min) was observed in all samples, independent of preparation (whole capsules, crushed contents) or dose (40 mg, 80 mg). For both doses, the average percent released at first and last collection timepoints (10 and 60 min, respectively) was similar for whole versus crushed in each lot. In Study 2, recovery of crushed capsule contents was acceptable within 2 hours of addition to tested foods, buffers, or FeSSGF (recovery range: 92-102%), with minimal degradants detected. In Study 3, acceptable recovery was found when crushed capsule contents were dispersed in hot or cold water and added to a G-tube and a cup rinse was performed (recovery range: 91-97%).

Conclusion: Crushing valbenazine capsule contents did not impact in vitro dissolution performance. Mixing the contents with soft foods or liquids across a broad pH range or delivering them in tap water via G‑tube may be acceptable methods for administering valbenazine to patients who have difficulty swallowing.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/crushing-valbenazine-capsule-contents-for-potential-addition-to-soft-foods-or-administration-via-g-tube/