Development of α-Cyclodextrin-Based Orally Disintegrating Tablets for 4-Phenylbutyrate.

ABSTRACT: Despite major improvements brought about by the introduction of taste-masked formulations of 4-phenylbutyrate (PB), poor compliance remains a significant drawback to treatment for some pediatric and dysphagic patients with urea cycle disorders (UCDs). This study reports on the development of a cyclodextrin (CD)-based orally disintegrating tablet (ODT) formulation for PB as an alternative to existing formulations. This is based on previous reports of the PB taste-masking potential of CDs and the suitability of ODTs for improving compliance in pediatric and dysphagic populations. In preliminary studies, the interactions of PB with α and βCD in the solid state were characterized using X-ray diffraction, scanning electron microscopy, dissolution, and accelerated stability studies. Based on the

SUBMITTER: Commey KL 

PROVIDER: S-EPMC10818935 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature