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

Kindness L Commey^1,2, Airi Enaka¹, Ryota Nakamura¹

¹Faculty of Pharmaceutical Sciences, Sojo University, 4-22-1 Ikeda, Kumamoto 860-0082, Japan.

|January 23, 2024

Summary

New orally disintegrating tablets (ODTs) using cyclodextrin (CD) improve taste-masking for 4-phenylbutyrate (PB) in urea cycle disorder (UCD) patients. This formulation enhances compliance for pediatric and dysphagic individuals needing PB treatment.

Keywords:

4-phenylbutyrate cyclodextrins orally disintegrating tablets pediatric solid-state complexation

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Pediatric Formulations

Background:

Poor patient compliance with 4-phenylbutyrate (PB) treatment for urea cycle disorders (UCDs) persists despite taste-masked formulations.
Orally disintegrating tablets (ODTs) offer improved compliance, particularly for pediatric and dysphagic populations.
Cyclodextrins (CDs) have demonstrated potential for taste-masking PB.

Purpose of the Study:

To develop a novel cyclodextrin (CD)-based orally disintegrating tablet (ODT) formulation of 4-phenylbutyrate (PB).
To evaluate the feasibility of this ODT formulation as an alternative for UCD patients, especially pediatric and dysphagic individuals.

Main Methods:

Characterization of PB-CD interactions using X-ray diffraction, SEM, dissolution, and stability studies.
Formulation of lyophilized PB-CD systems into ODTs via wet granulation.
Evaluation of ODT physical characteristics, disintegration time, and pH stability.

Main Results:

The developed αCD-based ODT exhibited a disintegration time of 28 seconds.
The formulation achieved a suitable pH (≈5.5) for effective PB-CD complexation and taste masking.
ODTs demonstrated adequate physical properties and good storage stability.

Conclusions:

A novel cyclodextrin-based orally disintegrating tablet formulation for 4-phenylbutyrate has been successfully developed.
This ODT formulation shows promise as an improved alternative for urea cycle disorder patients, particularly pediatric and dysphagic individuals, by enhancing compliance.