The Development of a Chocolate-Based Chewable Tablet of Prednisolone—Enhancing the Palatability of Steroids for Pediatric Use

Author:

Yoo Okhee123ORCID,Tang Edith1ORCID,Hossain Md Lokman12ORCID,von Ungern-Sternberg Britta S.2345ORCID,Sommerfield David2345ORCID,Heath Chloe2345,Hauser Neil2345ORCID,Khan R. Nazim236ORCID,Locher Cornelia12ORCID,Nguyen Minh1,Lim Lee Yong12ORCID

Affiliation:

1. Discipline of Pharmacy, School of Allied Health, The University of Western Australia, Perth, WA 6009, Australia

2. Institute for Pediatric Perioperative Excellence, The University of Western Australia, Perth, WA 6009, Australia

3. Perioperative Medicine Team, Perioperative Care Program, Telethon Kids Institute, Perth, WA 6009, Australia

4. Division of Emergency Medicine, Anaesthesia and Pain Medicine, Medical School, The University of Western Australia, Perth, WA 6009, Australia

5. Department of Anaesthesia and Pain Medicine, Perth Children’s Hospital, Perth, WA 6009, Australia

6. Department of Mathematics and Statistics, The University of Western Australia, Perth, WA 6009, Australia

Abstract

Oral liquid prednisolone medications have poor acceptance among paediatric patients due to ineffective masking of the bitterness taste of prednisolone. This study aimed to develop a child-friendly prednisolone tablet using a patented chewable chocolate-based delivery system (CDS) previously applied successfully to mask the bitterness tastes of midazolam and tramadol. Prednisolone sodium phosphate (PSP) and prednisolone base (PB) CDS tablets were prepared, and the manufacturing process was optimised using a design of experiments (DoE) approach. Stability was assessed by quantifying residual drug content via a validated HPLC assay. A pilot randomised crossover taste study involving 25 young adult volunteers evaluated taste-masking effectiveness against Redipred™, a commercial oral PSP liquid medicine. The results showed that the PSP CDS tablet was chemically stable following storage for three months at ambient temperature, while the PB CDS tablet was unstable. The optimised PSP CDS tablet, manufactured at 50 °C with a stirring time of 26 h, was found to release over 80% of its drug load within 20 min in 0.1 M HCl and had a significantly better mean taste score compared to Redipred™ (7.08 ± 2.40 vs. 5.60 ± 2.33, p = 0.03). Fifty six percent of the participants preferred the PSP CDS tablet. In conclusion, compared to Redipred™, the CDS technology provided a more effective taste masking of PSP, potentially offering a child-friendly prednisolone formulation with improved compliance, dosing accuracy, and storage stability.

Funder

ANZCA Foundation, Australian and New Zealand College of Anaesthetists

Stan Perron Charitable Foundation

National Health and Medical Research Council Investigator Grant

Publisher

MDPI AG

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