Asthma is a leading cause of disease among children aged 5-14 years, with higher prevalence of asthma found in younger children, indigenous children and children with disability. Oral prednisolone is the most common steroid prescribed for managing asthma flare-ups in Australia.
However, prednisolone medicines for children have intolerable taste, with children often refusing to take them or spitting them out when compelled to do so. This leads to poor medication compliance, treatment failure and potential consecutive increased risk for perioperative complications.
This project aims to overcome the low acceptance of current prednisolone products by developing a novel palatable and chewable prednisolone tablet using our patented chewable Chocolate-based Delivery System (CDS) that meets pharmaceutical standards of quality and storage stability. A more palatable prednisolone will help improve medication compliance and reduce the trauma experienced by caregivers and children alike when the children are forced to take bitter medications.
By improving treatment compliance, patients’ respiratory function and symptoms can be better optimised prior to surgery leading to less perioperative complications as well as better treatment adherence and outcomes in the acute setting. A further outcome will be the continued upskilling of the research team allowing development of other novel more child-friendly medications which are clinically important for which currently paediatric formulation are lacking and/or are unpalatable.
Dr Chloe Heath, University of Western Australia and Telethon Kids Institute
Professor Lee Yong Lim, University of Western Australia
Associate Professor Connie Locher, University of Western Australia
The project was awarded $A70,000 funding through the ANZCA research grants program for 2023.
Oral liquid prednisolone medications have poor acceptance among paediatric patients due to ineffective masking of the bitterness taste of prednisolone. This research project was designed to develop a more palatable prednisolone to help improve medication compliance, improve treatment outcomes, and reduce the trauma experienced by children, parents/caregivers, and staff alike when the children are forced to take bitter medications.
Our team has previously developed and patented the Chocolate Delivery System (CDS) platform which uses chocolate to mask the flavour of bitter medications. In this project, we aimed to design, manufacture and evaluate a CDS formulation of prednisolone that meets industry standards of quality and effectively masks the bitter taste of prednisolone.
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 0.1MHCl and had a significantly better mean taste score compared to Redipred™. Fifty six percent of the participants preferred the PSP CDS tablet.
In summary, the patented CDS technology was transferable to prepare chemically stable PSP CDS tablet. Optimised tablets prepared at 50 °C and stirring time of 26 hours were stable for at least 3 months of storage at ambient conditions and showed immediate drug release profiles in vitro.
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.
Yoo O, Tang E, Hossain ML, von Ungern-Sternberg BS, Sommerfield D, Heath C, Hauser N, Khan N, Locher C, Nguyen M, Lim LY, Development of a Chocolate-Based Chewable Tablet of Prednisolone – Enhancing Palatability of Steroids for Paediatric Use, Pharmaceutics, 2024, 16, 1099. https://doi.org/10.3390/pharmaceutics16081099