Application of a novel particle coating technology for paediatric formulation development

The challenges presented in paediatric dosage formulations is well documented. Most importantly the unique profiles of this patient population must be considered as well as tolerances and thresholds for excipients that may be introduced in novel solid formulations -such as Oro-dispersible tablets.

Drug administration routes, varied children's preferences and the impact on dosage release are all challenges that have to be considered when considering paediatric formulations. In primary care the number of requests for extemporaneous formulations for paediatric patients is expensive and even then, may not achieve the desired result of improved compliance, resulting in diminished clinical efficacy as well as the obvious caveat that these formulations have not been properly studied in paediatric populations.

The European Medicines Agency stipulates various benefits when approaching paediatric populations with a patient centred perspective as a child may refuse to take medicine that is considered unpalatable. Oral route formulations available for paediatric populations include mini-tablets, granules/sprinkles and Oro-dispersible tablets (ODT). On a practical level however, there are still paediatric patients that struggle with some of these formulations, in particular primary care pharmacists report texture and perceived taste still being an issue.

These solid dose formulations "are most suited to highly soluble drugs, although the solubility of the drug needs to be balanced with taste-masking as highly soluble drugs will activate taste receptors on the tongue if they dissolve in saliva within the oral cavity". Which leads to the need for more research into other viable forms of dosage formulations.

The challenge of taste masking and predictable dose release, especially for higher dose formulations is still as relevant to the paediatric population. Being able to offer paediatric formulations that offer dose flexibility, safety and commercial feasibility would offer advantages to the pharmaceutical industry as well as to patients.

To address these challenges the proposed project would need to evaluate the feasibility and optimisation needs of novel dry coating technologies. To ameliorate issues of taste and acceptability amongst children but importantly recognise the need to explore a base line drug release profile and of course the applicability of dry coating compatibility.

Key objectives for the project would be to evaluate the parameters of the coating process and understand how these parameters are linked to the coating efficiency of neutral polymers on potential drug candidates. The next step is to assess it's viability with a range of different polymers based on the determined optimised parameters. Furthermore, to explore how a formulation for ODT would be incorporated using dry coated particles and then evaluating the drug release properties.

To ensure consistency a predictive modelling approach would be need to utilising the outcomes from the dry coating process optimisation, the drug properties, excipient/polymer properties and the tablet manufacturing processes. 1. Pediatric drug formulations: a review of challenges and progress

Verica Ivanovska , Carin M A Rademaker , Liset van Dijk , Aukje K Mantel-Teeuwisse. Pediatric drug formulations: a review of challenges and progress. https://pubmed.ncbi.nlm.nih.gov/25022739/ 2. EMA, "Guideline on Pharmaceutical Development of Medicines for Paediatric 3. Use,"Punam Mistry, Hannah Batchelor. Evidence of acceptability of oral paediatric medicines: a review

https://onlinelibrary.wiley.com/doi/10.1111/jphp.12610