Advancing non-sterile pediatric pharmacotherapy through automated compounding and 3D printing of ondansetron hcl dihydrate dosage forms.

BackgroundPediatric patients often require individualized medication dosing due to variations in age, weight, and swallowing ability. Commercial ondansetron HCl dihydrate formulations are limited by rigid dosing options, unpleasant taste (dysgeusia), and challenges with administration, which can result in poor adherence. Pharmaceutical compounding technologies, particularly those incorporating automation, offer a pathway toward patient-centric solutions. Semi-solid extrusion (SSE) 3D printing enables the controlled production of customized dosage forms.MethodsThis study investigated the development and quality performance of personalized ondansetron HCl dihydrate dosage forms produced using an SSE-based automated compounding system. Three dosage forms (semi-solid gel tablet, anhydrous troche, and orodispersible film (ODF)) were formulated in various ondansetron concentrations: 0.81-7.5 mg. Formulations were developed and printed at a hospital setting demonstrating real-life hospital pharmacy conditions. Quality evaluations followed United States Pharmacopeia (USP) guidelines.ResultsThe printed ondansetron HCl dihydrate formulations met USP acceptance criteria for mass and content uniformity, syringe homogeneity, visual inspection, chemical stability, and in vitro dissolution performance. ODFs demonstrated rapid disintegration and are particularly suited for pediatric use. All dosage forms were reproducibly manufactured using the automated SSE printing platform, supporting flexible, on-demand production tailored to patient needs.ConclusionSSE 3D printing offers a reliable and scalable compounding approach for producing personalized ondansetron HCl dihydrate formulations in hospital pharmacies. By integrating automation and digital manufacturing into pharmaceutical workflows, this study demonstrates the potential of next generation compounding systems to enhance dosing precision, regulatory compliance, and patient adherence in pediatric pharmacotherapy.