3D printing enables personalization, dosing precision of ondansetron HCl dihydrate

A recent study has shown the effectiveness and precision of semi-solid extrusion (SSE) 3D printing in producing various formulations of ondansetron HCl dihydrate 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 paediatric pharmacotherapy,” the investigators said.

In this study, the investigators probed the development and quality performance of personalized ondansetron HCl dihydrate dosage forms produced via an SSE-based automated compounding system. Three dosage forms (ie, semi-solid gel tablet, anhydrous troche, and orodispersible film [ODF]) were made in various ondansetron concentrations (0.81‒7.5 mg).

These formulations were developed and printed at a hospital setting, which exhibited real-life conditions in hospital pharmacies. The United States Pharmacopeia (USP) guidelines were followed to assess the quality of the various dosage forms.

Overall, the 3D-printed ondansetron HCl dihydrate formulations met the acceptance criteria of the USP for mass and content uniformity, syringe homogeneity, visual inspection, chemical stability, and in vitro dissolution performance. [J Oncol Pharm Pract 2026;32:71-86]

Specifically, ODFs displayed rapid disintegration, making it suitable for paediatric use. Notably, the automated SSE printing platform manufactured all dosage forms, supporting flexible, on-demand production tailored to patient needs.

“The results demonstrated the printer's capability to consistently produce stable pharmaceutical products with precise mass uniformity and high printing accuracy across diverse dosage forms, including gel tablets, anhydrous troches, and ODFs,” the investigators said.

“The comprehensive quality control tests including stability, drug uniformity, blend homogeneity during printing, and in-vitro dissolution studies underscore the reliability of the compounding system solution, paving the way for personalized medicine by modernizing manual compounding methods and enhancing patient care in hospital and commercial pharmacies,” they added.

Manual approach

In manual strategies, process controls often lack consistency and depend on operator variability, which can result in dose deviations and reduced reproducibility. [J Med Toxicol 2021;17:197-217]

Conversely, the SSE 3D printing platform allows batch traceability, electronic batch records, and precise dispensing, which lessens the risk of compounding errors and improves overall medication quality.

“This is especially important for vulnerable populations such as children and chemotherapy patients, where underdosing or inconsistent administration can lead to suboptimal therapeutic outcomes,” the investigators said. [Pharmaceutics 2023;15:416; Pharmaceutics 2024;16:678]

In paediatric patients, individualized medication dosing is necessary due to differences in age, weight, and swallowing ability. Commercial ondansetron HCl dihydrate formulations are often limited by rigid dosing options, unpleasant taste, and difficulty with administration, leading to poor adherence.

“Pharmaceutical compounding technologies, particularly those incorporating automation, offer a pathway toward patient-centric solutions,” the investigators said. “SSE 3D printing enables the controlled production of customized dosage forms.”

Furthermore, “[this] technology also opens the door for formulary expansion, allowing institutions to offer age-appropriate, dose-flexible, and palatable alternatives tailored to local patient populations,” they added.