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Automated 3D Printing-Based Non-Sterile Compounding Technology for Pediatric Corticosteroid Dosage Forms in a Health
M Brooke Bernhardt1, Farnaz Shokraneh2,3, Ludmila Hrizanovska2
1Department of Pharmacy and Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, TN 38105, USA.
Pharmaceutics
|June 27, 2025
Summary
Automated 3D printing enhances precision in compounding non-sterile pediatric medications. This technology improves accuracy and efficiency for personalized drug formulations, modernizing pharmacy workflows.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Pediatric Pharmacy
Background:
- Non-sterile pharmaceutical compounding is largely manual, lacking innovation.
- Automated compounding platforms offer potential for enhanced precision and efficiency.
Purpose of the Study:
- To implement and evaluate a 3D printing-based automated compounding platform for pediatric corticosteroid formulations.
- To assess the platform's versatility in creating diverse dosage forms with personalized strengths.
Main Methods:
- Personalized hydrocortisone dosage forms (gel tablets, troches, ODFs) were prepared using a semi-solid extrusion (SSE) 3D printing workflow.
- Automated dosing, syringe heating, and API-excipient blending were employed.
- Pharmacopeial criteria for mass and content uniformity were assessed.
Main Results:
- All compounded formulations met pharmacopeial standards for uniformity.
- Rapid drug release was observed for ODFs and troches ( >75% in 5 min); gel tablets showed slower release.
- Consistent API distribution was confirmed through in-process homogeneity testing.
Conclusions:
- Automated compounding technology is feasible for integration into pharmacy workflows.
- This technology improves accuracy, reduces variability, and streamlines production of customized pediatric medications.
- Automation has the potential to modernize non-sterile compounding and support individualized therapy.
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