Background: Pharmaceutical compounding remains a predominantly manual process with limited innovation, particularly in non-sterile applications. This study explores the implementation of an automated compounding platform based on 3D printing to enhance precision, efficiency, and adaptability in pediatric corticosteroid formulations. Methods: Personalized hydrocortisone dosage forms were prepared in a hospital pharmacy setting using a proprietary excipient base and standardized procedures, including automated dosing and syringe heating when required. Three dosage forms—3.2 mg gel tablets, 2.8 mg water-free troches, and 1.2 mg orodispersible films (ODFs)—were selected to demonstrate the platform’s versatility and to address pediatric needs for varying strengths and dosage types. All products were prepared using a reproducible semi-solid extrusion (SSE)-based workflow with the consistent API-excipient blending and automated deposition. Results: Analytical testing confirmed that all formulations met pharmacopeial criteria for mass and content uniformity. The ODF and troche forms achieved rapid drug release, exceeding 75% within 5 min, while the gel tablet showed a slower release profile, reaching 86% by 60 min. Additionally, in-process homogeneity testing across syringe printing cycles confirmed the consistent API distribution. Conclusions: The results support the feasibility of integrating automated compounding technologies into pharmacy workflows. Such systems can improve accuracy, minimize variability, and streamline the production of customized pediatric medications, particularly for drugs with poor palatability or narrow therapeutic windows. Overall, this study highlights the potential of automation to modernize non-sterile compounding, and to better support individualized therapy.
5 April 2022 in JACCP: Journal of the American College of Clinical Pharmacy
Introduction: The stability of cobimetinib prepared in a simple aqueous suspension was evaluated. This evaluation aimed to determine how well the compound maintains its integrity over time in a non-complex vehicle for pediatric applications. By monitoring concentration and purity over a defined period, the study provides insight into optimal storage conditions and potential limitations of the preparation. Methods: Cobimetinib tablets were dispersed in purified water to prepare oral suspensions with final concentrations of 1 mg/mL and 12 mg/mL. Each suspension was equally aliquoted and stored under two conditions: room temperature (20 ± 2 °C) and refrigerated conditions (4 °C) (n = 3 per condition). Samples were prepared and analyzed at predefined time points (days 0, 1, 2, 3, 7, 9, and 14) to evaluate stability over time. Physical stability was assessed by pH measurement, as well as visual inspection. Cobimetinib concentrations were quantified using ultra-performance liquid chromatography coupled with ultraviolet detection and mass spectrometry (UPLC-UV-MS). Results: No changes in pH were observed throughout the study. Visual inspections revealed no color change. The cobimetinib oral suspensions at concentrations of 1 mg/mL and 12 mg/mL retained 90 to 110% of their initial concentrations over 14 days when stored at both room temperature and 4 °C. Conclusion: The extemporaneously compounded cobimetinib oral suspensions, at concentrations of 1 mg/mL and 12 mg/mL, demonstrated acceptable stability for up to 14 days under both room temperature and 4 °C. These findings support its potential as a viable alternative dosage form for short-term use in clinical settings.