Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend^® excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies.

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.

Background: Pediatric 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. Methods: This 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. Results: The 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. Conclusion: SSE 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.

Background: Automated semi-solid extrusion (SSE) material deposition is a promising new technology for preparing personalized medicines for different patient groups and veterinary applications. The technology enables the preparation of custom-made oral elastic gel tablets of active pharmaceutical ingredient (API) by using a semi-solid polymeric printing ink. Methods: An automated SSE material deposition method was used for generating chewable gel tablets loaded with propranolol hydrochloride (-HCl) at three different API content levels (3.0 mg, 4.0 mg, 5.0 mg). The physical appearance, surface morphology, dimensions, mass and mass variation, process-derived solid-state changes, mechanical properties, and in-vitro drug release of the gel tablets were studied. Results: The inclusion of API (1% w/w) in the semi-solid CuraBlend^TM printing mixture decreased viscosity and increased fluidity, thus promoting the spreading of the mixture on the printed (material deposition) bed and the printing performance of the gel tablets. The printed gel tablets were elastic, soft, jelly-like, chewable preparations. The mechanical properties of the gel tablets were dependent on the printing ink composition (i.e., with or without propranolol HCl). The maximum load for the final deformation of the CuraBlend™-API (3.0 mg) gel tablets was very uniform, ranging from 73 N to 80 N. The in-vitro dissolution test showed that more than 85% of the drug load was released within 15–20 min, thus verifying the immediate-release behavior of these drug preparations. Conclusions: Automated SSE material deposition as a modified 3D printing method is a feasible technology for preparing customized oral chewable gel tablets of propranolol HCl.

Background/Objectives: An automated extrusion-based material deposition is a contemporary and rapid method for pharmaceutical dose-dispensing and preparing (printing) individualized solid dosage forms. The aim of this study was to investigate and gain knowledge of the feasibility of automated extrusion-based material deposition technology in preparing customized prednisolone (PRD)-loaded gel tablets for veterinary applications (primarily for dogs and cats). Methods: The PRD loads of the extrusion-based deposited gel tablets were 0.5% and 1.0%, and the target weights of tablets were 0.250 g, 0.500 g, and 1.000 g. The effects of the material deposition processes on the physical solid state, in vitro dissolution, and the physicochemical stability of PRD gel tablets were investigated. Results: The small-sized gel tablets presented a uniform round shape with an exceptionally smooth outer surface texture. The actual average weight of the tablets (n = 10) was very close to the target weight, showing the precision of the process. We found that PRD was in a pseudopolymorphic sesquihydrate form (instead of an initial PRD crystalline form II) in the gel tablets. In all the immediate-release gel tablets studied, more than 70% of the drug load was released within 30 min. The soft texture and dimensions of gel tablets affected the dissolution behaviour in vitro, suggesting the need for further development and standardization of a dissolution test method for such gel tablets. A short-term storage stability study revealed that the content of PRD did not decrease within 3 months. Conclusions: Automated extrusion-based material deposition is a feasible method for the rapid preparation of gel tablets intended for veterinary applications. In addition, the present technology and gel tablets could be used in pediatric and personalized medicine where precise dosing is crucial.

Background: Tablet splitting is widely used to individualize dosing of metoprolol tartrate when low-dose formulations are unavailable. However, splitting may lead to variability in dose accuracy, which can be clinically relevant at low dose strengths. This study compared the accuracy and precision of manual tablet splitting versus automated 3D printing for producing low-dose metoprolol tartrate tablets in a hospital setting. Methods: Commercial 25 mg metoprolol tartrate tablets from two manufacturers were manually split at Mayo Clinic into 12.5 mg halves and 6.25 mg quarters following established procedures. CurifyLabs’ Compounding System, including the Pharma Printer and CuraBlend^®-based formulations, was used at two hospital pharmacy sites and a compounding pharmacy to produce 6.25 mg and 12.5 mg tablets via 3D printing. Mass variation and content uniformity were evaluated using USP criteria and validated HPLC methods. Results: Manually split tablets showed high variability, with 6.25 mg quarters ranging from 24.9% to 142.8% API content and 12.5 mg halves from one manufacturer averaging only 66.6%, indicating frequent underdosing. In contrast, 3D-printed tablets achieved mean API contents within 90–103%, standard deviations below 5%, and acceptance values under 15 across all sites and formulations. Conclusion: Manual tablet splitting may not reliably meet pharmacopeial expectations for dose accuracy and content uniformity at lower dose strengths. Automated 3D printing produced consistent low-dose tablets and may offer a validated alternative where available.