3D-printed chewable Gummies: A customizable approach to formulate propranolol in the paediatric population

Paediatric patients, representing over 30 % of the global population, continue to face a critical shortage of age-appropriate pharmaceutical formulations. This gap is largely attributed to the high cost and complexity of paediatric drug development, resulting in the widespread off-label use of adult medications in children—an approach that compromises safety, therapeutic efficacy, and adherence. Conventional manufacturing methods often fail to meet essential paediatric requirements such as dose flexibility, palatability, and ease of administration, all of which are pivotal for ensuring treatment adherence. Providing that the European Paediatric Formulation Initiative (EuPFI) and EMA reflection papers suggest that chewable dosage forms are generally acceptable starting at around age 3, chewables are usually considered adequate for children from about 3 to 5 years onward. This study proposes a semisolid extrusion-based 3D printing methodology for the fabrication of chewable paediatric dosage forms—referred to as gummies—incorporating propranolol hydrochloride as a model hydrophilic drug commonly prescribed for cardiovascular and cardiac conditions in children. A hydrogel matrix consisting of 7 % w/w iota-carrageenan and 3 % w/w sodium alginate was optimized to ensure appropriate rheological properties, printability, and structural integrity. Fourier-transform infrared (FTIR) spectroscopy confirmed the uniform distribution of the active pharmaceutical ingredient within the matrix. Texture profile analysis revealed desirable mechanical properties when compared to those of commercially available gummies. Furthermore, the printed dosage units conformed to the European Pharmacopoeia quality specifications for mass uniformity and content uniformity. Notably, the simplicity and scalability of the presented approach suggest its suitability for implementation in both hospital and community pharmacy environments, facilitating decentralized manufacturing of personalized paediatric medications.