Pellets and gummies: seeking a 3D printed gastro-resistant omeprazole dosage for paediatric administration

Abstract

The production of 3D printed pharmaceuticals has thrived in recent years, as it allows the generation of cus-tomised medications in small batches. This is particularly helpful for patients who need specific doses or for-mulations, such as children. Compounding pharmacies seek alternatives to conventional solid oral doses, opting for oral liquid formulations. However, ensuring quality and stability, especially for pH-sensitive APIs like omeprazole, remains a challenge. This paper presents the application of semi-solid extrusion 3D printing tech-nology to develop patient-tailored medicinal gummies, with an eye-catching appearances, serving as an inno-vative omeprazole pharmaceutical form for paediatric use. The study compares 3D printing hydrogels with dissolved omeprazole to hydrogels loaded with gastro-resistant omeprazole pellets, a ground-breaking approach.. Gastro-resistance and dissolution profiles were studied using different methods for better comparison and to emphasize the significance of the assay's methodology. Both developed formulas exhibit proper rheology, good printability, and meet content and mass uniformity standards. However, the high gastro-resistance and suitable release profile of 3D printed chewable semi-solid doses with enteric pellets highlight this as an effective strategy to address the challenge of paediatric medication.