RESUMO
The creation of products with personalized or innovative features in the pharmaceutical sector by using innovative technologies such as three-dimensional (3D) printing is particularly noteworthy, especially in the realm of compounding pharmacies. In this work, 3D printed capsule devices (CDs) with different wall thicknesses (0.2, 0.3, 0.4, 0.6, and 0.9 mm) and sizes were designed and successfully fabricated varying printing parameters such as extrusion temperature, printing speed, material flow percent, and nozzle diameter. The physicochemical, pharmaceutical, and biopharmaceutical performance of these CDs was evaluated with the aim of achieving an immediate drug release profile comparable to hard gelatin capsules (HGC) for use in magistral compounding. It was observed that the disintegration time of the CDs increased with wall thickness, which correlated with a slower drug release rate. CDs with configurations presenting 0.4 mm wall thickness and sizes comparable to HGC n° 0, 1, and 2 demonstrated satisfactory weight uniformity, short disintegration times, and immediate drug release, indicating their potential as effective devices in future compounding pharmacy applications. In addition, a modified Weibull-type model was proposed that incorporates wall thickness as a new variable in predicting dissolution profiles. This model improves the process of selecting a specific wall thickness to achieve the desired dissolution rate within a specified time frame.
RESUMO
The use of 3D printing for the production of systems intended for oral delivery of diet supplements in the veterinary pharmacy constitutes an attractive technology that has remained unexplored. In this sense, this work studies the design and 3D printing of capsular devices that allow the modified release of urea, which is frequently used as a source of non-protein nitrogen in ruminants, but highly toxic if fast ingested. The devices were printed with combinations of polylactic acid (PLA, water-insoluble) and polyvinyl alcohol (PVA, water-soluble) in order to modulate the urea release through the different parts. The optimization of the designs as well as printing parameters such as extrusion temperature, printing speed, retraction distance and nozzle speed resulted critical to obtain successful capsular devices. In addition, the dissolution studies confirmed that the developed designs showed a controlled release of urea, especially the ones that presented internal partitions. Finally, Logistic and Weibull equations were the kinetic models that best fitted the experimental data corresponding to functions that describe S-shaped dissolution profiles. Overall, this work constitutes a proof of concept and provides the first steps in the development of 3D printed simple devices for the controlled release of supplements and drugs in veterinary pharmacy.
Assuntos
Impressão Tridimensional , Ureia , Animais , Comprimidos , Liberação Controlada de Fármacos , Preparações de Ação Retardada , Cápsulas , Água , Ruminantes , Tecnologia Farmacêutica/métodosRESUMO
The fabrication through FDM 3D printing of hollow systems intended for oral drug delivery constitutes an attractive technology to change personalized medications in the compounding pharmacy. In this sense, this work studied the design and 3D printing of one compartment capsular devices filled of drugs that could require a delayed release mechanism. The optimization of printing parameters such as material flow rate and printing speed by means of simple gcode modifications, resulted critical to allow the production of PVA capsular devices in a single manufacturing process. In addition, the disintegration and dissolution studies of the obtained capsular device confirmed the existence of a delayed drug release compared to commercial hard-gelatin capsules. Furthermore, the use of sinkers in the dissolution tests resulted in similar dissolution profiles regardless the rotation speed. Finally, Gompertz and Weibull equations were the kinetic models that best fitted the experimental data corresponding to immediate release with lag time type profiles. Overall, this work provides insights to understand the effect of the printing parameters on the production of PVA capsular devices and suggests a simple design and single manufacturing process that can be adopted in the future compounding pharmacy.