3D printed pharmaceuticals offers the potential to manufacture personalized medicines for patients. Such technology is of particular benefit to pediatric populations from the offer of increased patient compliance and dose flexibility. With a bench-to-patient approach, this study established and optimized the critical parameters of the semi-solid micro-extrusion 3D printing process to guarantee the quality attributes of the final dosage form. Pediatrics orodispersible printlets of hydrochlorothiazide were manufactured through the modification of printing parameters, as well as printing surfaces materials. The printlets were characterized and the dimensions were measured using a digital caliper and computer vision algorithm. This study identified that the printing surface material and the first printing layer are critical parameters for high-resolution printlets. Following the optimization of 3D printing parameters, high quality orodispersible printlets loaded with hydrochlorothiazide - specifically tailored for pediatric patient's dosage forms - were obtained (4.62 mm × 1.90 mm). Mass and content uniformity assays demonstrated that the printlets satisfied the requirements for orodispersible printlets set by the European Pharmacopoeia. As such, in order to transition from laboratory research towards the treatment of patients, distinguishing accurate 3D printing parameters is necessary for the manufacture of medicines with key quality attributes that follow Pharmacopoeia requirements.
Keywords: 3D printer parametrization; Hydrochlorothiazide orodispersible tablet; Pediatric drug delivery; Process Analytical Technology (PAT); Quality by design (QbD); Semi-solid micro-extrusion 3D printing.
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