Development of personalized dexamethasone orodispersible solid oral dosage forms by semisolid extrusion 3D printing

This work aimed to develop a semisolid extrusion 3D printing formulation that incorporates dexamethasone, a potent corticosteroid widely used to treat multiple ailments, that could be employed to manufacture personalized orodispersible dosage forms. Inks were optimized to allow proper extrusion and formulated to be composed of exclusively generally regarded as safe excipients which were also selected to account for a wide array of conditions and dietary restrictions. The influence of the design's physical characteristics (S/V and target weight) on disintegration time was studied and a S/V > 1.94 and a maximum weight of 165.39 mg were set as the limits to ensure the printlets can qualify as orodispersible. Printlets with doses ranging from 0.25 mg to 5 mg were manufactured and their disintegration time, dissolution and mass and content uniformity were evaluated. These dexamethasone dosage forms were able to disintegrate under the 3-minute mark and met the pharmacopoeia standards for mass and content uniformity for all 9 different designs printed. A 3D printing approach such as ours would allow to manufacture drugs specifically designed to meet the therapeutical needs of each patient without further dosage form modification while upholding the quality standards set for drugs manufacture. This, in turn, could improve the quality of care for paediatric or geriatric patients, groups that have more restricted access to suitable treatment options.