Individualized orodispersible pediatric dosage forms obtained by molding and semi-solid extrusion by 3D printing: A comparative study for hydrochlorothiazide
Date
2021Abstract
Orodispersible tablets are an excellent alternative regarding drug administration in pediatric patients. Nowadays
there are alternatives to the compression process including; molding techniques and semi-solid extrusion 3D
printing technology. Both constitute excellent options when producing individualized oral solid dosage forms for
pediatrics. The objective of this study was to compare the suitability of the molding and semi-solid extrusion 3D
printing technologies for orodispersible tablets and printlets. In order to evaluate performance, orodispersible
dosage forms containing 10 mg of hydrochlorothiazide were developed. The quality of the dosage forms was
tested in accordance with the requirements of the European Pharmacopoeia for oral solid dosage forms: mass
uniformity, content uniformity, disintegration time and dissolution. Due to the peculiarities of these dosage
forms, the dissolution test was performed using the flow through cell apparatus (type IV according to USP
classification). 100 orodisperable dosage forms were made using both systems. The elaboration time of molded
tablets and printlets was 15 min and 1 h respectively. Both dosage forms complied with mass uniformity test but
only printlets showed an acceptance value below limit. Disintegration time of printlets and molded tablets were
167 and 47 s respectively; the drug release was faster in the case of molded tablets. 3D printing by semi-solid
extrusion constitutes a valid future alternative for the individualization of medicines as it enables the produc
tion of orodispersible printlets with the required quality attributes. Moreover, size, shape, dosage and organo
leptic properties of the printlets can be changed, increasing the possibilities of dose individualization for
pediatric patients.