Individualized orodispersible pediatric dosage forms obtained by molding and semi-solid extrusion by 3D printing: A comparative study for hydrochlorothiazide

Abstract

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.