Hydroxypropyl-β-cyclodextrin-based fast dissolving carbamazepine printlets prepared by semisolid extrusion 3D printing

Abstract

This work aimed to explore for the first time the use of cyclodextrins to prepare printlets of poorly soluble drugs, such as carbamazepine, which require fine dose adjustment and rapid release. Orodispersible (flash) and immediate release formulations were 3D printed via semisolid extrusion of wet masses of hydroxypropyl-β-cyclodextrin (HPβCD) and cellulose ethers and regulating tablet porosity. Rheology of the wet masses allowed identifying printable compositions. Printing robustness was assessed evaluating weight, dimensions, hardness, drug content, and microstructure. Drug crystallinity, printlet disintegration and dissolution profiles were also characterized. The results highlight the feasibility of using HPβCD as excipient in printlets of poorly soluble drugs, and the possibilities of tuning drug release profiles through small changes in cellulose ethers nature and ratio. Semisolid extrusion-based 3D printing is revealed as a feasible approach to in situ form carbamazepine-HPβCD complexes and to produce printlets with suitable physical and drug release properties for oral delivery.

Keywords: 3D printed tablets; Additive manufacturing; Carbamazepine; Flash formulation; Hydroxypropyl-β-cyclodextrin; Semisolid extrusion.