Direct extrusion of hydroxypropyl beta-cyclodextrin (HP-β-CD)-based powder blends using the most innovative 3D printing technology, Direct Powder Extrusion (DPE), is offered for the first time .
In comparison to all 3DP techniques used to date, DPE enables the production of finished pharmaceutical forms in a single step from simple powder blends, which are melted at moderate temperatures and deposited layer by layer on the table.
Four different blends based on Niclosamide (NCS), a drug recently repositioned for its anti-cancer activity, were studied. The blends contained hydroxypropyl methylcellulose (HPMC) as the carrier polymer, polyethylene glycol (PEG 6000) as the plasticiser and HP-β-CD as the solubilising agent. Their direct extrusion had permitted the obtainment of tablets which, from the obtained results, proved to satisfy the tests required by the F.U. I. XII for the characterisation of these solid pharmaceutical forms.
The presence of HP-β-CD was fundamental for the formation of a ternary complex (NCS/HP-β-CD/HPMC) capable of increasing the aqueous solubility and dissolution rate of the model drug. In addition, the amorphization process undergone by the NCS during the printing phase induced a further improvement in its pharmacokinetic characteristics.
The success of the HP-β-CD and DPE combination has been demonstrated by numerous analyses (DSC, FT-IR, X-ray, and in vitro dissolution studies) and marks a breakthrough for the study of class II or IV drug under the Biopharmaceutics Classification System (BCS).
 Pistone, M., Racaniello, G.F., Arduino, I. et al. Direct cyclodextrin-based powder extrusion 3D printing for one-step production of the BCS class II model drug Niclosamide. Drug Deliv. and Transl. Res. (2022).
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