Abstract
Niclosamide (NCS) is a drug that has been used as an anthelmintic and anti-parasitic drug for about 40 years. Recently, some studies have highlighted its potential in treating various tumors, allowing a repositioning of this drug. Despite its potential, NCS is a Biopharmaceutical Classification System (BCS) Class II drug and is consequently characterized by low aqueous solubility, poor dissolution rate and reduced bioavailability, which limits its applicability. In this work, we utilize a very novel technique, direct powder extrusion (DPE) 3D printing, which overcomes the limitations of previously used techniques (fused deposition modelling, FDM) to achieve direct extrusion of powder mixtures consisting of NCS, hydroxypropyl methylcellulose (HPMC, Affinisol 15 LV), hydroxypropyl-β-cyclodextrin (HP-β-CD) and polyethylene glycol (PEG) 6000. For the first time, direct printing of powder blends containing HP-β-CD was conducted. For all tablets, in vitro dissolution studies showed sustained drug release over 48 h, but for tablets containing HP-β-CD, the release was faster. Solid-state characterization studies showed that during extrusion, the drug lost its crystal structure and was evenly distributed within the polymer matrix. All printed tablets have exhibited good mechanical and physical features and a stability of the drug content for up to 3 months. This innovative printing technique has demonstrated the possibility to produce personalized pharmaceutical forms directly from powders, avoiding the use of filament used by FDM.Graphical abstract
Highlights
Niclosamide (NCS) is a drug included in the World Health Organization’s Model List of Essential Medicines [1] and has been approved in 1982 by the FDA as an anti-parasitic and anthelmintic drug
The aim of this study was to explore the use of an innovative technology, the 3D printing (3DP) direct powder extrusion (DPE), highlighting the ability, for the first time, to directly extrude powders containing HP-β-CD, and to overcome the solubility limitations associated with NCS
This work presented and used for the first time a new printer, 3DForMe®, which is based on the ability to extrude powders directly, overcoming the filament preparation problem associated with fused deposition modeling (FDM)
Summary
Niclosamide (NCS) is a drug included in the World Health Organization’s Model List of Essential Medicines [1] and has been approved in 1982 by the FDA as an anti-parasitic and anthelmintic drug. Drug Delivery and Translational Research and reduced dissolution and absorption rate [4], being a class II drug according to the Biopharmaceutics Classification System (BCS) In this regard, there are several strategies to satisfy this need, including the conversion of a drug's solid state from crystalline to amorphous [13, 14]. There are numerous methods for obtaining ASD, but the most investigated one, in recent decades, is the hot melt extrusion (HME), a continuous process in which temperature and pressure are applied to soften or melt the starting material [15, 16] forcing it through an orifice and producing new products with uniform shape and density [15] This technique produces filaments that can be utilized for the preparation of personalized dosage forms by using three-dimensional (3D) printing
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