FDM 3D-Printed Sustained-Release Gastric-Floating Verapamil Hydrochloride Formulations with Cylinder, Capsule and Hemisphere Shapes, and Low Infill Percentage

The aim of this work was to design and fabricate fused deposition modeling (FDM) 3D-printed sustained-release gastric-floating formulations with different shapes (cylinder, capsule and hemisphere) and infill percentages (0% and 15%), and to investigate the influence of shape and infill percentage on the properties of the printed formulations.

Drug-loaded filaments containing HPMC, Soluplus^® and verapamil hydrochloride were prepared via hot-melt extrusion (HME) and then used to print the following gastric-floating formulations: cylinder-15, capsule-0, capsule-15, hemisphere-0 and hemisphere-15. The morphology of the filaments and the printed formulations were observed by scanning electron microscopy (SEM). The physical state of the drugs in the filaments and the printed formulations were characterized by X-ray diffraction (XRD), thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC). The printed formulations were evaluated in vitro, including the weight variation, hardness, floating time, drug content and drug release.

The results showed that the drug-loaded filament prepared was successful in printing the gastric floating formulations. Verapamil hydrochloride was proved thermally stable during HME and FDM, and in an amorphous state in the filament and the printed formulations. The shape and infill percentage of the printed formulations effected the hardness, floating time and in vitro drug release.

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Materials: Verapamil hydrochloride was purchased from Wuhan Yuancheng Gongchuang Technology Co., Ltd. (Wuhan, China). Commercial verapamil hydrochloride sustained-release tablets were purchased from Jiangsu Hengrui Medicine Co., Ltd. (Lianyungang, China). Hydroxypropyl methylcellulose (Affinisol™ HPMC HME 100lv) was donated by DOW Chemical Co., Ltd. (Shanghai, China). Polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol copolymer (Soluplus®) was donated by BASF Co., Ltd. (Ludwigshafen, Germany). Polyethylene glycol (PEG 400) was purchased from Coolaber Technology Co., Ltd. (Beijing, China). Methanol (chromatographic grade) was purchased from ThermoFisher Co., Ltd. (Waltham, MA, USA). Other chemicals were of analytical grade and were used as received.

Article information: Qian, H.; Chen, D.; Xu, X.; Li, R.; Yan, G.; Fan, T. FDM 3D-Printed Sustained-Release Gastric-Floating Verapamil Hydrochloride Formulations with Cylinder, Capsule and Hemisphere Shapes, and Low Infill Percentage. Pharmaceutics 2022, 14, 281. https://doi.org/10.3390/pharmaceutics14020281