Novel Gastroretentive Floating Pulsatile Drug Delivery System Produced via Hot-Melt Extrusion and Fused Deposition Modeling 3D Printing
Tóm tắt
This study was performed to develop novel core-shell gastroretentive floating pulsatile drug delivery systems using a hot-melt extrusion-paired fused deposition modeling (FDM) 3D printing and direct compression method. Hydroxypropyl cellulose (HPC) and ethyl cellulose (EC)-based filaments were fabricated using hot-melt extrusion technology and were utilized as feedstock material for printing shells in FDM 3D printing. The directly compressed theophylline tablet was used as the core. The tablet shell to form pulsatile floating dosage forms with different geometries (shell thickness: 0.8, 1.2, 1.6, and 2.0 mm; wall thickness: 0, 0.8, and 1.6 mm; and % infill density: 50, 75, and 100) were designed, printed, and evaluated. All core-shell tablets floated without any lag time and exhibited good floating behavior throughout the dissolution study. The lag time for the pulsatile release of the drug was 30 min to 6 h. The proportion of ethyl cellulose in the filament composition had a significant (p < 0.05) effect on the lag time. The formulation (2 mm shell thickness, 1.6 mm wall thickness, 100% infill density, 0.5% EC) with the desired lag time of 6 h was selected as an optimized formulation. Thus, FDM 3D printing is a potential technique for the development of complex customized drug delivery systems for personalized pharmacotherapy.
Từ khóa
Tài liệu tham khảo
Thitinan, 2012, Development of a gastroretentive pulsatile drug delivery platform, J. Pharm. Pharmacol., 64, 505, 10.1111/j.2042-7158.2011.01428.x
Jain, 2011, Recent technologies in pulsatile drug delivery systems, Biomatter, 1, 57, 10.4161/biom.1.1.17717
Sunil, 2011, Chronotherapeutic drug delivery systems: An approach to circadian rhythms diseases, Curr. Drug Deliv., 8, 622, 10.2174/156720111797635559
Maroni, 2010, Oral pulsatile delivery: Rationale and chronopharmaceutical formulations, Int. J. Pharm., 398, 1, 10.1016/j.ijpharm.2010.07.026
Streubel, 2006, Gastroretentive drug delivery systems, Expert Opin. Drug Deliv., 3, 217, 10.1517/17425247.3.2.217
Worsøe, J., Fynne, L., Gregersen, T., Schlageter, V., Christensen, L.A., Dahlerup, J.F., Rijkhoff, N.J., Laurberg, S., and Krogh, K. (2011). Gastric transit and small intestinal transit time and motility assessed by a magnet tracking system. BMC Gastroenterol., 11.
Butreddy, 2015, Enhancement of Solubility and Dissolution Rate of Trandolapril Sustained Release Matrix Tablets by Liquisolid Compact Approach, Asian J. Pharm., 9, 1
Amin, 2016, Development of Floating-Mucoadhesive Microsphere for Site Specific Release of Metronidazole, Adv. Pharm. Bull., 6, 195, 10.15171/apb.2016.027
Preda, 2003, Oxprenolol-loaded bioadhesive microspheres: Preparation and in vitro/in vivo characterization, J. Microencapsul., 20, 777
Garg, 2008, Progress in Controlled Gastroretentive Delivery Systems, Trop. J. Pharm. Res., 7, 1055, 10.4314/tjpr.v7i3.14691
Chen, 1999, Synthesis of superporous hydrogels: Hydrogels with fast swelling and superabsorbent properties, J. Biomed. Mater. Res., 44, 53, 10.1002/(SICI)1097-4636(199901)44:1<53::AID-JBM6>3.0.CO;2-W
Almutairy, 2016, Development of a floating drug delivery system with superior buoyancy in gastric fluid using hot-melt extrusion coupled with pressurized CO2, Pharmazie, 71, 128
Reddy, 2017, Development of Multiple-Unit Floating Drug Delivery System of Clarithromycin: Formulation, in vitro Dissolution by Modified Dissolution Apparatus, in vivo Radiographic Studies in Human Volunteers, Drug Res., 67, 412, 10.1055/s-0043-102952
Lalge, 2019, Preparation and evaluation of cefuroxime axetil gastro-retentive floating drug delivery system via hot melt extrusion technology, Int. J. Pharm., 566, 520, 10.1016/j.ijpharm.2019.06.021
Vo, 2016, A novel floating controlled release drug delivery system prepared by hot-melt extrusion, Eur. J. Pharm. Biopharm., 98, 108, 10.1016/j.ejpb.2015.11.015
He, 2014, Gastro-floating bilayer tablets for the sustained release of metformin and immediate release of pioglitazone: Preparation and in vitro/in vivo evaluation, Int. J. Pharm., 476, 223, 10.1016/j.ijpharm.2014.09.056
Tiwari, 2016, Contribution of hot-melt extrusion technology to advance drug delivery in the 21st century, Expert Opin. Drug Deliv., 13, 451, 10.1517/17425247.2016.1126246
Pimparade, 2015, Development of taste masked caffeine citrate formulations utilizing hot melt extrusion technology and in vitro-in vivo evaluations, Int. J. Pharm., 487, 167, 10.1016/j.ijpharm.2015.04.030
Maddineni, 2014, Formulation optimization of hot-melt extruded abuse deterrent pellet dosage form utilizing design of experiments, J. Pharm. Pharmacol., 66, 309, 10.1111/jphp.12129
Lakshman, 2008, Application of Melt Extrusion in the Development of a Physically and Chemically Stable High-Energy Amorphous Solid Dispersion of a Poorly Water-Soluble Drug, Mol. Pharm., 5, 994, 10.1021/mp8001073
Bhagurkar, 2016, Development of an Ointment Formulation Using Hot-Melt Extrusion Technology, AAPS PharmSciTech, 17, 158, 10.1208/s12249-015-0453-3
Dumpa, 2018, Chronotherapeutic Drug Delivery of Ketoprofen and Ibuprofen for Improved Treatment of Early Morning Stiffness in Arthritis Using Hot-Melt Extrusion Technology, AAPS PharmSciTech, 19, 2700, 10.1208/s12249-018-1095-z
Goole, 2016, 3D printing in pharmaceutics: A new tool for designing customized drug delivery systems, Int. J. Pharm., 499, 376, 10.1016/j.ijpharm.2015.12.071
Trenfield, 2018, 3D Printing Pharmaceuticals: Drug Development to Frontline Care, Trends Pharmacol. Sci., 39, 440, 10.1016/j.tips.2018.02.006
Fu, 2018, 3D printing of vaginal rings with personalized shapes for controlled release of progesterone, Int. J. Pharm., 539, 75, 10.1016/j.ijpharm.2018.01.036
Sadia, 2018, Channelled tablets: An innovative approach to accelerating drug release from 3D printed tablets, J. Control. Release, 269, 355, 10.1016/j.jconrel.2017.11.022
Liang, 2018, 3D printing of a wearable personalized oral delivery device: A first-in-human study, Sci. Adv., 4, 2544, 10.1126/sciadv.aat2544
Goyanes, 2016, 3D scanning and 3D printing as innovative technologies for fabricating personalized topical drug delivery systems, J. Control. Release, 234, 41, 10.1016/j.jconrel.2016.05.034
Chai, 2017, Fused Deposition Modeling (FDM) 3D Printed Tablets for Intragastric Floating Delivery of Domperidone, Sci. Rep., 7, 2829, 10.1038/s41598-017-03097-x
Li, 2018, Preparation and investigation of novel gastro-floating tablets with 3D extrusion-based printing, Int. J. Pharm., 535, 325, 10.1016/j.ijpharm.2017.10.037
Meena, 2014, Investigation of thermal and viscoelastic properties of polymers relevant to hot melt extrusion II: Cellulosic polymers, J. Excip. Food Chem., 5, 46
Zhang, 2019, Development and evaluation of pharmaceutical 3D printability for hot melt extruded cellulose-based filaments, J. Drug Deliv. Sci. Technol., 52, 292, 10.1016/j.jddst.2019.04.043
Maroni, 2017, 3D printed multi-compartment capsular devices for two-pulse oral drug delivery, J. Control. Release, 268, 10, 10.1016/j.jconrel.2017.10.008
Zhang, 2017, Hydroxypropyl methylcellulose-based controlled release dosage by melt extrusion and 3D printing: Structure and drug release correlation, Carbohydr. Polym., 177, 49, 10.1016/j.carbpol.2017.08.058
Yang, 2018, 3D printed tablets with internal scaffold structure using ethyl cellulose to achieve sustained ibuprofen release, Eur. J. Pharm. Sci., 115, 11, 10.1016/j.ejps.2018.01.005