Fused deposition modeling 3D printed oral famotidine pulsatile release tablets

doi:10.5246/jcps.2022.09.055

Abstract

Abstract:

The aim of this study was to prepare pulsatile release tablets which provide different drug delayed-release time and realize personalized administration according to the needs of patients. Fused deposition modeling (FDM) 3D printing technology was introduced into the field of pharmaceutics in this study, and the feasibility to prepare core-shell pulsatile release tablets was explored by combing 3D printing technology with the traditional manufacturing technology. The core of the pulsatile tablets was a commercial tablet obtained from the traditional technology, and the drug-free shell was prepared by the FDM 3D printing technology. Three kinds of tablet shells were designed using different parameters. Furthermore, the morphology, size, weight, hardness, and in vitro drug release of the 3D printed famotidine pusatile tablets were characterized and evaluated. The results showed that the 3D printed tablets appeared intact without any defects. Different parameters of outer shell affected the size, weight, hardness, and in vitro drug release of the tablets. The tablets achieved a personalized delayed release time varying from 5 to 7 h in vitro. In this way, a new method for preparing pulsatile release tablets and a new way for the personalized administration of pulsatile tablets were explored in this study.

Key words: FDM 3D printing, Pulsatile release, Oral preparation, Famotidine

Supporting:

Rui Li, Xiangyu Xu, Di Chen, Yue Zhang, Haonan Qian, Genao Zang, Guangrong Yan, Tianyuan Fan. Fused deposition modeling 3D printed oral famotidine pulsatile release tablets[J]. Journal of Chinese Pharmaceutical Sciences, 2022, 31(9): 657-664.

Figures/Tables 6

Table 1. Parameters of the three kinds of 3D printed pulsatile tablets.

Table 2. The measured weight and size of the 3D printed famotidine pulsatile tablets.

Table 3. The hardness of the 3D printed famotidine pulsatile tablets.

References 28

[1]	Long, J.; Gholizadeh, H.; Lu, J.; Bunt, C.; Seyfoddin, A. Application of fused deposition modelling (FDM) method of 3D printing in drug delivery. Curr. Pharm. Des. 2017, 23, 433–439.
[2]	Awad, A.; Trenfield, S.J.; Gaisford, S.; Basit, A.W. 3D printed medicines: a new branch of digital healthcare. Int. J. Pharm. 2018, 548, 586–596.
[3]	Konta, A.; García-Piña, M.; Serrano, D. Personalised 3D printed medicines: which techniques and polymers are more successful? Bioengineering. 2017, 4, 79.
[4]	Jamróz, W.; Kurek, M.; Czech, A.; Szafraniec, J.; Gawlak, K.; Jachowicz, R. 3D printing of tablets containing amorphous aripiprazole by filaments co-extrusion. Eur. J. Pharm. Biopharm. 2018, 131, 44–47.
[5]	Trenfield, S.J.; Goyanes, A.; Telford, R.; Wilsdon, D.; Rowland, M.; Gaisford, S.; Basit, A.W. 3D printed drug products: Non-destructive dose verification using a rapid point-and-shoot approach. Int. J. Pharm. 2018, 549, 283–292.
[6]	Prasad, L.K.; Smyth, H. 3D Printing technologies for drug delivery: a review. Drug Dev. Ind. Pharm. 2016, 42, 1019–1031.
[7]	Kempin, W.; Franz, C.; Koster, L.C.; Schneider, F.; Bogdahn, M.; Weitschies, W.; Seidlitz, A. Assessment of different polymers and drug loads for fused deposition modeling of drug loaded implants. Eur. J. Pharm. Biopharm. 2017, 115, 84–93.
[8]	Zhang, J.X.; Yang, W.W.; Vo, A.Q.; Feng, X.; Ye, X.Y.; Kim, D.W.; Repka, M.A. Hydroxypropyl methylcellulose-based controlled release dosage by melt extrusion and 3D printing: structure and drug release correlation. Carbohydr. Polym. 2017, 177, 49–57.
[9]	Melocchi, A.; Parietti, F.; Loreti, G.; Maroni, A.; Gazzaniga, A.; Zema, L. 3D printing by fused deposition modeling (FDM) of a swellable/erodible capsular device for oral pulsatile release of drugs. J. Drug Deliv. Sci. Technol. 2015, 30, 360–367.
[10]	Patil, S.S.; Shahiwala, A. Patented pulsatile drug delivery technologies for chronotherapy. Expert Opin. Ther. Pat. 2014, 24, 845–856.
[11]	Jain, D.; Raturi, R.; Jain, V.; Bansal, P.; Singh, R. Recent technologies in pulsatile drug delivery systems. Biomatter. 2011, 1, 57–65.
[12]	Díaz Nebreda, A.; Zappia, C.D.; Rodríguez González, A.; Sahores, A.; Sosa, M.; Burghi, V.; Monczor, F.; Davio, C.; Fernández, N.; Shayo, C. Involvement of histamine H1 and H₂ receptor inverse agonists in receptor’s crossregulation. Eur. J. Pharmacol. 2019, 847, 42–52.
[13]	Agarwal, V.; Bansal, M. Design and optimization of a chronotherapeutic dosage form for treatment of nocturnal acid breakthrough. Curr. Drug Deliv. 2012, 9, 608–616.
[14]	Agarwal, V.; Bansal, M. Statistical optimization and fabrication of a press coated pulsatile dosage form to treat nocturnal acid breakthrough. Curr. Drug Deliv. 2013, 10, 444–452.
[15]	Chen, D.; Xu, X.Y.; Li, R.; Zang, G.N.; Zhang, Y.; Wang, M.R.; Xiong, M.F.; Xu, J.R.; Wang, T.; Fu, H.; Hu, Q.; Wu, B.; Yan, G.R.; Fan, T.Y. Preparation and in vitro evaluation of FDM 3D-printed ellipsoid-shaped gastric floating tablets with low infill percentages. AAPS PharmSci. 2019, 21, 6.
[16]	Fu, J.H.; Yin, H.; Yu, X.; Xie, C.; Jiang, H.L.; Jin, Y.G.; Sheng, F.G. Combination of 3D printing technologies and compressed tablets for preparation of riboflavin floating tablet-in-device (TiD) systems. Int. J. Pharm. 2018, 549, 370–379.
[17]	Maroni, A.; Melocchi, A.; Parietti, F.; Foppoli, A.; Zema, L.; Gazzaniga, A. 3D printed multi-compartment capsular devices for two-pulse oral drug delivery. J. Control. Release. 2017, 268, 10–18.
[18]	Melocchi, A.; Parietti, F.; Maroni, A.; Foppoli, A.; Gazzaniga, A.; Zema, L. Hot-melt extruded filaments based on pharmaceutical grade polymers for 3D printing by fused deposition modeling. Int. J. Pharm. 2016, 509, 255–263.
[19]	Isreb, A.; Baj, K.; Wojsz, M.; Isreb, M.; Peak, M.; Alhnan, M.A. 3D printed oral theophylline doses with innovative ‘radiator-like’ design: impact of polyethylene oxide (PEO) molecular weight. Int. J. Pharm. 2019, 564, 98–105.
[20]	Pereira, B.C.; Isreb, A.; Forbes, R.T.; Dores, F.; Habashy, R.; Petit, J.B.; Alhnan, M.A.; Oga, E.F. ‘Temporary Plasticiser’: a novel solution to fabricate 3D printed patient-centred cardiovascular ‘Polypill’ architectures. Eur. J. Pharm. Biopharm. 2019, 135, 94–103.
[21]	Yang, Y.; Wang, H.H.; Li, H.C.; Ou, Z.M.; Yang, G.S. 3D printed tablets with internal scaffold structure using ethyl cellulose to achieve sustained ibuprofen release. Eur. J. Pharm. Sci. 2018, 115, 11–18.
[22]	Aho, J.; Bøtker, J.P.; Genina, N.; Edinger, M.; Arnfast, L.; Rantanen, J. Roadmap to 3D-printed oral pharmaceutical dosage forms: feedstock filament properties and characterization for fused deposition modeling. J. Pharm. Sci. 2019, 108, 26–35.
[23]	Matijašić, G.; Gretić, M.; Kezerić, K.; Petanjek, J.; Vukelić, E. Preparation of filaments and the 3D printing of dronedarone HCl tablets for treating cardiac arrhythmias. AAPS PharmSci. 2019, 20, 310.
[24]	Arafat, B.; Wojsz, M.; Isreb, A.; Forbes, R.T.; Isreb, M.; Ahmed, W.; Arafat, T.; Alhnan, M.A. Tablet fragmentation without a disintegrant: a novel design approach for accelerating disintegration and drug release from 3D printed cellulosic tablets. Eur. J. Pharm. Sci. 2018, 118, 191–199.
[25]	Palekar, S.; Nukala, P.K.; Mishra, S.M.; Kipping, T.; Patel, K. Application of 3D printing technology and quality by design approach for development of age-appropriate pediatric formulation of baclofen. Int. J. Pharm. 2019, 556, 106–116.
[26]	Khaled, S.A.; Alexander, M.R.; Wildman, R.D.; Wallace, M.J.; Sharpe, S.; Yoo, J.; Roberts, C.J. 3D extrusion printing of high drug loading immediate release paracetamol tablets. Int. J. Pharm. 2018, 538, 223–230.
[27]	Tan, D.; Maniruzzaman, M.; Nokhodchi, A. Advanced pharmaceutical applications of hot-melt extrusion coupled with fused deposition modelling (FDM) 3D printing for personalised drug delivery. Pharmaceutics. 2018, 10, 203.
[28]	Li, Q.J.; Guan, X.Y.; Cui, M.S.; Zhu, Z.H.; Chen, K.; Wen, H.Y.; Jia, D.Y.; Hou, J.; Xu, W.T.; Yang, X.G.; Pan, W.S. Preparation and investigation of novel gastro-floating tablets with 3D extrusion-based printing. Int. J. Pharm. 2018, 535, 325–332.