熔融沉积成型技术在口服固体制剂领域的研究进展

赵新宇, 韦文清, 牛睿蓉, 蒋曙光

中国药学杂志 ›› 2021, Vol. 56 ›› Issue (16) : 1291-1298.

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中国药学杂志
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中国药学杂志 ›› 2021, Vol. 56 ›› Issue (16) : 1291-1298. DOI: 10.11669/cpj.2021.16.003
综述

熔融沉积成型技术在口服固体制剂领域的研究进展

  • 赵新宇, 韦文清, 牛睿蓉, 蒋曙光*
作者信息 +

Research Progress of Fused Deposition Modelling in the Field of Oral Solid Preparations

  • ZHAO Xin-yu, WEI Wen-qing, NIU Rui-rong, JIANG Shu-guang*
Author information +
文章历史 +

摘要

作为在药物制剂领域中应用最为广泛的三维(three-dimensional,3D)打印技术,熔融沉积成型(fused deposition modelling,FDM)技术的制剂开发研究与日俱进。笔者介绍了FDM 3D打印的工艺过程,列举了目前已应用于FDM 3D打印的药用聚合物,回顾了近年来FDM 3D打印在个性化口服固体制剂领域的应用研究,初步总结了FDM 3D打印在制剂开发方面的优势及面临的挑战。FDM 3D打印在口服固体制剂领域的应用研究显示了其制剂灵活性、多功能性、低成本等颠覆传统制剂技术的显著优势,高度符合个性化医疗需求,但该技术的商业化应用还需要克服制剂和质量监管方面的诸多挑战。

Abstract

Fused deposition modelling (FDM) is the most widely studied 3D printing technology in the field of pharmaceutical preparations and it improves with each passing day. This review focuses on the technological process of FDM 3D printing, lists the pharmaceutical polymers used in FDM 3D printing, summarizes the application of FDM 3D printing in the field of oral solid preparations in recent years, and preliminarily discusses the advantages and challenges of FDM 3D printing development of preparations. The application research of FDM 3D printing in oral solid preparations shows that FDM 3D printing technology has significant advantages overturning traditional preparation technology including preparation flexibility, versatility, low cost, and is highly compatible with personalized medicine. However, this technology's commercial application still needs to overcome the challenges of preparations and quality regulatory.

关键词

熔融沉积成型 / 3D打印 / 口服固体制剂 / 药用聚合物 / 个性化医疗

Key words

fused deposition molding / 3D printing / oral solid preparation / pharmaceutical polymer / personalized medicine

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赵新宇, 韦文清, 牛睿蓉, 蒋曙光. 熔融沉积成型技术在口服固体制剂领域的研究进展[J]. 中国药学杂志, 2021, 56(16): 1291-1298 https://doi.org/10.11669/cpj.2021.16.003
ZHAO Xin-yu, WEI Wen-qing, NIU Rui-rong, JIANG Shu-guang. Research Progress of Fused Deposition Modelling in the Field of Oral Solid Preparations[J]. Chinese Pharmaceutical Journal, 2021, 56(16): 1291-1298 https://doi.org/10.11669/cpj.2021.16.003
中图分类号： R944   

参考文献

[1] ALOMARI M, MOHAMED F H, BASIT A W, et al. Personalised dosing: Printing a dose of one's own medicine [J]. Int J Pharm, 2015, 494(2): 568-577.
[2] ACOSTA-VELEZ G F, LINSLEY C S, ZHU T Z, et al. Photocurable Bioinks for the 3D Pharming of Combination Therapies [J]. Polymers-Basel, 2018, 10(12): 1372-1406.
[3] WANG X, ZHANG C, PING Q N. Advances of 3D printing technology in advanced pharmaceutical preparations[J]. J China Pharm Univ(中国药科大学学报), 2016,47(2):140-147.
[4] ARAUJO M R P, SA-BARRETO L L, GRATIERI T, et al. The digital pharmacies era: how 3D printing technology using fused deposition modeling can become a reality [J]. Pharmaceutics, 2019, 11(3): 128-142.
[5] AIMAR A, PALERMO A, INNOCENTI B, et al. The Role of 3D printing in medical applications: a state of the art [J]. J Healthc Eng, 2019, 2019:5340616.
[6] GINSBURG G S, MCCARTHY J J. Personalized medicine: revolutionizing drug discovery and patient care[J]. Trends Genet, 2001 ,19(12):491-496.
[7] ARAFAT B, WOJSZ M, ISREB A, et al. Tablet fragmentation without a disintegrant: a novel design approach for accelerating disintegration and drug release from 3D printed cellulosic tablets [J]. Eur J Pharm Sci, 2018, 118: 191-199.
[8] ELEFTHERIADIS G K, RITZOULIS C, BOUROPOULOS N, et al. Unidirectional drug release from 3D printed mucoadhesive buccal films using FDM technology: In vitro and ex vivo evaluation [J]. Eur J Pharm Biopharm, 2019, 144: 180-192.
[9] AZAD M A, OLAWUNI D, KIMBELL G, et al. Polymers for extrusion-based 3D printing of pharmaceuticals: a holistic materials-process perspective [J]. Pharmaceutics, 2020, 12(2): 124-158.
[10] ZHANG J, FENG X, PATIL H, et al. Coupling 3D printing with hot-melt extrusion to produce controlled-release tablets [J]. Int J Pharm, 2017, 519(1-2): 186-197.
[11] SADIA M, SOSNICKA A, ARAFAT B, et al. Adaptation of pharmaceutical excipients to FDM 3D printing for the fabrication of patient-tailored immediate release tablets [J]. Int J Pharm, 2016, 513(1-2): 659-668.
[12] CROWLEY M M, ZHANG F, REPKA M A, et al. Pharmaceutical applications of hot-melt extrusion: Part I [J]. Drug Dev Ind Pharm, 2007, 33(9): 909-926.
[13] PATIL H, TIWARI R V, REPKA M A. Hot-melt extrusion: from theory to application in pharmaceutical formulation [J]. Aaps Pharmscitech, 2016, 17(1): 20-42.
[14] GOYANES A, FERNANDEZ-FERREIRO A, MAJEED A, et al. PET/CT imaging of 3D printed devices in the gastrointestinal tract of rodents [J]. Int J Pharm, 2018, 536(1): 158-164.
[15] JONATHAN G, KARIM A. 3D printing in pharmaceutics: a new tool for designing customized drug delivery systems [J]. Int J Pharm, 2016, 499(1-2): 376-394.
[16] SOLANKI N G, TAHSIN M, SHAH A V, et al. Formulation of 3D printed tablet for rapid drug release by fused deposition modeling: screening polymers for drug release, drug-polymer miscibility and printability [J]. J Pharm Sci, 2018, 107(1): 390-401.
[17] PIETRZAK K, ISREB A, ALHNAN M A. A flexible-dose dispenser for immediate and extended release 3D printed tablets [J]. Eur J Pharm Biopharm, 2015, 96:380-387.
[18] YANG Y, WANG H, LI H, et al. 3D printed tablets with internal scaffold structure using ethyl cellulose to achieve sustained ibuprofen release [J]. Eur J Pharm Sci, 2018, 115: 11-18.
[19] KEMPIN W, FRANZ C, KOSTER L C, et al. Assessment of different polymers and drug loads for fused deposition modeling of drug loaded implants [J]. Eur J Pharm Biopharm, 2017, 115: 84-93.
[20] GIRI B R, SONG E S, KWON J, et al. Fabrication of intragastric floating, controlled release 3D printed theophylline tablets using hot-melt extrusion and fused deposition modeling [J]. Pharmaceutics, 2020, 12(1): 77-93.
[21] KIMURA S, ISHIKAWA T, IWAO Y, et al. Fabrication of zero-order sustained-release floating tablets via fused depositing modeling 3D printer [J]. Chem Pharm Bull, 2019, 67(9): 992-999.
[22] PATLOLLA A, COLLINS G, ARINZEH T L. Solvent-dependent properties of electrospun fibrous composites for bone tissue regeneration [J]. Acta Biomater, 2010, 6(1): 90-101.
[23] BERTESTEANU S, CHIFIRIUC M C, GRUMEZESCU A M, et al. Biomedical applications of synthetic, biodegradable polymers for the development of anti-infective strategies [J]. Curr Med Chem, 2014, 21(29): 3383-3390.
[24] FARAH S, ANDERSON D G, LANGER R. Physical and mechanical properties of PLA, and their functions in widespread applications-A comprehensive review [J]. Adv Drug Deliv Rev, 2016, 107: 367-392.
[25] PALEKAR S, NUKALA P K, MISHRA S M, et al. Application of 3D printing technology and quality by design approach for development of age-appropriate pediatric formulation of baclofen [J]. Int J Pharm, 2019, 556: 106-116.
[26] XU X W, ZHAO J Z, WANG M N, et al. 3D Printed polyvinyl alcohol tablets with multiple release profiles[J]. Sci Rep, 2020, 10(1): 564-578.
[27] SAVIANO M, AQUINO R P, DEL GAUDIO P, et al. Poly(vinyl alcohol) 3D printed tablets: the effect of polymer particle size on drug loading and process efficiency [J]. Int J Pharm, 2019, 561: 561-568.
[28] DUMPA N R, BANDARI S, REPKA M A. Novel gastroretentive floating pulsatile drug delivery system produced via hot-melt extrusion and fused deposition modeling 3D printing [J]. Pharmaceutics, 2020, 12(1): 52-65.
[29] MATIJASIC G, GRETIC M, KEZERIC K, et al. Preparation of filaments and the 3D printing of dronedarone HCl tablets for treating cardiac arrhythmias [J]. Aaps Pharmscitech, 2019, 20(8): 111-113.
[30] SCOUTARIS N, ROSS S A, DOUROUMIS D. 3D Printed "Starmix" drug loaded dosage forms for paediatric applications [J]. Pharm Res, 2018, 35(2): 42-53.
[31] PANDEY M, CHOUDHURY H, FERN J L C, et al. 3D printing for oral drug delivery: a new tool to customize drug delivery [J]. Drug Deliv Transl Res, 2020: 132-148.
[32] KEMPIN W, DOMSTA V, GRATHOFF G, et al. Immediate release 3D-printed tablets produced via fused deposition modeling of a thermo-sensitive drug [J]. Pharm Res, 2018, 35(6): 31-25.
[33] GULTEKIN H E, TORT S, ACARTURK F. An effective technology for the development of immediate release solid dosage forms containing low-dose drug: fused deposition modeling 3D printing [J]. Pharm Res, 2019, 36(9): 42-56.
[34] XU X W, ZHAO J Z, WANG M N, et al. 3D printed polyvinyl alcohol tablets with multiple release profiles [J]. Sci Rep, 2019, 9: 564-578.
[35] TAGAMI T, NAGATA N, HAYASHI N, et al. Defined drug release from 3D-printed composite tablets consisting of drugloaded polyvinylalcohol and a water-soluble or water-insoluble polymer filler [J]. Int J Pharm, 2018, 543(1-2): 361-367.
[36] TAN Y J N, YONG W P, KOCHHAR J S, et al. On-demand fully customizable drug tablets via 3D printing technology for personalized medicine [J]. J Controlled Release, 2020, 322: 42-52.
[37] GIOUMOUXOUZIS C I, TZIMTZIMIS E, KATSAMENIS O L, et al. Fabrication of an osmotic 3D printed solid dosage form for controlled release of active pharmaceutical ingredients [J]. Eur J Pharm Sci, 2020, 143: 26-39.
[38] CHEN D, XU X Y, LI R, et al. Preparation and in vitro evaluation of FDM 3D-printed ellipsoid-shaped gastric floating tablets with low infill percentages [J]. Aaps Pharmscitech, 2020, 21(1): 23-36.
[39] SHIN S, KIM T H, JEONG S W, et al. Development of a gastroretentive delivery system for acyclovir by 3D printing technology and its in vivo pharmacokinetic evaluation in Beagle dogs [J]. PLoS One, 2019, 14(5): 56-73.
[40] LAMICHHANE S, PARK J B, SOHN D H, et al. Customized novel design of 3D printed pregabalin tablets for intra-gastric floating and controlled release using fused deposition modeling [J]. Pharmaceutics, 2019, 11(11): 564-578.
[41] GIOUMOUXOUZIS C I, BAKLAVARIDIS A, KATSAMENIS O L, et al. A 3D printed bilayer oral solid dosage form combining metformin for prolonged and glimepiride for immediate drug delivery [J]. Eur J Pharm Sci, 2018, 120: 40-52.
[42] PEREIRA B C, ISREB A, FORBES R T, et al. 'Temporary Plasticiser': A novel solution to fabricate 3D printed patient-centred cardiovascular 'Polypill' architectures [J]. Eur J Pharm Biopharm, 2019, 135: 94-103.
[43] GENINA N, BOETKER J P, COLOMBO S, et al. Anti-tuberculosis drug combination for controlled oral delivery using 3D printed compartmental dosage forms: From drug product design to in vivo testing [J]. J Controlled Release, 2017, 268: 40-48.
[44] ZHOU Y H, LIN W, ZHOU W Z, et al. Fused deposition 3D printing technology to prepare digoxin sub-dose tablets [J]. J Guangdong Pharm Coll(广东药科大学学报), 2020, 36(3): 329-333.
[45] MA W. Research progress of 3D printing technology in pharmaceutical preparations[J]. Pharm Today(今日药学), 2018, 28(3):204-206.
[46] TRENFIELD S J, AWAD A, MADLA C M, et al. Shaping the future: recent advances of 3D printing in drug delivery and healthcare [J]. Expert Opin Drug Deliv, 2019, 16(10): 1081-1094.
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