Preparation and characterization of polypills containing aspirin and simvastatin using 3D printing technology for the prevention of cardiovascular diseases

References

• World Health Organization [Internet]. [cited 2012 Nov 22]. Available from: http://www.who.int/mediacentre/news/notes/2012/ncd_20121109/en/index.html
   Google Scholar
• Chow CK, Meng Q. Polypills for primary prevention of cardiovascular disease. Nat Rev Cardiol. 2019;16(10):602–611.
   PubMed Web of Science ®Google Scholar
• Kumar V, Prasad B, Singh S. Pharmaceutical issues in the development of a polypill for the treatment of cardiovascular diseases. Drug Discov Today Ther Strateg. 2008;5(1):63–71.
   Google Scholar
• Genina N, Boetker JP, 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 Control Release. 2017;268:40–48.
   PubMed Web of Science ®Google Scholar
• Alhnan MA, Okwuosa TC, Sadia M, et al. Emergence of 3D printed dosage forms: opportunities and challenges. Pharm Res. 2016;33(8):1817–1832.
   PubMed Web of Science ®Google Scholar
• Trenfield SJ, Awad A, Madla CM, et al. Shaping the future: recent advances of 3D printing in drug delivery and healthcare. Expert Opin Drug Deliv. 2019;16(10):1081–1094.
   PubMed Web of Science ®Google Scholar
• Awad A, Yao A, Trenfield SJ, et al. 3D printed tablets (printlets) with Braille and Moon patterns for visually impaired patients. Pharmaceutics. 2020;12(2):172.
   Web of Science ®Google Scholar
• Liang K, Carmone S, Brambilla D, et al. 3D printing of a wearable personalized oral delivery device: a first-in-human study. Sci Adv. 2018;4(5):eaat2544.
   PubMed Web of Science ®Google Scholar
• Goyanes A, Madla CM, Umerji A, et al. Automated therapy preparation of isoleucine formulations using 3D printing for the treatment of MSUD: first single-centre, prospective, crossover study in patients. Int J Pharm. 2019;567:118497.
   PubMed Web of Science ®Google Scholar
• Goyanes A, Scarpa M, Kamlow M, et al. Patient acceptability of 3D printed medicines. Int J Pharm. 2017;530(1–2):71–78.
   PubMedGoogle Scholar
• Trenfield SJ, Tan HX, Goyanes A, et al. Non-destructive dose verification of two drugs within 3D printed polyprintlets. Int J Pharm. 2020;577:119066.
   PubMed Web of Science ®Google Scholar
• Awad A, Fina F, Trenfield SJ, et al. 3D printed pellets (miniprintlets): a novel, multi-drug, controlled release platform technology. Pharmaceutics. 2019;11(4):148.
   Web of Science ®Google Scholar
• Robles-Martinez P, Xu X, Trenfield SJ, et al. 3D printing of a multi-layered polypill containing six drugs using a novel stereolithographic method. Pharmaceutics. 2019;11(6):274.
   Web of Science ®Google Scholar
• Xu X, Robles-Martinez P, Madla CM, et al. Stereolithography (SLA) 3D printing of an antihypertensive polyprintlet: case study of an unexpected photopolymer-drug reaction. Addit Manuf. 2020;33:101071.
   Web of Science ®Google Scholar
• Khaled SA, Burley JC, Alexander MR, et al. 3D printing of five-in-one dose combination polypill with defined immediate and sustained release profiles. J Control Release. 2015;217:308–314.
   PubMed Web of Science ®Google Scholar
• Alomari M, Vuddanda PR, Trenfield SJ, et al. Printing T3 and T4 oral drug combinations as a novel strategy for hypothyroidism. Int J Pharm. 2018;549(1–2):363–369.
   PubMedGoogle Scholar
• Pereira BC, Isreb A, Forbes RT, et al. ‘Temporary Plasticiser’: a novel solution to fabricate 3D printed patient-centred cardiovascular ‘Polypill’ architectures. Eur J Pharm Biopharm. 2019;135:94–103.
   PubMed Web of Science ®Google Scholar
• Goyanes A, Wang J, Buanz A, et al. 3D printing of medicines: engineering novel oral devices with unique design and drug release characteristics. Mol Pharm. 2015;12(11):4077–4084.
   PubMed Web of Science ®Google Scholar
• Maroni A, Melocchi A, Parietti F, et al. 3D printed multi-compartment capsular devices for two-pulse oral drug delivery. J Control Release. 2017;268:10–18.
   PubMed Web of Science ®Google Scholar
• Jamróz W, Szafraniec J, Kurek M, et al. 3D printing in pharmaceutical and medical applications – recent achievements and challenges. Pharm Res. 2018;35(9):176
   PubMed Web of Science ®Google Scholar
• Fina F, Goyanes A, Gaisford S, et al. Selective laser sintering (SLS) 3D printing of medicines. Int J Pharm. 2017;529(1–2):285–293.
   PubMed Web of Science ®Google Scholar
• Tan D, Nokhodchi A, Maniruzzaman M. 3D and 4D printing technologies: innovative process engineering and smart additive manufacturing. In: Maniruzzaman M, editor. 3D and 4D printing in biomedical applications: process engineering and additive manufacturing. Newark (NJ): Wiley; 2019. p. 25–52.
   Google Scholar
• Ligon SC, Liska R, Stampfl J, et al. Polymers for 3D printing and customized additive manufacturing. Chem Rev. 2017;117(15):10212–10290.
   PubMed Web of Science ®Google Scholar
• Heller C, Schwentenwein M, Russmueller G, et al. Vinyl esters: low cytotoxicity monomers for the fabrication of biocompatible 3D scaffolds by lithography based additive manufacturing. J Polym Sci A Polym Chem. 2009;47(24):6941–6954.
   Web of Science ®Google Scholar
• Sandler N, Määttänen A, Ihalainen P, et al. Inkjet printing of drug substances and use of porous substrates-towards individualized dosing. J Pharm Sci. 2011;100(8):3386–3395.
   PubMed Web of Science ®Google Scholar
• Azad MA, Olawuni D, Kimbell G, et al. Polymers for extrusion-based 3D printing of pharmaceuticals: a holistic materials–process perspective. Pharmaceutics. 2020;12(2):124.
   PubMed Web of Science ®Google Scholar
• Khaled SA, Alexander MR, Irvine DJ, et al. Extrusion 3D printing of paracetamol tablets from a single formulation with tunable release profiles through control of tablet geometry. AAPS PharmSciTech. 2018;19(8):3403–3413.
   PubMed Web of Science ®Google Scholar
• Linares V, Casas M, Caraballo I. Printfills: 3D printed systems combining fused deposition modeling and injection volume filling. Application to colon-specific drug delivery. Eur J Pharm Biopharm. 2019;134:138–143.
   PubMed Web of Science ®Google Scholar
• Goyanes A, Martinez PR, Buanz A, et al. Effect of geometry on drug release from 3D printed tablets. Int J Pharm. 2015;494(2):657–663.
   PubMed Web of Science ®Google Scholar
• Homaee Borujeni S, Mirdamadian SZ, Varshosaz J, et al. Three-dimensional (3D) printed tablets using ethyl cellulose and hydroxypropyl cellulose to achieve zero order sustained release profile. Cellulose. 2020;27(3):1573–1589.
   Web of Science ®Google Scholar
• Liu S, Zhao P, Wu S, et al. A Pellet 3D printer: device design and process parameters optimization. Adv Polym Technol. 2019;2019:1–8.
   Web of Science ®Google Scholar
• Goyanes A, Allahham N, Trenfield SJ, et al. Direct powder extrusion 3D printing: fabrication of drug products using a novel single-step process. Int J Pharm. 2019;567:118471.
   PubMed Web of Science ®Google Scholar
• Munjal M, Stodghill SP, ElSohly MA, et al. Polymeric systems for amorphous Δ9-tetrahydrocannabinol produced by a hot-melt method. Part I: chemical and thermal stability during processing. J Pharm Sci. 2006;95(8):1841–1853.
   PubMed Web of Science ®Google Scholar
• Munjal M, ElSohly MA, Repka MA. Polymeric systems for amorphous Δ9-tetrahydrocannabinol produced by a hot-melt method. Part II: effect of oxidation mechanisms and chemical interactions on stability. J Pharm Sci. 2006;95(11):2473–2485.
   PubMed Web of Science ®Google Scholar
• Newa M, Bhandari KH, Kim JA, et al. Preparation and evaluation of fast dissolving ibuprofen-polyethylene glycol 6000 solid dispersions. Drug Deliv. 2008;15(6):355–364.
   PubMed Web of Science ®Google Scholar
• Kamel R, Abbas H. PLGA-based monolithic filaments prepared by hot-melt extrusion: in-vitro comparative study. Ann Pharm Françaises. 2018;76(2):97–106.
   PubMedGoogle Scholar
• Zhang J, Feng X, Patil H, et al. Coupling 3D printing with hot-melt extrusion to produce controlled-release tablets. Int J Pharm. 2017;519(1–2):186–197.
   PubMed Web of Science ®Google Scholar
• Tagami T, Fukushige K, Ogawa E, et al. 3D printing factors important for the fabrication of polyvinylalcohol filament-based tablets. Biol Pharm Bull. 2017;40(3):357–364.
   PubMed Web of Science ®Google Scholar
• 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. Eur J Pharm Sci. 2018;118:191–199.
   PubMed Web of Science ®Google Scholar
• Wang L, Asgharnejad M. Second-derivative UV spectrometric determination of simvastatin in its tablet dosage form. J Pharm Biomed Anal. 2000;21(6):1243–1248.
   PubMed Web of Science ®Google Scholar
• Juhl WE, Kirchhoefer RD. Aspirin – a national survey I: semiautomated determination of aspirin in bulk and tablet formulations and salicylic acid in tablet formulations. J Pharm Sci. 1980;69(5):544–548.
   PubMed Web of Science ®Google Scholar
• Sadia M, Isreb A, Abbadi I, et al. From ‘fixed dose combinations’ to ‘a dynamic dose combiner’: 3D printed bi-layer antihypertensive tablets. Eur J Pharm Sci. 2018;123:484–494.
   PubMed Web of Science ®Google Scholar
• Hao S, Wang B, Wang Y, et al. Preparation of Eudragit L 100-55 enteric nanoparticles by a novel emulsion diffusion method. Colloids Surf B Biointerfaces. 2013;108:127–133.
   PubMed Web of Science ®Google Scholar
• Wen H, Jung H, Li X. Drug delivery approaches in addressing clinical pharmacology-related issues: opportunities and challenges. AAPS J. 2015;17(6):1327–1340.
   PubMed Web of Science ®Google Scholar
• Tubic-Grozdanis M, Hilfinger JM, Amidon GL, et al. Pharmacokinetics of the CYP 3A substrate simvastatin following administration of delayed versus immediate release oral dosage forms. Pharm Res. 2008;25(7):1591–1600.
   PubMed Web of Science ®Google Scholar
• Tan DK, Maniruzzaman M, Nokhodchi A. Development and optimisation of novel polymeric compositions for sustained release theophylline caplets (PrintCap) via FDM 3D printing. Polymers. 2019;12(1):27.
   Web of Science ®Google Scholar
• Korte C, Quodbach J. Formulation development and process analysis of drug-loaded filaments manufactured via hot-melt extrusion for 3D-printing of medicines. Pharm Dev Technol. 2018;23(10):1117–1127.
   PubMed Web of Science ®Google Scholar
• Oblom H, Zhang J, Pimparade M, et al. 3D-printed isoniazid tablets for the treatment and prevention of tuberculosis-personalized dosing and drug release. AAPS PharmSciTech. 2019;20(2):52.
   PubMed Web of Science ®Google Scholar
• Melocchi A, Parietti F, Maroni A, et al. Hot-melt extruded filaments based on pharmaceutical grade polymers for 3D printing by fused deposition modeling. Int J Pharm. 2016;509(1–2):255–263.
   PubMed Web of Science ®Google Scholar
• Thiry J, Krier F, Evrard B. A review of pharmaceutical extrusion: critical process parameters and scaling-up. Int J Pharm. 2015;479(1):227–240.
   PubMed Web of Science ®Google Scholar
• Capone C, Di Landro L, Inzoli F, et al. Thermal and mechanical degradation during polymer extrusion processing. Polym Eng Sci. 2007;47(11):1813–1819.
   Web of Science ®Google Scholar
• Van Duong T, Reekmans G, Venkatesham A, et al. Spectroscopic investigation of the formation and disruption of hydrogen bonds in pharmaceutical semicrystalline dispersions. Mol Pharm. 2017;14(5):1726–1741.
   PubMedGoogle Scholar
• Joshi BV, Patil VB, Pokharkar VB. Compatibility studies between carbamazepine and tablet excipients using thermal and non-thermal methods. Drug Dev Ind Pharm. 2002;28(6):687–694.
   PubMed Web of Science ®Google Scholar
• Botha SA, Lötter AP. Compatibility study between naproxen and tablet excipients using differential scanning calorimetry. Drug Dev Ind Pharm. 1990;16(4):673–683.
   Web of Science ®Google Scholar
• Juluri A, Popescu C, Zhou L, et al. Taste masking of griseofulvin and caffeine anhydrous using Kleptose Linecaps DE17 by hot melt extrusion. AAPS PharmSciTech. 2016;17(1):99–105.
   PubMed Web of Science ®Google Scholar
• Jayaramudu T, Raghavendra GM, Varaprasad K, et al. Preparation and characterization of poly(ethylene glycol) stabilized nano silver particles by a mechanochemical assisted ball mill process. J Appl Polym Sci. 2016;133(7):43027–43035.
   Web of Science ®Google Scholar
• Gu F, Ning J, Fan H, et al. Preparation and characterization of simvastatin/DMβCD complex and its pharmacokinetics in rats. Acta Pharm. 2018;68(2):145–157.
   PubMed Web of Science ®Google Scholar
• Campanella L, Micieli V, Tomassetti M, et al. Quantitative determination of acetylsalicylic acid in commercial drugs using DSC: comparison with titration and UV spectrophotometric methods. J Therm Anal Calorim. 2010;102(1):249–259.
   Web of Science ®Google Scholar
• Akhayere E, Kavaz D, Vaseashta A. Synthesizing nano silica nanoparticles from barley grain waste: effect of temperature on mechanical properties. Polish J Environ Stud. 2019;28:1–9.
   Web of Science ®Google Scholar
• Fayed MH, Mahrous GM, Ibrahim MA, et al. Influence of Carbopol 71G-NF on the release of dextromethorphan hydrobromide from extended-release matrix tablets. Pharm Dev Technol. 2013;18(5):971–981.
   PubMed Web of Science ®Google Scholar
• Fini A, Moyano JR, Ginés JM, et al. Diclofenac salts, II. Solid dispersions in PEG6000 and Gelucire 50/13. Eur J Pharm Biopharm. 2005;60(1):99–111.
   PubMed Web of Science ®Google Scholar
• Scoutaris N, Ross S, Douroumis D. 3D printed “Starmix” drug loaded dosage forms for paediatric applications. Pharm Res. 2018;35(2):34–45.
   PubMed Web of Science ®Google Scholar
• Venkataram S, Khohlokwane M, Wallis SH. Differential scanning calorimetry as a quick scanning technique for solid state stability studies. Drug Dev Ind Pharm. 1995;21(7):847–855.
   Web of Science ®Google Scholar
• Rao M, Ranpise A, Borate S, et al. Mechanistic evaluation of the effect of sintering on Compritol 888 ATO matrices. AAPS PharmSciTech. 2009;10(2):355–360.
   PubMed Web of Science ®Google Scholar
• Islam MT, Scoutaris N, Maniruzzaman M, et al. Implementation of transmission NIR as a PAT tool for monitoring drug transformation during HME processing. Eur J Pharm Biopharm. 2015;96:106–116.
   PubMed Web of Science ®Google Scholar