Investigating the application of FDM 3D printing pattern in preparation of patient-tailored dosage forms
Abstract
Aim: The aim of this work was to investigate the effect of printing pattern on physical attributes and dissolution of fused deposition modeling 3D printed caplets. Methods: Hydrochlorothiazide-loaded polyvinyl alcohol filaments were prepared by hot melt extrusion. Caplets printed in hexagonal (HexCap), diamond infill (DiaCap) in three different sizes using fused deposition modeling 3D printer and evaluated for hardness, disintegration and dissolution. Results: DiaCaps exhibited higher hardness than HexCaps. Disintegration time for HexCaps was <20 mins. while DiaCaps took 25–40 mins. DiaCaps showed 20–30% lower release at all time points compared with HexCaps. Conclusion: Although composition, processing parameters were same, mere change in printing pattern alters disintegration and dissolution. Findings of this study can be invaluable in developing patient-tailored medicines.
References
- 1 US FDA. Paving the way for personalized medicine (2013). https://www.fdanews.com/ext/resources/files/10/10-28-13-Personalized-Medicine.pdf (last accessed on January 11th 2018).
- 2 . Emergence of 3D printed dosage forms: opportunities and challenges. Pharm. Res. 33(8), 1817–1832 (2016).
- 3 . Fabrication of extended-release patient-tailored prednisolone tablets via fused deposition modelling (FDM) 3D printing. Eur. J. Pharm. Sci. 68, 11–17 (2015).
- 4 Defined drug release from 3D-printed composite tablets consisting of drug-loaded polyvinylalcohol and a water-soluble or water-insoluble polymer filler. Int. J. Pharm. 543(1–2), 361–367 (2018).
- 5 Drug delivery systems for programmed and on-demand release. Adv. Drug Deliv. Rev. 132, 104–138 (2018).
- 6 3D printing of medicines: engineering novel oral devices with unique design and drug release characteristics. Mol. Pharm. 12(11), 4077–4084 (2015).
- 7 . 3D printed drug delivery and testing systems – a passing fad or the future? Adv. Drug Deliv. Rev. 132, 139–168 (2018).
- 8 . Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms. Expert Opin. Drug Deliv. 12(11), 1727–1740 (2015).
- 9 Nanosuspensions as advanced printing ink for accurate dosing of poorly soluble drugs in personalized medicines. Int. J. Pharm. 420(1), 93–100 (2011).
- 10 A step toward development of printable dosage forms for poorly soluble drugs. J. Pharm. Sci. 102(10), 3694–3704 (2013).
- 11 . Personalized therapeutics and pharmacogenomics: integral to personalized health care. Pharm. Res. 34(8), 1535–1538 (2017).
- 12 . Oral drug delivery in personalized medicine: unmet needs and novel approaches. Int. J. Pharm. 404(1–2), 1–9 (2011).
- 13 . Regulating 3D-printed medical products. Sci. Transl. Med. 10(461), eaan6521 (2018).
- 14 . 3D printed medicines: a new branch of digital healthcare. Int. J. Pharm. 548, 586–596 (2018).
- 15 . 3D printing in pharmaceutical and medical applications – recent achievements and challenges. Pharm. Res. 35(9), 176 (2018).
- 16 . Reshaping drug development using 3D printing. Drug Discov. Today 23, 1547–1555 (2018).
- 17 . Effect of geometry on drug release from 3D printed tablets. Int. J. Pharm. 494(2), 657–663 (2015).
- 18 3D printed orodispersible films with aripiprazole. Int. J. Pharm. 533(2), 413–420 (2017).
- 19 . 3D printing pharmaceuticals: drug development to frontline care. Trends Pharmacol. Sci. 39(5), 440–451 (2018).
- 20 . An investigation into the use of polymer blends to improve the printability of and regulate drug release from pharmaceutical solid dispersions prepared via fused deposition modeling (FDM) 3D printing. Eur. J. Pharm. Biopharm. 108, 111–125 (2016).
- 21 . 3D printing in pharmaceutics: a new tool for designing customized drug delivery systems. Int. J. Pharm. 499(1–2), 376–394 (2016).
- 22 . A new chapter in pharmaceutical manufacturing: 3D-printed drug products. Adv. Drug Deliv. Rev. 108, 39–50 (2017).
- 23 . A lower temperature FDM 3D printing for the manufacture of patient-specific immediate release tablets. Pharm. Res. 33(11), 2704–2712 (2016).
- 24 Adaptation of pharmaceutical excipients to FDM 3D printing for the fabrication of patient-tailored immediate release tablets. Int. J. Pharm. 513(1–2), 659–668 (2016).
- 25 . Addressing unmet clinical needs with 3D printing technologies. Adv. Healthcare Mater. 7(17), 1800417 (2018).
- 26 Material considerations for fused-filament fabrication of solid dosage forms. Pharmaceutics 10(2), 44 (2018).
- 27 . Channelled tablets: an innovative approach to accelerating drug release from 3D printed tablets. J. Control. Rel. 269, 355–363 (2018).
- 28 . Formulation of 3D printed tablet for rapid drug release by fused deposition modeling: screening polymers for drug release, drug-polymer miscibility and printability. J. Pharm. Sci. 107(1), 390–401 (2018).
- 29 . 3D printing in pharmaceutics: a new tool for designing customized drug delivery systems. Int. J. Pharm. 499(1–2), 376–394 (2016).
- 30 . Coupling 3D printing with hot-melt extrusion to produce controlled-release tablets. Int. J. Pharm. 519(1–2), 186–197 (2017).
- 31 . Nimodipine semi-solid capsules containing solid dispersion for improving dissolution. Int. J. Pharm. 359(1–2), 144–149 (2008).
- 32 . 3D printing of modified-release aminosalicylate (4-ASA and 5-ASA) tablets. Eur. J. Pharm. Biopharm. 89, 157–162 (2015).
- 33 . Desktop 3D printing of controlled release pharmaceutical bilayer tablets. Int. J. Pharm. 461(1–2), 105–111 (2014).
- 34 . A flexible-dose dispenser for immediate and extended release 3D printed tablets. Eur. J. Pharm. Biopharm. 96, 380–387 (2015).
- 35 . Formulation of 3D printed tablet for rapid drug release by fused deposition modeling: screening polymers for drug release, drug-polymer miscibility and printability. J. Pharma. Sci. 107(1), 390–401 (2018).
- 36 . Personalised 3D printed medicines: which techniques and polymers are more successful? Bioengineering 4(4), 79 (2017).
- 37 PET/CT imaging of 3D printed devices in the gastrointestinal tract of rodents. Int. J. Pharm. 536(1), 158–164 (2018).
- 38 . 3D-printing and the effect on medical costs: a new era? Expert Rev. Pharmacoeconomics Outcomes Res. 16(1), 23–32 (2016).
- 39 . Tuning solubility and stability of hydrochlorothiazide co-crystals. Acta Crystallogr. B 70(1), 81–90 (2014).
- 40 . Application of 3D printing technology and quality by design approach for development of age-appropriate pediatric formulation of baclofen. Int. J. Pharm. 556, 106–116 (2018).
- 41 . Development of a solid supersaturated self-nanoemulsifying preconcentrate (S-superSNEP) of fenofibrate using dimethylacetamide and a novel co-processed excipient. Drug Dev. Ind. Pharm. 1–10 (2018).
- 42 . Stability and solubility of celecoxib-PVP amorphous dispersions: a molecular perspective. Pharm. Res. 21(10), 1762–1769 (2004).
- 43 Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs 74(16), 1871–1889 (2014).
- 44 . Patient acceptability of 3D printed medicines. Int. J. Pharm. 530(1–2), 71–78 (2017).
- 45 . Investigation of thermal and viscoelastic properties of polymers relevant to hot melt extrusion, IV: affinisol HPMC HME polymers. AAPS PharmSciTech 17(1), 148–157 (2016).
- 46 . Polyvinyl alcohol in hot melt extrusion to improve the solubility of drugs (2017). https://www.europeanpharmaceuticalreview.com/wp-content/uploads/PVA-in-HME-to-Improve-Solubility_Poster_A3_EN_MSIG_Mar2017_low.pdf (last accessed on January 11th 2018).
- 47 . Hot-melt extrusion of polyvinyl alcohol for oral immediate release applications. Int. J. Pharm. 492(1–2), 1–9 (2015).
- 49 . Hot-melt extruded filaments based on pharmaceutical grade polymers for 3D printing by fused deposition modeling. 509(1–2), 255–263 (2016).
- 50 . Kinetic modeling on drug release from controlled drug delivery systems. Acta Pol. Pharm. 67(3), 217–223 (2010).
- 51 . Modeling and comparison of dissolution profiles. Eur. J. Pharm. Sci. 13(2), 123–133 (2001).
- 52 Quality by design approach to understand the physicochemical phenomena involved in controlled release of captopril SR matrix tablets. Int. J. Pharm. 477(1–2), 431–441 (2014).
- 53 . Kinetics of drug release from hydrogel matrices. J. Control. Rel. 2, 277–288 (1985).
- 54 . Application of fused deposition modelling (FDM) method of 3D printing in drug delivery. Curr. Pharm. Des. 23(3), 433–439 (2017).
- 55 . Fused-filament 3D printing of drug products: microstructure analysis and drug release characteristics of PVA-based caplets. Int. J. Pharm. 514(1), 290–295 (2016).
- 56 Extrusion 3D printing of paracetamol tablets from a single formulation with tunable release profiles through control of tablet geometry. AAPS PharmSciTech 19(8), 3403–3416 (2018).
- 57 . 3D printed oral solid dosage forms containing hydrochlorothiazide for controlled drug delivery. J. Drug Deliv. Sci. Technol. 40, 164–171 (2017).
- 58 . 3D printing of five-in-one dose combination polypill with defined immediate and sustained release profiles. J. Control. Release 217, 308–314 (2015).