A novel scalable manufacturing process for the production of hydrogel-forming microneedle arrays

International Journal of Pharmaceutics

Volumn 494, Issue 1, 2015, Pages 417-429

  Lutton, Rebecca E M ^a   Larrañeta, Eneko ^a   Kearney, Mary Carmel ^a   Boyd, Peter ^a   Woolfson, A David ^a   Donnelly, Ryan F ^a  

^a QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

Author keywords

Commercialisation; Drug delivery; Injection moulding; Manufacture; Microneedle; Scalable

Indexed keywords

METAL; SILICONE; HYDROGEL; SILICONE DERIVATIVE;

AQUEOUS SOLUTION; ARTICLE; CENTRIFUGATION; COMMERCIAL PHENOMENA; COMPRESSIVE STRENGTH; HYDROGEL; INJECTION MOULDING PROCESS; MICRONEEDLE; MICRONEEDLE ARRAY; MICROTECHNOLOGY; PRIORITY JOURNAL; PROCESS TECHNOLOGY; ROLLER CASTING; SCALE UP; SKIN; CHEMISTRY; DEVICES; DRUG DELIVERY SYSTEM; NEEDLE; PHARMACEUTICS; PROCEDURES; SYNTHESIS;

DRUG DELIVERY SYSTEMS; HYDROGELS; NEEDLES; SILICONES; TECHNOLOGY, PHARMACEUTICAL;

EID: 84940399404     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2015.08.049     Document Type: Article

References (53)

1. S. Aoyagi, H. Izumi, Y. Isono, M. Fukuda, and H. Ogawa Laser fabrication of high aspect ratio thin holes on biodegradable polymer and its application to a microneedle Sens. Actuators A Phys. 139 2007 293 302 10.1016/j.sna.2006.11.022
2. Brookhaven National Laboratory, 2013. Femtosecond Laser Micromachining [WWW Document]. URL http://www.inst.bnl.gov/programs/laseropt/lasers/micromach.shtml (accessed 1.5.14.).
3. ® High Consistency Silicone Rubber. [WWW Document].
4. R. Crowson parts fabrication: principles and process Handbook of Manufacturing Engineering Second ed. 2006 Taylor & Francis
5. G.M. Cruise, D.S. Scharp, J. Hubbell, and a Characterization of permeability and network structure of interfacially photopolymerized poly(ethylene glycol) diacrylate hydrogels Biomaterials 19 1998 1287 1294
6. P.C. DeMuth, Y. Min, B. Huang, J.A. Kramer, A.D. Miller, D.H. Barouch, P.T. Hammond, and D.J. Irvine Polymer multilayer tattooing for enhanced DNA vaccination Nat. Mater. 12 2013 367 376 10.1038/nmat3550
7. R.F. Donnelly, D.I. Morrow, P.A. McCarron, A.D. Woolfson, A. Morrissey, P. Juzenas, A. Juzeniene, V. Iani, H.O. McCarthy, and J. Moan Microneedle arrays permit enhanced intradermal delivery of a preformed photosensitizer Photochem. Photobiol. 85 2009 195 204
8. R.F. Donnelly, M.J. Garland, D.I. Morrow, K. Migalska, T.R. Singh, R. Majithiya, and A.D. Woolfson Optical coherence tomography is a valuable tool in the study of the effects of microneedle geometry on skin penetration characteristics and in-skin dissolution J. Control. Release 147 2010 333 341 10.1016/j.jconrel.2010.08.008
9. R.F. Donnelly, T.R.R. Singh, and A.D. Woolfson Microneedle-based drug delivery systems: microfabrication and safety Drug Deliv. 17 2010 187 207 10.3109/10717541003667798 Microneedle-based
10. R.F. Donnelly, R. Majithiya, T.R.R. Singh, D.I.J. Morrow, M.J. Garland, Y.K. Demir, K. Migalska, E. Ryan, D. Gillen, C.J. Scott, and A.D. Woolfson Design, optimization and characterisation of polymeric microneedle arrays prepared by a novel laser-based micromoulding technique Pharm. Res. 28 2011 41 57 10.1007/s11095-010-0169-8
11. R.F. Donnelly, T.R. Singh, D.I.J. Morrow, and A.D. Woolfson Microneedle Mediated Transdermal and Intradermal Drug Delivery 2012 Wiley-Blackwell Oxford
12. R.F. Donnelly, D.I.J. Morrow, M.T.C. Mccrudden, A.Z. Alkilani, E.M. Vicente-Pérez, C. O'Mahony, P. González-Vázquez, P.A. Mccarron, and A.D. Woolfson Hydrogel-forming and dissolving microneedles for enhanced delivery of photosensitizers and precursors Photochem. Photobiol. 2013 641 647 10.1111/php.12209
13. R.F. Donnelly, M.T.C. McCrudden, A. Zaid Alkilani, E. Larrañeta, E. McAlister, A.J. Courtenay, M.-C. Kearney, T.R.R. Singh, H.O. McCarthy, V.L. Kett, E. Caffarel-Salvador, S. Al-Zahrani, and A.D. Woolfson Hydrogel-forming microneedles prepared from super swelling polymers combined with lyophilised wafers for transdermal drug delivery PLoS One 9 2014 e111547 10.1371/journal.pone.0111547
14. R.F. Donnelly, K. Moffatt, A.Z. Alkilani, E.M. Vicente-Pérez, J. Barry, M.T.C. McCrudden, and A.D. Woolfson Hydrogel-forming microneedle arrays can be effectively inserted in skin by self-application: a pilot study centred on pharmacist intervention and a patient information leaflet Pharm. Res. 2014 1 11 10.1007/s11095-014-1301-
15. H.J.G.E. Gardeniers, R. Luttge, E.J.W. Berenschot, M.J. De Boer, S.Y. Yeshurun, M. Hefetz, R. Van Oever, and A. Van den Berg Silicon Micromachined Hollow Microneedles for Transdermal Liquid Transport J. Microelectromech. Syst. 12 6 2003 855 862
16. M.J. Garland, T.R.R. Singh, A.D. Woolfson, and R.F. Donnelly Electrically enhanced solute permeation across poly(ethylene glycol)-crosslinked poly(methyl vinyl ether-co-maleic acid) hydrogels: effect of hydrogel crosslink density and ionic conductivity Int. J. Pharm. 406 2011 91 98 10.1016/j.ijpharm.2011.01.002
17. S.D. Gittard, B. Chen, H. Xu, A. Ovsianikov, B.N. Chichkov, N. Monteiro-Riviere, and a Narayan The effects of geometry on skin penetration and failure of polymer microneedles J. Adhes. Sci. Technol. 27 2013 227 243 10.1080/01694243.2012.705101
18. Y.A. Gomaa, D.I. Morrow, M.J. Garland, R.F. Donnelly, L.K. El-Khordagui, and V.M. Meidan Effects of microneedle length, density, insertion time and multiple applications on human skin barrier function: assessments by transepidermal water loss Toxicol. In. Vitro 24 2010 1971 1978
19. Hammond, M., 2011. Four tips for successful silicone molding [WWW Document]. Med. Des. URL http://medicaldesign.com/contract-manufacturing/four-tips-successful-silicone-molding (accessed 6.4.15.).
20. H. Huang, L.-M. Yang, and J. Liu Micro-hole drilling and cutting using femtosecond fiber laser Opt. Eng. 53 2014 51513
21. J. Ji, F.E. Tay, J. Miao, and C. Iliescu Microfabricated silicon microneedle array for transdermal drug delivery J. Phys. Conf. Ser. 34 2006 1127 1131 10.1088/1742-6596/34/1/186
22. S. Keten, Z. Xu, B. Ihle, and M.J. Buehler Nanoconfinement controls stiffness, strength and mechanical toughness of [beta]-sheet crystals in silk Nat. Mater. 9 2010 359 367
23. J.D. Kim, M. Kim, H. Yang, K. Lee, and H. Jung Droplet-born air blowing: novel dissolving microneedle fabrication J. Control. Release 170 2013 430 436 http://dx.doi.org/10.1016/j.jconrel.2013.05.026
24. J.S. Kochhar, W.J. Goh, S.Y. Chan, and L. Kang A simple method of microneedle array fabrication for transdermal drug delivery Drug Dev. Ind. Pharm. 39 2013 299 309 10.3109/03639045.2012.679361
25. E. Larrañeta, J. Moore, E.M. Vicente-Pérez, P. González-Vázquez, R. Lutton, A.D. Woolfson, and R.F. Donnelly A proposed model membrane and test method for microneedle insertion studies Int. J. Pharm. 472 2014 65 73 10.1016/j.ijpharm.2014.05.042
26. E. Larrañeta, R.E.M. Lutton, A.J. Brady, E.M. Vicente-Pérez, and A.D. Woolfson Microwave-assisted preparation of hydrogel-forming microneedle arrays for transdermal drug delivery applications Macromol. Mater. Eng. 2015
27. LaserFocusWorld, 2007. INDUSTRIAL LASERS. Laser micromachining expands as technology develops [WWW Document]. URL http://www.laserfocusworld.com/articles/print/volume-43/issue-6/features/industrial-lasers-laser-micromachining-expands-as-technology-develops.html (accessed 1.5.14.).
28. K. Lee, and H. Jung Drawing lithography for microneedles: a review of fundamentals and biomedical applications Biomaterials 33 2012 7309 7326
29. M.A. Ling Teo, C. Shearwood, K.C. Ng, J. Lu, and S. Moochhala In vitro and in vivo characterization of MEMS microneedles Biomed. Microdevices 7 2005 47 52 10.1007/s10544-005-6171-y
30. Y. Liu, E. Lotero, and J.G. Goodwin Effect of water on sulfuric acid catalyzed esterification J. Mol. Catal. A-Chem. 245 2006 132 140
31. R.E.M. Lutton, J. Moore, E. Larrañeta, S. Ligett, A.D. Woolfson, and R.F. Donnelly Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation Drug Deliv. Transl. 5 4 2015 313 331 10.1007/s13346-015-0237-z
32. W. Martanto, S.P. Davis, N.R. Holiday, J. Wang, H.S. Gill, and M.R. Prausnitz Transdermal delivery of insulin using microneedles in vivo Pharm. Res. 21 2004 947 952
33. W. Martanto, J.S. Moore, O. Kashlan, R. Kamath, P.M. Wang, J.M. O'Neal, and M.R. Prausnitz Microinfusion using hollow microneedles Pharm. Res. 23 2006 104 113 10.1007/s11095-005-8498-8
34. C.J. Martin, C.J. Allender, K.R. Brain, Morrissey a, and J.C. Birchall Low temperature fabrication of biodegradable sugar glass microneedles for transdermal drug delivery applications J. Control. Release 158 2012 93 101 10.1016/j.jconrel.2011.10.024
35. K. Migalska, D.I.J. Morrow, M.J. Garland, R. Thakur, A.D. Woolfson, and R.F. Donnelly Laser-engineered dissolving microneedle arrays for transdermal macromolecular drug delivery Pharm. Res. 28 2011 1919 1930 10.1007/s11095-011-0419-4
36. M. Morton Rubber Technology 3rd ed. 2013 Springer Netherlands
37. New World Encyclopedia, 2011. Structural engineering [WWW Document]. URL (accessed 5.28.15.).
38. O. Olatunji, D.B. Das, M.J. Garland, L. Belaid, and R.F. Donnelly Influence of array interspacing on the force required for successful microneedle skin penetration: theoretical and practical approaches J. Pharm. Sci. 102 2013 1209 1221
39. S.-J. Paik, S. Byun, J.-M. Lim, Y. Park, A. Lee, S. Chung, J. Chang, K. Chun, and D. Dan Cho In-plane single-crystal-silicon microneedles for minimally invasive microfluid systems Sens. Actuators A Phys. 114 2004 276 284 10.1016/j.sna.2003.12.029
40. S. Ranganna Handbook of Analysis and Quality Control for Fruit and Vegetable Products 1986 Tata McGraw-Hill Education reprint, r. ed
41. Y. Sato, M. Tsukamoto, T. Nariyama, K. Nakai, F. Matsuoka, K. Takahashi, S. Masuno, T. Ohkubo, and H. Nakano Analysis of laser ablation dynamics of CFRP in order to reduce heat affected zone Proc. SPIE 8967 2014 89670M
42. T.R.R. Singh, P.A. McCarron, A.D. Woolfson, and R.F. Donnelly Investigation of swelling and network parameters of poly(ethylene glycol)-crosslinked poly(methyl vinyl ether-co-maleic acid) hydrogels Eur. Polym. J. 45 2009 1239 1249 10.1016/j.eurpolymj.2008.12.019
43. T.R.R. Singh, M.J. Garland, C.M. Cassidy, K. Migalska, Y.K. Demir, S. Abdelghany, E. Ryan, A.D. Woolfson, R.F. Donnelly, and T.R.R. Singh Microporation techniques for enhanced delivery of therapeutic agents Recent Pat. Drug. Deliv. Formul. 4 1 2010 1 17
44. T.R.R. Singh, A.D. Woolfson, and R.F. Donnelly Investigation of solute permeation across hydrogels composed of poly(methyl vinyl ether-co-maleic acid) and poly(ethylene glycol) J. Pharm. Pharmacol. 62 2010 829 837 10.1211/jpp.62.07.0003
45. Stavinoha, K., 2001. Micromachine with ultrafast pulsing [WWW Document]. LaserFocusWorld. URL http://www.laserfocusworld.com/articles/print/volume-37/issue-6/optoelectronics-world/technology-review/micromachine-with-ultrafast-pulsing.html (accessed 1.5.14.).
46. Trautmann, a., Heuck, F., Mueller, C., Ruther, P., Paul, O., 2005. Replication of microneedle arrays using vacuum casting and hot embossing. Dig. Tech. Pap. - Int. Conf. Solid State Sensors Actuators Microsystems, TRANSDUCERS '05 2, 1420-1423. 2005.1497348.
47. K. Tsuchiya, S. Jinnin, H. Yamamoto, Y. Uetsuji, and E. Nakamachi Design and development of a biocompatible painless microneedle by the ion sputtering deposition method Precis. Eng. 34 2010 461 466 10.1016/j.precisioneng.2010.01.006
48. UL LLC, 2014. Compressive Properties - ISO 604 [WWW Document]. URL asp (accessed 9.29.14.).
49. U.G.K. Wegst, H. Bai, E. Saiz, A.P. Tomsia, and R.O. Ritchie Bioinspired structural materials Nat. Mater. 14 2015 23 36
50. K.L. Yung, Y. Xu, C. Kang, H. Liu, K.F. Tam, S.M. Ko, F.Y. Kwan, and T.M.H. Lee Sharp tipped plastic hollow microneedle array by microinjection moulding J. Micromech. Microeng. 22 2012 015016 10.1088/0960-1317/22/1/015016
51. 2 laser cutting of low carbon steel (S235) AIP Conf. Proc. 1569 2013
52. J. Zhang, Z. Wang, J. Liu, S. Chen, and G. Liu Self-assembled Nanostructures Science and Technology 2006 Springer US
53. J. Zhu, Q. Shen, Y. Cao, H. Wang, X. Chen, and D. Chen Characterization of out-of-plane cone metal microneedles and the function of transdermal delivery Microsyst. Technol. 19 2012 617 621 10.1007/s00542-012-1672-0