Transdermal delivery of relatively high molecular weight drugs using novel self-dissolving microneedle arrays fabricated from hyaluronic acid and their characteristics and safety after application to the skin

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 86, Issue 2, 2014, Pages 267-276

  Liu, Shu ^a   Jin, Mei Na ^a   Quan, Ying Shu ^a,b   Kamiyama, Fumio ^b   Kusamori, Kosuke ^a   Katsumi, Hidemasa ^a   Sakane, Toshiyasu ^a   Yamamoto, Akira ^a  

^a KYOTO PHARMACEUTICAL UNIVERSITY   (Japan)

^b CosMED Pharmaceutical Co Ltd ^*  (Japan)

Author keywords

Absorption enhancement; Barrier disruption; Drug absorption; Hyaluronic acid; Microneedle; Transdermal absorption; Transdermal drug delivery

Indexed keywords

DEXTRAN; FLUORESCEIN ISOTHIOCYANATE; HYALURONIC ACID;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DISSOLUTION; DRUG DELIVERY DEVICE; DRUG FORMULATION; DRUG PENETRATION; DRUG SAFETY; FLUORESCENCE MICROSCOPE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; IN VITRO STUDY; MALE; MICRONEEDLE; MOLECULAR WEIGHT; NONHUMAN; RAT; SKIN CONDUCTANCE; SKIN IRRITATION; SKIN WATER LOSS; SKINFOLD THICKNESS; STRATUM CORNEUM; TRANSDERMAL DRUG ADMINISTRATION;

ABSORPTION ENHANCEMENT; BARRIER DISRUPTION; DRUG ABSORPTION; HYALURONIC ACID; MICRONEEDLE; TRANSDERMAL ABSORPTION; TRANSDERMAL DRUG DELIVERY;

ADMINISTRATION, CUTANEOUS; ANIMALS; DEXTRANS; DRUG DELIVERY SYSTEMS; FLUORESCEIN-5-ISOTHIOCYANATE; HUMANS; HYALURONIC ACID; MICROINJECTIONS; MOLECULAR WEIGHT; NEEDLES; PERMEABILITY; PHARMACEUTICAL PREPARATIONS; RATS; SAFETY; SKIN; SKIN ABSORPTION;

EID: 84896404676     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2013.10.001     Document Type: Article

References (47)

1. Y.C. Kim, J.H. Park, and M.R. Prausnitz Microneedles for drug and vaccine delivery Adv. Drug Deliv. Rev. 64 2012 1547 1568
2. V. Sachdeva, and A.K. Banga Microneedles and their applications Recent Pat. Drug Deliv. Formul. 5 2011 95 132
3. D.V. McAllister, P.M. Wang, S.P. Davis, J.H. Park, P.J. Canatella, M.G. Allen, and M.R. Prausnitz Microfabricated needles for transdermal delivery of macromolecules and nanoparticles: fabrication methods and transport studies Proc. Natl. Acad. Sci. U.S.A. 100 2003 13755 13760 (Pubitemid 37499139)
4. R.K. Sivamani, B. Stoeber, G.C. Wu, H. Zhai, D. Liepmann, and H. Maibach Clinical microneedle injection of methyl nicotinate: stratum corneum penetration Skin Res. Technol. 11 2005 152 156 (Pubitemid 40542856)
5. 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 (Pubitemid 43214666)
6. S.A. Coulman, A. Anstey, C. Gateley, A. Morrissey, P. McLoughlin, C. Allender, and J.C. Birchall Microneedle mediated delivery of nanoparticles into human skin Int. J. Pharm. 2009 190 200
7. S. Kaushik, A.H. Hord, D.D. Denson, D.V. McAllister, S. Smitra, M.G. Allen, and M.R. Prausnitz Lack of pain associated with microfabricated microneedles Anesth. Analg. 92 2001 502 504 (Pubitemid 32127644)
8. H.S. Gill, D.D. Denson, B.A. Burris, and M.R. Prausnitz Effect of microneedle design on pain in human volunteers Clin. J. Pain. 24 2008 585 594
9. M.R. Prausnitz Microneedles for transdermal drug delivery Adv. Drug Deliv. Rev. 56 2004 581 587 (Pubitemid 38326934)
10. Y. Xie, B. Xu, and Y. Gao Controlled transdermal delivery of model drug compounds by MEMS microneedle array Nanomedicine 1 2005 184 190 (Pubitemid 43963615)
11. R.F. Donnelly, D.I.J. Morrow, P.A. McCarron, A.D. Woolfson, A. Morrissey, P. Juzenas, A. Juzeniene, V. Iani, H.O. McCarthy, and J. Moan Microneedle-mediated intradermal delivery of 5-aminolevulinic acid: Potential for enhanced topical photodynamic therapy J. Control. Release 129 2008 154 162
12. G. Yan, K.S. Warner, J. Zhang, S. Sharma, and B.K. Gale Evaluation needle length and density of microneedle arrays in the pretreatment of skin for transdermal drug delivery Int. J. Pharm. 391 2010 7 12
13. S.L. Banks, R.R. Pinninti, H.S. Gill, P.A. Crooks, M.R. Prausnitz, and A.L. Stinchcomb Flux across microneedle-treated skin is increased by increasing charge of naltrexone and naltrexol in vitro Pharm. Res. 25 2008 1677 1685
14. H. Chen, H. Zhu, J. Zheng, D. Mou, J. Wan, J. Zhang, T. Shi, Y. Zhao, H. Xu, and X. Yang Iontophoresis-driven penetration of nanovesicles through microneedle-induced skin microchannels for enhancing transdermal delivery of insulin J. Control. Release 139 2009 63 72
15. A.J. Harvey, S.A. Kaestner, D.E. Sutter, N.G. Harvey, J.A. Mikszta, and R.J. Pettis Microneedle-based intradermal delivery enables rapid lymphatic uptake and distribution of protein drugs Pharm. Res. 28 2011 107 116
16. P.M. Wang, M. Cornwell, J. Hill, and M.R. Prausnitz Precise microinjection into skin using hollow microneedles J. Invest. Dermatol. 126 2006 1080 1087
17. Y. Wu, Y. Gao, G. Qin, S. Zhang, Y. Qiu, F. Li, and B. Xu Sustained release of insulin through skin by intradermal microdelivery system Biomed. Microdev. 12 2010 665 671
18. C.P. Zhou, Y.L. Liu, H.L. Wang, P.X. Zhang, and J.L. Zhang Transdermal delivery of insulin using microneedle rollers in vivo Int. J. Pharm. 392 2010 127 133
19. X. Chen, T.W. Prow, M.L. Crichton, D.W.K. Jenkins, M.S. Roberts, I.H. Frazer, G.J.P. Fernando, and M.A.F. Kendall Dry-coated microprojection array patches for targeted delivery of immunotherapeutics to the skin J. Control. Release 139 2009 212 220
20. H.S. Gill, and M.R. Prausnitz Coating formulations for microneedles Pharm. Res. 24 2007 1369 1380 (Pubitemid 46870599)
21. H.S. Gill, and M.R. Prausnitz Coated microneedles for transdermal delivery J. Control. Release 117 2007 227 237 (Pubitemid 46161873)
22. J.H. Park, M.G. Allen, and M.R. Prausnitz Polymer microneedles for controlled-release drug delivery Pharm. Res. 23 2006 1008 1019 (Pubitemid 43781409)
23. C.Y. Jin, M.H. Han, S.S. Lee, and Y.H. Choi Mass producible and biocompatible microneedle patch and functional verification of its usefulness for transdermal drug delivery Biomed. Microdev. 11 2009 1195 1203
24. 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 characterization of polymeric microneedle arrays prepared by a novel laser-based micromoulding technique Pharm. Res. 28 2011 41 57
25. Y. Ito, E. Hagiwara, A. Saeki, N. Sugioka, and K. Takada Feasibility of microneedles for percutaneous absorption of insulin Eur. J. Pharm. Sci. 29 2006 82 88 (Pubitemid 44279397)
26. J.W. Lee, J.H. Park, and M.R. Prausnitz Dissolving microneedles for transdermal drug delivery Biomaterials 29 2008 2113 2124
27. G. Li, A. Badkar, S. Nema, C.S. Kolli, and A.K. Banga In vitro transdermal delivery of therapeutic antibodies using maltose microneedles Int. J. Pharm. 368 2008 109 115
28. R.F. Donnelly, D.I.J. Morrow, R. Majithiya, T.R.R. Singh, K. Migalska, P.A. McCarron, C. O'Mahony, and A.D. Woolfson Processing difficulties and instability of carbohydrate microneedle arrays Drug Dev. Ind. Pharm. 35 2009 1242 1254
29. Y. Ito, H. Murano, N. Hamasaki, K. Fukushima, and K. Takada Incidence of low bioavailability of leuprolide acetate after percutaneous administration to rats by dissolving microneedles Int. J. Pharm. 407 2011 126 131
30. J.H. Park, M.G. Allen, and M.R. Prausnitza Biodegradable polymer microneedles: Fabrication, mechanics and transdermal drug delivery J. Control. Release 104 2005 51 66 (Pubitemid 40615235)
31. M. Takaya, T. Yoshikazu, K. Takahiro, M. Yasushi, T. Hitoshi, W. Makoto, and H. Katsumi Sugar micro needles as transdermal drug delivery system Biomed. Microdev. 7 2005 185 188
32. S.P. Sullivan, D.G. Koutsonanos, M. Del Pilar Martin, J.W. Lee, V. Zarnitdyn, S.O. Choi, N. Murthy, R.W. Compans, I. Skountzou, and M.R. Prausnitz Dissolving polymer microneedle patches for influenza vaccination Nat. Med. 16 2010 915 920
33. H. Katsumi, S. Liu, Y. Tanaka, K. Hitomi, R. Hayashi, Y. Hirai, K. Kusamori, Y.-S. Quan, F. Kamiyama, T. Sakane, and A. Yamamoto Development of a novel self-dissolving microneedle array of alendronate, a nitrogen-containing bisphosphonate: evaluation of transdermal absorption, safety, and pharmacological effects after application in rats J. Pharm. Sci. 101 2011 3220 3238
34. S. Liu, M. Jin, Y.-S. Quan, F. Kamiyama, H. Katsumi, T. Sakane, and A. Yamamoto The development and characteristics of novel microneedle arrays fabricated from hyaluronic acid, and their application in transdermal delivery of insulin J. Control. Release 161 2012 933 941
35. J.H. Draize, G. Woodard, and H.O. Calvery Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes J. Pharmacol. Exp. Ther. 82 1944 377 390
36. F.J. Verbaan, S.M. Bal, D.J. van den Berg, W.H. Groenink, H. Verpoorten, R. Lüttge, and J.A. Bouwstra Assembled microneedle arrays enhance the transport of compounds varying over a large range of molecular weight across human dermatomed skin J. Control. Release 117 2007 238 245 (Pubitemid 46161879)
37. W. Martanto, J.S. Moore, T. Couse, and M.R. Prausnitz Mechanism of fluid infusion during microneedle insertion and retraction J. Control. Release 112 2006 357 361 (Pubitemid 43737149)
38. C.S. Kolli, and A.K. Banga Characterization of solid maltose microneedles and their use for transdermal delivery Pharm. Res. 25 2008 104 113
39. L. Yang, M. Mao-Qiang, M. Taljebini, P.M. Elias, and K.R. Feingold Topical stratum corneum lipids accelerate barrier repair after tape stripping, solvent treatment and some but not all types of detergent treatment Br. J. Dermatol. 133 1995 679 685
40. P.G. van der Valk, and H.I. Maibach A functional study of the skin barrier to evaporative water loss by means of repeated cellophane-tape stripping Clin. Exp. Dermatol. 15 1990 180 182 (Pubitemid 20164898)
41. J.W. Fluhr, O. Kuss, T. Diepgen, S. Lazzerini, A. Pelosi, M. Gloor, and E. Berardesca Testing for irritation with a multifactorial approach: comparison of eight non-invasive measuring techniques on five different irritation types Br. J. Dermatol. 145 2001 696 703 (Pubitemid 33078338)
42. M. Pearton, C. Allender, K. Brain, A. Anstey, C. Gateley, N. Wilke, A. Morrissey, and J. Birchall Gene delivery to the epidermal cells of human skin explants using microfabricated microneedles and hydrogel formulations Pharm. Res. 25 2008 407 416 (Pubitemid 351257969)
43. D.J. Davies, R.J. Ward, and J.R. Heylings Multi-species assessment of electrical resistance as a skin integrity marker for in vitro percutaneous absorption studies Toxicol. In Vitro. 18 2004 351 358 (Pubitemid 38376369)
44. T.O. Herndon, S. Gonzalez, T.R. Gowrishankar, R.R. Anderson, and J.C. Weaver Transdermal microconduits by microscission for drug delivery BMC Med. 2 2004 1 12
45. S.S. Lanke, C.S. Kolli, J.G. Strom, and A.K. Banga Enhanced transdermal delivery of low molecular weight heparin by barrier perturbation Int. J. Pharm. 365 2009 26 33
46. T. Yamamoto, and Y. Yamamoto Electrical properties of the epidermal stratum corneum Med. Biol. Eng. (Mar.) 1976 151 158
47. J. Gupta, H.S. Gill, S.N. Andrews, and M.R. Prausnitz Kinetics of skin resealing after insertion of microneedles in human subjects J. Control. Release 54 2011 148 155