Microneedles and other physical methods for overcoming the stratum corneum barrier for cutaneous gene therapy

Critical Reviews in Therapeutic Drug Carrier Systems

Volumn 23, Issue 3, 2006, Pages 205-258

  Coulman, Sion ^a   Allender, Chris ^a   Birchall, James ^a  

^a CARDIFF UNIVERSITY   (United Kingdom)

Author keywords

Gene delivery; Gene therapy; Microneedles; Skin; Stratum corneum

Indexed keywords

ANESTHETIC AGENT; ASCORBIC ACID; BETA GALACTOSIDASE; CHITOSAN; DESMOPRESSIN; DICLOFENAC; DNA VACCINE; ERYTHROPOIETIN; FLUOROURACIL; GRANISETRON; INSULIN; LIPOPLEX; NAKED DNA; NIOSOME; NUCLEIC ACID; OPIATE; PLASMID DNA; PROTEIN DERIVATIVE; SILICON; TETANUS TOXOID; TITANIUM; VACCINE;

ANTIGEN PRESENTING CELL; ARGON LASER; BASAL CELL; CLINICAL RESEARCH; DERMIS; DERMOEPIDERMAL JUNCTION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG PENETRATION; ELECTROPORATION; EPIDERMOLYSIS BULLOSA; EX VIVO STUDY; GENE GUN; GENE REPLACEMENT THERAPY; GENE SEQUENCE; GENE THERAPY; GENE TRANSFER; GENODERMATOSIS; HAIR FOLLICLE; HAIR GROWTH; HEPATITIS B; HUMAN; IMMUNOCOMPETENT CELL; INFLUENZA; INSULIN BLOOD LEVEL; IONTOPHORESIS; JET INJECTION; LASER; LENTIVIRUS VECTOR; MACROMOLECULE; MICRONEEDLE; NANOPARTICLE; NEODYMIUM LASER; NONHUMAN; NONVIRAL GENE DELIVERY SYSTEM; NONVIRAL GENE THERAPY; PARTICLE SIZE; RADIOFREQUENCY ABLATION; RETROVIRUS VECTOR; REVIEW; SCANNING ELECTRON MICROSCOPY; SKIN BLEEDING; SKIN EPITHELIUM; SKIN FUNCTION; SKIN INJURY; SKIN NERVE; SKIN PERMEABILITY; SKIN STRUCTURE; SKIN SURFACE; STRATUM CORNEUM; TRANSGENE; ULTRASOUND; VIRAL GENE DELIVERY SYSTEM; VIRAL GENE THERAPY; VIRUS VECTOR; WOUND HEALING; XERODERMA PIGMENTOSUM;

EID: 33845648163     PISSN: 07434863     EISSN: None     Source Type: Journal    
DOI: 10.1615/CritRevTherDrugCarrierSyst.v23.i3.20     Document Type: Review

References (225)

1. Babiuk S, Baca-Estrada M, Babiuk LA, Ewen C, Foldvari M. Cutaneous vaccination: the skin as an immunologically active tissue and the challenge of antigen delivery. JControl Release. 2000;66:199-214.
2. Partidos CD, Beignon AS, Mawas F, Belliard G, Briand JP, Muller S. Immunity under the skin: potential application for topical delivery of vaccines. Vaccine. 2003;21(7-8):776-80.
3. Glenn GM, Kenney RT, Ellingsworth LR, Frech SA, Hammond SA, Zoeteweij JP. Transcutaneous immunization and immunostimulant strategies: capitalizing on the immunocompetence of the skin. Expert Rev Vaccines. 2003;2(2):253-67.
4. Partidos CD, Muller S. Decision-making at the surface of the intact or barrier disrupted skin: potential applications for vaccination or therapy. Cell Mol Life Sci. 2005;62(13):1418-24.
5. Menon GK. New insights into skin structure: scratching the surface. Adv Drug Del Rev. 2002;54(Supp 1):S3-S17.
6. Menon GK, Elias PM. The epidermal barrier and strategies for surmounting it: an overview. In:Hengge UR, Volc-Platzer B, editors. The skin and gene therapy. Berlin: Springer, 2001.
7. Williams AC. Structure and function of human skin. In:Williams A, editor. Transdermal and topical drug delivery. London: Pharmaceutical Press, 2003.
8. Roberts MS, Walters KA. The relationship between structure and barrier function of skin. In:Roberts MS, Walters KA, editors. Dermal absorption and toxicity assessment. New York: Marcel Dekker, 1998.
9. Scheulplein RL, Blank IH. Permeability of the skin. Physiol Rev. 1971;51:702-47.
10. Lajtha LG. Stem cell concepts. Differentiation. 1979;14:23-34.
11. Haake A, Scott GA, Holbrook KA. Structure and function of the skin: overview of the epidermis and dermis. In: Freinkel RK, Woodley DT, editors. The biology of the skin. 1 ed. New York: The Parthenon Publishing Group, 2001.
12. Montagna W, Parakkal PF. The structure and function of skin. 3 ed. New York: Academic Press Inc, 1974.
13. Jonkman MF. Hereditary skin diseases of hemidesmosomes. J of Dermatol Sci. 1999;20(2):103-21.
14. Kaur P, Li A. Adhesive properties of human basal epidermal cells: an analysis of keratinocyte stem cells, transit amplifying cells, and postmitotic differentiating cells. J Inv Derm.. 2000;114(3):413-20.
15. Fuchs E. Epidermal differentiation: the bare essentials. J Cell Biol. 1990;111:2807-14.
16. Dean DA, Strong DD, Zimmer WE. Nuclear entry of nonviral vectors. Gene Ther. 2005;12(11):881-90.
17. Eckert RL. Structure, function and differentiation of the keratinocyte. Physiol Rev. 1989;69:1316-46.
18. Odland G. A submicroscopic granular component in human skin. J Inv Derm.. 1960;34:11-15.
19. Lechardeur D, Verkman AS, Lukacs GL. Intracellular routing of plasmid DNA during non-viral gene transfer. Adv Drug Del Rev. 2005;57(5):755-67.
20. Wolff K. The fascinating story that began in 1868. Boca Raton: CRC Press, 1991.
21. Schuler G, Steinman RM. Murine epidermal Langerhans cells mature into potent immunostimulatory dendritic cells in vitro. J Exp Med. 1985;161:526-46.
22. Larregina AT, Falo LD. Changing paradigms in cutaneous immunology: adapting with dendritic cells. J Invest Derm. 2005;124(1):1-12.
23. Elias PM. Stratum corneum defensive functions: an integrated view. J Invest Derm. 2005;125(2):183-200.
24. Elias PM. Epidermal lipids, barrier function, and desquamation. J Invest Derm. 1983;80:44s-49s.
25. Wertz PW, van den Bergh. Review. The physical, chemical and functional properties of lipids in the skin and other biological barriers. Chem Physics Lipids. 1998;91:85-96.
26. Sondell B, Thornell LE, Egelrud T. Evidence that stratum corneum chymotryptic enzyme is transported to the stratum corneum extracellular space via lamellar bodies. J Inv Derm. 1995;104(5):819-23.
27. Hilliges M, Wang L, Johansson O. Ultrastructural evidence for nerve fibers within all vital layers of the human epidermis. J Inv Derm. 1995;104(1):134-37.
28. Vaalasti A, Tainio H, Johansson O, Rechardt L. Light and electron microscopic immunocytochemical demonstration of intraepidermal CGRP-containing nerves in human skin. Skin Pharm. 1988;1:225-29.
29. Singh S, Swerlick RA. Structure and function of the cutaneous vasculature. In:Freinkel RK, Woodley DT, editors. The biology of the skin. 1 ed. New York: The Parthenon Publishing Group, 2001.
30. Potten CS, Booth C. Keratinocyte stem cells: a commentary. J Inv Derm.. 2002;119(4):888-99.
31. Gambardella L, Barrandon Y. The multifaceted adult epidermal stem cell. Curr Opinion Cell Biol. 2003;15(6):771-7.
32. Alonso L, Fuchs E. Stem cells in the skin: waste not, want not. Genes Dev. 2003;17(10):1189-200.
33. Alonso L, Fuchs E. Stem cells of the skin epithelium. Proc Nat Acad Sci USA. 2003;100 Suppl 1:11830-5.
34. Spradling A, Drummond-Barbosa D, Kai T. Stem cells find their niche. Nature. 2001; 414(6859):98-104.
35. Jones PH, Harper S, Watt FM. Stem cell patterning and fate in human epidermis. Cell. 1995;80(1):83-93.
36. Ghazizadeh S, Taichman LB. Organization of stem cells and their progeny in human epidermis. J Inv Derm. 2005;124(2):367-72.
37. Williams IR, Kupper TS. Minireview: immunity at the surface: homeostatic mechanisms of the skin immune system. Life Sci. 1996;58(18):1485-507.
38. Banchereau J, Steinman RM. Dendritic cells and the control of immunity. Nature. 1998; 392:245-52.
39. Morel PA, Falkner D, Plowey J, Larregina AT, Falo LD. DNA immunisation: altering the cellular localisation of expressed protein and the immunisation route allows manipulation of the immune response. Vaccine. 2004;22(3-4):447-56.
40. Howarth M, Elliott T. The processing of antigens delivered as DNA vaccines. Immunol Rev. 2004;199:27-39.
41. Larregina AT, Watkins SC, Erdos G, Spencer LA, Storkus WJ, Beer Stolz D, Falo LD, Jr. Direct transfection and activation of human cutaneous dendritic cells. Gene Ther. 2001; 8(8):608-17.
42. Kutzler MA, Weiner DB. Developing DNA vaccines that call to dendritic cells. J Clin Inv. 2004;114(9):1241-4.
43. Pardoll DM, Beckerleg AM. Exposing the immunology of naked DNA vaccines. Immunity. 1995;3(2):165-69.
44. Greenhalgh DA, Rothnagel JA, Roop DR. Epidermis: an attractive target tissue for gene therapy. J Inv Derm.. 1994;103(5 Suppl):63S-69S.
45. Kitagawa T, Iwazawa T, Robbins PD, Lotze MT, Tahara H. Advantages and limitations of particle-mediated transfection (gene gun) in cancer immuno-gene therapy using IL-10, IL-12 or B7-1 in murine tumor models. J Gene Med. 2003;5(11):958-65.
46. Meuli M, Liu Y, Liggitt D, Kashani-Sabet M, Knauer S, Meuli-Simmen C, Harrison MR, Adzick NS, Heath TD, Debs RJ. Efficient gene expression in skin wound sites following local plasmid injection. J Inv Derm.. 2001;116(1):131-35.
47. Andree C, Swain WF, Page CP, Macklin MD, Slama J, Hatzis D, Eriksson E. In vivo transfer and expression of a human epidermal growth factor gene accelerates wound repair. Proc Nat Acad Sci USA. 1994;91(25):12188-92.
48. Eriksson E, Yao F, Svensjo T, Winkler T, Slama J, Macklin MD, Andree C, McGregor M, Hinshaw V, Swain WF. In vivo gene transfer to skin and wound by microseeding. J Surg Res.1998;78(2):85-91.
49. Yao F, Eriksson E. Gene therapy in wound repair and regeneration. Wound Repair Regen. 2000;8(6):443-51.
50. Khavari PA. Gene therapy for genetic skin disease. The J Inv Derm.. 1998;110(4):462-67.
51. Uitto J, Pulkkinen L. The genodermatoses: candidate diseases for gene therapy. Human Gene Ther. 2000;11(16):2267-75.
52. van Ruissen F, Jansen BJ, de Jongh GJ, Zeeuwen PL, Schalkwijk J. A partial transcriptome of human epidermis. Genomics. 2002;79(5):671-8.
53. Irvine AD, McLean WH. The molecular genetics of the genodermatoses: progress to date and future directions. Br J Derm. 2003;148(1):1-13.
54. Magnaldo T, Sarasin A. Xeroderma pigmentosum: from symptoms and genetics to gene-based skin therapy. Cells Tissues Organs. 2004;177(3):189-98.
55. Jiang QJ, Uitto J. Animal models of epidermolysis bullosa - targets for gene therapy. J Inv Derm.2005; 124(3):xi-xiii.
56. Arin MJ, Roop DR. Inducible mouse models for inherited skin diseases: implications for skin gene therapy. Cells Tissues Organs. 2004;177(3):160-8.
57. Dellambra E, Pellegrini G, Guerra L, Ferrari G, Zambruno G, Mavilio F, De Luca M. Toward epidermal stem cell-mediated ex vivo gene therapy of junctional epidermolysis bullosa. Human Gene Therapy. 2000;11(16):2283-7.
58. Ferrari S, Pellegrini G, Mavilio F, De Luca M. Gene therapy approaches for epidermolysis bullosa. Clinics Derm. 2005;23(4):430-36.
59. Hengge UR. Progress and prospects of skin gene therapy: a ten year history. Clinics Derm. 2005;23(1):107-14.
60. Woodley DT, Keene DR, Atha T, Huang Y, Ram R, Kasahara N, Chen M. Intradermal injection of lentiviral vectors corrects regenerated human dystrophic epidermolysis bullosa skin tissue in vivo. Molec Ther. 2004;10(2):318-26.
61. Ortiz-Urda S, Lin Q, Yant SR, Keene D, Kay MA, Khavari PA. Sustainable correction of junctional epidermolysis bullosa via transposon-mediated nonviral gene transfer. Gene Ther. 2003;10:1099-104.
62. Ortiz-Urda S, Thyagarajan B, Keene DR, Lin Q, Fang M, Calos MP, Khavari PA. Stable nonviral correction of inherited human disease. Nat Med. 2002;8(10):1166-70.
63. Lleres D, Weibel JM, Heissler D, Zuber G, Duportail G, Mely Y. Dependence of the cellular internalization and transfection efficiency on the structure and physicochemical properties of cationic detergent/DNA/liposomes. J Gene Med. 2004;6(4):415-28.
64. Lian T, Ho RJ. Design and characterization of a novel lipid-DNA complex that resists serum-induced destabilization. J Pharm Sci. 2003;92(12):2373-85.
65. Cui Z, Mumper RJ. Chitosan-based nanoparticles for topical genetic immunization. J Control Release. 2001;75:409-19.
66. Cui Z, Mumper RJ. Topical immunization using nanoengineered genetic vaccines. J Control Release. 2002;81:173-84.
67. Cui Z, Mumper RJ. Genetic immunization using nanoparticles engineered from microemulsion precursors. Pharm Res. 2002;19(7):939-46.
68. Lombry C, Dujardin N, Preat V. Transdermal delivery of macromolecules using skin electroporation. Pharm Res. 2000;17(1):32-7.
69. Chaote KA, Khavari PA. Direct cutaneous gene delivery in a human genetic skin disease. Human Gene Ther. 1997;8:1659-65.
70. Mikszta JA, Sullivan VJ, Dean C, Waterston AM, Alarcon JB, Dekker JP, Brittingham JM, Huang J, Hwang CR, et al. . Protective immunization against inhalational anthrax: a comparison of minimally invasive delivery platforms. J Infect Dis. 2005;191(2):278-88.
71. Glenn GM, Scharton-Kersten T, Vassell R, Mallett CP, Hale TL, Alving CR. Cutting edge: transcutaneous immunization with cholera toxin protects mice against lethal mucosal toxin challenge. J Immunol. 1998;161(7):3211-14.
72. Glenn GM, Scharton-Kersten T, Vassell R, Mallett CP, Hale TL, Alving CR. Skin immunization made possible by cholera toxin. Nature. 1998;391:851.
73. Partidos CD, Beignon AS, Brown F, Kramer E, Briand JP, Muller S. Applying peptide antigens onto bare skin: induction of humoral and cellular immune responses and potential for vaccination. J Control Release. 2002;85(1-3):27-34.
74. Tang DC, DeVit M, Johnston SA. Genetic immunization is a simple method for eliciting an immune response. Nature.1992; 356:152-54.
75. Dean HJ, Haynes J, Schmaljohn C. The role of particle-mediated DNA vaccines in biodefense preparedness. Adv Drug Deliv Rev. 2005;57(9):1315-42.
76. Garmory HS, Perkins SD, Phillpotts RJ, Titball RW. DNA vaccines for biodefence. Adv Drug Deliv Rev. 2005;57(9):1343-61.
77. Kaiser J. Influenza: girding for disaster: searching for all-powerful flu weapons. Science. 2004;306(5695):395.
78. Pertmer TM, Eisenbraun MD, McCabe D, Prayaga SK, Fuller DH, Haynes JR. Gene gun-based nucleic acid immunization: elicitation of humoral and cytotoxic T lymphocyte responses following epidermal delivery of nanogram quantities of DNA. Vaccine. 1995;13(15):1427-30.
79. Kwissa M, Kampen J, Zurbriggen R, Gluck R, Reimann J, Schirmbeck R. Efficient vaccination by intradermal or intramuscular inoculation of plasmid DNA expressing hepatitis B surface antigen under desmin promoter/enhancer control. Vaccine. 2000;18:2337-44.
80. Tacket CO, Roy MJ, Widera G, Swain WF, Broome S, Edelman R. Phase 1 safety and immune response studies of a DNA vaccine encoding hepatitis B surface antigen delivered by a gene delivery device. Vaccine. 1999;17:2826-9.
81. Osorio JE, Zuleger CL, Burger M, Chu Q, Payne LG, Chen D. Immune responses to hepatitis B surface antigen following epidermal powder immunization. Immunol Cell Bioly. 2003;81(1):52-8.
82. Xiao-wen H, Shu-han S, Zhen-lin H, Jun L, Lei J, Feng-juan Z, Ya-nan Z, Ying-jun G. Augmented humoral and cellular immune responses of a hepatitis B DNA vaccine encoding HBsAg by protein boosting. Vaccine. 2005; 3(14):1649-56.
83. Roberts LK, Barr LJ, Fuller DH, McMahon CW, Leese PT, Jones S. Clinical safety and efficacy of a powdered hepatitis B nucleic acid vaccine delivered to the epidermis by a commercial prototype device. Vaccine. 2005;23(40):4867-78.
84. Van Kampen KR, Shi Z, Gao P, Zhang J, Foster KW, Chen DT, Marks D, Elmets CA, Tang DC. Safety and immunogenicity of adenovirus-vectored nasal and epicutaneous influenza vaccines in humans. Vaccine. 2005;23(8):1029-36.
85. La Montagne JR, Fauci AS. Intradermal influenza vaccination - can less be more? New England JMed. 2004;351(22):2330-2.
86. Watabe S, Xin KQ, Ihata A, Liu LJ, Honsho A, Aoki I, Hamajima K, Wahren B, Okuda K. Protection against influenza virus challenge by topical application of influenza DNA vaccine. Vaccine. 2001;19(31):4434-44.
87. Dean HJ, Chen D. Epidermal powder immunization against influenza. Vaccine. 2004; 23(5):681-86.
88. Chen D, Endres RL, Erickson CA, Weis KF, McGregor MW, Kawaoka Y, Payne LG. Epidermal immunization by a needle-free powder delivery technology: immunogenicity of influenza vaccine and protection in mice. Nature Med. 2000;6(10):1187-90.
89. Fensterle J, Grode L, Hess J, Kaufmann SHE. Effective DNA vaccination against listeriosis by prime/boost inoculation with the gene gun. J Immunol. 1999;163:4510-18.
90. Liu LJ, Watabe S, Yang J, Hamajima K, Ishii N, Hagiwara E, Onari K, Xin KQ, Okuda K. Topical application of HIV DNA vaccine with cytokine-expression plasmids induces strong antigen-specific immune responses. Vaccine. 2001; 0(1-2):42-8.
91. Giri M, Ugen KE, Weiner DB. DNA vaccines against human immunodeficiency virus type 1 in the past decade. Clin Microbiol Rev. 2004;17(2):370-89.
92. Lisziewicz J, Trocio J, Whitman L, Varga G, Xu J, Bakare N, Erbacher P, Fox C, Woodward R, Markham P, Arya S, Behr JP, Lori F. DermaVir: a novel topical vaccine for HIV/AIDS. J Inv Derm.. 2005;124(1):160-9.
93. Lisziewicz J, Kelly L, Lori F. Topical DermaVir vaccine targeting dendritic cells. Curr Drug Deliv. 2006;3(1):83-88.
94. Aguiar JC, Hedstrom RC, Rogers WO, Charoenvit Y, Sacci JB, Jr., Lanar DE, Majam VF, Stout RR, Hoffman SL. Enhancement of the immune response in rabbits to a malaria DNA vaccine by immunization with a needle-free jet device. Vaccine. 2001;20(1-2):275-80.
95. Barry BW. Review: Novel mechanisms and devices to enable successful transdermal drug delivery. Eur J Pharm Sci. 2001;14:101-14.
96. Mitragotri S. Breaking the skin barrier. Adv Drug Deliv Rev. 2004;56(5):555-6.
97. Bos JD, Meinardi MMHM. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Derm. 2000;9(3):165-69.
98. Prausnitz MR, Mitragotri S, Langer R. Current status and future potential of transdermal drug delivery. Nature Rev: Drug Disc. 2004;3(2):115-24.
99. Banga AK, Prausnitz MR. Assessing the potential of skin electroporation for the delivery of protein- and gene-based drugs. Trends Biotech. 1998;16(10):408-12.
100. Medi BM, Singh J. Electronically facilitated transdermal delivery of human parathyroid hormone (1-34). Intern J Pharm. 2003;263:25-33.
101. Chen T, Langer R, Weaver JC. Charged microbeads are not transported across the human stratum corneum in vitro by short high-voltage pulses. Bioelectrochem and Bioenerg. 1999;48:181-92.
102. Kari B. Control of blood glucose levels in alloxan-diabetic rats by iontophoresis of insulin. Diabetes Technol Ther. 1986;35:217-21.
103. Wu J, Chappelow J, Yang J, Weimann L. Defects generated in human stratum corneum specimens by ultrasound. Ultrasound in Med Biol. 1998;24(5):705-10.
104. Lavon I, Kost J. Ultrasound and transdermal drug delivery. Drug Disc Today. 2004;9(15):670-6.
105. Tezel A, Paliwal S, Shen Z, Mitragotri S. Low-frequency ultrasound as a transcutaneous immunization adjuvant. Vaccine. 2005;23(29):3800-7.
106. Doukas AG, Kollias N. Transdermal drug delivery with a pressure wave. Adv Drug Deliv Rev. 2004;56(5):559-79.
107. Lee S, McAuliffe DJ, Flotte TJ, Kollias N, Doukas AG. Photomechanical transcutaneous delivery of macromolecules. J Inv Derm.. 1998; 111(6):925-29.
108. McGrew RE, McGrew M. Encyclopedia of medical history. New York: McGraw-Hill, 1985.
109. Zahn JD, Deshmukh AA, Pisano AP, Liepmann D. Continuous on-chip micropumping through a microneedle. Proceedings of 14th International Conference on Micro Electro Mechanical Systems; 2001 Jan 21-25; Interlaken, Switzerland. New York: IEEE; 2001.
110. Baxter J, Mitragotri S. Jet-induced skin puncture and its impact on needle-free jet injections: experimental studies and a predictive model. J Control Release. 2005;106(3):361-73.
111. Hengge UR, Walker PS, Vogel JC. Expression of naked DNA in Human, Pig and Mouse Skin. J Clin Inv. 1996;97(12):2911-16.
112. Hengge UR, Chan EF, Foster RA, Walker PS, Vogel JC. Cytokine gene expression in epidermis with biological effects following injection of naked DNA. Nature Genetics. 1995; 10(2):161-6.
113. Sawamura D, Meng X, Ina S, Ishikawa H, Tamai K, Nomura K, Hanada K, Hashimoto I, Kaneda Y. In vivo transfer of a foreign gene to keratinocytes using the hemagglutinating virus of Japan-liposome method. J Inv Derm.. 1997;108(2):195-9.
114. Sawamura D, Yasukawa K, Kodama K, Yokota K, Sato-Matsumura KC, Tosihiro T, Shimizu H. The majority of keratinocytes incorporate intradermally injected plasmid DNA regardless of size, but only a small proportion of cells can express the gene product. The J Inv Derm.. 2002;118(6):967-71.
115. Barry ME, Pinto-Gonzalez D, Orson FM, McKenzie GJ, Petry GR, Barry MA. Role of endogenous endonucleases and tissue site in transfection and CpG-mediated immune activation after naked DNA injection. Human Gene Ther. 1999;10(15):2461-80.
116. Ruponen M, Honkakoski P, Ronkko S, Pelkonen J, Tammi M, Urtti A. Extracellular and intracellular barriers in non-viral gene delivery. J Control Release. 2003;93(2):213-7.
117. Wiethoff CM, Middaugh CR. Barriers to nonviral gene delivery. J Pharm Scie. 2003;92(2):203-17.
118. Lechardeur D, Sohn KJ, Haardt M, Joshi PB, Monck M, Graham RW, Beatty B, Squire J, O'Brodovich H, Lukacs GL. Metabolic instability of plasmid DNA in the cytosol: a potential barrier to gene transfer. Gene Ther. 1999;6(4):482-97.
119. Howell DP, Krieser RJ, Eastman A, Barry MA. Deoxyribonuclease II is a lysosomal barrier to transfection. Molec Ther. 2003;8(6):957-63.
120. Belting M, Sandgren S, Wittrup A. Nuclear delivery of macromolecules: barriers and carriers. Adv Drug Deliv Rev. 2005;57(4):505-27.
121. Drabick JJ, Glasspool-Malone J, Somiari S, King A, Malone RW. Cutaneous transfection and immune responses to intradermal nucleic acid vaccination are significantly enhanced by in vivo electropermeabilization. Molec Ther. 2001;3(2):249-55.
122. Glasspool-Malone J, Somiari S, Drabick JJ, Malone RW. Efficient nonviral cutaneous transfection. Molec Ther. 2000;2(2):140-46.
123. Babiuk S, Baca-Estrada ME, Foldvari M, Baizer L, Stout R, Storms M, Rabussay D, Widera G, Babiuk L. Needle-free topical electroporation improves gene expression from plasmids administered in porcine skin. Molec Ther. 2003;8(6):992-8.
124. Chesnoy S, Huang L. Enhanced cutaneous gene delivery following intradermal injection of naked DNA in a high ionic strength solution. Molec Ther. 2002;5(1):57-62.
125. Hoffmann RM. The Hair follicle as a gene therapy target. Nat Biotech. 2000;18:20-21.
126. Ohyama M, Vogel JC. Gene delivery to the hair follicle. J Inv Derm Symp Proc. 2003;8(2):204-6.
127. Fan H, Lin Q, Morrissey GR, Khavari PA. Immunization via hair follicles by topical application of naked DNA to normal skin. Nat Biotech. 1999;17:870-72.
128. Domashenko A, Gupta S, Cotsarelis G. Efficient delivery of transgenes to human hair follicle progenitor cells using topical lipoplex. Nat Biotech. 2000;18:420-23.
129. Li L, Hoffmann RM. The feasibility of targeted selective gene therapy of the hair follicle. Nat Med. 1995;1(7):705-06.
130. Hoffman RM. Immune reactions in skin and hair follicle gene therapy. Molec Ther. 2003;7(3):294-95.
131. Birchall JC, Marichal C, Campbell L, Alwan A, Hadgraft J, Gumbleton M. Gene expression in an intact ex vivo skin tissue model following percutaneous delivery of cationic liposome-plasmid DNA complexes. Int J Pharm. 2000;197(1-2):233-8.
132. Alexander MY, Akhurst RJ. Liposome-mediated gene transfer and expression via the skin. Human Molec Genetics. 1995;4(12):2279-85.
133. Babiuk S, Baca-Estrada ME, Pontarollo R, Foldvari M. Topical delivery of plasmid DNA using biphasic lipid vesicles (Biphasix). J Pharm Pharmac. 2002;54(12):1609-14.
134. Shi Z, Curiel DT, Tang D. DNA-based non-invasive vaccination onto the skin. Vaccine. 1999;17:2136-41.
135. Baca-Estrada ME, Foldvari M, Babiuk SL, Babiuk LA. Vaccine delivery: lipid-based delivery systems. J Biotech. 2000;83(1-2):91-104.
136. Raghavachari N, Fahl WE. Targeted gene delivery to skin cells in vivo: a comparative study of liposomes and polymers as delivery vehicles. Jof Pharm Sc. 2002;91(3):615-22.
137. Vyas SP, Singh RP, Jain S, Mishra V, Mahor S, Singh P, Gupta PN, Rawat A, Dubey P. Non-ionic surfactant based vesicles (niosomes) for non-invasive topical genetic immunization against hepatitis B. Int J Pharm. 2005;296(1-2):80-6.
138. Foldvari M, Kumar P, King M, Batta R, Michel D, Badea I, Wloch M. Gene delivery into human skin in vitro using biphasic lipid vesicles. Curr Drug Del. 2006;3(1):89-93.
139. Cevc G, Schatzlein A, Blume G. Transdermal drug carriers: basic properties, optimization and transfer efficiency in the case of epicutaneously applied peptides. J Control Release. 1995;36:3-16.
140. Kim A, Lee EH, Choi SH, Kim CK. In vitro and in vivo transfection efficiency of a novel ultradeformable cationic liposome. Biomaterials. 2004;25(2):305-13.
141. Meidan VM, Bonner MC, Michniak BB. Transfollicular drug delivery - Is it a reality? Inter J Pharm. 2005;306(1-2):1-14.
142. Klein T, Wolf E, Wu R, Sanford J. High velocity microprojectiles for delivering nucleic acids into living cells. Nature. 1987;327:70-73.
143. Fynan EF, Webster RG, Fuller DH, Haynes JR, Santoro JC, Robinson HL. DNA vaccines: Protective immunizations by parenteral, mucosal and gene-gun innoculations. Proc Nat Acad Sci USA. 1993;90:11478-82.
144. Dileo J, Miller TE, Chesnoy S, Huang L. Gene transfer to subdermal tissues via a new gene gun design. Human Gene Ther. 2003;14(1):79-88.
145. Lin MTS, Pulkkinen L, Uitto J, Yoon K. The gene gun: current applications in cutaneous gene therapy. Inter J of Derm. 2000;39:161-70.
146. Wang S, Joshi S, Lu S. Delivery of DNA to skin by particle bombardment. Methods Molec Biol. 2004;245:185-96.
147. Han R, Reed CA, Cladel NM, Christensen ND. Immunization of rabbits with cottontail rabbit papillomavirus E1 and E2 genes: protective immunity induced by gene gun-mediated intracutaneous delivery but not by intramuscular injection. Vaccine. 2000;18(26):2937-44.
148. PowderMed. http://www.powdermed.com/developmentOverview.htm. [www] [cited 2006 26th March]; Available from: http://www.powdermed.com
149. Heiser WC. Gene transfer into mammalian cells by particle bombardment. Anal Biochem. 1994;217(2):185-96.
150. Wang J, Murakami T, Hakamata Y, Ajiki T, Jinbu Y, Akasaka Y, Ohtsuki M, Nakagawa H, Kobayashi E. Gene gun-mediated oral mucosal transfer of interleukin 12 cDNA coupled with an irradiated melanoma vaccine in a hamster model: successful treatment of oral melanoma and distant skin lesion. Cancer Gene Ther. 2001;8(10):705-12.
151. Tanelian DL, Barry MA, Johnston SA, Le T, Smith G. Controlled gene gun delivery and expression of DNA within the cornea. Biotechniques. 1997;23(3):484-88.
152. Yang NS, Burkholder J, Roberts B, Martinell B, McCabe D. In vivo and in vitro gene transfer to mammalian somatic cells by particle bombardment. Proc Nat Acad Sci USA.1990;87(24):9568-72.
153. Cheng L, Ziegelhoffer PR, Yang N. In vivo promoter activity and transgene expression in mammalian somatic tissues evaluated by using particle Bombardment. Proc Nat Acad Sci USA.1993;90(10):4455-59.
154. Fuller DH, Corb MM, Barnett S, Steimer K, Haynes JR. Enhancement of immunodeficiency virus-specific immune responses in DNA-immunized rhesus macaques. Vaccine. 1997;15(8):924-26.
155. Udvardi A, Kufferath I, Grutsch H, Zatloukal K, Volc-Platzer B. Uptake of exogenous DNA via the skin. J Molec Med. 1999;77(10):744-50.
156. Kendall M, Mitchell T, Wrighton-Smith P. Intradermal ballistic delivery of microparticles into excised human skin for pharmaceutical applications. J Biomech. 2004;37(11):1733-41.
157. Raju PA, Truong NK, Kendall MAF. Assessment of epidermal cell viability by near infrared multi-photon microscopy following ballistic delivery of gold microparticles. Vaccine. (in press) 158.
158. Kendall M. Engineering of needle-free physical methods to target epidermal cells for DNA vaccination. Vaccine. (in press)
159. Perkin FS. Jet injection of insulin in treatment of diabetes mellitus. Proc Ameri. Diabetes Associ. 1950;10:185-99.
160. Hingson RA, Davis HS, Rosen M. Historical development of jet injection and envisioned uses in mass immunization and mass therapy based upon 2 decades experience. Military Med. 1963;128(6):516.
161. Schramm-Baxter J, Mitragotri S. Needle-free jet injections: dependence of jet penetration and dispersion in the skin on jet power. J Control Release. 2004; 97(3):527-35.
162. Modamio P, Lastra CF, Marino EL. A comparative in vitro study of percutaneous penetration of beta-blockers in human skin. Int J Pharm. 2000;194(2):249-59.
163. Bremseth DL, Pass F. Delivery of insulin by jet injection: recent observations. Diabetes Technol Ther. 2001;3:225-32.
164. Mumper RJ, Cui Z. Genetic immunization by jet injection of targeted pDNA-coated nanoparticles. Methods. 2003;31(3):255-62.
165. Sawamura D, Ina S, Itai K, Meng X, Kon A, Tamai K, Hanada K, Hashimoto I. In vivo gene introduction into keratinocytes using jet injection. Gene Ther. 1999;6(10):1785-7.
166. Cui Z, Baizer L, Mumper RJ. Intradermal immunization with novel plasmid DNA-coated nanoparticles via a needle-free injection device. J Biotech. 2003;102(2):105-15.
167. Lee WR, Shen SC, Wang KH, Hu CH, Fang JY. The effect of laser treatment on skin to enhance and control transdermal delivery of 5-fluorouracil. J Pharm Sci. 2002;91(7):1613-26.
168. Fujiwara A, Hinokitani T, Goto K, Arai T. Partial ablation of porcine stratum corneum by argon-fluoride excimer laser to enhance transdermal drug permeability. Lasers Med Sci. 2005; 19:210.
169. Nelson JS, McCullough JL, Glenn TC, Wright WH, Liaw L-HL, Jacques SL. Mid-Infrared laser ablation of stratum corneum enhances in vitro percutaneous transport of drugs. J Inv Derm. 1991;97(5):874-79.
170. Fang JY, Lee WR, Shen SC, Fang YP, Hu CH. Enhancement of topical 5-aminolaevulinic acid delivery by erbium:YAG laser and microdermabrasion: a comparison with iontophoresis and electroporation. Br J Derm. 2004;151(1):132-40.
171. Lee W-R, Shen S-C, Lai H-H, Hu C-H, Fang J-Y. Transdermal drug delivery enhanced and controlled by erbium:YAG laser: a comparative study of lipophilic and hydrophilic drugs. J Control Release. 2001;75(1-2):155-66.
172. Lee WR, Shen SC, Kuo-Hsien W, Hu CH, Fang JY. Lasers and microdermabrasion enhance and control topical delivery of vitamin C. J Invest Derm. 2003;121(5):1118-25.
173. Fang JY, Lee WR, Shen SC, Wang HY, Fang CL, Hu CH. Transdermal delivery of macromolecules by erbium:YAG laser. J Control Release. 2004; 100(1):75-85.
174. Sintov AC, Krymberk I, Daniel D, Hannan T, Sohn Z, Levin G. Radiofrequency-driven skin microchanneling as a new way for electrically assisted transdermal delivery of hydrophilic drugs. J Control Release. 2003;89:311-20.
175. Levin G, Gershonowitz A, Sacks H, Stern M, Sherman A, Rudaev S, Zivin I, Phillip M. Transdermal delivery of human growth hormone through RF-microchannels. Pharm Res. 2005;22(4):550-5.
176. Birchall J, Coulman S, Anstey A, Gateley C, Sweetland H, Gershonowitz A, Neville L, Levin G. Cutaneous gene expression of plasmid DNA in excised human skin following delivery via microchannels created by radio frequency ablation. Int J Pharm. 2006;312(1-2):15-23.
177. Bates M. Needle-free drug delivery system blasts through the skin. Pharm Technol. 2004:18-20.
178. Herndon T, Gonzalez S, Gowrishankar TR, Anderson R, Weaver J. Transdermal microconduits by microscission for drug delivery and sample acquisition. BMC Med. 2004; 2(1):12.
179. Gerstel MS, Place VA.Drug Delivery Device. U.S. Patent 3,964,482. 1976.
180. Henry S, McAllister DV, Allen M, Prausnitz MR. Microfabricated microneedles: a novel approach to transdermal drug delivery. J Pharm Sci. 1998;87(8):922-25.
181. Henry S, McAllister DV, Allen M, Prausnitz MR. Micromachined microneedles for the transdermal delivery of drugs. 11th IEEE Micro Electro Mech Syst Workshop; Heidelberg. 1998.
182. Gardeniers JGE, Berenschot JW, de Boer MJ, Yeshurun Y, Hefetz M, van't Oever R, van den Berg A. Silicon micromachined hollow microneedles for transdermal liquid transfer. [www] [cited 2003 13th January]; Available from: http://ieeexplore.ieee.org/iel5/7726/21214/00984224.pdf?arnumber=984224
183. Haider I, Pettis RJ, Davison N, Clarke R, Zahn JD. Biomedical and fluid flow characterization of microneedle-based drug delivery devices. [www] [cited 2002 24th October]; Available from: http://asb-biomech.org/onlineabs/ abstracts2001/-pdf/080.pdfhttp://asbbiomech.org/onlineabs/abstracts2001/pdf/080. pdf
184. Newton AM, Lal A, Chen X. Ultrasonically driven microneedle arrays. Adv Drug Deliv Rev. 2003;2003:77-88.
185. Teo MAL, Shearwood C, Ng KC, Lu J, Moochhala S. In vitro and in vivo characterization of MEMS microneedles. Biomed Microdevices. 2005;7(1):47-52.
186. Sivamani RK, Stoeber B, Wu GC, Zhai H, Liepmann D, Maibach H. Clinical microneedle injection of methyl nicotinate: stratum corneum penetration. Skin Res Technol. 2005;11(2):152-56.
187. Watkins C, Hopkins J, Harkiss G. Reporter gene expression in dendritic cells after gene gun administration of plasmid DNA. Vaccine. 2005;23(33):4247-56.
188. Xie Y, Xu B, Gao Y. Controlled transdermal delivery of model drug compounds by MEMS microneedle array. Nanomedicine: Nanotech Biol Med. 2005;1(2):184-90.
189. Griss P, Tolvanen-Laasko HK, Merilainen P, Stemme G. Characterization of micromachined spiked biopotential electrodes. IEEE Trans Biomed Eng. 2002;49(6):597-603.
190. Prausnitz MR. Microneedles for transdermal drug delivery. Adv Drug Deliv Rev. 2004; 56(5):581-7.
191. Chabri F, Bouris K, Jones T, Barrow D, Hann A, Allender C, Brain K, Birchall J. Microfabricated silicon microneedles for nonviral cutaneous gene delivery. Br J Derm. 2004;150(5):869-77.
192. Wilke N, Hibert C, O'Brien J, Morrissey A. Silicon microneedle electrode array with temperature monitoring for electroporation. Sensors Actuators A: Phys. 2005;123-124:319-25.
193. Wilke N, Mulcahy A, Ye S-R, Morrissey A. Process optimization and characterization of silicon microneedles fabricated by wet etch technology. Microelectron J. 2005;36(7):650-56.
194. Reed ML, Wu C, Kneller J, Watkins S, Vorp DA, Nadeem A, Weiss LE, Rebello K, Mescher M, et al. Micromechanical devices for intravascular drug delivery. J Pharm Sci. 1998;87(11):1387-94.
195. McAllister DV, Wang PM, Davis SP, Park JH, Canatella PJ, Allen MG, Prausnitz MR. Microfabricated needles for transdermal delivery of macromolecules and nanoparticles: fabrication methods and transport studies. Proc Nat Acad Sci USA. 2003;100(24):13755-60.
196. Birchall JC, Coulman S, Pearton M, Allender C, Brain K, Anstey A, Gateley C, Wilke N, Morrissey A. Cutaneous DNA delivery and gene expression in ex vivo human skin explants via wet-etch microfabricated microneedles. J Drug Target. 2005;13(7):415-21.
197. Coulman SA, Barrow D, Anstey A, Gateley C, Morrissey A, Wilke N, Allender C, Brain K, Birchall JC. Minimally invasive cutaneous delivery of macromolecules and plasmid DNA via microneedles. Curr Drug Deliv. 2006;3(1):65-75.
198. Matriano JA, Cormier M, Johnson J, Young WA, Buttery M, Nyam K, Daddona PE. Macroflux microprojection array patch technology: a new and efficient approach for intracutaneous immunization. Pharm Res. 2002;19(1):63-70.
199. Martanto W, Davis SP, Holiday NR, Wang J, Gill HS, Prausnitz MR. Transdermal delivery of insulin using microneedles in vivo. Pharm Res. 2004;21(6):947-52.
200. Cormier M, Johnson B, Ameri M, Nyam K, Libiran L, Zhang DD, Daddona P. Transdermal delivery of desmopressin using a coated microneedle array patch system. J Control Release. 2004;97(3):503-11.
201. Lin W, Cormier M, Samiee A, Griffin A, Johnson B, Teng CL, Hardee GE, Daddona PE. Transdermal delivery of antisense oligonucleotides with microprojection patch (Macroflux) technology. Pharm Res. 2001;18(12):1789-93.
202. Wang PM, Cornwell M, Prausnitz MR. Minimally invasive extraction of dermal interstitial fluid for glucose monitoring using microneedles. Diabetes Technol Ther. 2005;7(1):131-41.
203. Park J-H, Allen MG, Prausnitz MR. Biodegradable polymer microneedles: Fabrication, mechanics and transdermal drug delivery. J Control Release. 2005; 104(1):51-66.
204. Kuo S, Chou Y. A novel polymer microneedle and PDMS micromolding Technique. Tamkang. J Sci Eng. 2004;7(2):95-98.
205. McAllister DV, Cros F, Davis SP, Matta LM, Prausnitz MR, Allen MG. Three-dimensional hollow microneedle and microtube arrays. Proceedings of 10th International Conference on Solid State Sensors and Actuators (Transducers '99); 1999 June 7-10. Sendai, Japan: Institute of Electrical Engineers of Japan; 1999.
206. Davis SP, Martanto W, Allen MG, Prausnitz MR. Hollow metal microneedles for insulin delivery to diabetic rats. IEEE Trans Biomed Eng. 2005;52(5):909-15.
207. Wang PM, Cornwell MG, Prausnitz MR. Effects of microneedle tip geometry on injection and extraction in the skin. Proceedings of 2nd Joint EMBS-BMES Conference; 2002 23-26 Oct; Houston. New York: IEEE; 2002.
208. Mukerjee EV, Collins SD, Isseroff RR, Smith RL. Microneedle array for transdermal biological fluid extraction and in situ analysis. Sensors and Actuators A. 2004;114:267-75.
209. Zahn JD, Deshmukh A, Pisano AP, Liepmann D. Continuous on-chip micropumping for microneedle enhanced drug delivery. Biomed Microdevices. 2004;6(3):183-90.
210. Prausnitz MR, Ackley DE, Gyory JR. Microfabricated microneedles for transdermal drug delivery. In:Rathbone MJ, Hadgraft J, Roberts MS, editors. Drugs and the pharmaceutical sciences: modified-release drug delivery technology. New York: Marcel Dekker, 2003.
211. Widera G, Johnson J, Kim L, Libiran L, Nyam K, Daddona PE, Cormier M. Effect of delivery parameters on immunization to ovalbumin following intracutaneous administration by a coated microneedle array patch system. Vaccine. (in press)
212. Zheng H, Park JJ, Chen L, Mishra S. Transdermal microneedle array. [www] [cited 2003 13 January]; Available from: http://www.ece.umd.edu
213. Davis SP, Landis BJ, Adams ZH, Allen MG, Prausnitz MR. Insertion of microneedles into skin: measurement and prediction of insertion force and needle fracture force. J Biomech. 2004;37(8):1155-63.
214. Aggarwal P, Johnston CR. Geometrical effects in mechanical characterizing of microneedle for biomedical applications. Sensors Actuators B. 2004;102:226-34.
215. Yang M, Zahn JD. Microneedle insertion force reduction using vibratory actuation. Biomed Microdevices. 2004;6(3):177-82.
216. Panchagnula R, Stemmer K, Ritschel WA. Animal models for transdermal drug delivery. Meth Find Exp Clin Pharm. 1997;19:335-41.
217. Sekkat NK, Kalia YN, Guy RH. Biophysical study of porcine ear skin in vitro and its comparison to human skin in vivo. J Pharm Sci. 2002;91(11):2376-81.
218. Kaushik S, Hord AH, Denson DD, McAllister DV, Smitra S, Allen MG, Prausnitz MR. Lack of pain associated with microfabricated microneedles. Anaesthesia Analgesia. 2001; 92:502-04.
219. Miyano T, Tobinaga Y, Kanno T, Matsuzaki Y, Takeda H, Wakui M, Hanada K. Sugar micro needles as transdermic drug delivery system. Biomed Microdevices. 2005;7(3):185-88.
220. Shirkhanzadeh M. Microneedles coated with porous calcium phosphate ceramics: Effective vehicles for transdermal delivery of solid trehalose. J Mater Sci: Mater Med. 2005; 16(1):37-45.
221. Smart WH, Subramanian K. The use of silicon microfabrication technology in painless blood glucose monitoring. Diabetes Technol Ther. 2000;2(4):549-59.
222. Ciernik IF, Krayenbuhl BH, Carbone DP. Puncture-mediated gene transfer to the skin. Human Gene Ther. 1996;7:893-99.
223. Mikszta JA, Alarcon JB, Brittingham JM, Sutter DE, Pettis RJ, Harvey NG. Improved genetic immunization via micromechanical disruption of skin-barrier function and targeted epidermal delivery. Nature Med. 2002;8(4):415-19.
224. Chiarello K. Breaking the barrier: advances in transdermal technology. Pharm Technol. 2004;28(10):46-56.
225. Griss P, Stemme G. Side-opened out-of-plane microneedles for microfluidic transdermal liquid transfer. IEEE J Microelectromech Syst. 2003;12(3):296-301.