Iontophoretic delivery of peptide drugs

Journal of Controlled Release

Volumn 41, Issue 1-2, 1996, Pages 33-48

  Green, Philip G ^a  

^a BD Technologies   (United States)

Author keywords

Drug delivery; Electrotransport; Iontophoresis; Peptide; Transdermal

Indexed keywords

ADRENALIN; ANGIOTENSIN; ARGIPRESSIN; ARGIPRESSIN[DEGLYCINAMIDE]; BUSERELIN; CALCITONIN; CHOLECYSTOKININ OCTAPEPTIDE; CORTICOSTEROID; GONADORELIN; GONADORELIN DERIVATIVE; GROWTH HORMONE RELEASING FACTOR; INSULIN DERIVATIVE; IONTOCAINE; LEUPRORELIN; LIDOCAINE; LOCAL ANESTHETIC AGENT; NAFARELIN; OCTREOTIDE; PARATHYROID HORMONE; PARATHYROID HORMONE[1-34]; PEPTIDE; PILOCARPINE; RO 23 7861; SALCATONIN; UNCLASSIFIED DRUG;

CLINICAL TRIAL; CONFERENCE PAPER; DIFFUSION; DRUG ADMINISTRATION; DRUG BLOOD LEVEL; ELECTROOSMOSIS; HUMAN; INTRAMUSCULAR DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; IONTOPHORESIS; NONHUMAN; PRIORITY JOURNAL; REPRODUCIBILITY; SKIN PENETRATION; TRANSDERMAL DRUG ADMINISTRATION;

EID: 0030222336     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/0168-3659(96)01354-5     Document Type: Conference Paper

References (87)

1. [1] P. Singh and H.I. Maibach, Iontophoresis in drug delivery: basic principles and applications, Crit. Rev. Ther. Drug. Carrier. Syst. 11 (1994) 161-213.
2. [2] B.H. Sage, C.R Bock, J.D. DeNuzzio and R.H. Hoke, Technological and developmental issues of iontophoretic transport of peptide and protein drugs, in: V.H.L. Lee, M. Hashida and Y. Mizushima (Eds.), Trends and Future Perspectives in Peptide and Protein Drugs. Harwood Academic Publishers, Chur, Switzerland, 1995, pp. 111-134.
3. [3] P. Singh and H.I. Maibach, Transdermal iontophoresis pharmacokinetic considerations, Clin. Pharmacokin. 26 (1994) 327-334.
4. [4] Y.W. Chien, O. Siddiqui, W-M Shi, P. Lelawongs and J-C Liu, Direct current iontophoretic transdermal delivery of peptide and protein drugs, J. Pharm. Sci. 78 (1989) 376-383.
5. [5] C. Cullander and R.H. Guy, (D) Routes of delivery: case studies (6) Transdermal delivery of peptides and proteins, Adv. Drug Del. Rev. 8 (1992) 291-329.
6. [6] D. Marrero and R.R. Burnette, Comparison between the iontophoretic and passive transport of thyrotropin releasing hormone across excised nude mouse skin, J. Pharm. Sci. 75 (1986) 738-743.
7. [7] B.L. Shapiro, T.V Pence and L. Waewick, Insulin iontophoresis in cystic fibrosis, Proc. Soc. Exp. Biol. Med. 149 (1975) 592-593.
8. [8] R.L. Stephen, T.J. Petelenz and S.C. Jacobson, Potential novel methods for insulin administration: I. Iontophoresis, Biomed. Biochem. Acta. 3 (1984) 553-558.
9. [9] B.R. Meyer, W. Kreis, J. Eshbach, V. O'Mara, S. Rosen, D. Sibalis, Successful transdermal administration of therapeutic doses of a polypeptide to normal human volunteers, Clin. Pharmacol. Ther. 44 (1988) 607-612.
10. [10] B.R. Meyer, W. Kreis, J. Eschbach, V. O'Mara, S. Rosen and D. Sibalis, Transdermal versus subcutaneous leuprolide: a comparison of acute pharmacodynamic effect, Clin. Pharm. Ther. 48 (1990) 340-345.
11. [11] M. Fu Lu, D. Lee, R. Carlson, G. Subba Rao, H.W. Hui, L. Adjei, M. Herrin, D. Sundberg and L. Hsu, The effects of formulation variables on iontophoretic transdermal delivery of leuprolide to humans, Drug Dev. Ind. Pharm. 19 (1993) 1557-1571.
12. [12] M. Ashburn, J. Streisand, J. Zhang, G. Love, M. Rowin, S. Niu, J. Kievit, J.R. Kroep and M.J. Mertens, The iontophoresis of fentanyl citrate in humans, Anesthesiology 82 (1995) 1146-1153.
13. [13] M. Ashburn, R.L. Stephen, E. Ackerman, T.J. Petelenz, B. Hare, W.L. Pace and A.A Hofmann, Iontophoretic delivery of morphine for post operative analgesia, J. Pain Symp. Manage. 7 (1992) 27-33.
14. [14] R. Haak and S.K. Gupta, Pulsatile drug delivery from electrotransport therapeutic systems, in: R. Gurny, H.E. Junginger and N.A. Peppas (Eds.), Pulsatile Drug Delivery Current Applications and Future Trends, Wiss. Verl.-Ges., Stuttgart, Germany, 1993, pp. 99-112.
15. [15] P. Lelawongs, J-C. Liu and Y.W. Chien, Transdermal iontophoretic delivery of arginine - vasopressin (II): evaluation of electrical and operational factors, Int. J. Pharm. 61 (1990) 179-188.
16. [16] J. Nestor, T. Ho, R.A. Simpson, B.L. Horner, G.H. Jones, G.I. McCrae and B.H. Vickey, Synthesis and biological activity of some very hydrophobic superagonist analogs of luteinizing hormone releasing hormone, J. Med. Chem. 25 (1982) 795-801.
17. [17] B.H. Sage and J.E. Riviere, Model systems in iontophoresis - transport efficacy, Adv. Drug Del. Rev. 9 (1992) 265-287.
18. [18] P.G. Green, B. Shroot, F. Bernerd, W.R. Pilgrim and R.H. Guy, In-vitro and in-vivo iontophoresis of a tripeptide across nude rat skin, J. Control. Release 20 (1992) 209-218.
19. [19] S. Kumar, H. Char, S. Patel, D. Peimontese, K. Iqbal, A.W. Malik, E. Neugroschel and C.R. Behl, Effect of iontophoresis on in-vitro skin permeation of an analogue of growth hormone releasing factor in the hairless guinea pig model, J. Pharm. Sci. 81 (1992) 635-639.
20. [20] D.T-W. Lau, J.W. Sharkey, L. Petryk, F.A. Mancuso, Z. Yu and F.L.S. Tse, Effect of current magnitude and drug concentration on iontophoretic delivery of octreotide acetate (Sandostatin®) in the rabbit, Pharm. Res. 11 (1994) 1742-1746.
21. [21] M.J. Pikal, The role of electroosmotic flow in transdermal iontophoresis, Adv. Drug Deliv. Rev. 9 (1992) 201-237.
22. [22] R.R. Burnette, Iontophoresis, in: J. Hadgraft and R.H. Guy (Eds.), Transdermal Drug Delivery - Developmental Issues and Research Initiatives. Marcel Dekker, New York, 1989, pp. 247-291.
23. [23] S.M. Sims, W.I. Higuchi and V. Srinivasan, Skin alteration and convective solvent flow effects during iontophoresis. I. Neutral solute transport across human skin, Int. J. Pharm. 69 (1991) 109-121.
24. [24] S. Kumar, H. Char, S. Patel, D. Piemontese, A.W. Malick, K. Iqbal, E. Neugroschel, C.R. Behl, In-vivo transdermal iontophoretic delivery of growth hormone releasing factor GRF (1-44) in hairless guinea pigs, J. Control. Release 18 (1992) 213-220.
25. [25] V. Srinivasan, W.I. Higuchi and M.H. Su, Baseline studies with the four electrode system: the effect of skin permeability increase and water transport on the flux of a model uncharged solute during iontophoresis, J. Control. Release 10 (1989) 157-165.
26. [26] M.B. Delgado-Charro and R.H. Guy, Characterization of convective flow during iontophoresis, Pharm. Res. 11 (1994) 929-935.
27. [27] A. Kim, P.G. Green, G. Rao and R.H. Guy, Convective solvent flow across the skin during iontophoresis, Pharm. Res. 10 (1993) 1315-1320.
28. [28] J.A. Tamada, N.J.V. Bohannon, R.O. Potts, Measurement of glucose in diabetic subjects using noninvasive transdermal extraction, Nat. Med. 1 (1995) 1198-1201.
29. [29] P.G. Green, R.S. Hinz, F.C. Szoka and R.H. Guy, Iontophoretic delivery of a series of tripeptides across the skin in-vitro, Pharm. Res. 8 (1991) 1121-1127.
30. [30] A.J. Hoogstraate, V. Srinivasan, S.M. Sims and W.I. Higuchi, Iontophoretic enhancement of peptides: behavior of leuprolide versus model permeants, J. Control. Release 31 (1994) 41-47.
31. [31] M. Delgado-Charro and R.H. Guy, Iontophoretic delivery of nafarelin across the skin, Int. J. Pharm. 117 (1995) 165-173.
32. [32] D. Sibalis, Electrolyte Transdermal Delivery of Polypeptides. U.S. Patent 4,878,892, 7 November 1989.
33. [33] W.H.M. Craane-van Hinsberg, L. Bax, N.H.M. Flinterman, J. Verhoef, H.E. Junginger and H.E. Bodde, Iontophoresis of a model peptide across human skin in-vitro. Effects of iontophoresis protocol, pH and ionic strength on peptide flux and skin impedance, Pharm. Res. 11 (1994) 1296-1300.
34. [34] L.L. Miller, C.J. Kolaskie, G.A. Smith and J. Rivier, Transdermal iontophoresis of gonadotropin releasing hormone (LHRH) and two analogues, J. Pharm. Sci. 79 (1990) 490-493.
35. [35] D.B. Bommannan, J. Tamada, L. Leung and R.O. Potts, Effect of electroporation on transdermal iontophoretic delivery of luteinizing hormone releasing hormone (LHRH) in-vitro, Pharm. Res. 11 (1994) 1809-1814.
36. [36] M.C. Heit, P.L. Williams, F.L. Jayes, S.K. Chang and J.E. Riviere, Transdermal iontophoretic peptide delivery: in-vitro and in-vivo studies with luteinizing hormone releasing hormone, J. Pharm. Sci. 82 (1993) 240-243.
37. [37] M.C. Heit, N.A. Monteiro-Riviere, F.L. Jayes and J.E. Riviere, Transdermal iontophoretic delivery of luteinizing hormone releasing hormone (LHRH): effect of repeated administration, Pharm. Res. 11 (1994) 1000-1003.
38. [38] V. Srinivasan, M.H. Su, W. Higuchi and C.R. Behl, Iontophoresis of polypeptides: effect of ethanol pretreatment of human skin, J. Pharm. Sci. 79 (1990) 588-591.
39. [39] P. Knoblauch and F. Moll, In-vitro pulsatile and continuous transdermal delivery of buserelin by iontophoresis, J. Control. Release 26 (1993) 203-212.
40. [40] A.K. Banga, M. Katakam and R. Mitra, Transdermal iontophoretic delivery and degradation of vasopressin across human cadaver skin, Int. J. Pharm. 116 (1995) 211-216.
41. [41] P. Lelawongs, J.C. Liu, O. Siddiqui, Y.W. Chien, Transdermal iontophoretic delivery of arginine-vasopressin I. Physicochemical consideration, Int. J. Pharm. 56 (1989) 13-22.
42. [42] K. Morimoto, Y. Iwakura, M. Miyazaki and E. Nakatani, Effect of proteolytic enzyme inhibitors on enhancement of transdermal iontophoretic delivery of vasopressin and an analogue in rats, Int. J. Pharm. 81 (1992) 119-125.
43. [43] Y. Iwajura and K. Morimoto, Transdermal iontophoretic delivery of vasopressin and its analogues in rats, S.T.P. Pharma. 1 (1991) 387-390.
44. [44] A.J. Banga and Y.W. Chien, Hydrogel-based iontophoretic delivery devices for transdermal delivery of peptide/protein drugs, Pharm. Res. 10 (1993) 697-702.
45. [45] M. Martin, P. Curley, J. Devane and J. Kelly, In-vitro transdermal delivery of desmopressin, in: R.C. Scott, R.H. Guy, J. Hadgraft and H.E. Bodde (Eds.), Prediction of Percutaneous Penetration, IBC Technical Services Ltd, London, UK, 1991, pp. 97-104.
46. [46] A.B. Brady, J. Corish and O.I. Corrigan, Passive and electrically assisted transdermal delivery of desamino-8-D-arginino vasopressin in-vitro from a gel matrix, in: R.C. Scott, R.H. Guy, J. Hadgraft and H.E. Bodde (Eds.), Prediction of Percutaneous Penetration, IBC Technical Services Ltd, London, UK, 1991, pp. 401-409.
47. [47] K. Morimoto, Y. Iwakura, E. Nakatani, M. Miyazaki and H. Tojima, Effects of proteolytic enzyme inhibitors of absorption enhancers on the transdermal iontophoretic delivery of calcitonin in rats, J. Pharm. Pharmacol. 44 (1992) 216-218.
48. [48] D.F. Hager, F.A. Mancuso, J.P. Nazareno, J.W. Sharkey and J.R. Siverly, Evaluation of a cultured skin equivalent as a model for iontophoretic transport, J. Control. Release 30 (1994) 117-123.
49. [49] S. Thysman, C. Hanchard, V. Preat, Human calcitonin delivery in rats by iontophoresis, J. Pharm. Pharmacol. 46 (1994) 725-730.
50. [50] K. Iga, H. Okada and Y. Matsumoto, A Matrix for Iontophoresis. European Patent Application 643,981 A1, 20 September 1994.
51. [51] M. Clemmesy, G. Courraze, B. Bevan and F. Puisieux, Mechanism involved in iontophoretic transport of angiotensin, Pharm Res. 12 (1995) 998-1002.
52. [52] B. Kari, Control of blood glucose levels in alloxan-diabetic rabbits by iontophoresis of insulin, Diabetes 35 (1986) 217-221.
53. [53] J-C. Liu, Y. Sun, O. Siddiqui, Y.W. Chien, W-M. Shi and J. Li, Blood glucose control in diabetic rats by transdermal iontophoretic delivery of insulin, Int. J. Pharm. 44 (1988) 197-204.
54. [54] B.R. Meyer, H.L. Katzeff, J.C. Eschbach, J. Trimmer, S.B. Zacharias, S. Rosen and D. Sibalis, Transdermal delivery of human insulin to albino rabbits under electrical current, Am. J. Med. Sci. 297 (1989) 321-325.
55. [55] B.H. Sage, Molecules for Iontophoretic Delivery. European Patent Application 552 878 A2, 12 January 1993.
56. [56] H.B. Lee and B.C. Shin, Transdermal Administration Method of Protein or Peptide Drug and its Administration Device Thereof. US Patent Application 5,250,023, 5 October 1993.
57. [57] Y.W Chien, P. Lelawongs and O. Siddiqui, Facilitated transdermal delivery of therapeutic peptides and proteins by iontophoretic delivery devices, J. Control. Release 13 (1990) 263-268.
58. [58] L. Langkaer, J. Brange, G.M. Grodsky and R.H. Guy, Transdermal delivery of monomeric insulin analogues by iontophoresis. Proc. Intern. Symp. Control. Rel. Bioact. Mater. 21 (1994) 172-173.
59. [59] N.H Yoshida and M.S Roberts, Solute molecular size and transdermal iontophoresis across excised human skin, J. Control. Release 25 (1993) 171-195.
60. [60] K. Oldenburg, K.T. Vo, G.A Smith and H.E. Selick, Iontophoretic delivery of oligonucleotides across full thickness hairless mouse skin, J. Pharm. Sci. 84 (1995) 915-921.
61. [61] S. DelTerzo, C.R. Behl and R.A. Nash, Iontophoretic transport of a homologous series of ionized and non-ionized model compounds: influence of hydrophobicity and mechanistic interpretation, Pharm. Res. 6 (1989) 85-90.
62. [62] R.W Alder, Strain effects on amine basicities, Chem. Rev. 89 (1989) 1215-1223.
63. [63] U. Tauber, Drug metabolism in the skin: advantages and disadvantages. Iontophoresis, in: J. Hadgraft and R.H. Guy (Eds.), Transdermal Drug Delivery - Developmental Issues and Research Initiatives. Marcel Dekker, New York, 1989, pp. 99-112.
64. [64] X.H. Zhou and A. Li Wan, A comparison of enzymatic activities of tissue lining portals of drug absorption, using the rat as a model, Int. J. Pharm. 62 (1990) 259-267.
65. [65] P.K. Shah and R.T. Borchardt, A comparison of peptidase activities and peptide metabolism in cultured mouse keratinocytes and neonatal mouse epidermis, Pharm. Res. 8 (1991) 70-75.
66. [66] T. Egelrud, Purification and preliminary characterization of stratum corneum chymotryptic enzyme: a proteinase that may be involved in desquamation, J. Invest. Dermatol. 101 (1993) 200-204.
67. [67] N. Horie, K. Fukuyama, I. Yoshimasa and W. Epstein, Detection and characterization of epidermal proteases by polyacrylamide gel electrophoresis, Comp. Biochem. Physiol. 77B (1984) 349-353.
68. [68] T. Hibino, Purification and characterisation of keratin hydrolase in psoriatic epidermis: application of keratin agarose plate and keratin polyacrylamide enzymography methods, Anal. Biochem. 147 (1985) 342-354.
69. [69] L. Hansson, M. Stromquist, A. Backman, P. Wallbrandt, A. Carlstein and T. Egelrud, Cloning, expression and characterisation of stratum corneum chymotryptic enzyme, a skin specific human serine protease, J. Biol. Chem. 269 (1994) 19420-19426.
70. [70] T. Rosendal, Studies on the conducting properties of the human skin to direct current, Acta. Physiol. Scand. 5 (1942-1943) 130.
71. [71] M.C. Heit, A. McFarland, R. Bock and J.E. Riviere, Isoelectric focusing and capillary zone electrophoresis studies using luteinizing hormone releasing hormone and its analog, J. Pharm. Sci. 83 (1994) 654-656.
72. [72] B. VanOrman Huff, G.G. Liversidge and G.L. McIntire, The electrophoretic mobility of tripeptide as a function of pH and ionic strength: comparison with iontophoretic flux data, Pharm. Rev. 12 (1995) 751-755.
73. [73] J.B. Phipps and J.R Gyory, Transdermal ion migration, Adv. Drug. Del. Rev. 9 (1992) 137-176.
74. [74] T. Bagniefski and R.R Burnette, A comparison of pulsed and continuous current iontophoresis, J. Control. Release 11 (1990) 113-122.
75. [75] J.P. Phipps, R.V. Padmanabhan and G.A. Lattin, Iontophoretic delivery of model inorganic and drug ions, J. Pharm. Sci. 78 (1987) 365-369.
76. [76] Y.W. Chien and A.K. Banga, Iontotherapeutic Devices, Reservoirs, Electrode Devices Therefore Process and Unit Dose, US Patent 5,250,022, 5 October 1993.
77. [77] J.B. Phipps, Iontophoresis Electrode. US Patent 5,084,008, 28 January 1992.
78. [78] C. Cullander, G. Rao and R.H Guy, Why silver/silver chloride? Criteria for iontophoresis electrodes, in: K.R. Brain, V.J. James and K.A. Walters (Eds.), Prediction of Percutaneous Penetration Vol 3b, STS Publishing, Cardiff, UK, 1993, pp. 381-390.
79. [79] J.G. Wagner, Kinetics of pharmacologic responses. I. Proposed relationships between responses and drug concentration in intact animal and man, J. Theor. Biol. 20 (1968) 173-201.
80. [80] L. B. Lloyd, J.E. Beck and T.J Petelenz, Rehydratable Product and Method of Preparation Thereof. US Patent 5,328,455, 12 July 1994.
81. [81] L. B. Lloyd, J.E. Beck, T.J Petelenz, C.H. Holt and W.F. Felman, Improved Electrode for Iontophoresis. World Patent Application 94/22528, 13 October 1994.
82. [82] J.R. Gyory and J.R. Perry, Iontophoretic Delivery Device and Methods of Hydrating Same. US Patent 5,310,404, 10 May 1994.
83. [83] H.C.A. Evers, F.B. Broberg, J.D. DeNuzzio and R.A. Hoke, User Activated Iontophoretic Device and Method for Using Same. World Patent Application 93/18727, 30 September 1993.
84. [84] Y. Konno, M. Mitoni, T. Sonobe and S. Yamaguchi, Plaster Structural Assembly for Iontophoresis. US Patent 4,842,577, 27 June 1989.
85. [85] R.P. Haak, J.R. Gyory, F. Theeuwes, F.A. Landrau, N. Roth and R.M. Meyers, Iontophoretic Delivery Device and Methods of Hydrating Same. US Patent 5,288, 289, 22 February 1994.
86. [86] R.P. Haak, J.R. Gyory, F. Theeuwes, F.A. Landrau, N. Roth and R.M. Meyers, Iontophoretic Delivery Device and Methods of Hydrating Same. US Patent 5,320,598, 14 June 1994.
87. [87] R.P. Haak, J.R. Gyory, F. Theeuwes, F.A. Landrau, N. Roth and R.M. Meyers, Iontophoretic Delivery Device and Methods of Hydrating Same. US Patent 5,385,543, 31 January 1995.