Effect of transdermal iontophoresis codelivery of hydrocortisone on metoclopramide pharmacokinetics and skin-induced reactions in human subjects

Journal of Pharmaceutical Sciences

Volumn 88, Issue 10, 1999, Pages 1030-1035

  Cormier, Michel ^a   Chao, Stella T ^a,b   Gupta, Suneel K ^a   Haak, Ron ^a  

^a ALZA CORPORATION   (United States)

^b ELAN PHARMACEUTICALS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIEMETIC AGENT; ANTIINFLAMMATORY AGENT; HYDROCORTISONE; METOCLOPRAMIDE;

AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DELIVERY SYSTEM; HUMAN; IN VITRO STUDY; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; STEADY STATE; TRANSDERMAL DRUG ADMINISTRATION;

EID: 0032862724     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1021/js980491+     Document Type: Article

References (38)

1. Shaw, J. E. Pharmacokinetics of Nitroglycerin and Clonidine Delivered by the Transdermal Route. Am. Heart J. 1984, 108, 217-223.
2. Enscore, D. J.; Osborne, J. L.; Shaw J. E. In Vitro/in Vivo Functionality of Catapres-TTS. Methods Find. Exp. Clin. Pharmacol. 1989, 11, 173-178.
3. Knepp, V. M.; Hadgraft, J.; Guy, R. H. Transdermal Drug Delivery: Problems and Possibilities. Crit, Rev. Ther. Drug Carrier Syst. 1987, 4, 13-37.
4. Wilson, D. E.; Kaidbey, K.; Boike, S. C.; Jorkaski, D. K. Use of Topical Corticosteroid Pretreatment to Reduce the Incidence and Severity of Skin Reactions Associated with Testosterone Transdermal Therapy. Clin. Therap. 1998, 20, 299-306.
5. Dick, J. B. C.; Northridge D. B.; Lawson, A. A. H. Skin Reactions to Long-Term Transdermal Clonidine. Lancet 1987, 1, 516.
6. Patil, S. M.; Hogan, D. J.; Maibach, H. I. Transdermal Drug Delivery Systems: Adverse Dermatologic Reactions. In Dermatotoxicology Fifth Edition, Marzuli, F. N., Maibach, H. I., Eds.; Taylor & Francis: Philadelphia, 1996; pp 389-396.
7. Kalish, R. S.; Wood, J. A.; Wille, J. J.; Kydonieus, A. Sensitization of Mice to Topically Applied Drugs: Albuterol, Chlorpheniramine, Clonidine and Nadolol. Contact Dermatitis 1896, 35, 76-82.
8. Mize N. K; Johnson J. A.; Hansch C.; Cormier M. Quantitative Structure-activity Relationship and Cytotoxicity. Curr. Probl. Dermatol. 1995, 23, 224-229.
9. Sharpe, R. J.; Chandrasekar, A.; Arndt, K. A.; Wang, Z. S.; Galli, S. J. Inhibition of Cutaneous Contact Hypersensitivity in the Mouse with Systemic or Topical Spiperone: Topical Application of Spiperone Produces Local Immunosuppression without Inducing Systemic Neuroleptic Effects. J. Invest. Dermatol. 1992, 99, 594-600.
10. Kalish, R. S.; Wood, J. A.; Kydonieus, A.; Wille, J. J. Prevention of Contact Sensitivity to Topically Applied Drugs by Ethacrynic Acid: Potential Application to Transdermal Drug Delivery. J. Controlled Release 1997, 48, 79-87.
11. Cormier, M.; Ledger, P. W.; Amkraut A. A. Reduction or Prevention of Skin Irritation or Sensitization during Transdermal Administration of a Irritating or Sensitizing Drug. US Patent 5, 451, 407, 1995.
12. Cormier, M.; Ledger, P. W.; Amkraut, A. A.; Marty, J. P. Method for Reducing Sensitization or Irritation in Transdermal Drug Delivery and Means Therefor. US Patent 5, 304, 379, 1994.
13. Cormier, M.; Ledger, P. W.; Amkraut, A. A. Reduction or prevention of skin irritation by drugs. US Patent 5, 130, 139, 1992.
14. Mize N.; Buttery M.; Ruis N.; Leung I.; Cormier M.; Daddona P. Antiflammin 1 Peptide Delivered Noninvasively by Iontophoresis Reduces Irritant-induced Inflammation in Vivo. Exp. Dermatol. 1997, 6, 181-185.
15. Amkraut, A. A.; Jordan, W. P.; Taskovich L. Effect of Coadministration of Corticosteroids on the Development of Contact Sensitization. J. Am. Acad. Dermatol. 1996, 35, 27-31.
16. Ito, M. K.; O'Connor, D. T. Skin Pretreatment and the Use of Transdermal Clonidine. Am. J. Med. 1991, 91, 42S-49S.
17. Sommer, A.; Veraart, J.; Neumann, M.; Kessels, A. Evaluation of the Vasoconstrictive Effects of topical steroids by Laser-Doppler-perfusion-imaging. Acta Derm. Venereol. 1998, 78, 15-18.
18. Stoughton, R., B. The Vasoconstrictor Assay in Bioequivalence Testing: Practical Concerns and Recent Developments. Int. J. Dermatol. 1992, 31s1, 26-28.
19. Haak, R. H.; Gupta, S. K. Pulsatile Drug Delivery from Electrotransport Therapeutic Systems. In Pulsatile Drug Delivery. Current Applications and Future Trends; Gurny, R., Junginger, H. E., Pappas, N. A., Eds.; Wissenschaftliche Verlagsgesellschaft mbH: Stuttgart, 1993; pp 99-112.
20. Scott, N. R.; Dixon, P. F. Determination of Cortisol in Human Plasma by Reversed-phase High-performance Liquid Chromatography. J. Chromatogr. 1979, 164, 29-34.
21. Buss, D. C.; Hutchings, A. D.; Scott, S.; Routledge, P. A. A Rapid Liquid Chromatographic Method for the Determination of Metoclopramide in Human Plasma. Ther. Drug Monit. 1990, 12, 293-296.
22. Wagner, J. G.; Nelson, E. Percent Absorbed Time Plots Derived from Blood Level and/or Urinary Excretion Data. J. Pharm. Sci. 1983, 52, 610-611.
23. Wilhelm, K. P.; Maibach, H. I. Skin Color Reflectance Measurements for Objective Quantification of Erythema in Human Beings. J. Am. Acad. Dermatol. 1989, 21, 1306-1310.
24. AHFS 98 Drug Information; McEvoy, G. K., Ed; American Society of Health-System Pharmacists: Bethesda, MD, 1998; 2438-2445.
25. Lin, R. Y.; Ou, Y. C.; Chen, W. Y. The Role of Electroosmotic Flow on In-vitro Transdermal Iontophoresis. J. Controlled Release 1997, 43, 23-33.
26. Burnette, R. R.; Ongpipattanakul, B. Characterization of the Pore Transport Properties and Tissue Alteration of Excised Human Skin during Iontophoresis. J. Pharm. Sci. 1988, 77, 132-137.
27. Foreman, M. I.; Clanachan, I. Steroid Diffusion and Binding in Human Stratum Corneum. J. Chem. Soc. 1984, 80, 3439-3944.
28. Ruddy, S. B.; Hadzija, B. W. Iontophoretic Permeability of Polyethylene Glycols through Hairless Rat Skin. Application of Hydrodynamic Theory for Hindered Transport through Liquid Filled Pores. Drug Des. Discovery. 1992, 8, 207-224.
29. Delgado-Charro, M. B.; Guy R. H. Characterization of Convective Solvent Flow During Iontophoresis. Pharm. Res. 1994, 11, 929-935.
30. Attwood, D.; Florence, A. T. Pharmaceutical Aspects of Solubilization. In Surfactant Systems. Their Chemistry, Pharmacy and Biology; Attwood, D, Florence, A. T., Eds.; Chapman and Hall: London, New York, 1983; pp 293-387.
31. Sokoloski, T. D. Solutions and Phase Equilibria. In Remington's Pharmaceutical Sciences, 18th ed.; Gennaro A. R., Ed.; Mack Publishing Company: Easton, PA, 1990; pp 207-227.
32. Riviere, J. E.; Monteiro-Riviere, N. A.; Inman, A. O. Determination of Lidocaine Concentrations in Skin after Transdermal Iontophoresis: Effect of Vasoactive Drugs. Pharm. Res. 1992, 9, 211-214.
33. Schimmer, B. P.; Parker, K. L. Adrenocorticotropic Hormone; Adrenocortical Steroids and their Analogues; Inhibitors of the Synthesis and Actions of Adrenocortical Hormones. In Goodman & Gilman's The Pharmacological Basis of Therapeutics, 9th ed.; Hardman, J. G., Limbird, L. E.; Molinoff, P. B., Ruddon, H. W., Eds.; The McGraw-Hill Companies Inc.: New York, 1996; pp 1465-1485.
34. Burrows, W. M.; Stoughton, R. B. Inhibition of Induction of Human Contact Sensitization by Topical Glucocorticosteroids. Arch. Dermatol. 1976, 112, 175-178.
35. Novak, E.; Francom, S. F.; Schlael, C. A. Adrenal Suppression with High-potency Corticosteroid Ointment Formulations in Normal Subjects. Clin. Ther. 1983, 6, 59-71.
36. Munro, D.D. The Effect of percutaneously Absorbed Steroids on Hypothalamic-pituitary-adrenal Function after Intensive Use in In-patients. Br. J. Dermatol. 1976, 94s12, 67-76.
37. Lubach, D.; Bensmann, A.; Bornemann, U. Steroid-induced Dermal Atrophy. Investigations on Discontinuous Application. Dermatologica 1989, 179, 67-72.
38. Ledger, P. W.; Cormier, M.; Campbell, P. Reduction of Skin Irritation during Electrotransport Delivery. US Patent 5, 693, 010, 1997.