Impact of humidity on in vitro human skin permeation experiments for predicting in vivo permeability

Journal of Pharmaceutical Sciences

Volumn 104, Issue 12, 2015, Pages 4223-4231

  Ishida, Masahiro ^a   Takeuchi, Hiroyuki ^a   Endo, Hiromi ^a   Yamaguchi, Jun Ichi ^a  

^a TAISHO PHARMACEUTICAL CO LTD   (Japan)

Author keywords

humidity level; in vitro permeation experiment; in vitro in vivo correlations; permeability; pharmacokinetics; skin; SKIN CAD; transdermal drug delivery; TTS

Indexed keywords

ISOSORBIDE DINITRATE; NICOTINE; SILICONE; DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; ARTIFICIAL MEMBRANE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG PENETRATION; HUMAN; HUMAN TISSUE; HUMIDITY; IN VITRO STUDY; IN VIVO STUDY; MALE; MATHEMATICAL MODEL; MAXIMUM PLASMA CONCENTRATION; PLASMA CONCENTRATION-TIME CURVE; PREDICTION; SKIN PENETRATION; TIME TO MAXIMUM PLASMA CONCENTRATION; TRANSDERMAL DRUG DELIVERY SYSTEM; BIOLOGICAL MODEL; CHEMISTRY; CUTANEOUS DRUG ADMINISTRATION; DRUG DELIVERY SYSTEM; METABOLISM; MIDDLE AGED; PERMEABILITY; PROCEDURES; SKIN; SKIN ABSORPTION;

ADMINISTRATION, CUTANEOUS; DRUG DELIVERY SYSTEMS; HUMANS; HUMIDITY; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; PERMEABILITY; PHARMACEUTICAL PREPARATIONS; SKIN; SKIN ABSORPTION;

EID: 84954396066     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24656     Document Type: Article

References (39)

1. OECD. 2010. OECD guidance notes on dermal absorption. Paris.
2. Franz TJ,. 1975. Percutaneous absorption. On the relevance of in vitro data. J Invest Dermatol 64 (3): 190-195.
3. Welin-berger K, Neelissen JA, Emanuelsson BM, Bjornsson MA, Gjellan K,. 2003. In vitro-in vivo correlation in man of a topically applied local anesthetic agent using numerical convolution and deconvolution. J Pharm Sci 92 (2): 398-406.
4. Trauer S, Patzelt A, Otberg N, Knorr F, Rozycki C, Balizs G, Buttemeyer R, Linscheid M, Liebsch M, Lademann J,. 2009. Permeation of topically applied caffeine through human skin-A comparison of in vivo and in vitro data. Br J Clin Pharmacol 68 (2): 181-186.
5. Yang Y, Manda P, Pavurala N, Khan MA, Krishnaiah YS,. 2015. Development and validation of in vitro-in vivo correlation (IVIVC) for estradiol transdermal drug delivery systems. J Control Release 210: 58-66.
6. Sato K, Oda T, Sugibayashi K, Morimoto Y,. 1988. Estimation of blood concentration of drugs after topical application from in vitro skin permeation data.I. prediction by convolution and confirmation by deconvolution. Chem Pharm Bull 36 (6): 2232-2238.
7. Kawamata H, Tojo K,. 2002. Prediction of plasma concentration of GTS-21 in hairless rats following monolithic transdermal delivery. Biol Pharm Bull 25 (3): 342-345.
8. Akomeah FK, Martin GP, Brown MB,. 2007. Variability in human skin permeability in vitro: Comparing penetrants with different physiochemical properties. J Pharm Sci 96 (4): 824-834.
9. Tominaga K, Tojo K,. 2010. Effect of environmental temperature on transdermal drug penetration. Biol Pharm Bull 33 (12): 1983-1987.
10. Chang SK, Riviere JE,. 1993. Effect of humidity and occlusion on the percutaneous absorption of parathion in vitro. Pharm Res 10 (1): 152-155.
11. Potts RO,. 1986. Stratum corneum hydration: Experimental techniques and interpretations of results. J Soc Cosmet Chem 37: 9-33.
12. OECD. 2004. OECD guideline for the testing of chemicals. Skin Absorption: in vitro Method. Paris.
13. Roskos KV, Maibach HI, Guy RH,. 1989. The effect of aging on percutaneous absorption in man. J Pharmacokinet Biopharm 17 (6): 617-630.
14. Takeuchi H, Ishida M, Urano H, Sugibayashi K,. 2012. Prediction of blood concentration of nicotine or lidocaine after application of their dermal tapes in human from the in vitro permeation through Yucatan micropig skin. J Pharm Sci Technol 72 (4): 251-261.
15. Sandby-moller J, Poulsen T, Wulf HC,. 2003. Epidermal thickness at different body sites: Relationship to age, gender, pigmentation, blood content, skin type and smoking habits. Acta Derm Venereol 83 (6): 410-413.
16. Bronaugh RL, Stewart RF, Congdon ER,. 1982. Methods for in vitro percutaneous absorption studies II. animal models for human skin. Toxicol App Pharmacol 62 (3): 481-488.
17. TM. Pharm Technol Jpn 17 (5): 771-778.
18. Isowaki A, Ohtori A, Matsuo Y, Tojo K,. 2003. In vitro/in vivo/in silico evaluation for transdermal prednisolone delivery systems. Kagaku kogaku Ronbunshu 29 (6): 760-763.
19. Nakamura A, Mori D, Tojo K,. 2012. Evaluation of the predicted time-concentration profile of serum tulobuterol in human after transdermal application. Chem Pharm Bull 60 (3): 300-305.
20. Hikima T, Kaneda N, Matsuo K, Tojo K,. 2012. Prediction of percutaneous absorption in human using three-dimensional human cultured epidermis LabCyte EPI-MODEL. Biol Pharm Bull 35 (3): 362-368.
21. Tojo K, Chiang CC, Chien YW,. 1987. Drug permeation across the skin: Effect of penetrant hydrophilicity. J Pharm Sci 76 (2): 123-126.
22. Tojo K,. 1988. Concentration profile in plasma after transdermal drug delivery. Int J Pharm 43 (3): 201-205.
23. Schaefer H, Zesch A,. 1975. Penetration of vitamin A acid into human skin. Acta Dermato Suppl 74: 50-55.
24. Benowitz NL, Jacob III P, Denaro C, Jenkins R,. 1991. Stable isotope studies of nicotine kinetics and bioavailability. Clin Pharmacol Ther 49 (3): 270-277.
25. Straehl P, Galeazzi RL,. 1985. Isosorbide dinitrate bioavailability, kinetics, and metabolism. Clin Pharmacol Ther 38 (2): 140-149.
26. Sato K, Sugibayashi K, Morimoto Y,. 1991. Species differences in percutaneous absorption of nicorandil. J Pharm Sci 80 (2): 104-107.
27. Urae A, Irie S, Amamoto T, Yoshiie H, Egawa A, Nakagawa T, Azuma F, Nagasawa T, Kawai H, Yokota N,. 1994. Comparative bioavailability study of Ba37142 (Nicotine TTS) after a single application to different skin sites in Japanese smokers. J Clin Ther Med 10 (Suppl 3): 53-62.
28. ® Tape S (TY-0161): Plasma concentrations of isosorbide dinitrate after application of TY-0161 followed by change of application site. Jpn Pharmacol Ther 21 (4): 1059-1066.
29. Horikoshi T, Hanada J, Mune C,. 1995. Examination of skin excitability of Flanders tape S (improved product). Nishinihon J Dermatol 57 (4): 822-824.
30. Ishinaga T, Komatsu C, Tanoiri T, Tokuhisa Y, Tateishi O, Okamura T,. 1987. Study of the percutaneous absorption of isosorbide dinitrate, relationship between plasma concentration, applicated area and dermal condition. Clin All-Round 36 (3): 543-547.
31. Bos JD, Meinardi MM,. 2000. The 500 dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol 9 (3): 165-169.
32. Flynn GL, Yalkowsky SH,. 1972. Correlation and prediction of mass transport across membranes I: Influence of alkyl chain length on flux-determining properties of barrier and diffusant. J Pharm Sci 61 (6): 838-852.
33. Yano T, Nakagawa A, Tsuji M, Noda K,. 1986. Skin permeability of various non-steroidal anti-inflammatory drugs in man. Life Sci 39 (12): 1043-1050.
34. Scheuplein RJ, Blank IH, Brauner GJ, Macfarlane DJ,. 1969. Percutaneous absorption of steroids. J Invest Dermatol 52 (1): 63-70.
35. Michaels AS, Chandrasekaran SK, Shaw JE,. 1975. Drug permeation through human skin: Theory and in vitro experimental measurement. AIChE J 21 (5): 985-996.
36. Kasting GB, Barai ND,. 2003. Equilibrium water sorption in human stratum corneum. J Pharm Sci 92 (8): 1624-1631.
37. Wang TF, Kasting GB, Nitsche JM,. 2006. A multiphase microscopic diffusion model for stratum corneum permeability. I. Formulation, solution, and illustrative results for representative compounds. J Pharm Sci 95 (3): 620-648.
38. Dancik Y, Miller MA, Jaworska J, Kasting GB,. 2013. Design and performance of a spreadsheet-based model for estimating bioavailability of chemicals from dermal exposure. Drug Deliv Rev 65: 221-236.
39. Vanakoski J, Seppala T, Sievi E, Lunell E,. 1996. Exposure to high ambient temperature increases absorption and plasma concentrations of transdermal nicotine. Clin Pharm Ther 60 (3): 308-315.