Potential treatment of atopic dermatitis: tolerability and safety of cream containing nanoparticles loaded with hydrocortisone and hydroxytyrosol in human subjects

Drug Delivery and Translational Research

Volumn 9, Issue 2, 2019, Pages 469-481

  Siddique, Muhammad Irfan ^a,b   Katas, Haliza ^a   Jamil, Adawiyah ^c   Mohd Amin, Mohd Cairul Iqbal ^a   Ng, Shiow Fern ^a   Zulfakar, Mohd Hanif ^a   Nadeem, Syed Maaz ^b  

^a UNIVERSITI KEBANGSAAN MALAYSIA   (Malaysia)

^b UNIVERSITY OF VETERINARY AND ANIMAL SCIENCES   (Pakistan)

^c UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTER   (Malaysia)

Author keywords

Atopic dermatitis; Nanomedicine; Semi solid; Skin; Topical drug delivery

Indexed keywords

CHITOSAN NANOPARTICLE; CORTICOTROPIN; HYDROCORTISONE; HYDROXYTYROSOL; MELANIN; 3,4-DIHYDROXYPHENYLETHANOL; ANTIINFECTIVE AGENT; ANTIINFLAMMATORY AGENT; GLUCOCORTICOID; NANOPARTICLE; PHENETHYL ALCOHOL; SKIN CREAM;

ADULT; ARTICLE; ATOPIC DERMATITIS; BLOOD BIOCHEMISTRY; CONTROLLED STUDY; CORTICOTROPIN BLOOD LEVEL; CREAM; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; DRUG TOLERABILITY; ERYTHEMA; FEMALE; FOURIER TRANSFORM INFRARED SPECTROSCOPY; HISTOPATHOLOGY; HUMAN; HUMAN EXPERIMENT; HUMAN TISSUE; IN VIVO STUDY; NANOENCAPSULATION; NORMAL HUMAN; PARTICLE SIZE; PH; PHYSICAL APPEARANCE; PRIORITY JOURNAL; SKIN BIOPSY; SKIN IRRITATION; SKIN WATER LOSS; VISCOELASTICITY; VISCOSITY; ZETA POTENTIAL; ADOLESCENT; ANALOGS AND DERIVATIVES; ANATOMY AND HISTOLOGY; CUTANEOUS DRUG ADMINISTRATION; DOUBLE BLIND PROCEDURE; DRUG EFFECT; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL; SKIN; YOUNG ADULT;

ADMINISTRATION, CUTANEOUS; ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS; ANTI-INFLAMMATORY AGENTS; DERMATITIS, ATOPIC; DOUBLE-BLIND METHOD; FEMALE; GLUCOCORTICOIDS; HUMANS; HYDROCORTISONE; MIDDLE AGED; NANOPARTICLES; PHENYLETHYL ALCOHOL; SKIN; SKIN CREAM; YOUNG ADULT;

EID: 85062888579     PISSN: 2190393X     EISSN: 21903948     Source Type: Journal    
DOI: 10.1007/s13346-017-0439-7     Document Type: Article

References (39)

1. Blank IH, Moloney J, Emslie AG, Simon I, Apt C. The diffusion of water across the stratum corneum as a function of its water content. J Investig Dermatol. 1984;82(2):188–94.
2. Hagströmer L, Kuzmina N, Lapins J, Talme T, Emtestam L. Biophysical assessment of atopic dermatitis skin and effects of a moisturizer. Clin Exp Dermatol. 2006;31(2):272–7.
3. Segre JA. Epidermal barrier formation and recovery in skin disorders. J Clin Invest. 2006;116(5):1150–8.
4. Buraczewska I, Broström U, Lodén M. Artificial reduction in transepidermal water loss improves skin barrier function. Br J Dermatol. 2007;157(1):82–6.
5. Roberts MS, Walters KA. Human skin morphology and dermal absorption. Drugs Pharm Sci. 2008;177:1.
6. Madison KC. Barrier function of the skin: “la raison d’etre” of the epidermis. J Investig Dermatol. 2003;121(2):231–41.
7. McAleer MA, Irvine AD. The multifunctional role of filaggrin in allergic skin disease. J Allergy Clin Immunol. 2013;131(2):280–91.
8. Ibler KS, Jemec GB. Novel investigational therapies for atopic dermatitis. Expert Opin Investig Drugs. 2015;24(1):61–8.
9. Banciu M, Schiffelers RM, Fens MH, Metselaar JM, Storm G. Anti-angiogenic effects of liposomal prednisolone phosphate on B16 melanoma in mice. J Control Release. 2006;113(1):1–8.
10. Abramovits W, Berman B, Cohen D, et al. Pathways to managing atopic dermatitis. Suppl J Clin Aesthet Dermatol. 2013;6(7):S3–S18.
11. Arkwright PD, Motala C, Subramanian H, Spergel J, Schneider LC, Wollenberg A. Management of difficult-to-treat atopic dermatitis. J Allergy Clin Immunol Pract. 2013;1(2):142–51.
12. Marro D, Guy RH, Delgado-Charro MB. Characterization of the iontophoretic permselectivity properties of human and pig skin. J Control Release. 2001;70(1):213–7.
13. Kaplun-Frischoff Y, Touitou E. Testosterone skin permeation enhancement by menthol through formation of eutectic with drug and interaction with skin lipids. J Pharm Sci. 1997;86(12):1394–9.
14. Thong H-Y, Zhai H, Maibach HI. Percutaneous penetration enhancers: an overview. Skin Pharmacol Physiol. 2007;20(6):272–82.
15. Cheng CJ, Tietjen GT, Saucier-Sawyer JK, Saltzman WM. A holistic approach to targeting disease with polymeric nanoparticles. Nat Rev Drug Discov. 2015;14(4):239–47.
16. Batheja P, Sheihet L, Kohn J, Singer AJ, Michniak-Kohn B. Topical drug delivery by a polymeric nanosphere gel: formulation optimization and in vitro and in vivo skin distribution studies. J Control Release. 2011;149(2):159–67.
17. Ilium L. Chitosan and its use as a pharmaceutical excipient. Pharm Res. 1998;15(9):1326–31.
18. Wedmore I, McManus JG, Pusateri AE, Holcomb JB. A special report on the chitosan-based hemostatic dressing: experience in current combat operations. J Trauma Acute Care Surg. 2006;60(3):655–8.
19. Hussain Z, Katas H, Amin MCIM, Kumolosasi E, Buang F, Sahudin S. Self-assembled polymeric nanoparticles for percutaneous co-delivery of hydrocortisone/hydroxytyrosol: an ex vivo and in vivo study using an NC/Nga mouse model. Int J Pharm. 2013;444(1):109–19.
20. Liang C-H, Chou T-H. Effect of chain length on physicochemical properties and cytotoxicity of cationic vesicles composed of phosphatidylcholines and dialkyldimethylammonium bromides. Chem Phys Lipids. 2009;158(2):81–90.
21. Agnihotri SA, Mallikarjuna NN, Aminabhavi TM. Recent advances on chitosan-based micro-and nanoparticles in drug delivery. J Control Release. 2004;100(1):5–28.
22. Raposo SC, Simões SD, Almeida AJ, Ribeiro HM. Advanced systems for glucocorticoids’ dermal delivery. Expert opinion on drug delivery. 2013;10(6):857–77.
23. Vauthier C, Bouchemal K. Methods for the preparation and manufacture of polymeric nanoparticles. Pharm Res. 2009;26(5):1025–58.
24. Iyer KS, Raston CL, Saunders M. Hierarchical aqueous self-assembly of C 60 nano-whiskers and C 60–silver nano-hybrids under continuous flow. Lab Chip. 2007;7(9):1121–4.
25. Colombo A, Briançon S, Lieto J, Fessi H. Project, design, and use of a pilot plant for nanocapsule production. Drug Dev Ind Pharm. 2001;27(10):1063–72.
26. Siddique MI, Katas H, Amin IM, et al. Minimization of local and systemic adverse effects of topical glucocorticoids by nanoencapsulation: in vivo safety of hydrocortisone–hydroxytyrosol loaded chitosan nanoparticles. J Pharm Sci. 2015;104(12):4276–86.
27. Mohanraj V, Chen Y. Nanoparticles—a review. Trop J Pharm Res. 2006;5(1):561–73.
28. Jaya S, Durance T, Wang R. Physical characterization of drug loaded microcapsules and controlled in vitro release study. Open Biomater Journal. 2010;2(1)
29. Socrates G. Infrared and Raman characteristic group frequencies: tables and charts. Hoboken: John Wiley & Sons; 2004.
30. Kolbe L, Kligman AM, Schreiner V, Stoudemayer T. Corticosteroid-induced atrophy and barrier impairment measured by non-invasive methods in human skin. Skin Res Technol. 2001;7(2):73–7.
31. Kikuchi K, Tagami H. Comparison of the effects of daily applications between topical corticosteroid and tacrolimus ointments on normal skin: evaluation with noninvasive methods. Dermatology. 2002;205(4):378–82.
32. Green BG. Measurement of sensory irritation of the skin. American Journal of Contact Dermatitis. 2000;11(3):170–80.
33. Siddique MI, Katas H, Amin MCIM, Ng S-F, Zulfakar MH, Jamil A. In-vivo dermal pharmacokinetics, efficacy, and safety of skin targeting nanoparticles for corticosteroid treatment of atopic dermatitis. Int J Pharm. 2016;507(1):72–82.
34. Abdel-Mottaleb M, Moulari B, Beduneau A, Pellequer Y, Lamprecht A. Surface-charge-dependent nanoparticles accumulation in inflamed skin. J Pharm Sci. 2012;101(11):4231–9.
35. Boyd C. Náray-Fejes-Tóth a. Steroid-mediated regulation of the epithelial sodium channel subunits in mammary epithelial cells. Endocrinology. 2007;148(8):3958–67.
36. Bárány E, Lindberg M, Lodén M. Unexpected skin barrier influence from nonionic emulsifiers. Int J Pharm. 2000;195(1):189–95.
37. Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. Can Med Assoc J. 2005;172(3):367–79.
38. Rochling FA. Evaluation of abnormal liver tests. Clinical cornerstone. 2001;3(6):1–12.
39. Hultsch T, Kapp A, Spergel J. Immunomodulation and safety of topical calcineurin inhibitors for the treatment of atopic dermatitis. Dermatology. 2005;211(2):174–87.