In-Vivo Acute Dermal Irritation Study Of Desonide-Curcumin Niosomal Gel: An Experimental Approachs
Keywords:
Curcumin, Desonide, Niosomal gel, Topical delivery, Dermal irritation, OECD 404 guideline, Draize scoring, Wistar rats, Skin safety evaluationAbstract
Topical niosomal gels have gained considerable attention for enhancing localized drug delivery and reducing systemic side effects. Desonide, a corticosteroid, and curcumin, a natural anti-inflammatory compound, are both recognized for their therapeutic potential in treating skin inflammation. This study aimed to evaluate the dermal irritation potential of a Curcumin–Desonideniosomal gel in Wistar rats using OECD guideline 404. Thirty Wistar albino rats were randomly divided into five groups (n = 6 each): Group I (Normal Control), Group II (Positive Control with 0.8% formaldehyde), Group III (Placebo gel base), Group IV (Curcumin–Desonideniosomal gel), and Group V (Marketed Diclofenacniosomal gel). Skin reactions were observed and scored at 24, 48, and 72 hours post-application using the Draize scoring system for erythema, edema, and swelling. The results demonstrated no skin reactions in the normal control group, while the formaldehyde-treated group showed severe irritation with high scores across all parameters. The placebo group exhibited only very slight irritation at 24 hours that resolved by 48 hours. The Curcumin–Desonideniosomal gel group showed minimal erythema at 24 hours, with no edema or swelling, and no signs of irritation at 48 and 72 hours. The marketed niosomal gel also showed minimal erythema with no other adverse effects. These findings confirm that the Curcumin–Desonideniosomal gel is well-tolerated and non-irritant, supporting its potential as a safe and effective topical formulation for anti-inflammatory therapy.
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References
Medzhitov R. Origin and physiological roles of inflammation. Nature. 2008 Jul 24;454(7203):428–35. doi:10.1038/nature07201
Prausnitz MR, Langer R. Transdermal drug delivery. Nat Biotechnol. 2008 Nov;26(11):1261–8. doi:10.1038/nbt.1504
Moghassemi S, Hadjizadeh A. Nano niosomes as nanoscale drug‐delivery systems: an illustrated review. J Control Release. 2014 Jul 10;185:22–36. doi:10.1016/j.jconrel.2014.04.015
Sharma A, Sharma US. Liposomes in drug delivery: progress and limitations. Int J Pharm. 1997 Aug 26;154(2):123–40. doi:10.1016/S0378 5173(97)00135 X
Eichenfield LF, Lucky AW, Boguniewicz M, Langley RG, Simpson EL, Maloney JM, et al. Safety and efficacy of desonide hydrogel 0.05% in children with atopic dermatitis. J Am AcadDermatol. 2007 Feb;56(2):222–8. doi:10.1016/j.jaad.2006.09.040
Gupta SC, Patchva S, Aggarwal BB. Therapeutic roles of curcumin: lessons learned from clinical trials. AAPS J. 2013 Mar;15(1):195–218. doi:10.1208/s12248 012 9437 4
Manca ML, Castangia I, Zaru M, Lai F, Valenti D, Sinico C, et al. Nanosystems for topical delivery of curcumin: a promising therapeutic strategy for inflammatory skin conditions. Colloids Surf B Biointerfaces. 2015 May;123:566–72. doi:10.1016/j.colsurfb.2014.11.031
Aggarwal BB, Harikumar KB. Potential therapeutic effects of curcumin, the anti inflammatory agent, against neurodegenerative, cardiovascular, pulmonary, metabolic, autoimmune and neoplastic diseases. Int J Biochem Cell Biol. 2009 Jan;41(1):40–59. doi:10.1016/j.biocel.2008.06.010
Baek JS, Cho CW. Niosomal formulations for delivery of dermatological drugs. Arch Pharm Res. 2020 Jan;43(1):1–12. doi:10.1007/s12272 019 01167 3
Raza K, Singh B, Lohan S, Sharma G, Negi P, Yachha Y, et al. Nano based drug delivery systems for topical application: formulation and evaluation. Drug DevInd Pharm. 2017 Mar;43(3):381–92. doi:10.1080/03639045.2016.1248790
OECD. OECD Guidelines for the Testing of Chemicals. Test No. 404: Acute Dermal Irritation/Corrosion. OECD; 2015.
Waman RL, Loksh KR. Development and validation of reversed phase high performance liquid chromatography method for simultaneous estimation of desonide and curcumin in topical dosage form. Asian J Pharm. 2024;18(3):866. doi:10.22159/ajp.2024v18i3.73921
Kaur CD, Saraf S. Topical vesicular delivery system for anti inflammatory agents: design and development. Artif Cells Blood SubstitImmobilBiotechnol. 2011;39(3):130–8. doi:10.3109/10731199.2010.511294
Jain S, Jain P, Umamaheshwari RB, Jain NK. Transfersomes—a novel vesicular carrier for enhanced transdermal delivery: development, characterization, and performance evaluation. Drug DevInd Pharm. 2003 Nov;29(9):1013–26. doi:10.1081/DDC 120024582
Turner PV, Brabb T, Pekow C, Vasbinder MA. Administration of substances to laboratory animals: routes of administration and factors to consider. J Am Assoc Lab Anim Sci. 2011 Sep;50(5):600–13.
Bhardwaj A, Kansal S, Kumar M, Rawat M, Chauhan NS, Sardana S. Development and evaluation of niosomal gel for topical delivery of benzoyl peroxide. Drug DelivLett. 2018 Mar;8(1):11–20.
ECD. OECD Guidelines for the Testing of Chemicals. Section 4. Test No. 404: Acute Dermal Irritation/Corrosion. OECD; 2015.
OECD. Guidance Document on Integrated Approaches to Testing and Assessment (IATA) for Skin Irritation/Corrosion. Series No. 203. OECD; 2014.
Draize JH. Appraisal of the safety of chemicals in foods, drugs and cosmetics. Assoc Food Drug Off U S. 1959;49:2–56.
Balls M, Goldberg AM, Fentem JH, Broadhead CL, Burch RL, Festing MF, et al. The three Rs: the way forward. Altern Lab Anim. 1995 Nov;23(6):838–66.
Parasuraman S. Toxicological screening. J PharmacolPharmacother. 2011 Apr;2(2):74–9. doi:10.4103/0976 500X.81834
Pathan IB, Setty CM. Chemical penetration enhancers for transdermal drug delivery systems. Trop J Pharm Res. 2009 Apr;8(2):173–9. doi:10.4314/tjpr.v8i2.46416
Benson HA. Transdermal drug delivery: penetration enhancement techniques. Curr Drug Deliv. 2005 Feb;2(1):23–33. doi:10.2174/1567201052773066
Festing MF, Altman DG. Guidelines for the design and statistical analysis of experiments using laboratory animals. ILAR J. 2002;43(4):244–58. doi:10.1093/ilar.43.4.244
Pandey M, Choudhury H, Lim YM, Kok YY, Rajinikanth PS, Abdullah AH, et al. Skin irritation testing of transdermal patches containing anti inflammatory drugs using formalin as a positive control. Drug DelivTransl Res. 2020 Apr;10(2):324–33. doi:10.1007/s13346 019 00699 7
Jain A, Jain S, Jain RK, Mahajan SC. Development and evaluation of niosomal gel of diclofenac for transdermal delivery. J Drug DelivTher. 2014;4(2):74–80. doi:10.22270/jddt.v4i2.526
Draize JH, Woodard G, Calvery HO. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J PharmacolExpTher. 1944 Dec;82(3):377–90.
OECD. Test No. 404: Acute Dermal Irritation/Corrosion. OECD; 2015.
Gad SC. Animal Models in Toxicology. 3rd ed. Boca Raton: CRC Press; 2015. Chapter 14, Dermal Toxicity and Irritation Studies, p. 483–500.
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