Eco-friendly preparation, characterization, evaluation of anti-melanogenesis/antioxidant effect and in vitro/in vivo safety profile of kojic acid loaded niosome as skin lightener preparation

References

• Sonthalia S, Daulatabad D, Sarkar R. Glutathione as a skin whitening agent: facts, myths, evidence and controversies. Indian J Dermatol Venereol Leprol. 2016;82(3):262–272.
   PubMed Web of Science ®Google Scholar
• Hashemi SM, Emami S. Kojic acid-derived tyrosinase inhibitors: synthesis and bioactivity. mazums-pbr. 2015;1(1):1–17.
   Google Scholar
• Noh JM, Kwak SY, Kim DH, et al. Kojic acid–tripeptide amide as a new tyrosinase inhibitor. Peptide Sci Original Res Biomol. 2007;88(2):300–307.
   Google Scholar
• Silpa-Archa N, Kohli I, Chaowattanapanit S, et al. Postinflammatory hyperpigmentation: a comprehensive overview: epidemiology, pathogenesis, clinical presentation, and noninvasive assessment technique. J Am Acad Dermatol. 2017;77(4):591–605.
   PubMed Web of Science ®Google Scholar
• James WD, Elston D, Berger T. Andrew’s diseases of the skin E-book: clinical dermatology. Amsterdam: Elsevier Health Sciences; 2011.
   Google Scholar
• Duarte I, Campos Lage AC. Frequency of dermatoses associated with cosmetics. Contact Dermatitis. 2007;56(4):211–213.
   PubMed Web of Science ®Google Scholar
• Nicolaidou E, Katsambas AD. Pigmentation disorders: hyperpigmentation and hypopigmentation. Clin Dermatol. 2014;32(1):66–72.
   PubMed Web of Science ®Google Scholar
• Avazpour S, Pardakhty A, Nabatian E, et al. Economical approach for determination of kojic acid by nanostructured ionic liquid-based carbon paste sensor. BioNanoSci. 2020;10(2):502–511.
   Web of Science ®Google Scholar
• Lim JTE. Treatment of melasma using kojic acid in a gel containing hydroquinone and glycolic acid. Dermatol Surg. 1999;25(4):282–284.
   PubMed Web of Science ®Google Scholar
• Saeedi M, Eslamifar M, Khezri K. Kojic acid applications in cosmetic and pharmaceutical preparations. Biomed Pharmacother. 2019;110:582–593.
   PubMed Web of Science ®Google Scholar
• Burnett CL, Bergfeld WF, Belsito DV, et al. Final report of the safety assessment of kojic acid as used in cosmetics. Int J Toxicol. 2010;29(6 Suppl):244S–2473.
   PubMed Web of Science ®Google Scholar
• Serra-Baldrich E, Tribó MJ, Camarasa JG. Allergic contact dermatitis from kojic acid. Contact Dermatitis. 1998;39(2):86–87.
   PubMed Web of Science ®Google Scholar
• García-Gavín J, González-Vilas D, Fernández-Redondo V, et al. Pigmented contact dermatitis due to kojic acid. A paradoxical side effect of a skin lightener. Contact Dermatitis. 2010;62(1):63–64.
   PubMed Web of Science ®Google Scholar
• Khezri K, Saeedi M, Morteza-Semnani K, et al. An emerging technology in lipid research for targeting hydrophilic drugs to the skin in the treatment of hyperpigmentation disorders: kojic acid-solid lipid nanoparticles. Artif Cells Nanomed Biotechnol. 2020;48(1):841–853.
   PubMed Web of Science ®Google Scholar
• Sharma V, Anandhakumar S, Sasidharan M. Self-degrading niosomes for encapsulation of hydrophilic and hydrophobic drugs: an efficient carrier for cancer multi-drug delivery. Mater Sci Eng C Mater Biol Appl. 2015;56:393–400.
   PubMed Web of Science ®Google Scholar
• Khatoon M, Shah KU, Din FU, et al. Proniosomes derived niosomes: recent advancements in drug delivery and targeting. Drug Deliv. 2017;24(sup1):56–69.
   PubMedGoogle Scholar
• Marianecci C, Di Marzio L, Rinaldi F, et al. Niosomes from 80s to present: the state of the art. Adv Colloid Interface Sci. 2014;205:187–206.
   PubMed Web of Science ®Google Scholar
• Azeem A, Anwer MK, Talegaonkar S. Niosomes in sustained and targeted drug delivery: some recent advances. J Drug Target. 2009;17(9):671–689.
   PubMed Web of Science ®Google Scholar
• Manconi M, Sinico C, Valenti D, et al. Niosomes as carriers for tretinoin: III. A study into the in vitro cutaneous delivery of vesicle-incorporated tretinoin. Int J Pharm. 2006;311(1-2):11–19.
   PubMed Web of Science ®Google Scholar
• Desnita R, Luliana S, Anggraini S. In vitro penetration of alpha arbutin niosome span 60 system in gel preparation. Pharmaciana. 2017;7(2):249–256.
   Google Scholar
• Radmard A, Saeedi M, Morteza-Semnani K, et al. An eco-friendly and green formulation in lipid nanotechnology for delivery of a hydrophilic agent to the skin in the treatment and management of hyperpigmentation complaints: arbutin niosome (Arbusome). Colloids Surf B Biointerfaces. 2021;201:111616.
   PubMed Web of Science ®Google Scholar
• Junyaprasert VB, Singhsa P, Suksiriworapong J, et al. Physicochemical properties and skin permeation of Span 60/Tween 60 niosomes of ellagic acid. Int J Pharm. 2012;423(2):303–311.
   PubMed Web of Science ®Google Scholar
• Hashemi SMH, Enayatifard R, Akbari J, et al. Venlafaxine HCl encapsulated in niosome: green and eco-friendly formulation for the management of pain. AAPS PharmSciTech. 2022;23(5):149.
   PubMed Web of Science ®Google Scholar
• Pereira-Lachataignerais J, Pons R, Panizza P, et al. Study and formation of vesicle systems with low polydispersity index by ultrasound method. Chem Phys Lipids. 2006;140(1-2):88–97.
   PubMed Web of Science ®Google Scholar
• Khan MI, Madni A, Hirvonen J, et al. Ultrasonic processing technique as a green preparation approach for diacerein-loaded niosomes. AAPS PharmSciTech. 2017;18(5):1554–1563.
   PubMed Web of Science ®Google Scholar
• Kumar PP, Gayatri P, Sunil R, et al. Atorvastatin loaded solid lipid nanoparticles: formulation, optimization, and in vitro characterization. IOSR J Pharm. 2012;2(5):23–32.
   Google Scholar
• Enayatifard R, Akbari J, Saeedi M, et al. Investigating the effect of coated lipid nano particles of spironolactone with chitosan on their properties. J Mazandaran Univ Med Sci. 2018;28(162):25–36.
   Google Scholar
• Boskabadi M, Saeedi M, Akbari J, et al. Topical gel of vitamin a solid lipid nanoparticles: a hopeful promise as a dermal delivery system. Adv Pharm Bull. 2021;11(4):663–674. Epub 2020/10/03.
   PubMed Web of Science ®Google Scholar
• Saeedi M, Morteza-Semnani K, Akbari J, et al. Brain targeting of venlafaxine HCl as a hydrophilic agent prepared through green lipid nanotechnology. J Drug Delivery Sci Technol. 2021;66:102813.
   Web of Science ®Google Scholar
• Akbari J, Saeedi M, Morteza-Semnani K, et al. An Eco-Friendly and hopeful promise platform for delivering hydrophilic wound healing agents in topical administration for wound disorder: diltiazem-Loaded niosomes. J Pharm Innov. 2023;18:1–17.
   Google Scholar
• Tavano L, Muzzalupo R, Picci N, et al. Co-encapsulation of lipophilic antioxidants into niosomal carriers: percutaneous permeation studies for cosmeceutical applications. Colloids Surf B Biointerfaces. 2014;114:144–149.
   PubMed Web of Science ®Google Scholar
• Namdeo A, Jain N. Liquid crystalline pharmacogel based enhanced transdermal delivery of propranolol hydrochloride. J Control Release. 2002;82(2–3):223–236.
   PubMed Web of Science ®Google Scholar
• Morteza-Semnani K, Saeedi M, Akbari J, et al. Green formulation, characterization, antifungal and biological safety evaluation of terbinafine HCl niosomes and niosomal gels manufactured by eco-friendly green method. J Biomater Sci Polym Ed. 2022;33(18):2325–2352.
   PubMed Web of Science ®Google Scholar
• Attwood D, Florence AT. FASTtrack physical pharmacy. London: Pharmaceutical Press; 2012.
   Google Scholar
• Rostamkalaei SS, Akbari J, Saeedi M, et al. Topical gel of metformin solid lipid nanoparticles: a hopeful promise as a dermal delivery system. Colloids Surf B Biointerfaces. 2019;175:150–157.
   PubMed Web of Science ®Google Scholar
• Varshosaz J, Pardakhty A, Hajhashemi V-I, et al. Development and physical characterization of sorbitan monoester niosomes for insulin oral delivery. Drug Deliv. 2003;10(4):251–262.
   PubMed Web of Science ®Google Scholar
• Tavano L, Mazzotta E, Muzzalupo R. Innovative topical formulations from diclofenac sodium used as surfadrug: the birth of diclosomes. Colloids Surf B Biointerfaces. 2018;164:177–184.
   PubMed Web of Science ®Google Scholar
• Moazeni E, Gilani K, Sotoudegan F, et al. Formulation and in vitro evaluation of ciprofloxacin containing niosomes for pulmonary delivery. J Microencapsul. 2010;27(7):618–627.
   PubMed Web of Science ®Google Scholar
• Tajbakhsh M, Saeedi M, Morteza-Semnani K, et al. Innovation of testosome as a green formulation for the transdermal delivery of testosterone enanthate. J Drug Delivery Sci Technol. 2020;57:101685.
   Web of Science ®Google Scholar
• Akbari J, Saeedi M, Morteza-Semnani K, et al. Innovative topical niosomal gel formulation containing diclofenac sodium (niofenac). J Drug Targeting. 2022;30(1):108–117.
   PubMed Web of Science ®Google Scholar
• Mishra V, Bansal KK, Verma A, et al. Solid lipid nanoparticles: emerging colloidal nano drug delivery systems. Pharmaceutics. 2018;10(4):191.
   PubMed Web of Science ®Google Scholar
• Akbari J, Saeedi M, Morteza-Semnani K, et al. The design of naproxen solid lipid nanoparticles to target skin layers. Colloids Surf B Biointerfaces. 2016;145:626–633.
   PubMed Web of Science ®Google Scholar
• Taymouri S, Varshosaz J. Effect of different types of surfactants on the physical properties and stability of carvedilol nano-niosomes. Adv Biomed Res. 2016;5(1):48.
   PubMedGoogle Scholar
• Basiri L, Rajabzadeh G, Bostan A. Physicochemical properties and release behavior of Span 60/Tween 60 niosomes as vehicle for α-Tocopherol delivery. LWT. 2017;84:471–478.
   Web of Science ®Google Scholar
• Akbari J, Saeedi M, Enayatifard R, et al. Curcumin niosomes (curcusomes) as an alternative to conventional vehicles: a potential for efficient dermal delivery. J Drug Delivery Sci Technol. 2020;60:102035.
   Web of Science ®Google Scholar
• Nasseri B. Effect of cholesterol and temperature on the elastic properties of niosomal membranes. Int J Pharm. 2005;300(1-2):95–101.
   PubMed Web of Science ®Google Scholar
• Mokhtar M, Sammour OA, Hammad MA, et al. Effect of some formulation parameters on flurbiprofen encapsulation and release rates of niosomes prepared from proniosomes. Int J Pharm. 2008;361(1-2):104–111.
   PubMed Web of Science ®Google Scholar
• Lademann J, Weigmann H-J, Rickmeyer C, et al. Penetration of titanium dioxide microparticles in a sunscreen formulation into the horny layer and the follicular orifice. Skin Pharmacol Appl Skin Physiol. 1999;12(5):247–256.
   PubMedGoogle Scholar
• Kheradmandnia S, Vasheghani FE, Nosrati M, et al. The effect of process variables on the properties of ketoprofen loaded solid lipid nanoparticles of beeswax and carnauba wax. Iran. J. Chem. Chem. Eng. 2010; 29:181–187.
   Google Scholar
• Veerareddy PR, Bobbala SKR. Enhanced oral bioavailability of isradipine via proniosomal systems. Drug Dev Ind Pharm. 2013;39(6):909–917.
   PubMed Web of Science ®Google Scholar
• Pancholi K, Stride E, Edirisinghe M. In vitro method to characterize diffusion of dye from polymeric particles: a model for drug release. Langmuir. 2009;25(17):10007–10013.
   PubMed Web of Science ®Google Scholar
• Shinde U, Pokharkar S, Modani S. Design and evaluation of microemulsion gel system of nadifloxacin. Indian J Pharm Sci. 2012;74(3):237–247.
   PubMed Web of Science ®Google Scholar
• Bousmina M. Rheology of polymer blends: linear model for viscoelastic emulsions. Rheol Acta. 1999;38(1):73–83.
   Web of Science ®Google Scholar
• Carvalho FC, Barbi MS, Sarmento VHV, et al. Surfactant systems for nasal zidovudine delivery: structural, rheological and mucoadhesive properties. J Pharm Pharmacol. 2010;62(4):430–439.
   PubMed Web of Science ®Google Scholar
• Moghassemi S, Hadjizadeh A. Nano-niosomes as nanoscale drug delivery systems: an illustrated review. J Control Release. 2014;185:22–36.
   PubMed Web of Science ®Google Scholar
• Mahale N, Thakkar P, Mali R, et al. Niosomes: novel sustained release nonionic stable vesicular systems—an overview. Adv Colloid Interface Sci. 2012;183-184:46–54.
   PubMed Web of Science ®Google Scholar
• Wester RC, Maibach HI. Animal models for percutaneous absorption. In Topical drug bioavailability, bioequivalence, and penetration. New York: Springer; 1993. p. 333–349.
   Google Scholar
• Godin B, Touitou E. Transdermal skin delivery: predictions for humans from in vivo, ex vivo and animal models. Adv Drug Deliv Rev. 2007;59(11):1152–1161.
   PubMed Web of Science ®Google Scholar
• Príborský J, Mühlbachová E. Evaluation of in‐vitro percutaneous absorption across human skin and in animal models. J Pharm Pharmacol. 1990;42(7):468–472.
   PubMed Web of Science ®Google Scholar
• Kravchenko I, Boyko Y, Novikova N, et al. Influence of cholesterol and its esters on skin penetration in vivo and in vitro in rats and mice. Ukr Bioorg Acta. 2011;1:17–21.
   Google Scholar
• Tavano L, Alfano P, Muzzalupo R, et al. Niosomes vs microemulsions: new carriers for topical delivery of capsaicin. Colloids Surf B Biointerfaces. 2011;87(2):333–339.
   PubMed Web of Science ®Google Scholar
• Khezri K, Saeedi M, Morteza-Semnani K, et al. A promising and effective platform for delivering hydrophilic depigmenting agents in the treatment of cutaneous hyperpigmentation: kojic acid nanostructured lipid carrier. Artif Cells Nanomed Biotechnol. 2021;49(1):38–47.
   PubMed Web of Science ®Google Scholar
• Boo YC. p-Coumaric acid as an active ingredient in cosmetics: a review focusing on its antimelanogenic effects. Antioxidants. 2019;8(8):275.
   Web of Science ®Google Scholar
• Mathieu V, Pirker C, Martin de Lassalle E, et al. The sodium pump α1 Sub‐unit: a disease progression–related target for metastatic melanoma treatment. J Cell Mol Med. 2009;13(9b):3960–3972.
   PubMed Web of Science ®Google Scholar
• Zhu Y, Huang R, Zhu R, et al. DeepScreen: an accurate, rapid, and anti‐interference screening approach for nanoformulated medication by deep learning. Adv Sci (Weinh). 2018;5(9):1800909.
   PubMedGoogle Scholar
• Ghafelehbashi R, Akbarzadeh I, Yaraki MT, et al. Preparation, physicochemical properties, in vitro evaluation and release behavior of cephalexin-loaded niosomes. Int J Pharm. 2019;569:118580.
   PubMedGoogle Scholar
• Khoee S, Yaghoobian M. Niosomes: a novel approach in modern drug delivery systems. Nanostructures for drug delivery. Amsterdam: Elsevier; 2017. p. 207–237.
   Google Scholar
• Girao H, Mota C, Pereira P. Cholesterol may act as an antioxidant in lens membranes. Curr Eye Res. 1999;18(6):448–454.
   PubMed Web of Science ®Google Scholar
• Sadeghi Ghadi Z, Ebrahimnejad P. Curcumin entrapped hyaluronan containing niosomes: Preparation, characterisation and in vitro/in vivo evaluation. J Microencapsul. 2019;36(2):169–179.
   PubMed Web of Science ®Google Scholar
• Rigopoulos D, Gregoriou S, Katsambas A. Hyperpigmentation and melasma. J Cosmet Dermatol. 2007;6(3):195–202.
   PubMedGoogle Scholar
• Ansari M, Hasani S. Synthesis and characterization of a novel niosome system containing adiantum Capillus-Veneris for breast cancer therapy. IJPHO. 2020;10(4): 230–240.
   Google Scholar
• Gatabi ZR, Saeedi M, Morteza-Semnani K, et al. Green preparation, characterization, evaluation of anti-melanogenesis effect and in vitro/in vivo safety profile of kojic acid hydrogel as skin lightener formulation. J Biomater Sci Polym Ed. 2022;33(17):2270–2291.
   PubMed Web of Science ®Google Scholar
• Oh M-J, Abdul Hamid M, Ngadiran S, et al. Ficus deltoidea (Mas cotek) extract exerted anti-melanogenic activity by preventing tyrosinase activity in vitro and by suppressing tyrosinase gene expression in B16F1 melanoma cells. Arch Dermatol Res. 2011;303(3):161–170.
   PubMed Web of Science ®Google Scholar
• Lajis AFB, Hamid M, Ariff AB. Depigmenting effect of kojic acid esters in hyperpigmented B16F1 melanoma cells. J Biomed Biotechnol. 2012;2012:1–9.
   PubMedGoogle Scholar
• Panzella L, Napolitano A. Natural and bioinspired phenolic compounds as tyrosinase inhibitors for the treatment of skin hyperpigmentation: recent advances. Cosmetics. 2019;6(4):57.
   Google Scholar
• Yu F, Tang X, Qu B, et al. Kojic acid inhibited melanin synthesis by tyrosinase pathway in pteria penguin. Aquac Res. 2020;51(4):1584–1591.
   Web of Science ®Google Scholar
• Chang T-S. Natural melanogenesis inhibitors acting through the down-regulation of tyrosinase activity. Materials. 2012;5(9):1661–1685.
   Web of Science ®Google Scholar
• Uchegbu IF, Vyas SP. Non-ionic surfactant based vesicles (niosomes) in drug delivery. Int J Pharm. 1998;172(1-2):33–70.
   Web of Science ®Google Scholar
• Chaikul P, Khat-Udomkiri N, Iangthanarat K, et al. Characteristics and in vitro anti-skin aging activity of gallic acid loaded in cationic CTAB niosome. Eur J Pharm Sci. 2019;131:39–49.
   PubMed Web of Science ®Google Scholar
• Mahant S, Kumar S, Nanda S, et al. Microsponges for dermatological applications: perspectives and challenges. Asian J Pharm Sci. 2020;15(3):273–291.
   PubMed Web of Science ®Google Scholar
• Fulton JE, Jr., Farzad‐Bakshandeh A, Bradley S. Studies on the mechanism of action of topical benzoyl peroxide and vitamin a acid in acne vulgaris. J Cutan Pathol. 1974;1(5):191–200.
   PubMed Web of Science ®Google Scholar
• Goyal G, Garg T, Malik B, et al. Development and characterization of niosomal gel for topical delivery of benzoyl peroxide. Drug Deliv. 2015;22(8):1027–1042.
   PubMed Web of Science ®Google Scholar
• Patel KK, Kumar P, Thakkar HP. Formulation of niosomal gel for enhanced transdermal lopinavir delivery and its comparative evaluation with ethosomal gel. AAPS Pharmscitech. 2012;13(4):1502–1510.
   PubMed Web of Science ®Google Scholar