Holistic development of coal tar lotion by embedding design of experiments (DoE) technique: preclinical investigations

References

• Cancer IAR. Polynuclear aromatic compounds, part 4, bitumens, coal-tars and derived products, shale-oils and soots. In: IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans. Vol. 35. Lyon, France: World Health Organization; 1985. p.39-219.
   Google Scholar
• Downing JG, Bauer CW. Low and high temperature coal tars in the treatment of eczema and psoriasis; a clinical investigation and evaluation. Arch Derm Syphilol. 1948;57(6):985–990.
   PubMedGoogle Scholar
• Thami G, Sarkar R. Coal tar: past, present and future. Clin Exp Dermatol. 2002;27(2):99–103.
   PubMed Web of Science ®Google Scholar
• Sala M, Elaissari A, Fessi H. Advances in psoriasis physiopathology and treatments: up to date of mechanistic insights and perspectives of novel therapies based on innovative skin drug delivery systems (ISDDS). J Control Release. 2016;239:182–202.
   PubMed Web of Science ®Google Scholar
• Pradhan M, Singh D, Singh MR. Novel colloidal carriers for psoriasis: current issues, mechanistic insight and novel delivery approaches. J Control Release. 2013;170(3):380–395.
   PubMed Web of Science ®Google Scholar
• Christophers E. Psoriasis–epidemiology and clinical spectrum. Clin Exp Dermatol. 2001;26(4):314–320.
   PubMed Web of Science ®Google Scholar
• Ogawa E, Sato Y, Minagawa A, et al. Pathogenesis of psoriasis and development of treatment. J Dermatol. 2018;45(3):264–272.
   PubMed Web of Science ®Google Scholar
• Chestnov O. Global report on psoriasis. Geneva: World Health Organization; 2016.
   Google Scholar
• Feldman SR, Goffe B, Rice G, et al. The challenge of managing psoriasis: unmet medical needs and stakeholder perspectives. Am Health Drug Benefits. 2016;9(9):504–513.
   PubMed Web of Science ®Google Scholar
• Rahman M, Alam K, Ahmad MZ, et al. Classical to current approach for treatment of psoriasis: a review. Endocr Metab Immune Disord Drug Targets. 2012;12(3):287–302.
   PubMedGoogle Scholar
• Raut AS, Prabhu RH, Patravale VB. Psoriasis clinical implications and treatment: a review. Crit Rev Ther Drug Carrier Syst. 2013;30(3):183–216.
   PubMed Web of Science ®Google Scholar
• Roelofzen JH, Aben KK, van der Valk PG, et al. Coal tar in dermatology. J Dermatolog Treat. 2007;18(6):329–334.
   PubMed Web of Science ®Google Scholar
• Paghdal KV, Schwartz RA. Topical tar: back to the future. J Am Acad Dermatol. 2009;61:294–302.
   PubMed Web of Science ®Google Scholar
• Gruber M, Klein R, Foxx M. Chemical standardization and quality assurance of whole crude coal tar USP utilizing GLC procedures. J Pharm Sci. 1970;59(6):830–834.
   PubMed Web of Science ®Google Scholar
• Agency EP. Toxicological profile for polycyclic hydrocarbons (PAHs). Washington: Environmental Protection Agency; 1994.
   Google Scholar
• Litofsky IB. A review of analytical methodology for the determination of polycyclic aromatic hydrocarbons in coal tar products. Cutan Ocul Toxicol. 1999;18:151–153.
   Web of Science ®Google Scholar
• Raza K, Thakur S, Singal P, et al. Development and validation of a rapid spectrofluorimetric method for quantification of coal tar in topical formulations. J Adv Sci Res. 2012;3:37–39.
   Google Scholar
• Saunders J, Davis H, Coetzee L, et al. A novel skin penetration enhancer: evaluation by membrane diffusion and confocal microscopy. J Pharm Pharm Sci. 1999 Sep-Dec;2(3):99–107.
   PubMed Web of Science ®Google Scholar
• Warshaw IB, Logun JE. Inventors; Dome Chemicals, Inc., Indiana, assignee. Protein-tar acid dermatological preparation. United State Patent; 1958.
   Google Scholar
• Wershaw IB. Inventor; Dome Chemicals, Inc., New York, assignee. Crude coal tar dermatological compositions. United State Patent; 1950.
   Google Scholar
• Bhatia A, Mangat P, Jain B, et al. Washability and fabric-staining properties of a novel phospholipid-structured coal tar formulation. J Dermatolog Treat. 2008;19(2):105–110.
   PubMed Web of Science ®Google Scholar
• Bhatia A, Raza K, Singh B, et al. Phospholipid-based formulation with improved attributes of coal tar. J Cosmet Dermatol. 2009;8(4):282–288.
   PubMed Web of Science ®Google Scholar
• Bhatia A, Singh B, Amarji B, et al. Novel stain-free lecithinized coal tar formulation for psoriasis. Int J Dermatol. 2011;50(10):1246–1248.
   PubMed Web of Science ®Google Scholar
• Bhatia A, Kapoor DN, Bangar B. Inventors; improved coal tar formulation for treatment of dandruff and other scalp diseases and its method of preparation thereof. Worldwide application; 2013.
   Google Scholar
• Cavazzuti M. Design of experiments. In: Cavazzuti M, editor. From theory to design scientific and technological aspects in mechanics. Verlag Berlin Heidelberg: Springer; 2013. p. 13–42.
   Google Scholar
• Singh B, Kumar R, Ahuja N. Optimizing drug delivery systems using systematic “design of experiments.” Part I: fundamental aspects. Crit Rev Ther Drug Carrier Syst. 2004;22(1):27–105.
   Web of Science ®Google Scholar
• Van Buskirk GA, Asotra S, Balducci C, et al. Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm. AAPS PharmSciTech. 2014;15(3):665–693.
   PubMed Web of Science ®Google Scholar
• Raza K, Thakur S, Singal P, et al. Development and validation of a rapid spectrofluorimetric method for quantification of coal tar in topical formulations. J Adv Sci Res. 2012;3(3):37–39.
   Google Scholar
• Harmonisation IC. Validation of analytical procedures: text and methodology Q2(R1). International Conference on Hormonisation; Geneva, Switzerland; 1996. p. 1–17.
   Google Scholar
• Bhatia A, Mangat P, Jain B, et al. Washability and fabric-staining properties of a novel phospholipid-structured coal tar formulation. J Dermatolog Treat. 2008;19(2):105–110.
   PubMed Web of Science ®Google Scholar
• Sharma M, Sharma G, Singh B, et al. Systematically optimized imiquimod-loaded novel hybrid vesicles by employing design of experiment (DoE) approach with improved biocompatibility, stability, and dermatokinetic profile. AAPS PharmSciTech. 2019;20(4):156.
   PubMed Web of Science ®Google Scholar
• Bhatia A, Singh B, Wadhwa S, et al. Novel phospholipid-based topical formulations of tamoxifen: evaluation for antipsoriatic activity using mouse-tail model. Pharm Dev Technol. 2014;19(2):160–163.
   PubMed Web of Science ®Google Scholar
• Bosman B, Matthiesen T, Hess V, et al. A quantitative method for measuring antipsoriatic activity of drugs by the mouse tail test. Skin Pharmacol. 1992;5(1):41–48.
   PubMedGoogle Scholar
• van der Fits L, Mourits S, Voerman JS, et al. Imiquimod-induced psoriasis-like skin inflammation in mice is mediated via the IL-23/IL-17 axis. J Immunol. 2009;182(9):5836–5845.
   PubMed Web of Science ®Google Scholar
• Doppalapudi S, Jain A, Chopra DK, et al. Psoralen loaded liposomal nanocarriers for improved skin penetration and efficacy of topical PUVA in psoriasis. Eur J Pharm Sci. 2017;96:515–529.
   PubMed Web of Science ®Google Scholar
• Jain A, Doppalapudi S, Domb AJ, et al. Tacrolimus and curcumin co-loaded liposphere gel: synergistic combination towards management of psoriasis. J Control Release. 2016;243:132–145.
   PubMed Web of Science ®Google Scholar
• Ellman GL. Tissue sulfhydryl groups. Arch Biochem Biophys. 1959;82(1):70–77.
   PubMed Web of Science ®Google Scholar
• Gornall AG, Bardawill CJ, David MM. Determination of serum proteins by means of the biuret reaction. J Biol Chem. 1949;177(2):751–766.
   PubMed Web of Science ®Google Scholar
• Kumar A, Lalitha S, Mishra J. Possible nitric oxide mechanism in the protective effect of hesperidin against pentylenetetrazole (PTZ)-induced kindling and associated cognitive dysfunction in mice. Epilepsy Behav. 2013;29(1):103–111.
   PubMed Web of Science ®Google Scholar
• Wills ED. Mechanisms of lipid peroxide formation in animal tissues. Biochem J. 1966;99(3):667–676.
   PubMed Web of Science ®Google Scholar
• Hormonization IC. Stability testing of new drug substances and drug products. Q1A(R2). International Conference on Hormonization; Geneva, Switzerland; 2003. p. 24.
   Google Scholar
• Arnold WP. Tar. Clin Dermatol. 1997 Sep-Oct;15(5):739–744.
   PubMed Web of Science ®Google Scholar
• Roelofzen JH, Aben KK, van der Valk PG, et al. Coal tar in dermatology. J Dermatolog Treat. 2007;18(6):329–334.
   PubMed Web of Science ®Google Scholar
• Pal R. Rheology of highly flocculated oil in water emulsion. Chem Eng Commun. 1990;98(1):211–222.
   Web of Science ®Google Scholar
• Sjöblom J, Stenius P, Simon S, et al. Emulsion stabilization. In: Tadros T, editor. Encyclopedia of colloid and interface science. Berlin, Heidelberg: Springer; 2013. p.415-454.
   Google Scholar
• Zhang M, Yang B, Liu W, et al. Influence of hydroxypropyl methylcellulose, methylcellulose, gelatin, poloxamer 407 and poloxamer 188 on the formation and stability of soybean oil-in-water emulsions. AJPS. 2017;12(6):521–531.
   Google Scholar
• Choi MJ, Maibach HI. Liposomes and niosomes as topical drug delivery systems. Skin Pharmacol Appl Skin Physiol. 2005;18:209–219.
   Google Scholar
• Egbaria K, Weiner N. Liposomes as a topical drug delivery system. Adv Drug Deliv Rev. 1990;5:287–300.
   Google Scholar
• Lane ME. Skin penetration enhancers. Int J Pharm. 2013;447(1–2):12–21.
   PubMed Web of Science ®Google Scholar
• Peralta MF, Guzmán ML, Pérez AP, et al. Liposomes can both enhance or reduce drugs penetration through the skin. Sci Rep. 2018;8(1):13253.
   PubMed Web of Science ®Google Scholar
• Clark RA, Kupper TS. Misbehaving macrophages in the pathogenesis of psoriasis. J Clin Invest. 2006;116(8):2084–2087.
   PubMed Web of Science ®Google Scholar
• Stratis A, Pasparakis M, Rupec RA, et al. Pathogenic role for skin macrophages in a mouse model of keratinocyte-induced psoriasis-like skin inflammation. J Clin Invest. 2006;116(8):2094–2104.
   PubMed Web of Science ®Google Scholar
• Wang H, Peters T, Kess D, et al. Activated macrophages are essential in a murine model for T cell-mediated chronic psoriasiform skin inflammation. J Clin Invest. 2006;116(8):2105–2114.
   PubMed Web of Science ®Google Scholar
• Corrocher R, Ferrari S, de Gironcoli M, et al. Effect of fish oil supplementation on erythrocyte lipid pattern, malondialdehyde production and glutathione-peroxidase activity in psoriasis. Clin Chim Acta. 1989;179(2):121–131.
   PubMed Web of Science ®Google Scholar
• Kadam DP, Suryakar AN, Ankush RD, et al. Role of oxidative stress in various stages of psoriasis. Indian J Clin Biochem. 2010;25(4):388–392.
   PubMedGoogle Scholar
• Haarmann-Stemmann T, Abel J, Fritsche E, et al. The AHR-Nrf2 pathway in keratinocytes: on the road to chemoprevention? J Invest Dermatol. 2012;132(1):7–9.
   PubMed Web of Science ®Google Scholar
• Tsuji G, Takahara M, Uchi H, et al. Identification of ketoconazole as an AHR-Nrf2 activator in cultured human keratinocytes: the basis of its anti-inflammatory effect. J Invest Dermatol. 2012;132(1):59–68.
   PubMed Web of Science ®Google Scholar
• van den Bogaard EH, Bergboer JG, Vonk-Bergers M, et al. Coal tar induces AHR-dependent skin barrier repair in atopic dermatitis. J Clin Invest. 2013;123(2):917–927.
   PubMed Web of Science ®Google Scholar
• Kolluri SK, Weiss C, Koff A, et al. p27Kip1 induction and inhibition of proliferation by the intracellular Ah receptor in developing thymus and hepatoma cells. Genes Dev. 1999;13(13):1742–1753.
   PubMed Web of Science ®Google Scholar
• Lloyd RV, Erickson LA, Jin L, et al. p27kip1: a multifunctional cyclin-dependent kinase inhibitor with prognostic significance in human cancers. Am J Pathol. 1999;154(2):313–323.
   PubMed Web of Science ®Google Scholar
• Zhao HW, Yin XJ, Frazer D, et al. Effects of paving asphalt fume exposure on genotoxic and mutagenic activities in the rat lung. Mutat Res. 2004;557(2):137–149.
   PubMed Web of Science ®Google Scholar