Formulation development and accelerated stability testing of a novel sunscreen cream for ultraviolet radiation protection in high altitude areas

References

• Banerjee S, Chattopadhyay P, Ghosh A, et al. Accelerated stability testing of a transdermal patch composed of eserine and pralidoxime chloride for prophylaxis against (±)-anatoxin a poisoning. J Food Drug Anal. 2014;22:264–270.
   Web of Science ®Google Scholar
• Matthews BR. Regulatory aspects of stability testing in Europe. Drug Dev Ind Pharm. 1999;25:831–856.
   PubMed Web of Science ®Google Scholar
• Bora NS, Mazumder B, Chattopadhyay P. Prospects of topical protection from ultraviolet radiation exposure: a critical review on the juxtaposition of the benefits and risks involved with the use of chemoprotective agents. J Dermatolog Treat. 2018;29:256–268.
   PubMed Web of Science ®Google Scholar
• Antoniou C, Kosmadaki MG, Stratigos AJ, et al. Sunscreens-what's important to know. J Eur Acad Dermatol Venereol. 2008;22:1110–1119.
   PubMed Web of Science ®Google Scholar
• Serpone N, Dondi D, Albini A. Inorganic and organic UV filters: their role and efficacy in sunscreens and suncare products. Inorganica Chim Acta. 2007;360:794–802.
   Web of Science ®Google Scholar
• Sierra AF, Ramírez MLG, Campmany ACC, et al. In vivo and in vitro evaluation of the use of a newly developed melatonin loaded emulsion combined with UV filters as a protective agent against skin irradiation. J Dermatol Sci. 2013;69:202–214.
   PubMed Web of Science ®Google Scholar
• Heneweer M, Muusse M, Berg M. v d, et al. Additive estrogenic effects of mixtures of frequently used UV filters on pS2-gene transcription in MCF-7 cells. Toxicol Appl Pharmacol. 2005;208:170–177.
   PubMed Web of Science ®Google Scholar
• Schlumpf M, Cotton B, Conscience M, et al. In vitro and in vivo estrogenicity of UV screens. Environ Health Perspect. 2001;109:239–244.
   PubMed Web of Science ®Google Scholar
• Stern RS. Risk reduction for nonmelanoma skin cancer with childhood sunscreen use. Arch Dermatol. 1986;122:537.
   PubMed Web of Science ®Google Scholar
• Damiani E, Baschong W, Greci L. UV-Filter combinations under UV-A exposure: Concomitant quantification of over-all spectral stability and molecular integrity. J Photochem Photobiol B Biol. 2007;87:95–104.
   PubMed Web of Science ®Google Scholar
• Hanson KM, Gratton E, Bardeen CJ. Sunscreen enhancement of UV-induced reactive oxygen species in the skin. Free Radic Biol Med. 2006;41:1205–1212.
   PubMed Web of Science ®Google Scholar
• Thiele JJ, Dreher F, Packer L. Antioxidant defense systems in skin. J Toxicol Cutan Ocul Toxicol. 2002;21:119–160.
   Web of Science ®Google Scholar
• Vijayalaxmi, Reiter RJ, Tan D-X, et al. Melatonin as a radioprotective agent: a review. Int J Radiat Oncol. 2004;59:639–653.
   PubMed Web of Science ®Google Scholar
• Xanthopoulou MN, Nomikos T, Fragopoulou E, et al. Antioxidant and lipoxygenase inhibitory activities of pumpkin seed extracts. Food Res Int. 2009;42:641–646.
   Web of Science ®Google Scholar
• Bora NS, Pathak MP, Mandal S, et al. Safety assessment and toxicological profiling of a novel combinational sunprotective dermal formulation containing melatonin and pumpkin seed oil. Regul Toxicol Pharmacol. 2017;89:1–12.
   PubMed Web of Science ®Google Scholar
• Bora NS, Mazumder B, Mandal S, et al. Amelioration of UV radiation-induced photoaging by a combinational sunscreen formulation via aversion of oxidative collagen degradation and promotion of TGF-β-Smad-mediated collagen production. Eur J Pharm Sci. 2019;127:261–275.
   PubMed Web of Science ®Google Scholar
• Favier V, Falvey M, Rabatel A, et al. Interpreting discrepancies between discharge and precipitation in high-altitude area of Chile’s Norte Chico region (26–32°S). 2009;45:1–20.
   Google Scholar
• Blumthaler M, Ambach W, Ellinger R. Increase in solar UV radiation with altitude. J Photochem Photobiol B Biol. 1997;39:130–134.
   Web of Science ®Google Scholar
• Ben LJ, Mckenzie RL. Where on earth has the highest UV? Otago, New Zealand: National Institute of Water and Atmospheric Research (NIWA); 2006.
   Google Scholar
• DSM Nutritional Products Ltd. DSM SUNSCREEN OPTIMIZERTM [Internet]. DSM SUNSCREEN Optim 2017; Available from: https://www.sunscreen-optimizer.com/user/table.html.
   Google Scholar
• Puglia C, Bonina F, Rizza L, et al. Lipid nanoparticles as carrier for octyl-methoxycinnamate: in vitro percutaneous absorption and photostability studies. J Pharm Sci. 2012;101:301–311.
   PubMed Web of Science ®Google Scholar
• Jain D, Pathak K. Design, characterization, and evaluation of meloxicam gel prepared by suspension and solution polymerization using solubility parameter as the basis for development. AAPS PharmSciTech. 2010;11:133–142.
   PubMed Web of Science ®Google Scholar
• Nesseem DI. Formulation and evaluation of itraconazole via liquid crystal for topical delivery system. J Pharm Biomed Anal. 2001;26:387–399.
   PubMed Web of Science ®Google Scholar
• Neto HS, Novák C, Matos JR. Thermal analysis and compatibility studies of prednicarbate with excipients used in semi solid pharmaceutical form. J Therm Anal Calorim. 2009;97:367–374.
   Web of Science ®Google Scholar
• Nesseem D. Formulation of sunscreens with enhancement sun protection factor response based on solid lipid nanoparticles. Int J Cosmet Sci. 2011;33:70–79.
   PubMed Web of Science ®Google Scholar
• Buhse L, Kolinski R, Westenberger B, et al. Topical drug classification. Int J Pharm. 2005;295:101–112.
   PubMed Web of Science ®Google Scholar
• Roland I, Piel G, Delattre L, et al. Systematic characterization of oil-in-water emulsions for formulation design. Int J Pharm. 2003;263:85–94.
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation. Stability Testing of New Drug Substances and Products Q1A (R2) [Internet]. Geneva, Switzerland; 2003. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_%0AProducts/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__%0AGuideline.pdf.
   Google Scholar
• Myers WD, Ludden PA, Nayigihugu V, et al. Technical note: a procedure for the preparation and quantitative analysis of samples for titanium dioxide. J Anim Sci. 2004;82:179–183.
   PubMed Web of Science ®Google Scholar
• Peruchi LM, Rath S. Development and application of a HPLC method for eight sunscreen agents in suncare products. Int J Cosmet Sci. 2012;34:226–233.
   PubMed Web of Science ®Google Scholar
• Yeligar VC, Gaikwad RG, Patil KD, et al. Development of spectrophotometric method and validation for melatonin in tablet dosage form. World J Pharm Pharm Sci. 2016;5:1440–1451.
   Google Scholar
• Rezig L, Chouaibi M, Msaada K, et al. Chemical composition and profile characterisation of pumpkin (Cucurbita maxima) seed oil. Ind Crop Prod. 2012;37:82–87.
   Web of Science ®Google Scholar
• Reis Mansur MCPP, Leitão SG, Cerqueira-Coutinho C, et al. In vitro and in vivo evaluation of efficacy and safety of photoprotective formulations containing antioxidant extracts. Brazilian J Pharmacogn. 2016;26:251–258.
   Google Scholar
• Khalid N, Kobayashi I, Neves MA, et al. Preparation and characterization of water-in-oil-in-water emulsions containing a high concentration of L-ascorbic acid. Biosci Biotechnol Biochem. 2013;77:1171–1178.
   PubMed Web of Science ®Google Scholar
• ISO 21148. Cosmetics — Microbiology — General instructions for microbiological examination. 2017.
   Google Scholar
• ISO 21149. Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria. 2017.
   Google Scholar
• ISO 22717. Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa. 2015.
   Google Scholar
• ISO 22718. Cosmetics - Microbiology - Detection of Staphylococcus aureus. 2015.
   Google Scholar
• ISO 16212. Cosmetics - Microbiology - Enumeration of yeast and mould. 2017.
   Google Scholar
• Hashem FM, Shaker DS, Ghorab MK, et al. Formulation, characterization, and clinical evaluation of microemulsion containing clotrimazole for topical delivery. AAPS PharmSciTech. 2011;12:879–886.
   PubMed Web of Science ®Google Scholar
• Smaoui S, Ben Hlima H, Ben Chobba I, et al. Development and stability studies of sunscreen cream formulations containing three photo-protective filters. Arab J Chem. 2017;10:S1216–S1222.
   Web of Science ®Google Scholar