Formulation and Characterization of Ceramide Nanoemulgel Lip Serum: Optimization Using Response Surface Methodology
DOI:
https://doi.org/10.51887/jpfi.v15i1.2250Keywords:
ceramide, lip serum, nanoemulgel, response surface methodology, Simplex Lattice DesignAbstract
Lip skin possesses a thin stratum corneum (10–15 μm) with low ceramide and lipid content, rendering it particularly susceptible to dehydration and environmental damage. This study aimed to develop and characterize a ceramide nanoemulgel lip serum using Response Surface Methodology (RSM) with Simplex Lattice Design (SLD) optimization, and to evaluate its efficacy in improving lip moisture in vivo. Nanoemulsion optimization was performed using Design Expert® v.13.0, with grape seed oil (1–2%), Tween 80 (6–10%), and Kolliphor® RH40 (6–10%) as independent variables, and pH and percent transmittance as responses. The optimal formula comprised grape seed oil 1.346%, Tween 80 7.001%, and Kolliphor® RH40 9.652% (desirability 0.967). The optimized nanoemulsion was incorporated into a nanoemulgel with 0.2% Carbopol 940. Physicochemical evaluation revealed a particle size of 18.1 nm, a low polydispersity index, zeta potential of +2.0 mV, pH 5.5, and viscosity of 386.4 cP. Physical stability was maintained over 12 weeks under three storage conditions without significant change (p>0.05). Irritation testing on 5 panelists yielded negative results. The in vivo efficacy testing demonstrated a statistically significant improvement in lip moisture (p<0.001): ceramide nanoemulgel achieved 22%, compared to base lip serum (11%) and negative control (3.33%).
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References
Clogston, J.D., & Patri, A.K. (2011). Zeta potential measurement. In S.E. McNeil (Ed.), Characterization of Nanoparticles Intended for Drug Delivery (pp. 63–70). Humana Press.
Coderch, L., López, O., de la Maza, A., & Parra, J.L. (2015). Ceramides and skin function. American Journal of Clinical Dermatology, 4(2), 107–129.
Cornell, J.A. (2002). Experiments with Mixtures: Designs, Models, and the Analysis of Mixture Data (3rd ed.). John Wiley & Sons.
Courage & Khazaka (2013). Information and Operating Instructions for the Skin-O-Mat. Courage + Khazaka Electronic GmbH, Cologne.
Draize, J.H., Woodard, G., & Calvery, H.O. (1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. Journal of Pharmacology and Experimental Therapeutics, 82(3), 377–390.
Federer, W.T. (1955). Experimental Design: Theory and Application. Macmillan Company.
Fernandes, L., Casal, S., Cruz, R., Pereira, J.A., & Ramalhosa, E. (2013). Seed oils of ten traditional Portuguese grape varieties with interesting chemical and antioxidant properties. Food Research International, 50(1), 161–166.
Honary, S., & Zahir, F. (2013). Effect of zeta potential on the properties of nano-drug delivery systems. Tropical Journal of Pharmaceutical Research, 12(2), 255–264.
Islam, M.T., Rodríguez-Hornedo, N., Ciotti, S., & Ackermann, C. (2004). Rheological characterization of topical carbomer gels neutralized to different pH. Pharmaceutical Research, 21(7), 1192–1199.
Jaiswal, M., Dudhe, R., & Sharma, P.K. (2015). Nanoemulsion: An advanced mode of drug delivery system. 3 Biotech, 5(2), 123–127.
Khan, M.A., Yue, C., Fang, Z., et al. (2024). Fabrication and characterization of oil-in-water nanoemulsions. Food Hydrocolloids, 152, 109891.
Khurana, S., Jain, N.K., & Bedi, P.M. (2013). Nanoemulsion based gel for transdermal delivery of meloxicam. Drug Development and Industrial Pharmacy, 39(9), 1338–1346.
Kim, H., Lee, J., Park, S., et al. (2024). Topical delivery of ceramide by oil-in-water nanoemulsion for skin barrier restoration. International Journal of Pharmaceutics, 651, 123738.
Kumar, M., & Mandal, A. (2018). Characterization and evaluation of surfactant for enhanced oil recovery. Journal of Petroleum Science and Engineering, 162, 868–875.
Lambers, H., Piessens, S., Bloem, A., Pronk, H., & Finkel, P. (2006). Natural skin surface pH is on average below 5, which is beneficial for its resident flora. International Journal of Cosmetic Science, 28(5), 359–370.
McClements, D.J. (2012). Nanoemulsions versus microemulsions: Terminology, differences, and similarities. Soft Matter, 8(6), 1719–1729.
Park, K., Ikushiro, H., Seo, H.S., et al. (2016). ER stress stimulates production of the key antimicrobial peptide, cathelicidin. PNAS, 113(13), E1920–E1929.
Saberi, A.H., Fang, Y., & McClements, D.J. (2013). Effect of glycerol on formation, stability, and properties of vitamin E-enriched nanoemulsions. Journal of Colloid and Interface Science, 411, 105–113.
SCCS (2016). Opinion on phenoxyethanol in cosmetic products (SCCS/1575/16). European Commission.
Schild, J., Kalvodová, A., Zbytovská, J., Farwick, M., & Pyko, C. (2024). The role of ceramides in maintaining lip skin barrier function. Journal of Cosmetic Dermatology, 23(1), 15–24.
Schmid-Wendtner, M.H., & Korting, H.C. (2006). The pH of the skin surface and its impact on the barrier function. Skin Pharmacology and Physiology, 19(6), 296–302.
Solans, C., & Solé, I. (2012). Nano-emulsions: Formation by low-energy methods. Current Opinion in Colloid & Interface Science, 17(5), 246–254.
Verdier-Sévrain, S., & Bonté, F. (2018). Skin hydration: A review on its molecular mechanisms. Journal of Cosmetic Dermatology, 6(2), 75–82.
Waghule, T., Singhvi, G., Dubey, S.K., et al. (2019). Microneedles: A smart approach and increasing potential for transdermal drug delivery system. Biomedicine & Pharmacotherapy, 109, 1249–1258.
World Medical Association (WMA) (2013). Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA, 310(20), 2191–2194.
Xu, Y., Liu, Y., Zhu, J., et al. (2024). Optimisation of ceramide nanoemulsion for enhanced transdermal delivery. International Journal of Pharmaceutics, 662, 124451.
Yamamoto, T., Hattori, M., & Yoshida, H. (2016). The roughness of lip skin is related to the ceramide content of the stratum corneum. International Journal of Cosmetic Science, 38(6), 639–643.
Yamamoto, T., Kubo, Y., Shuto, E., & Nakamura, M. (2020). The efficacy of synthetic pseudo-ceramide formulations for lip dryness. Journal of Cosmetic Dermatology, 19(11), 2985–2991.
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