Desarrollo, caracterización y evaluación por bioingeniería cutánea de una emulsión natural para proporcionar una base portadora estandarizada para preparaciones magistrales tópicas

Autores/as

DOI:

https://doi.org/10.33448/rsd-v11i16.38290

Palabras clave:

Productos naturales; Farmacia de manipulación; Bioingeniería de la piel; Ensayo clínico.

Resumen

O uso de produtos contendo substâncias naturais e sustentáveis tem mostrado um crescimento notável no mercado farmacêutico e cosmético, bem como na farmácia de manipulação. Este trabalho objetivou desenvolver, caracterizar e avaliar a bioengenharia cutânea de emulsões naturais e sustentáveis, proporcionando uma base veicular para preparações tópicas. Nove emulsões O/A foram desenvolvidas mudando a cera autoemulsionante não iônica (Cetearyl Olivate (and) Sorbitan Olivate, Cetearyl Glucoside (and) Cetearyl Alcohol, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters (and) Glyceryl Stearate (and) Cetearyl Alcohol (and) Sodium Stearoyl Lactylate), with or without the anionic co-emulsifier (Sodium Stearoyl Glutamate), com ou sem o coemulsificante aniônico (Sodium Stearoyl Glutamate). Elas foram caracterizadas através de testes de estabilidade preliminar, reologia e estudo da estabilidade físico-química acelerada. Quatro formulações foram aprovadas (FB1, FB2, FB3 e FB5), mas apenas FB1 (Cetearyl Olivate (and) Sorbitan Olivate with Sodium Stearoyl Glutamate) foi considerada estável, sendo selecionada para a avaliação de eficácia de preservação, e para a bioengenharia cutânea. A hidratação e a perda de água transepidérmica (TEWL) do estrato córneo foram analisadas comparando com uma base veicular tópica convencional (Emulsifying Wax NF). O estudo clínico mostrou que FB1 melhorou a hidratação cutânea sem mudanças sifnificativas para o TEWL, mas demonstrou valores consideráveis. A FB1 pode ser classificada como “skin friendly” e representa um promissor veículo natural e sustentável para preparações farmacêuticas manipuladas.

Biografía del autor/a

Guilherme Carneiro Leal, State University of Londrina

State University of Londrina, Brazil

Citas

Ali, S. M., & Yosipovitch, G. (2013). Skin pH: From basic science to basic skin care. Acta Dermato-Venereologica. 93(3), 261-267. 10.2340/00015555-1531

Amberg, N., & Fogarassy, C. (2019) Green Consumer Behavior in the Cosmetics Market. Resources. 8(3), 137. https://doi.org/10.3390/resources8030137

ANVISA (2004). Cosmetic product stability guide. National Health Surveillance Agency: Brasília, Brazil.

ANVISA (2012). Cosmetic product quality control guide. National Health Surveillance Agency: Brasília, Brazil.

ANVISA (2019). Cosmetic product quality control guide. National Health Surveillance Agency: Brasília, Brazil.

ANVISA (2022). Resolution No. 630, of March 10, 2022. National Health Surveillance Agency: Brasília, Brazil.

Barros, C., & Barros, R. B. G. (2020). Natural and Organic Cosmetics: Definition and Concepts. Preprints. 2020050374 10.20944/preprints202005.0374.v2

Bazin, R., & Fanchon, C. (2006). Equivalence of face and volar forearm for the testing of moisturizing and firming effect of cosmetics in hydration and biomechanical studies. International Journal of Cosmetic Science. 28(6), 453–460. https://doi.org/10.1111/j.1467-2494.2006.00352.x

Bruschi, M. L., Cardoso, M. L. C., Lucchesi, M. B., & Gremião, M. P. D. (2003). Gelatin microparticles containing propolis obtained by spray-drying technique: Preparation and characterization. International Journal of Pharmaceutics. 264(1–2), 45–55. https://doi.org/10.1016/S0378-5173(03)00386-7

Chen, G., & Tao, D. (2005). An experimental study of stability of oil-water emulsion. Fuel Processing Technology. 86(5), 499–508. https://doi.org/10.1016/j.fuproc.2004.03.010

Darlenski, R., Sassning, S., Tsankov, N., & Fluhr, J. W. (2009). Non-invasive in vivo methods for investigation of the skin barrier physical properties. European Journal of Pharmaceutics and Biopharmaceutics. 72(2), 295-303. https://doi.org/10.1016/j.ejpb.2008.11.013

Dickinson, K. L., Wiegand, U. K., & Thijssen, J. H. J. (2019). Soft meets hard -- how does freeze-thaw cycling affect the microstructure of particle-stabilised emulsions? 1–31. https://doi.org/10.48550/arXiv.1902.08531

Dini, I., & Laneri, S. (2021). The New Challenge of Green Cosmetics: Natural Food Ingredients for Cosmetic Formulations. Molecules. 26(13), 3921. https://doi.org/10.3390/molecules26133921

Du Plessis, J., Stefaniak, A., Eloff, F., John, S., Agner, T., Chieh Chou, T., Nixon, R., Steiner, M., Franken, A., Kudla, I., & Holness, L. (2013). International guidelines for the in vivo assessment of skin properties in non-clinical settings: Part 2. transepidermal water loss and skin hydration. Skin Research and Technology. 19(3), 265–278. https://doi.org/10.1111/srt.12037

ECOCERT. [S. l.] (2012). Ecocert benchmark for natural and organic cosmetics. Available at: http://brazil.ecocert.com/system/files/Referencial-Cosmeticos-Naturais-e-Organicos-Ecocert.pdf. Access on: 12 Jul. 2020.

Epstein H. (2009). Cosmeceutical vehicles. Clin Dermatol. 27(5), 453–460.

Filipe, G. A., Bigotto, B. G., Rocha, C. B., Chue-Goncalves, M., Kobayashi, R. K. T., Lonni, A. A. S. G., & Celligoi, M. A. P. C. (2022). Development of a multifunctional and self-preserving cosmetic formulation using sophorolipids and palmarosa essential oil against acne-causing bacteria. Journal of Applied Microbiology. 132, 10 – 25. https://doi.org/10.1111/jam.15659

Fluhr, J. W., Feingold, K. R., & Elias, P. M. (2006). Transepidermal water loss reflects permeability barrier status: Validation in human and rodent in vivo and ex vivo models. Experimental Dermatology. 15(7), 483–492. https://doi.org/10.1111/j.1600-0625.2006.00437.x

Fonseca-Santos, B., Corrêa, M. A., Chorilli, M. (2015). Sustainability, natural and organic cosmetics: Consumer, products, efficacy, toxicological and regulatory considerations. Braziliam Journal of Pharmaceutical Science. 51(1), 17–26. https://doi.org/10.1590/S1984-82502015000100002

Furman, A. C., Veit, M. T., Palácio, S. M., Gonçalves, & G. C., Barbieri, J. C. Z. (2022). Sustainability in the production process of the cosmetic industry: a literature review. Research, Society and Development. 11(13), pág. e586111335852. https://doi.org/10.33448/rsd-v11i13.35852

Gonçalves, G., & Campos, P. (2009). Application of biophysics methods in the study of the effectiveness of dermocosmetic products. Brazilian Journal of Pharmaceutical Sciences. 45(1), 1-10. https://doi.org/10.1590/S1984-82502009000100002

Hecht, L. L., Wagner, C., Landfester, K., Landfester, K., & Schuchmann, H. P. (2011). Surfactant concentration regime in miniemulsion polymerization for the formation of MMA nanodroplets by high-pressure homogenization. Langmuir. 27(6), 2279–2285. https://doi.org/10.1021/la104480s

Heinrich, U., Koop, U., Leneveu-Duchemin, M. C., Osterrieder, K., Bielfeldt, S., Chkarnat, C., Degwert, J., Häntschel, D., Jaspers, S., Nissen, H. P., Rohr, M., Schneider, G., & Tronnier, H. (2003). Multicentre comparison of skin hydration in terms of physical-, physiological- and product-dependent parameters by the capacitive method (Corneometer CM 825). International Journal of Cosmetic Science. 25(1-2), 45-53. https://doi.org/10.1046/j.1467-2494.2003.00172.x

Isaac, V. L. B., Cefali, L. C., Chiari, B. G., Almeida, M. G. J., Ribeiro, H. M., & Corrêa, M. A. (2013). Effect of various thickening agents on the rheological Properties of oil-in-water emulsions containing nonionic emulsifier. Journal of Dispersion Science and Technology. 34(6), 880–885. https://doi.org/10.1080/01932691.2012.695952

Izquierdo, P., Wiechers, J. W., Escribano, E., Garcia-Celma, M. J., Tadros, T. F., Esquena, J., Dederen, J. C., & Solan, C. (2007). A Study on the Influence of Emulsion Droplet Size on the Skin Penetration of Tetracaine. Skin pharmacology and physiology. 20, 263–270. https://doi.org/10.1159/000106076

Jaksic, I., Lukic, M., Malenovic, A., Reichl, S., Hoffmann, C., Muller-Goymann, C., Daniels, R., & Savic, S. (2012). Compounding of a topical drug with prospective natural surfactant- stabilized pharmaceutical bases: Physicochemical and in vitro/in vivo characterization - A ketoprofen case study. European Journal of Pharmaceutics and Biopharmaceutics. 80(1), 164–175. https://doi.org/10.1016/j.ejpb.2011.09.001

Larson, R. G., & Wei, Y. (2019). A review of thixotropy and its rheological modeling. Journal of Rheology. 63(3), 477–501. https://doi.org/10.1122/1.5055031

Lerche, D., & Sobisch, T. (2011). Direct and accelerated characterization of formulation stability. Journal of Dispersion Science and Technology. 32(12), 1799–1811. https://doi.org/10.1080/01932691.2011.616365

Lodén, M., & Wessman, C. (2001). The influence of a cream containing 20% glycerin and its vehicle on skin barrier properties. International Journal of Cosmetic Science. 23(2), 115–119. https://doi.org/10.1046/j.1467-2494.2001.00060.x

Logger, J. G. M., Olydam, J. I., der Weng, W. W., & Erp, P. E. J. (2019). Noninvasive Skin Barrier Assessment: Multiparametric Approach and Pilot Study. Cosmetics. 6. https://doi.org/10.3390/cosmetics6010020

Lonni, A. A. S. G.; Munhoz, V.M.; Lopes, G. C.; Longhini, R.; Pangoni, F. B. B.; Santos, R. S.; Junqueira, M. V.; Natali, M. R. M.; Leite-Mello, E. V. S.; Guimaraes, F. B.; Baesso, M. L.; Scarminio, Ieda S; Bruschi, M. L.; Mello, J. C. P. (2015). Development and characterization of multiple emulsions for controlled release of Trichilia catigua (Catuaba) extract. Pharmaceutical Development and Technology, 1-10. http://dx.doi.org/10.3109/10837450.2015.1081611

Otto, A., Wiechers, J. W., Kelly, C. L., Dederen, J. C., Hadgraft, J., & Du Plessis, J. (2010). Effect of Emulsifiers and Their Liquid Crystalline Structures in Emulsions on Dermal and Transdermal Delivery of Hydroquinone, Salicylic Acid and Octadecenedioic Acid. Skin Pharmacology and Physiology. 23, 273-282. https://doi.org/10.1159/000314702

PHARMACOPOEIA. (2019). Brazilian Pharmacopeia, v. 1. 6° ed. Brasília, Brazil.

Prestes, P. S., Peres, D. D., de Freitas, A. Z., Consiglieri, V. O., Kaneko, T. M., Velasco, M. V., & Baby, A. R. (2016). Particle size and morphological characterization of cosmetic emulsified systems by optical coherence tomography (OCT). Brazilian Journal of Pharmaceutical Sciences. 52(2), 273–280. https://doi.org/10.1590/S1984-82502016000200005

Ribeiro, A. S., Estanqueiro, M., Oliveira, M. B., & Lobo, J. M. S. (2015). Main Benefits and Applicability of Plant Extracts in Skin Care Products. Cosmetics. 2(2), 48-65. https://doi.org/10.3390/cosmetics2020048

Rogiers, V. (2001). EEMCO Guidance for the Assessment of Transepidermal Water Loss in Cosmetic Sciences. Skin Pharmacology and Applied Skin Physiology. 14(2): 117–128. https://doi.org/10.1159/000056341

Sánchez-Regãna, M., Llambí-Mateos F., Salleras-Redonnet, M., Iglesias Sancho, M., Collgros Totosaus, H., & Umbert-Millet, P. (2013). Compounding as a Current Therapeutic Option in Dermatology. Actas Dermo-Sifiliográficas. 104(9), 738–756. https://doi.org/10.1016/j.ad.2012.03.007

Savic, S., Tamburic, S., Kovacevic, A., Daniels, R., & Müller-Goymann, C. (2008). Natural surfactant-based emulsion systems: The influence of common pharmaceutical excipients on colloidal structure and physical stability. Journal of Dispersion Science and Technology. 29(9), 1276–1287. https://doi.org/10.1080/01932690701857558

Silva, A. C., Amaral, M. H., González-Mira, E., Santos, D., & Ferreira, D. (2012). Solid lipid nanoparticles (SLN) - based hydrogels as potential carriers for oral transmucosal delivery of Risperidone: Preparation and characterization studies. Colloids and Surfaces B: Biointerfaces. 93, 241–248. https://doi.org/10.1016/j.colsurfb.2012.01.014

Siska, B., Snejdrova, E., Machac, I., Dolecek, P., & Martiska, J. (2019). Contribution to the rheological testing of pharmaceutical semisolids. Pharmaceutical Development and Technology. 24(1), 80-88. https://doi.org/10.1080/10837450.2018.1425432

Surber C., & Smith E.W. (2005). The mystical effects of dermatological vehicles. Dermatology. 210(2), 157-68. https://doi.org/10.1159/000082572

Thiemann, A., & Petersen, W. (2016). Emulsifier system influences O/W emulsion preservation. Personal Care. 60–62.

Willenbacher, N., & Georgieva, K. Rheology of disperse systems. In: Bröckel, U., Meier, W., & Wagner, G. Product Design and Engineering: Formulation of Gels and Pastes. Weinheim: Wiley-VCH. (2013), p. 7-49.

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Publicado

16/12/2022

Cómo citar

LEAL, G. C. .; COSTA, I. M. da .; SILVA, J. B. da .; SANTOS, R. S. dos .; BRUSCHI, M. L.; MELLO, J. C. P. de; NAKAMURA, C. V. .; LONNI, A. A. S. G. . Desarrollo, caracterización y evaluación por bioingeniería cutánea de una emulsión natural para proporcionar una base portadora estandarizada para preparaciones magistrales tópicas. Research, Society and Development, [S. l.], v. 11, n. 16, p. e509111638290, 2022. DOI: 10.33448/rsd-v11i16.38290. Disponível em: https://rsdjournal.org/index.php/rsd/article/view/38290. Acesso em: 30 jun. 2024.

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Ciencias de la salud