Category Archives: Cosmetics

Catechin in avocado seed as a skin lightening agent

J Pharm Pharmacogn Res 8(5): 449-456, 2020.

Original Article

The activity of avocado (Persea americana Mill.) seed extract containing catechin as a skin lightening agent

[Actividad del extracto de semilla de aguacate (Persea americana Mill.) conteniendo catequina como agente aclarante de la piel]

Ni Putu Linda Laksmiani*, I Komang N. Sanjaya, Ni Putu E. Leliqia

Department of Pharmacy, Mathematics and Natural Science Faculty, Udayana University, Indonesia.
Abstract

Context: Indonesia is a tropical country with high UV rays. UV rays can increase melanin synthesis in the skin and cause the skin to become darker and hyperpigmented. One way to overcome this problem is the use of skin lightening agents through the mechanism of tyrosinase inhibition. Flavonoids have antioxidant activity and inhibit the process of melanogenesis.  Also, avocado seeds contain secondary metabolites of flavonoids in the form of catechin.

Aims: To determine the potential and activity of catechin as skin lightening agent against the target protein, tyrosinase, by in silico test using molecular docking method and in vitro test compared to kojic acid.

Methods: In silico assay was carry out using a computational method with autodock 4.2 program to demonstrate the affinity of active compound (catechin) with tyrosinase as the target protein by evaluating the binding energy value. Inhibition of tyrosinase is one way to inhibit the formation of melanin, so the skin becomes brighter. Spectrophotometry method was conducted to measure the absorbance of dopachrome and calculate the percentage of tyrosinase inhibition to be altered as IC50.

Results: The energy values ​​of catechin and kojic acid in tyrosinase enzymes were -7.64 kcal/mol and -5.03 kcal/mol, respectively. The energy value of the catechin bond was smaller than kojic acid in the tyrosinase. The bond energy value showed that catechin had greater potential than kojic acid as a skin lightening agent by inhibiting tyrosinase in silico using the molecular docking method. The IC50 value from ethyl acetate extract of avocado seeds disrupt the tyrosinase using the in vitro test was 93.02 ± 1.98 mg/mL, while IC50 kojic acid was 48.67 ± 0.1 mg/mL.

Conclusions: Avocado seeds extract containing catechin has a potential activity as a lightening agent by inhibiting the tyrosinase. Further research must be done to fractionation the extract to get a significant effect.

Keywords: avocado seed; in silico; in vitro; tyrosinase inhibitor.

Resumen

Contexto: Indonesia es un país tropical con altos rayos UV. Los rayos UV pueden aumentar la síntesis de melanina en la piel y hacer que la piel se vuelva más oscura e hiperpigmentada. Una forma de superar este problema es el uso de agentes para aclarar la piel a través del mecanismo de inhibición de la tirosinasa. Los flavonoides tienen actividad antioxidante e inhiben el proceso de melanogénesis. Además, las semillas de aguacate contienen metabolitos secundarios de flavonoides en forma de catequina.

Objetivos: Determinar el potencial y la actividad de la catequina como agente para aclarar la piel contra la proteína objetivo, tirosinasa, mediante prueba in silico utilizando el método de acoplamiento molecular y la prueba in vitro en comparación con el ácido kójico.

Métodos: El ensayo in silico se llevó a cabo utilizando un método computacional con el programa Autodock 4.2 para demostrar la afinidad del compuesto activo (catequina) con la tirosinasa como la proteína diana mediante la evaluación del valor de energía de unión. La inhibición de la tirosinasa es una forma de inhibir la formación de melanina, por lo que la piel se vuelve más brillante. El método de espectrofotometría se realizó para medir la absorbancia del dopacromo y calcular el porcentaje de inhibición de la tirosinasa que se alterará como IC50.

Resultados: Los valores de energía de catequina y ácido kójico en las enzimas tirosinasa fueron -7,64 kcal/mol y -5,03 kcal/mol, respectivamente. El valor energético del enlace de catequina fue menor que el ácido kójico en la tirosinasa. El valor de la energía de enlace mostró que la catequina tuvo un mayor potencial que el ácido kójico como agente para aclarar la piel al inhibir la tirosinasa in silico utilizando el método de acoplamiento molecular. El valor IC50 del extracto de acetato de etilo de las semillas de aguacate alteró la tirosinasa usando la prueba in vitro que fue 93,02 ± 1,98 mg/mL, mientras que para el ácido kójico fue 48,67 ± 0,1 mg/mL.

Conclusiones: El extracto de semillas de aguacate que contiene catequina tiene una actividad potencial como agente aclarante al inhibir la tirosinasa. Se deben realizar más investigaciones para fraccionar el extracto para obtener un efecto significativo.

Palabras Clave: in silico; in vitro; semilla de aguacate; tirosinasa inhibidor.

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Citation Format: Laksmiani NPLL, Sanjaya IKN, Leliqia NPE (2020) The activity of avocado (Persea americana Mill.) seed  extract containing catechin as a skin lightening agent. J Pharm Pharmacogn Res 8(5): 449–456.

© 2020 Journal of Pharmacy & Pharmacognosy Research (JPPRes)

Jojoba oil extraction yield modeling and optimization

J Pharm Pharmacogn Res 7(5): 357-380, 2019.

Original Article | Artículo Original

Modeling and optimization of jojoba oil extraction yield using Response Surface Methodology

[Modelado y optimización del rendimiento de extracción de aceite de jojoba mediante la metodología de superficie de respuesta]

Iyad Al-Sheikh1, Jehad A.A. Yamin2*

1Department of Pharmacy, Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman 11733, Jordan.
2Mechanical Engineering Department, School of Engineering, The University of Jordan, Amman 11942, Jordan.
Abstract

Context: Jordan is looking for a cheap and locally affordable source for its cosmetics, fuel and medical applications. Jojoba offers one solution to such problems. It is considered as a good medicinal plant that can be used for several applications.

Aims: To evaluate the effect of parameters as mixing speed, temperature, feedstock grain size, mixture ratio and mixing time on the jojoba yield.

Methods: The mathematical model combining the effect of all the above variables was then used to find the optimum combination for maximum yield. Response Surface Methodology (RSM) technique was used for modeling and optimization. Based on the Pareto chart of parameters effect, the seed size was the most significant followed with temperature effect.

Results: It was found that the optimum values obtained for best yield were seed size of about 0.48 mm, the temperature of about 65°C and mixing time of 2.8 hours maximum yield of about 56% wt can be obtained.

Conclusions: A mathematical model was successfully built and tested for the Jojoba oil yield under different conditions. The optimum parameters that produced the highest yield were also found.

Keywords: ANOVA; DOE; experimental model; optimization; response surface methodology; yield.

Resumen

Contexto: Jordania está buscando una fuente barata y localmente asequible para sus cosméticos, combustible y aplicaciones médicas. Jojoba ofrece una solución a tales problemas. Esta se considera una buena planta medicinal que se puede utilizar para varias aplicaciones.

Objetivos: Evaluar el efecto de parámetros como la velocidad de mezcla, la temperatura, el tamaño de grano de la materia prima, la relación de mezcla y el tiempo de mezcla en el rendimiento de jojoba.

Métodos: El modelo matemático que combina el efecto de todas las variables anteriores se utilizó para encontrar la combinación óptima para obtener el máximo rendimiento. Se utilizó la técnica de metodología de superficie de respuesta (RSM) para el modelado y la optimización. Basado en la gráfico de Pareto del efecto de los parámetros, el tamaño de semilla fue el más significativo seguido del efecto de la temperatura.

Resultados:Se encontró que los valores óptimos para el mejor rendimiento fueron el tamaño de semilla de aproximadamente 0,48 mm, la temperatura 65°C y el tiempo de mezcla de 2,8 horas, y se obtiene un rendimiento máximo de aproximadamente 56% en peso.

Conclusiones: Se construyó y probó con éxito un modelo matemático para el rendimiento del aceite de jojoba en diferentes condiciones. También se encontraron los parámetros óptimos que produjeron el mayor rendimiento.

Palabras Clave: ANOVA, DOE; método de superficie de respuesta; modelo experimental; optimización; rendimiento.

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Citation Format: Al-Sheikh I, Yamin JAA (2019) Modelling and optimization of jojoba oil extraction yield using Response Surface Methodology. J Pharm Pharmacogn Res 7(5): 367–380.

© 2019 Journal of Pharmacy & Pharmacognosy Research (JPPRes)

Depigmentation effect of Quercus infectoria and Terminalia chebula

J Pharm Pharmacogn Res 5(5): 270-277, 2017.

Original Article | Artículo Original

Quercus infectoria and Terminalia chebula decrease melanin content and tyrosinase activity in B16/F10 cell lines

[Quercus infectoria y Terminalia chebula disminuyen el contenido de melanina y la actividad tirosinasa en las líneas celulares B16/F10]

Akram Jamshidzadeh1, Yaser Shokri2**, Nahid Ahmadi1, Neda Mohamadi3, Fariba Sharififar3*

1Toxicology Department, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
2Herbal and Traditional Medicines Research Center, Department of Pharmacognosy, Kerman University of Medical Sciences, Kerman, Iran.
3Pharmaceutics Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.

E-mail: *fa.sharififar@gmail.com, **yashokri@yahoo.com

Abstract

Context: One of the most complained skin cares in ethnic skin like Asian women is hyperpigmentation, and lightening preparations have been long-standing desired. Due to the side effects of current drugs, medicinal plants have attracted more attentions as a source of novel drugs. Mazo (Quercus infectoria galls) and Terminalia chebula fruits have been suggested in Persian Traditional Medicine as a safe treatment for hyperpigmentation.

Aims: To evaluate the cytotoxicity and the effect on melanin synthesis in B16/F10 melanoma of Q. infectoria and T. chebula extracts.

Methods: After collection and scientific authentication, plants were extracted by maceration method with methanol and were standardized based on total phenolic content. MTT assay and colorimetric method were used for cytotoxicity and determination of melanin content and tyrosinase activity in B16/F10 cells, respectively. Kojic acid was used as a reference compound.

Results: Total phenolic content of Q. infectoria and T. chebula was determined as 287.34 ± 4.21 and 172.61 ± 8.67 mg gallic acid equivalent/g dried extract, respectively. Both plants decreased cell viability at 100 µg/mL and significantly reduced intercellular melanin to 66.25% and 71.1%, respectively in comparison to kojic acid (56.63%) at 50 µg/mL. In the same concentration, 65.7% and 71.2% tyrosinase activity was inhibited by Q. infectoria and T. chebula, which significantly were different from control (p<0.001).

Conclusions: These findings suggest that both plants especially Q. infectoria could inhibit melanogenesis in non-toxic concentrations and would be a good candidate for further studies.

Keywords: B16/F10 melanoma cells; depigmentation; melanin; Quercus infectoria; Terminalia chebula.

Resumen

Contexto: Uno de los cuidados de la piel más reclamados en la piel étnica de las mujeres asiáticas es la hiperpigmentación, y se han deseado, desde hace mucho tiempo, preparaciones de aclaramiento. Debido a los efectos secundarios de los fármacos actuales, las plantas medicinales han atraído más atenciones como fuente de nuevos fármacos. Mazo (agallas de Quercus infectoria) y frutos de Terminalia chebula han sido sugeridos en la medicina tradicional persa como un tratamiento seguro para la hiperpigmentación.

Objetivos: Evaluar la citotoxicidad y el efecto sobre la síntesis de melanina en células de melanoma B16/F10 de los extractos de Q. infectoria y T. chebula.

Métodos: Después de la recolección y la autenticación científica, las plantas se extrajeron por método de maceración con metanol y se normalizaron en base al contenido fenólico total. El ensayo MTT y el método colorimétrico se utilizaron para la citotoxicidad y la determinación del contenido de melanina y la actividad tirosinasa en células B16/F10, respectivamente. Se usó ácido kójico como compuesto de referencia.

Resultados: El contenido fenólico total de Q. infectoria y T. chebula se determinó como 287,34 ± 4,21 y 172,61 ± 8,67 mg equivalente de ácido gálico/g de extracto seco, respectivamente. Ambas plantas disminuyeron la viabilidad celular a 100 μg/mL y redujeron significativamente la melanina intercelular a 66,25% y 71,1%, respectivamente, en comparación con el ácido kójico (56,63%) a 50 μg/mL. En la misma concentración, Q. inhiboria y T. chebula inhibieron el 65,7% y el 71,2% de actividad tirosinasa, que fueron significativamente diferentes del control (p <0,001).

Conclusiones: Estos hallazgos sugieren que ambas plantas, especialmente Q. infectoria, podrían inhibir la melanogénesis en concentraciones no tóxicas y sería un buen candidato para estudios posteriores.

Palabras Clave: células de melanoma B16/F10; despigmentación; melanina; Quercus infectoria; Terminalia chebula.

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Citation Format: Jamshidzadeh A, Shokri Y, Ahmadi N, Mohamadi N, Sharififar F (2017) Quercus infectoria and Terminalia chebula decrease melanin content and tyrosinase activity in B16/F10 cell lines. J Pharm Pharmacogn Res 5(5): 270–277.
This article has been cited by:
Şenol FS, Şekeroğlu N, Gezici S, Kiliç E, Erdoğan Orhan İ (2018) Neuroprotective potential of the fruit (acorn) from Quercus coccifera L. Turkish Journal of Agriculture and Forestry 42(2): 82-87. DOI: 10.3906/tar-1711-18

© 2017 Journal of Pharmacy & Pharmacognosy Research (JPPRes)

Brazilian agriculture as source of raw material to organic cosmetics

J Pharm Pharmacogn Res 5(3): 165-166, 2017.

Letter to the Editor | Carta al Editor

The profile of Brazilian agriculture as source of raw material to obtain organic cosmetics

[El perfil de la agricultura brasileña como fuente de materia prima para obtener cosméticos orgánicos]

Neila de Paula Pereira, Douglas Dourado*

Laboratory of Research of Medicines and Cosmetics (LAPEMEC). Federal University of Bahia (UFBA), Salvador, Brazil.
*E-mail: douglas.dourado@ufba.br; dougydourado@gmail.com

Dear Editor:

The concept of organic products has expanded beyond food sector foods. Althougth it still causes resistance in some people, it has already captured a wide public, since the basic conditions that define organic products are an absence of agricultural toxins and chemical fertilizers during cultivation. True organic cosmetics are composed only of natural ingredients, with a minimum of 95% of the raw materials used, produced according to the precepts of organic agriculture. They also do not contain preservatives, synthetic fragrances, or petroleum derivatives, among other components of non-natural origin (Kapsnet, 2007; Ethos, 2012). This differentiates them in terms of composition from other cosmetics that claim to possess organic ingredients, i.e., among other non-organic raw materials that make up such products, which additionally contain organic ingredients.

Pereira (2009) has stated that the cosmetics represent the greatest investment in research involving natural raw materials, especially in Brazil, which with the exploration of its biodiversity, adopted agroforestry type production processes that integrate vegetation production with the ecosystem, producing environmental, social, and economic benefits. Therefore, a significant element in the spread of organic cosmetics in Brazil is related to policies for sustainability, which promote environmental integrity through the practice of using non-extractive raw materials, as well as recycling packaging. To assure that all the requirements of organic products are met agencies emerged (ECOCERT and IBD) inspect and certify the production from the raw materials stage through to the finished product (Higuchi, 2013). At the beginning of the 1980, the Institute of Biodynamic Development was founded (IBD, 2009). The only 100% nationally regulated institute, internationally recognized, which carries the credentials for exports destined for all countries. In addition, health researchers are concerned about the raw materials used in the manufacture of cosmetics, which cause allergies, proposing therefore, organic cosmetics as an alternative (De Buzin, 2016).

With one of the most notable floras in the world for sustainable research, the Brazilian Amazon region currently counts on financial incentives from the Brazilian Government for private national and foreign businesses. The ongoing implantation of a Biocosmetics Research and Development Network (REDEBIO) aims to stimulate research involving natural resources from the Brazilian states that make up the zone defined as “Amazônia Legal”. The objective of this region, still under development in Brazil, is principally to aggregate value to products manufactured in small local industries through the use of sustainable technology currently being established. Certain certified raw materials already included in the country’s sustainability program, have also begun to be cultivated according to the requirements of organic cultivation (Neves, 2009). The majority are species of Amazonian vegetation: Euterpe oleracea (Açai), Orbignya martiana (Babaçu), Theobroma grandi-florum (Cupuaçu), Carapas guianensis (Andiroba), Pentaclethra macroloba (Pracaxi), Copaifera landesdorffi (Copaiba), Platonia insignis (Bacuri), Theobroma cacao (Cacao), Virola surinamensis (Ucuuba) and Bertholletia excelsa (Brazil nut). These generate phytopreparations, such as oils, extracts, and dyes that are widely used in the manufacture of Brazilian organic cosmetics with scientifically proven topical and capillary benefits (ABIHPEC, 2012). In the final balance, Brazilian organic cosmetics should continue to gain force over the next few years, especially with the regulation of the organic cosmetics market that is being drafted by the Brazilian Ministry of Agriculture. Moreover, lines of ecologically aware products that provide quality of life for both for rural and metropolitan communities show a tendency to occupy greater space in the market.

References

ABIHPEC (2012) Brazilian Association of the Personal Hygiene, Perfumery and Cosmetics Industry. http://www.abihp-ec.org.br/bb/principiosativos.php. [Consulted December 10, 2016].

De Buzin EJWK (2016) Mercado de produtos orgânicos em Goiânia: Venda direta. PhD Thesis, Department of Agronomy, Federal University of Goias, Goiânia, Brazil.

Ethos (2012) Institute of Business and Social Responsibility. http://www1.ethos.org.br/EthosWeb/Default.aspx. [Consulted December 5, 2016].

Higuchi CT (2013) The rational use of cosmetics and its disposal and aware of appeal for use products organic and natural sources. InterfacEHS 8(3): 138-142.

IBD (2009) Guidelines for certification of health care products and organic beauty, and natural and organic raw materials and natural. http://www.ibd.com.br. [Consulted December 1, 2016].

Kapsner T (2007) Organic cosmetic standards: A new formulation challenge. Cosmet Toiletries 122: 71‑78.

Neves K (2009) Green formulation. Cosmet Toiletries 21: 22-30.

Pereira NP (2009) Sustainability of cosmetic products in Brazil. J Cosmet Dermatol 8: 160‑161.

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Citation Format: Pereira NP, Dourado D (2017) The profile of Brazilian agriculture as source of raw material to obtain organic cosmetics. J Pharm Pharmacogn Res 5(3): 165-166.

© 2017 Journal of Pharmacy & Pharmacognosy Research (JPPRes)

Emulsifying systems of raw material grease from Brazil flora

J Pharm Pharmacogn Res 3(5): 130-140, 2015.

Original Article | Artículo Original

Development and evaluation of emulsifying systems of the material grease from Brazilian flora

[Desarrollo y evaluación de sistemas emulsionantes a partir de grasas de la flora brasileña]

Douglas Dourado1,2*, Camilla Barreto1, Rafaela S. Fernandes1, Ian M.R. Blanco1, Danilo Oliveira3, Neila Pereira1, Mateus F. Leite3

1Laboratory of Research of Medicines and Cosmetics, LAPEMEC. Federal University of Bahia. UFBA, Salvador, Brazil. 2Laboratory of Molecular Interactions and Chemical and Photochemical Reactivity, IMRCP. University Paul Sabatier, Toulouse, France. 3Multidisciplinary Institute for Health, Federal University of Bahia, UFBA, Vitoria da Conquista, Brazil.
Abstract

Context: Oils and butter of seed from Brazilian biodiversity are extending the range of innovative products for cosmetics development. They have a fat potential similar to skin composition, leading to the improved performance of these product.

Aims: Improve the emulsions spreadability through prior screening of grease composition and studying the viscosity, and the emulsions accelerated stability.

Methods: Emulsions were formulated using oils from semiarid plants from Bahia: Syagrus coronate, Pachira retusa, and Pachira aquatica, so as to compare them with oils already standard in the production of cosmetics. Spreadability and stability tests were made comparing the results. The same criteria were used with Amazon seed butter: Virola surinamensis, Butyrospermum parkii, Astrocaryum murumuru, Theobroma cacao and Theobroma grandiflorum. For the emulsions screening and performance, a system was developed for oil/ butter, following tests of accelerated stability, viscosity, and spreadability.

Results: The combined system of spreadability was optimized using screening. Emollients containing oleic and palmitic acids, and light chain fatty acids obtained good spreadability. The oil emulsion containing Pachira retusa and Virola surinamensis butter had a higher viscosity.

Conclusions: With high content of fatty acids such as oleic, palmitic or the light chain fatty acids obtain an appropriated appearance, texture, and spreadability for cosmetic use. Thus, oils with a low fatty acid content may be combined with butter that have a high fatty acid content and vice-versa. Analyzing and strategically combining grease composition, one can optimize the performance of cosmetic formulations.

Keywords: Raw material grease; screening; spreadability; viscosity.

Resumen

Contexto: Los aceites y mantecas de semillas de la biodiversidad brasileña están ampliando la gama de productos innovadores para el desarrollo de los cosméticos. Estos tienen una grasa potencial similar a la composición de la piel, dando lugar a la mejora del rendimiento de estos productos.

Objetivos: Mejorar la capacidad de extensión de las emulsiones mediante el cribado previo de la composición de grasa y el estudio de la viscosidad y la estabilidad acelerada de las emulsione.

Métodos: Las emulsiones se formularon utilizando aceites de plantas semiáridas de Bahía: Syagrus coronata, Pachira retusa, Pachira aquatica y mantecas de semillas de la Amazona: Virola surinamensis, Butyrospermum parkii, Astrocaryum murumuru, Theobroma cacao y Theobroma grandiflorum. Para el cribado y el rendimiento de las emulsiones se desarrolló un sistema aceite/manteca, seguido de pruebas de estabilidad acelerada, viscosidad y extensibilidad.

Resultados: Los emolientes que contenían ácidos oleico y palmítico, y ácidos grasos de cadena ligera obtuvieron buena extensibilidad. La emulsión de aceite de Pachira retusa y manteca de Virola surinamensis tuvo una viscosidad más alta.

Conclusiones: Con un alto contenido de ácidos grasos oleico, palmítico o los ácidos grasos de cadena ligera se obtienen apariencia, textura y extensibilidad adecuadas para uso cosmético. Por lo tanto, los aceites (contenido bajo de ácidos grasos) se pueden combinar con la manteca (alto contenido de ácidos grasos) y viceversa. Analizando y combinando estratégicamente la composición de grasa se puede optimizar el rendimiento de las formulaciones cosmética.

Palabras Clave: Cribado; extensibilidad; materia prima grasa; viscosidad.

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Citation Format: Dourado D, Barreto C, Fernandes RS, Blanco IMR, Oliveira D, Pereira N, Leite MF (2015) Development and evaluation of emulsifying systems of the material grease from Brazilian flora. J Pharm Pharmacogn Res 3(5): 130-140.
This article has been cited by:
Oliveira LP, de A Montenegro M, Lima FCA, Suarez PAZ, da Silva EC, Meneghetti MR, Meneghetti SMP (2019) Biofuel production from Pachira aquatic Aubl and Magonia pubescens A St-Hil: Physical-chemical properties of neat vegetable oils, methyl-esters and bio-oils (hydrocarbons). Industrial Crops and Products 127: 158–163. DOI: 10.1016/j.indcrop.2018.10.061
Raiser AL, de Sousa AM, Andrighetti CR, Ribeiro EB, Valladão DMS (2018) Evaluation of stability and potential antioxidant activity of munguba (Pachira aquatica Aublet) oil in cosmetic emulsions. Latin American Journal of Pharmacy 37 (8): 1491-1497. Website
de Sousa Coêlho E, Nunes Lopes GL, Martins Pinheiro I, Policarpo de Holanda JN, de Moraes Alves MM,  Carvalho Nogueira N, de Amorim Carvalho FA, Menezes Carvalho AL (2018) Emulgel based on amphotericin B and bacuri butter (Platonia insignis Mart.) for the treatment of cutaneous leishmaniasis: characterization and in vitro assays. Drug Development and Industrial Pharmacy. DOI: 10.1080/03639045.2018.1492610 
Antonia Cesar Nobre de Abrantes (2016) Obtenção de sistemas macroemulsionados a partir de óleos vegetais, para incorporar extrato seco de Punica granatum. Dissertação de mestrado em Química apresentada ao Programa de Pós-graduação em Química, Centro de Ciências Exatas e da Terra, Universidade Federal do Rio Grande do Norte, Natal. Website

© 2015 Journal of Pharmacy & Pharmacognosy Research (JPPRes)

CO 024: ALTERNATIVE METHODS IN THE SAFETY EVALUATION OF COSMETIC: EUROPEAN SITUATION

J Pharm Pharmacogn Res 2(Suppl. 1): S13, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 024: ALTERNATIVE METHODS IN THE SAFETY EVALUATION OF COSMETIC: EUROPEAN SITUATION

Vinardell MP.

Dep. Fisiología, Facultad de Farmacia, Universitat de Barcelona, Av. Joan XXIII s/n 08028 Barcelona, Spain. E-mail: mpvinardellmh@ub.edu
Abstract

From July 11, 2013 onward, cosmetic products placed on the market of European Economic Area are obliged to comply with the new European cosmetics regulations, of which some provisions will be enforced before the above date. These new cosmetic requirements are released in the form of EU regulations in the 27 EU member states plus Norway, Iceland and Liechtenstein, and implemented as national law, unlike the EU directives which need converting into each domestic version. This Regulation will replace the old cosmetics directive of and the subsequent 67 amendments. The new regulation simplifies the cosmetic requirements of European Economic Area, making itself a single law, and eliminate ambiguities that may occur among the member states during the enforcement process.

The European Cosmetic Regulation indicates that all cosmetic products in the European Union should be safe for the human health in the normal use conditions. In Europe the safety of cosmetics is based on the safety evaluation of each individual ingredient. Currently, the safety of cosmetic products has to be assessed prior to release by a ‘suitably qualified’ person. The new regulations specify that the qualifications should be in toxicology and that the assessment should follow a particular protocol.

Cosmetics in general, do not induce severe problems to health, but this is not synonymous of innocuous. All the substances that should represent any serious health risk are listed in the annexes of the Regulation, including forbidden products, with restrictions, colorants, preservatives and UV filter. In these cases, the responsible of safe evaluation is the European Commission through the Directorate General for Health and Consumers (DG SANCO), the safety evaluation performed by the Scientific Committee on Cosmetic Safety (SCCS). This evaluation is based on the data of the dossiers submitted by industry. The SCCS publishes an opinion that appears in the open DG SANCO web.

The European Directive on Cosmetic 2003/15/EC established since March 2009 a ban to use animals in the safety evaluation of cosmetic ingredients.

In practice, the safety evaluations of the SCCS are based on old studies done with animals and prior to the ban and recently on in vitro studies.

In this talk the percentage of in vitro methods evaluated by the SCCS since 2009 will be presented. One of the difficulties relative to the use of in vitro methods is the lack of validated ones. The most used in vitro methods presented in the dossiers are the studies of dermal absorption, mutagenicity and genotoxicity and in a less extents studies of eye irritation and dermal irritation.