Diseño de una metodología para el estudio de estabilidad integral de una emulsión cosmecéutica de aceite de germen de maíz virgen
Fecha
2021
Autores
González Duardo, Eliany
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Editor
Universidad Central ¨Marta Abreu¨ de Las Villas. Facultad de Química y Farmacia. Departamento de Farmacia
Resumen
El aceite de germen de maíz, por sus altos niveles de ácidos grasos poliinsaturados y de componentes con poder antioxidante, se utiliza ampliamente en la industria cosmética, por lo que en el Departamento de Farmacia de la UCLV se desarrolló una emulsión basada en él para el cuidado de la piel. El objetivo del presente trabajo es proponer una metodología para realizar los estudios de estabilidad integral de dicha formulación. Con este fin, siguiendo las recomendaciones de artículos científicos, normas y regulaciones vigentes, se realizó una valoración crítica de la calidad de la emulsión para luego decidir la realización del estudio de estabilidad. Adicionalmente se seleccionaron los ensayos para evaluar su estabilidad física, química, microbiológica y se diseñó el estudio, así como el envase definitivo. Se determinó que la emulsión posee componentes comúnmente utilizados en productos cosméticos, adecuada calidad tecnológica y estabilidad física satisfactoria según estudios preliminares. Para determinar la estabilidad integral las muestras pueden almacenarse a 5 ± 2 °C; 30 ± 2 °C y/o 40 ± 2 °C con una humedad relativa de 75 ± 5%, analizándolas a intervalos de 0; 1; 2; 3; 6; 9; 12; 18 y/o 24 meses dependiendo del tipo de estudio. Para su evaluación deben determinarse las características organolépticas, tamaño y distribución del tamaño de gotas, pH, viscosidad, contenido de α-tocoferol e índice de peróxidos, conteo microbiano y prueba de eficacia del conservante. El envase definitivo puede ser de polietileno de alta densidad o polipropileno, lo cual se definirá durante el estudio de estabilidad acelerada.
Palabras claves: aceite de germen de maíz, emulsión cosmecéutica, estabilidad integral.
Due to the high levels of polyunsaturated fatty acids and components with antioxidant power, corn germ oil is widely used in the cosmetic industry, which led to the development, in the Pharmacy Department of UCLV, of an emulsion based on it for skin care. The objective of the present work is to propose a methodology to carry out the integral stability studies of said formulation. Following the recommendations of scientific articles, guidelines and current regulations, a critical evaluation considering quality of the emulsion was carried out, in order to decide the development of the stability study. Additionally, assays included on the chemical, physical and microbial stability, as well as the final container were selected. As a result, there were found components commonly used in cosmetic products, a good technological quality and satisfactory physical stability according to preliminary studies. For the integral stability, samples should be stored at 5 ± 2 ° C; 30 ± 2 ° C and / or 40 ± 2 ° C with a relative humidity of 75 ± 5%, with a sampling time of 0; 1; 2; 3; 6; 9; 12; 18 and / or 24 months depending on the type of study. For the evaluation, organoleptic characteristics, droplet size and distribution, pH, viscosity, α-tocopherol content and peroxide index, microbial count and preservative efficacy test should be developed. The material for the final container should be high-density polyethylene or polypropylene, which will be defined during the accelerated stability study. Keywords: Corn germ oil, cosmeceutical emulsion, integral stability.
Due to the high levels of polyunsaturated fatty acids and components with antioxidant power, corn germ oil is widely used in the cosmetic industry, which led to the development, in the Pharmacy Department of UCLV, of an emulsion based on it for skin care. The objective of the present work is to propose a methodology to carry out the integral stability studies of said formulation. Following the recommendations of scientific articles, guidelines and current regulations, a critical evaluation considering quality of the emulsion was carried out, in order to decide the development of the stability study. Additionally, assays included on the chemical, physical and microbial stability, as well as the final container were selected. As a result, there were found components commonly used in cosmetic products, a good technological quality and satisfactory physical stability according to preliminary studies. For the integral stability, samples should be stored at 5 ± 2 ° C; 30 ± 2 ° C and / or 40 ± 2 ° C with a relative humidity of 75 ± 5%, with a sampling time of 0; 1; 2; 3; 6; 9; 12; 18 and / or 24 months depending on the type of study. For the evaluation, organoleptic characteristics, droplet size and distribution, pH, viscosity, α-tocopherol content and peroxide index, microbial count and preservative efficacy test should be developed. The material for the final container should be high-density polyethylene or polypropylene, which will be defined during the accelerated stability study. Keywords: Corn germ oil, cosmeceutical emulsion, integral stability.
Descripción
Palabras clave
Industria Cosmética, Cosmecéuticos, Aceite de Germen de Maíz, Antioxidantes