Determinación de la estabilidad de nuevos antídotos a base de melatonina: Cremas con Pemulen

Enith Del Carmen Moreno Batista

doi:10.48204/synergia.v5n2.11607

Submitted October 29, 2026

Published 2026-10-30

Artículos

Vol. 5 No. 2 (2026): Synergía

Determination of stability of new melatonin-based antidotes: Creams with Pemulen

Enith Del Carmen Moreno Batista⁺⁻

DOI https://doi.org/10.48204/synergia.v5n2.11607

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DOI: 10.48204/synergia.v5n2.11607

Published: 2026-10-30

How to Cite

Moreno Batista, E. D. C. (2026). Determination of stability of new melatonin-based antidotes: Creams with Pemulen. Synergía, 5(2), 341–353. https://doi.org/10.48204/synergia.v5n2.11607

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Abstract

Melatonin, known for its sleep-regulating effect, has demonstrated potent antioxidant, anti-inflammatory, and anti-aging properties and can penetrate the skin's lipid barrier to protect against ultraviolet radiation. Furthermore, Pemulen TR-1, a high-molecular-weight copolymer widely used as an emulsifying agent in oil-in-water (o/w) systems, is designed to generate stable dermocosmetic systems. This study aims to evaluate the stability of creams formulated with melatonin and the Pemulen TR-1® polymer, analyzing the influence of incorporating different antioxidant excipients during a 19-month storage period at room temperature. To this end, we used an experimental formulation and stability evaluation approach. We developed sixteen formulations under this parameter, varying the incorporation of antioxidant excipients such as ethylenediaminetetraacetic acid (EDTA), ascorbic acid, and tocopheryl acetate. We quantified the active ingredient using HPLC, following the parameters established by the United States Pharmacopeia (USP 38). The results showed that formulation C1, without antioxidant addition, exhibited the greatest chemical and visual stability, followed by C9 and C11. In contrast, C15, which included ascorbic acid, showed greater degradation, phase separation, and browning, indicating instability. Furthermore, viscosity and emulsion homogeneity are closely related to resistance to degradation. This work demonstrates that it is possible to obtain a stable melatonin cream without adding additional antioxidants, using a suitable emulsion system such as Pemulen®.

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References

De Teresa Galván, C., Guisado Barrilao, R., García, M. C., Ochoa, J., & Ocaña Wilhelmi, J.
(2008). Antioxidantes y ejercicio físico: funciones de la melatonina. Revista Andaluza
de Medicina del Deporte, 1(2), 61–72.
Ferlazzo, N., Andolina, G., Cannata, A., Costanzo, M. G., Rizzo, V., Currò, M., Ientile, R., &
Caccamo, D. (2020). Is melatonin the cornucopia of the 21st century? Antioxidants,
(11), 1088. https://doi.org/10.3390/antiox9111088
Illnait-Ferrer, J. (2012). Melatonina: actualidad de una hormona olvidada. Revista CENIC,
(3). Artículo en Redalyc Pemulen™ TR-1 NF polymer. (s. f.). Pharma Excipients.
Pemulen TR-1 NF polymer
Poza, J. J., Pujol, M., Ortega-Albás, J. J., Romero, O., & Grupo de Estudio de Insomnio de la
Sociedad Española de Sueño. (2018). Melatonina en los trastornos de sueño.
Neurología. https://doi.org/10.1016/j.nrl.2018.08.002
Rusanova, I., Martínez-Ruiz, L., Florido, J., Rodríguez-Santana, C., Guerra-Librero, A.,
Acuña-Castroviejo, D., & Escames, G. (2019). Protective effects of melatonin on the
skin: Future perspectives. International Journal of Molecular Sciences, 20(19), 4948.
https://doi.org/10.3390/ijms20194948
United States Pharmacopeial Convention. (2015). United States Pharmacopeia 38–National
Formulary 33 (USP 38–NF 33). United States Pharmacopeial Convention.
Ye, J., Wang, S., Deng, X., Yin, L., Xiong, B., & Wang, X. (2016). Melatonin increased maize
(Zea mays L.) seedling drought tolerance by alleviating drought-induced
photosynthetic inhibition and oxidative damage. Acta Physiologiae Plantarum, 38(2).
https://doi.org/10.1007/s11738-015-2045-y

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[1] De Teresa Galván, C., Guisado Barrilao, R., García, M. C., Ochoa, J., & Ocaña Wilhelmi, J.

[2] (2008). Antioxidantes y ejercicio físico: funciones de la melatonina. Revista Andaluza

[3] de Medicina del Deporte, 1(2), 61–72.

[4] Ferlazzo, N., Andolina, G., Cannata, A., Costanzo, M. G., Rizzo, V., Currò, M., Ientile, R., &

[5] Caccamo, D. (2020). Is melatonin the cornucopia of the 21st century? Antioxidants,

[6] (11), 1088. https://doi.org/10.3390/antiox9111088

[7] Illnait-Ferrer, J. (2012). Melatonina: actualidad de una hormona olvidada. Revista CENIC,

[8] (3). Artículo en Redalyc Pemulen™ TR-1 NF polymer. (s. f.). Pharma Excipients.

[9] Pemulen TR-1 NF polymer

[10] Poza, J. J., Pujol, M., Ortega-Albás, J. J., Romero, O., & Grupo de Estudio de Insomnio de la

[11] Sociedad Española de Sueño. (2018). Melatonina en los trastornos de sueño.

[12] Neurología. https://doi.org/10.1016/j.nrl.2018.08.002

[13] Rusanova, I., Martínez-Ruiz, L., Florido, J., Rodríguez-Santana, C., Guerra-Librero, A.,

[14] Acuña-Castroviejo, D., & Escames, G. (2019). Protective effects of melatonin on the

[15] skin: Future perspectives. International Journal of Molecular Sciences, 20(19), 4948.

[16] https://doi.org/10.3390/ijms20194948

[17] United States Pharmacopeial Convention. (2015). United States Pharmacopeia 38–National

[18] Formulary 33 (USP 38–NF 33). United States Pharmacopeial Convention.

[19] Ye, J., Wang, S., Deng, X., Yin, L., Xiong, B., & Wang, X. (2016). Melatonin increased maize

[20] (Zea mays L.) seedling drought tolerance by alleviating drought-induced

[21] photosynthetic inhibition and oxidative damage. Acta Physiologiae Plantarum, 38(2).

[22] https://doi.org/10.1007/s11738-015-2045-y

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