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Transdermal patch with nanoencapsulated melatonin in a self-emulsifying system for sustained release and dermatological applications (Machine-translation by Google Translate, not legally binding)CM Patents

Transdermal patch with nanoencapsulated melatonin in a self-emulsifying system for sustained release and dermatological applications. The present invention relates to a transdermal patch for the topical administration of melatonin, characterized by containing the active ingredient nanoencapsulated in a self-emulsifying system (SNEDDS). This system comprises a lipid phase, one or more non-ionic surfactants, co-surfactants, and optionally antioxidant and permeabilizing agents, allowing the spontaneous formation of a nanoemulsion in situ upon contact with skin moisture. The patch is designed to provide sustained release and high skin penetration of melatonin, overcoming the problems associated with its low aqueous solubility. The formulation has demonstrated biocompatibility with human fibroblasts and in vitro antitumor activity in melanoma cell lines, which expands its application beyond the treatment of insomnia, allowing its use as an adjuvant in dermatological, antioxidant, photoprotective and oncological therapies. (Machine-translation by Google Translate, not legally binding)

Datos clave

CategoríaInvención

Índice de la ficha

Updated at
05/11/2026
Numero publicacion
ES.3076184.A1
Fecha publicacion
13/08/2026
Anio publicacion
2026
Numero solicitud
ES20260030413

En detalle

Reivindicaciones

1. CLAIMS 1. Transdermal patch for the topical administration of melatonin, characterized in that it is composed of a functional layer, including: 2. -an adhesive polymeric matrix or support, compatible with prolonged cutaneous use and with controlled release properties; -an active phase containing nanoencapsulated melatonin in a self-emulsifying SNEDDS system that includes: - a lipophilic mixture of oils that act as solvents for the active ingredient; - one or more biocompatible non-ionic surfactants with a high hydrophilic-lipophilic balance (HLB), which promote the spontaneous formation of nanoemulsions upon contact with skin moisture; - co-surfactants that stabilize the emulsion and adjust the viscosity and release kinetics; - optionally, wetting or permeabilizing excipients that promote diffusion of the system through the stratum corneum. 3. Patch according to claim 1, wherein the adhesive matrix comprises a hydrophilic polymer selected from HPMC, xanthan gum, or combinations thereof. 4. Patch, according to claim 1, wherein the non-ionic surfactant with high HLB value is Labrasol®. 5. Patch, according to claim 1, wherein the co-surfactant is selected from Capyrol® 90, Transcutol® P, PEG 300, PEG 400 and other pharmaceutically acceptable glycols or combinations thereof. 6. Patch according to any of the preceding claims, characterized in that the SNEDDS formulation has an average particle size, after aqueous reconstitution, of less than 200 nm. 7. Patch according to any of the preceding claims, characterized in that the melatonin load incorporated in the formulation is greater than 1.5% w/w. 8. Patch according to any of the preceding claims, characterized in that it has a mechanical resistance greater than 700 mN and an elongation at break greater than 12 mm. 9. Patch according to any of the preceding claims, characterized in that the SNEDDS system comprises an optimized mixture of components, with relative proportions of 40% SNEDDS, 40% PEG 300 and 14.4% HPMC. 10. Use of a transdermal patch comprising nanoencapsulated melatonin in a SNEDDS-type self-emulsifying system for the treatment of cutaneous melanoma, characterized in that said patch releases melatonin in a sustained manner and facilitates its transdermal penetration, inducing a cytotoxic effect on human melanoma cells, particularly A375 and SK-MEL-31. 11. Use of a transdermal patch comprising nanoencapsulated melatonin in a SNEDDS-type self-emulsifying system as a topical antioxidant agent, being useful in the prevention or treatment of dermatological conditions associated with cutaneous oxidative stress. 12. Use of a transdermal patch comprising nanoencapsulated melatonin in a SNEDDS-type self-emulsifying system for the prevention or treatment of sleep disorders, jet lag syndrome, cutaneous oxidative stress, or dermatological pathologies associated with inflammation or mitochondrial damage.

Etiquetas

Inventores
Serrano López Dolores RemediosSerrano López, Dolores RemediosSimón Zorita Jesús AngelSimón Zorita, Jesús AngelTorrado Durán Juan JoséTorrado Durán, Juan JoséRomero Martínez, Manuel AlejandroRomero Martínez Manuel AlejandroGonzález Burgos, María ElenaGonzález Burgos María Elena
Solicitantes
Universidad Complutense de Madrid
Clasificacion ipc
A61K 31/ 4045 A IA61K 9/ 70 A IA61P 17/ 00 A IA61P 17/ 18 A IA61P 25/ 00 A IA61P 35/ 00 A I
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