article · European Journal of Pharmaceutical Sciences
This research developed and evaluated a topical gel formulation to improve the delivery of caffeine into the skin for managing cellulite, using ultrasound waves known as sonophoresis. Researchers prepared caffeine-loaded, Transcutol enriched cerosomes using a thin-film hydration method and statistical design to identify the most effective formulation. The leading formulation achieved high drug entrapment, optimal particle size, and strong stability, showing a distinctive fibre-like ceramide structure. When incorporated into a gel and tested on rat skin, applying sonophoresis alongside the gel resulted in superior caffeine deposition compared to using the gel alone or standard caffeine gel. Additionally, histopathological examination confirmed that the combination of the cerosome gel and ultrasound delivery was non-irritating to the skin, highlighting its potential effectiveness for topical cellulite treatments.
Cellulite affects many individuals, but delivering active compounds like caffeine deep enough into the skin remains a major barrier. By combining specialised nanoscale lipid carriers with gentle ultrasound waves, this approach allows greater amounts of caffeine to penetrate the skin safely and without irritation, offering a more effective pathway for non-invasive cosmetic and dermatological treatments.
This technology represents an applied formulation approach relevant to cosmetic, aesthetic, and dermatological product developers. It could enable non-invasive topical treatments for cellulite reduction, combining a topical cerosome gel with existing ultrasound delivery equipment. Tested in vivo in rat models, the work remains at an applied pre-clinical stage and would require human clinical trials and regulatory safety validation before near-market commercialisation.
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The goal of this research was to augment the deposition of caffeine loaded Transcutol® enriched cerosomes (TECs) gel for efficient topical treatment of cellulite utilizing the sonophoresis technique. Caffeine-loaded TECs were prepared using thin film hydration method applying 23 factorial design to study the impact of different factors, each with two levels on the entrapment efficiency (EE%), particle size (PS), polydispersity index (PDI), and zeta potential (ZP) of the formulated TECs. The studied factors were cetyl trimethyl ammonium bromide (CTAB) amount (mg) (X1), phosphatidylcholine (PC) amount (mg) (X2), and Transcutol® amount (mg) (X3). Design-Expert® software was utilized to determine the optimum TECs formulation. Afterward, the optimum TECs formulation was loaded into a gel and subjected to extra investigations. The optimum TECs formulation was (TEC5) which was prepared using 10 mg of CTAB, 150 mg of PC, and 10 mg of Transcutol®. TEC5 presented EE% of 87.44 ± 0.14 %, PS of 308.60 ± 13.38 nm, PDI of 0.455 ± 0.030, and ZP of 50.20 ± 1.55 mV. TEC5 had a fiber-like morphology, with elongated tubules of ceramide. Further, the optimum TECs formulation showed a high stability profile. Moreover, an in vivo dermatokinetic study showed superior deposition of caffeine from TEC5 gel coupled with the sonophoresis on rat skin compared to TEC5 gel and caffeine gel. Moreover, the histopathological study of TEC5 on rat skin confirmed the non-irritant nature of TEC 5 gel mediated by ultrasonic waves through the skin. Overall, the outcomes exposed the obvious superiority of sonophoresis delivered TECs-gel for topical delivery of caffeine for cellulite management.
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DOI: 10.1016/j.ejps.2024.106875
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