article · Pharmaceuticals
Acne vulgaris treatment can be enhanced by combining botanical extracts with established pharmaceutical agents in specialised drug delivery systems. A topical nano-phytosome formulation was developed using thin-film hydration to encapsulate bergamot essential oil and spironolactone. Optimisation testing established a stable formulation with high entrapment efficiency, nanoscale particle size, and stability over three months of storage. Molecular modelling demonstrated that the chemical constituents of bergamot essential oil support the anchoring of spironolactone within the carrier structure. In clinical evaluations, the combined formulation of bergamot essential oil and spironolactone within nano-phytosomes delivered a significantly improved therapeutic response against acne vulgaris compared to bergamot nano-phytosomes alone. The findings confirm that nano-phytosomes serve as effective carriers for topical essential oil delivery and facilitate a synergistic clinical effect when paired with spironolactone.
Acne vulgaris is a widespread skin condition requiring effective topical therapies that minimise adverse effects. By showing that natural bergamot oil works synergistically with spironolactone inside a nanoscale delivery system, this research provides evidence for hybrid therapeutic strategies. Such formulations can enhance drug delivery, improve clinical outcomes for patients, and offer more targeted options for dermatological care.
This work is relevant to pharmaceutical and dermatological product developers formulating topical acne treatments. Because the combination formulation has undergone in vitro characterisation, three-month stability testing, and human clinical evaluation, it represents applied and clinically tested research. Commercial translation would likely require formal clinical trials, scaled manufacturing of the nano-phytosomes, and regulatory clearance for combination drug products.
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The foremost target of the current work was to formulate and optimize a novel bergamot essential oil (BEO) loaded nano-phytosomes (NPs) and then combine it with spironolactone (SP) in order to clinically compare the efficiency of both formulations against acne vulgaris. The BEO-loaded NPs formulations were fabricated by the thin-film hydration and optimized by 32 factorial design. NPs’ assessments were conducted by measuring entrapment efficiency percent (EE%), particle size (PS), polydispersity index (PDI), and zeta potential (ZP). In addition, the selected BEO-NPs formulation was further combined with SP and then examined for morphology employing transmission electron microscopy and three months storage stability. Both BEO-loaded NPs selected formula and its combination with SP (BEO-NPs-SP) were investigated clinically for their effect against acne vulgaris after an appropriate in silico study. The optimum BEO-NPs-SP showed PS of 300.40 ± 22.56 nm, PDI of 0.571 ± 0.16, EE% of 87.89 ± 4.14%, and an acceptable ZP value of −29.7 ± 1.54 mV. Molecular modeling simulations showed the beneficial role of BEO constituents as supportive/connecting platforms for favored anchoring of SP on the Phosphatidylcholine (PC) interface. Clinical studies revealed significant improvement in the therapeutic response of BEO-loaded NPs that were combined with SP over BEO-NPs alone. In conclusion, the results proved the ability to utilize NPs as a successful nanovesicle for topical BEO delivery as well as the superior synergistic effect when combined with SP in combating acne vulgaris.
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DOI: 10.3390/ph16010128
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