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Rungta Institute of Pharmaceutical Sciences
Skin cancer is one of the most prevalent malignancies worldwide, often necessitating localized and targeted therapeutic approaches to minimize systemic side effects. This study focuses on the development and evaluation of a sprayable nano emulsion formulation co-loaded with 5-Fluorouracil (5-FU) and Tretinoin for enhanced topical treatment of skin cancer. 5-FU is a well-established chemotherapeutic agent that inhibits DNA synthesis, while Tretinoin promotes epidermal turnover and enhances drug penetration. The nano emulsion was formulated using isopropyl myristate as the oil phase, Tween 80 and Span 20 as surfactants, as a co-surfactant. A pseudo-ternary phase diagram was constructed to identify the optimal nano emulsion region. The resulting formulation was evaluated for droplet size, polydispersity index, zeta potential, pH, viscosity, spray ability, and thermodynamic stability. Ex vivo skin permeation studies were conducted using Franz diffusion cells, and cytotoxicity was assessed on melanoma cell lines using MTT assay. The optimized formulation exhibited a globule size of ~100 nm, low polydispersity index (<0.3), and suitable physicochemical characteristics for dermal application. Enhanced skin permeation, sustained drug release, and superior cytotoxic activity were observed compared to conventional cream formulations. The inclusion of Tretinoin significantly improved the penetration of 5-FU, demonstrating a synergistic effect. The study concludes that the sprayable nano emulsion system offers a promising and patient-friendly alternative for the localized treatment of skin cancer, with potential to improve therapeutic efficacy and minimize systemic toxicity.
5-Fluorouracil (5-FU) is a widely used topical chemotherapeutic agent that acts by inhibiting thymidylate synthase, thereby interfering with DNA synthesis and leading to apoptosis in rapidly dividing cancer cells. However, its clinical utility is often limited by poor skin penetration, instability, and irritation at the site of application. Tretinoin, a derivative of vitamin A, is known to promote skin turnover, enhance permeability of active agents, and has shown synergistic effects when used in combination with other anticancer agents, including 5-FU. The use of nano emulsion -based drug delivery systems has emerged as a promising approach to overcome the limitations of conventional topical formulations. Nano emulsions, with droplet sizes in the Nano meter range (typically 20–200 nm), offer advantages such as increased drug solubility, enhanced skin permeation, controlled drug release, physical stability, and better cosmetic acceptability. Furthermore, incorporating such systems into a sprayable dosage form offers ease of application, uniform dosing, and improved patient compliance.
Nano emulsion: -
A nano emulsion is a thermodynamically or kinetically stable colloidal dispersion consisting of two immiscible liquids (typically oil and water), stabilized by surfactants and/or co-surfactants, with droplet sizes ranging from 20 to 200 nanometers. Unlike conventional emulsions, nano emulsions have ultra-small droplet sizes, which impart them with unique physicochemical and biological advantages, especially in pharmaceutical and cosmetic formulations.
Key Characteristics of Nano emulsions:
Components of a Nano emulsion:
Aparna Tiwari, Ayushi Khadatkar, Sneha Singh, Anjali Sahu*, Rajesh Kumar Nema, Gyanesh Kumar Sahu, Development and Evaluation of Sprayable Nanoemulsion For Skin Cancer Using 5- Fluorouracil and Tretinoin, Int. J. Sci. R. Tech., 2025, 2 (6), 514-521. https://doi.org/10.5281/zenodo.15712250
10.5281/zenodo.15712250