Formulation, Characterization and in vivo Evaluation of 5-Fluorouracil-Loaded Polymeric Micelles for Non-Melanoma Skin Cancer
Navneet Mehan1★, Vipin Saini1★, Kumar Manish2★, Manoj Goyal3★, Sheetal Devi1★, Shinu Pottathil4★, Shery Jacob5★, Anroop B Nair6★★ Corresponding author
- 1M.M. College of Pharmacy, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, INDIA.
- 2Department of Pharmaceutics, ISF College of Pharmacy, Moga, Punjab, INDIA.
- 3Department of Anesthesia Technology, College of Applied Medical Sciences in Jubail, Imam Abdul Rahman Bin Faisal University, Jubail, SAUDI ARABIA.
- 4Department of Biomedical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, SAUDI ARABIA.
- 5Department of Pharmaceutical Sciences, College of Pharmacy, Gulf Medical University, Ajman, UNITED ARAB EMIRATES.
- 6Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, SAUDI ARABIA.
CORRESPONDENCE
Navneet Mehan
Dr. Vipin SainiM.M. College of Pharmacy, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, INDIA.
Received: 02-07-2024; Revised: 16-10-2024; Accepted: 12-02-2025.
Volume 59, Issue 2 · pp. 602–616 · PUBLISHED Apr-Jun 2025 · DOI: 10.5530/ijper.20251736
ABSTRACT
Background The goal of the study was to evaluate the prospective of fluorouracil-loaded polymeric micelles for topical delivery in non-melanoma skin cancer. Materials and Methods Polymeric micelles were developed by thin film hydration technique and characterized for physico-chemical properties, in vitrodrug release, ex vivo skin penetration as well as in vivo skin irritation and anticancer effect. Results Preliminary studies were carried out in twelve Formulations (FM1-FM12) and the Formulation (FM4) with the highest entrapment efficiency (~95%) and greater drug release (~98%) was developed into gels (FG1-FG5). The selected gel Formulation (FG4) exhibited adequate viscosity (~5000 cP), ideal pH (~6.8), higher drug content (~79%), greater drug permeation (~70%) and good stability for three months. In vivo skin irritation results indicated the developed formulation is non-irritant. MTT assay indicates dose-dependent effect of FG4 with IC50 of 15.56 μg/mL. Anti-cancer activity assessed in rat models indicates the prominent reduction in tumor burden (volume) by 80% following application of fluorouracil-loaded micellar gel for 1 month. The histopathological study further confirms the activity of developed gel in melanoma skin cancer. Conclusion The data observed suggests that the polymeric micelles could be a feasible option for delivering fluorouracil in the treatment of basal-cell carcinoma.
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Mehan, N., Saini, V., Manish, K., Goyal, M., Devi, S., Pottathil, S., Jacob, S., & Nair, A. B. (2025). Formulation, Characterization and in vivo Evaluation of 5-Fluorouracil-Loaded Polymeric Micelles for Non-Melanoma Skin Cancer. Indian Journal of Pharmaceutical Education and Research, 59(2), 602–616. https://doi.org/10.5530/ijper.20251736
