[ Pharmaceutical Sciences Asia - ONLINE ]
E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974


DOI: 10.29090/psa.2021.02.20.002Pharm Sci Asia 2021; 48(2), 147-163

Topical drug delivery of 5-fluorouracil proniosomal gel for the treatment of skin cancer: in vitro and in vivo evaluation

Jampala Rajkumar, Gadela Venkata Radha

- Department of Pharmaceutics, Gitam Institute of Pharmacy, Visakhapatnam, India.

The contemporaneous work was intended to investigate the efficacy of proniosomal gel as a topical vehicle for 5-Fluorouracil (5-FU) in the treatment of melanoma. 5-FU loaded proniosomal gel was formulated by the coacervation phase separation technique using various non-ionic surfactants (spans). The formulations were examined for different parameters such as particle size, drug percentage of entrapment efficiency (% EE), in vitro, ex vivo drug release, in vitro cytotoxicity and in vivo animal model study. The obtained % EE results for prepared proniosomal 5-FU gel in an acceptable range of desired sustaining effect. The cell toxicity in A-375 human melanoma cells revealed concentration mediated cell death. The % cell viability of A-375 human melanoma cells following loaded 5-FU gels and placebo gel treatment concentration at 10μg/mL for 24 hr incubation was 35.6±1.9% and 15.1±2.5% respectively. The prepared proniosomes with penetration enhancer were better than the pure drug. The flux value found from 5-FUPG-11 (23.9 μg/cm2/hr) was 4 times greater than that of the drug suspension (6.6 μg/cm2/hr). There is no substantial change witnessed in vesicular size or % EE of the preparations when stored at 2-8 ºC and 25±2 ºC for 90 days. The outcomes of biochemical assessment also showed that the 5-FU proniosomal gel formulation can be a good carrier choice for carrying the drug into skin layers and achieving the desired sustainment effect for managing of melanoma treatment through topical delivery of a 5-FU pronisomal formulation.


Proniosomal Gel; 5-Fluorouracil; A-375 Human Melanoma Cell Lines; Cytotoxicity; Topical Delivery; Skin Cancer

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