Designing 5-fluorouracil-loaded lipid nanoparticles using double emulsion and solvent evaporation for skin cancer therapy

Abstract

Author(s): Urvashi Jain, Harish Jaiswal

Implementing the Quality by Design (QbD) approach enables pharmaceutical researchers to effectively reduce the number of experimental tests conducted and the associated time required. This aids in identifying important factors that substantially influence the quality of the goods, including vital material characteristics, formulation factors, and crucial procedure factors. This study aims to integrate the advantageous characteristics of Lipid Nanoparticles (LNPs) and the QbD approach to create an innovative Drug Delivery System (DDS) for treating skin cancers and actinic keratosis. LNPs, known for their high efficacy in the topical treatment of skin diseases, were formulated to address the skin layer's intricate structure and facilitate enhanced absorption. The present investigation employed the QbD methodology to fabricate LNP formulations to enhance the dermal permeation of 5-Fluorouracil (5-FU), a commonly utilized agent for treating non-melanoma skin cancer. The Lipid Nanoparticles containing 5-Fluorouracil (5-FLLNP) were synthesized using the Double Emulsion - Solvent Evaporation (DE-SE) technique. The DE-SE involves a dual-stage procedure encompassing two distinct emulsification steps, thereby introducing a heightened level of complexity to the overall process. The stability of nanoparticles produced through a DE-SE method is uncertain due to the various formulations and process attributes involved. Using a DE-SE technique in producing 5- FLLNP is a viable method for DDS, offering a means to achieve a highquality product through implementing the QbD approach. Artificial Neural Networks (ANN) have successfully developed an optimal LNP formulation that ensures quality and falls within the designated Design Space (DS). 5- FLLNP formulation exhibited a greater cell viability of 73% compared to the pure 5-FU formulation, which had a cell viability of 68% for A431 cells.

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