Preparation and in vitro evaluation of topical gel of 5-fluorouracil
Abstract
Topical drug administration through the skin can be defined as the application of drug contains formulation directly to the skin for prophylactic, protective, or therapeutic purposes. 5-Fluorouracil is an antineoplastic agent used for the treatment of skin diseases such as actinic keratosis. The aim of this work was development a gel formulation of 5-FU using NaCMC and PVA as a gelling agent. Six formulations (F1-F6) were prepared using different concentrations of NaCMC and PVA as a gelling agent, glycerin as a humectant, and methyl hydroxyl benzoate preservative. The effect of gelling agent type and concentration on the extrudability, spreadability, rheology, and in vitro drug release was investigated. All the prepared gel exhibited acceptable physical properties such as homogeneity, clarity and consistency, pH value, extrudability and, spreadability. The best formulation F1 prepared by using 4% NaCMC as a gelling agent,5% glycerin as a humectant, and 0.2% methyl hydroxyl benzoate as a preservative with pH value 6.38±0.04, drug content 97.2±0.2, extrusion time 12±0.5sec with highest drug release 98.12% through 3h.
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