Revolutionizing Hyperpigmentation Solutions: Formulation and Characterization of Kojic Acid Gel

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Kojic acid is a skin-lightening agent that blocks the tyrosinase enzyme and inhibits melanin synthesis. While kojic acid has demonstrated effectiveness in hyperpigmentation treatment, the existing formulations often suffer from issues, such as poor skin penetration, instability, and skin irritation. The current study aimed to overcome these limitations by preparing a kojic acid gel formulation utilizing biocompatible polymers. These polymers included sodium alginate and xanthan gum to enhance therapeutic efficacy for hyperpigmentation treatment. Sodium alginate and xanthan gum were used as polymers, while the excipients included propylene glycol, glycerin, peppermint oil, methylparaben, and propylparaben. Design Expert 11 optimized topical gels' viscosity, spreadability, and permeation responses. The optimized gels were determined for organoleptic properties, pH, drug content, spreadability, viscosity, in-vitro drug permeation studies, Fourier Transform Infrared Spectroscopy (FTIR) analysis, anti-oxidant activity, antimicrobial activity, and stability study. Results indicated that the pH of the optimized sodium alginate gel was 6.6 and that of xanthan gum gel was 6.8. The spreadability was 28.5 g.cm/sec and 17 g.cm/sec for sodium alginate and xanthan gum gels, respectively. The viscosity was 5900 mPa.s for sodium alginate gels and 6854 mPa.s for xanthan gum gels. The drug content lied in the range of 90%-110%, which is according to United States Pharmacopeia standards. The permeation study showed an acceptable release profile for both gels. The anti-oxidant assay indicated an optimum anti-oxidant activity, while the antimicrobial activity test showed inhibitory action against bacteria. An accelerated stability study elucidated that the optimized gels had good stability. The results inferred that the prepared gel formulations of kojic acid were stable and reproducible.