FORMULATION AND EVALUATION OF NIOSOMAL GEL OF AZELAIC ACID FOR ANTIACNE ACTIVITY

Abstract

Objective: This study aimed to develop niosomes loaded with azelaic acid (AA) to administer in gel form. The primary objective was to achieve controlled and sustained release of the drug while minimizing potential side effects. Methods: Niosomes were fabricated using a combination of various non-ionic surfactants and cholesterol through the application of thin film hydration technique. Furthermore, the processing parameters were optimized and drug excipient compatibility study was conducted using FTIR spectroscopy. The formulations were extensively characterized in terms of entrapment efficiency, particle size, shape, and in vitro release. Subsequently, the improved niosomal dispersions were employed to formulate gels, which underwent analysis to evaluate their visual properties, pH, and rheological behavior. Stability study was also conducted. Results: Total 15 formulations were prepared, out of which 3 formulations F3, F9 and F15 were found to exhibit maximum entrapment efficiency. These formulation were having particle size 260.1 nm, 272.3 nm and 226.3 nm respectively. In vitro drug release was found to be maximum in F9 formulation. The release was found to be dose-dependent across all formulations, with regression values between 0.97 and 0.99, confirming first-order release kinetics. FTIR spectra indicated the absence of any drug-cholesterol-nonionic surfactant interaction in the formulation. The niosomal gel formulations exhibited optimal performance when stored within the temperature range of 4 to 8 °C. Conclusion: This investigation demonstrates the utility of the thin film hydration technique in effectively incorporating poorly water-soluble medications such as azelaic Acid (AA) into niosomes, resulting in high entrapment efficiency. These findings suggest that niosomes containing AA, when topically applied as a gel, have the potential to be an efficacious treatment for acne.