ABSTRACT:
This study focuses on the formulation, development, and evaluation of a bigel system incorporating azelaic acid (AzA) for effective acne management. Bigels are advanced drug delivery systems that combine the properties of hydrogels and organogels, offering improved drug delivery for topical applications. Azelaic acid was selected as the active pharmaceutical ingredient due to its anti-inflammatory, antimicrobial, antioxidant, and anti-keratinizing properties, which help in targeting the key pathogenic factors of acne such as follicular hyperkeratosis, microbial proliferation, and inflammation. The bigel formulations were prepared by combining hydrogel and organogel in different ratios, incorporating 5% w/w AzA. The prepared formulations were evaluated for physicochemical parameters including physical appearance, pH, viscosity, spreadability, extrudability, and drug content. All formulations exhibited acceptable characteristics with pH in the range of 6.5–7.1, indicating suitability for topical application. Viscosity was found to be inversely proportional to spreadability and extrudability. Drug content analysis revealed satisfactory incorporation of azelaic acid, with the optimized formulation showing 91.2% ± 1.25% drug content.Among all formulations, BG5 was identified as the optimized formulation due to its favorable balance of low viscosity, high spreadability, good extrudability, acceptable pH, and uniform drug distribution. The study demonstrates that bigels can improve the topical applicability, stability, and physicochemical performance of azelaic acid.Therefore, bigel systems show significant potential as a promising topical drug delivery approach for improved acne management.