DEVELOPMENT OF BIGELS CONTAINING ANTIFUNGAL AGENT FOR VAGINAL INFECTION

Abstract

Objective: Bigels are unique semi-solid preparations that have piqued the focus of numerous scientists owing to their significant advantages over ordinary gels. The purpose of this study was to develop and characterize innovative Bigels for applications in drug delivery by combining Hydroxypropyl methylcellulose hydrogel and sorbitan monostearate, oils like coconut and olive-based organogel. The existence of both aqueous and oil phases as bigel was revealed by microscopy. Methods: Hydrogels and organogels were prepared separately, and bigels were formed by combining hydrogel and organogel in a predetermined ratio. They were then analyzed employing various physicochemical tests i. e in vitro drug release, microscopy, and other techniques. Microscopy, viscosity measurement, mechanical analysis, and differential scanning calorimetry were used to examine the bigel's microstructures and physicochemical properties. Results: Tube inversion tests reveal that the bigel doesn’t flow under its own weight till 167 min. The microscopy suggested that the gels exhibited fiber-like structures due to the trapping of the organogel inside hydrogel molecules; this entrapment was demonstrated to be uniformly accomplished, resulting in formulation stability, and the DSC study reveals that the terbinafine is not decomposed also after formulating in bigel, and the terbinafine bigel was also found to be stable. The drug-loaded gels demonstrated effective antibacterial activity against Candida species. The formulated bigel shows initial release in 2 h and slowly release later in 4 h. The formed bigel is found to be stable after 3 mo with a pH range of 7.07±0.04, showing good spreadability and drug content was 99.99±0.75. Conclusion: Terbinafine, the drug of preference for the treatment of bacterial vaginosis, demonstrated diffusion-mediated drug release when placed into bigels. In general, the produced bigels might be employed as delivery vehicles for drugs delivered vaginally.