Development of Bigels Containing Antifungal Agent for Vaginal Infection

Abstract

Abstract Objective Bigels are developed and are unique semi-solid formulations that have captivated the interest of many researchers due to their significant benefits over ordinary gels. The goal of this research work was to create and characterize new bigels for drug delivery applications by combining Hydroxypropyl methylcellulose hydrogel with sorbitan monostearate oil (coconut and olive) based organogel. The microscopy revealed the presence of both aqueous & oil phases as bigel. Methods The hydrogels and organogels were prepared individually and then the bigels were prepared by mixing hydrogel and organogel in a defined ratio and then they were evaluated using physiochemical tests, in-vitro drug release, microscopy, etc. The microstructures and physicochemical characteristics of the bigel were tested using microscopy, viscosity measurement, mechanical analysis, and differential scanning calorimetry analysis. Results Tube inversion tests reveal that the bigel doesn’t flow under its own weight till 167 mins. 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 hours and slowly release later in 4 hours. The formed bigel is found to be stable after 3 months with a pH range of 7.07 ± 0.04, showing good spreadability and drug content was 99.99 ± 0.75. Conclusions 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.