Fabrication and Investigation of Luliconazole Based 2T-SLN Gel for the Amelioration of Vulvovaginal Candidiasis

Abstract

This chapter primarily focuses on fabrication and investigation of luliconazole based 2T-SLN gel for the amelioration of vulvovaginal candidiasis. Vulvovaginal candidiasis (VVC), is an exceedingly common mucosal infection of the lower female reproductive tract, caused mostly by the polymorphic opportunistic fungus Candida albicans. A member of the normal human microbiota, C. albicans commonly colonizes the vaginal lumen asymptomatically. Fungal resistance and infection recurrence are major problems with the existing treatment regimens for VVC, which compromises the therapeutic efficacy of antifungal medications and results in protracted treatment and low patient compliance. The core of the present research was the fabrication and investigation of 2 T- SLN (solid lipid nanoparticles) gel carrying luliconazole for the amelioration of VVC. ‘2T’ symbolizes transvaginal and thermosensitive attributes of the present formulation. The optimized SLNs yielded a particle size, polydispersity index and entrapment efficiency of 62.18 nm, 0.263 and 81.5% respectively. To formulate the 2 T-gel, the final SLNs were loaded into Carbopol 971P-NF and Triethanolamine-based gel. The 2 T-SLN gel was found to be easily spreadable and homogenous with mean extrudability (15 ± 0.4 g/cm²), viscosity (696.42 ± 2.34 Pa·s) and %drug content (93.24 ± 0.73%) values. The pH of the prepared 2 T-SLN gel (4.5 ± 0.5) was in concordance with the vaginal pH (normal conditions). For in-vitro characterization of an optimized 2 T-SLN gel, the release kinetics and anticandidal activity were assessed which offers a %cumulative drug release of 62 ± 0.5% in 72 h and 37.3 ± 1.5 mm zone of inhibition in 48 h. The optimized 2 T-SLN gel was found to be stable at room temperature for two months without any visible non-uniformity, cracking, or breaking. It also exhibits a skin-friendly profile with no noticeable symptoms of erythema or oedema. In conclusion, the current research serves as a new therapeutic perspective in assessing the activity of luliconazole for vaginal drug delivery using a 2 T-SLN gel system.