Factors Aff ecting Foam Stability of Clotrimazole Vaginal Foam

Abstract

Clotrimazole (CLT) is a broad-spectrum antifungal, synthetic imidazole derivative, used for Candida albicans the major cause of vaginitis. Vulvovaginal candidiasis (VVC) symptoms can cause discomfort and lower a women’s quality of life. Foams are used to apply formulation without the use of fi ngertips, the more stable the foam the better for coverage of larger surface area. CLT 2% vaginal foam were prepared as an O/W emulsion using Tween 20 and Span 20, Lemon oil, PEG 400, SLS, cetyl alcohol, and the formulas were evaluated for foamability and foam stability, foam density, cycles of freezing and thawing, heating, and cooling, and the impact of the chosen formula on Candida culture are all taken into consideration. The results showed that the CLT prepared successfully as vaginal foam, and the selected formula (F24) considered as the best formula which has good miscibility, texture and acceptable homogeneity, pH (4.8), drug content (97.5%), acceptable foamability and foam stability; foam expansion FE (70%), foam liquid stability (FLS) (40%), foam volume stability FVS (23.5%), gas fraction (GF) (35 mL), acceptable foam density (0.90), good stability at temperature changes, freeze–thaw cycle (pass), heating–cooling cycle (pass) with no phase separation, fast complete drug release (100% in about 40 min), no interaction between the solid components of the formula and acceptable inhibition zone against Candida strains. Finally, we can conclude that formulation of CLT as vaginal foam is an optimum method to improve patients’ compliance and cure the disease with low recurrence possibility due to fast release and long contact time with the aff ected area.