Quality by design approach in the formulation of vaginal tablet of fluconazole solid dispersion

Abstract

Vaginal Candidiasis had caused quite frequent gynecological medical consultations. Fluconazole is an antifungal drug that has poor solubility that hinders dissolution and antifungal activity. The study aimed to formulate the sustained release vaginal tablet of Fluconazole solid dispersion through the Design of Experiment approach to guarantee no compromise with the quality. In the first step, Plackett Burman Design was employed for the preliminary screening of the essential factors that would affect the tablet’s property. The significant factors were used further in applying the 32 factorial design and the responses were studied. The drug release, bioadhesive strength and swelling index were taken as the responses and considered as the vital critical quality attributes of the vaginal tablet. The design space was determined through the contour and response surface plots. The tablet was prepared within the design space with the drug release (99.97±0.1%), bioadhesive strength (1671.62±43.23 dynes/cm2), and swelling index (342.47±5 %) that suggested the values lie within the quality target product profile determined previously. The antifungal activity against C. albicans resulted in a larger inhibition zone for the solid dispersion-based tablet (51±3 mm) than the plain drug-based tablet (36±2 mm).