Development of Polymeric Nanoparticles Based Vaginal Film of Fluconazole

Abstract

The aim of the present work was to develop nanoparticle based fast dissolving vaginal film containing Fluconazole. Fluconazole is a triazole derivative used in the treatment of vaginal candidiasis. Polymeric nanoparticles were made using Chitosan and sodium tripolyphosphate (TPP) as a cross linking agent. Chitosan contains positive charge due to the presence of amino groups and TPP is polyanion which acquires opposite charge and acts as cross linking agent. This cross linked structure provides entrapment to the drug molecule. Nanoparticles were made using Ionic gelation method. Blank nanoparticles were evaluated for particle size, Polydispersity Index (PI) and zeta potential. Optimized batch of blank nanoparticles had 133.5 nm particle size, 0.239 PI and +30.7 mv zeta potential. Polymeric nanoparticles were formed to provide controlled release. Fluconazole loaded chitosan anoparticles were evaluated for particle size, PI and zeta potential. Optimized batch bhad 216 nm particle size, 0.117 PI and +33.4 mv zeta potential. Nanoparticles were also evaluated by transmission electron microscopy which confirmed the nano size of particles. Freeze drying was performed to obtain nanoparticles which were incorporated into the film for further evaluation. Fast dissolving film was prepared using HPMC E3 as a film forming polymer, Propylene glycol as a plasticizer and Sodium rboxymethyl cellulose as a suspending agent. Nanoparticles were loaded in fast dissolving film. Film was evaluated for % Elongation, Tensile strength, In-vitro disintegration time and Drug content. Fluconazole loaded fast dissolving film was compared with Fluconazole nanoparticles loaded fast dissolving film in terms of Tensile strength, % Elongation, In-vitro disintegration time and Drug content. Thus, nanoparticles loaded fast dissolving vaginal film will provide higher retention of the drug at the site of the application along with ease of application.