Formulation design and in vitro characterization of clotrimazole dental implant for periodontal diseases

Clotrimazole is an imidazole derivative novel broad spectrum antimicrobial agent extensively used topically for fungalinfection. The purpose of this study is to design and develop in situ implants containing clotrimazole that could be used inthe treatment of periodontal diseases by direct periodontal intrapocket administration. The dental film of clotrimazole wasprepared by solvent casting technique using hydroxyl propyl methyl cellulose, ethyl cellulose, hydroxyl propyl celluloseand chitosan in different concentrations as biodegradable rate controlling polymers. The drug polymers interaction wasstudied by Fourier Transform Infrared Spectroscopy (FTIR) and study suggesting no interaction between drug andpolymers. The implants were characterized for weight variation, thickness, surface pH, tensile strength, folding endurance,moisture content, viscosity, drug content uniformity, in vitro drug release, mass balance, drug release kinetic, stability andin vitro antibacterial activity studies. Mean weight data showed that the different films were uniform. Minimum thicknesswas obtained with film containing chitosan. Almost all dental film formulations having satisfactory tensile strength. Goodphysicochemical properties were shown by the films. In vitro drug release data indicate that the films showed an initial burstrelease followed by sustained release of the drug(s). In vitro drug release rate for selected dental implant formulation (F6,containing 4.5 % w/w of chitosan) was found to sustain clotrimazole over 10 h obeying zero order kinetic. The stabilitystudy did not show any significant changes. The study suggesting the film containing chitosan is a potential drug deliverydevice for the topical treatment of periodontal diseases.