Abstract
FORMULATION DEVELOPMENT AND CHARECTERIZATION OF SUBLINGUAL FAST DISSOLVING KETOCONAZOLE NIOSOMAL FILMS

*K. Sowmya and Dr. G. Praveen Kumar

ABSTRACT

Ketoconazole is a drug used to treat fungal infections in pet dogs. It can additionally be made use of to deal with Cushings illness. Niosomes were prepared and evaluated for their abilities to enhance systemic delivery of Ketoconazole, as compared to administration of oral tablets. FTIR Studies revealed that excipients were compatible with the drug. Pre-formulation study for the drug surfactant compatibility by FTIR gave conformation about their purity and showed no interaction between drug and selected surfactant various formulations were developed by using non ionic surfactants (cholesterol, span 60) these are thin film hydration. Developed niosomes were evaluated for size and shape, surface morphology, drug entrapment efficiency, in vitro drug release studies, stability properties. The best entrapment efficiency and the best in-vitro drug release profile were achieved by formulations. it was concluded that, Ketoconazole was successfully encapsulated into niosomes. Several in vitro and in vivo characterizations of both the drug-loaded niosomes and films were performed. Ketoconazole was first entrapped in different niosomal formulations, and drug-loaded niosomes with small size, low polydispersity, and high EE were selected for incorporation into different fast dissolving films, which were then evaluated for different physical characteristics. The optimal niosomal film showed sustained release of the drug compared to the medicated film containing the free drug. The in vitro release kinetics of drug from the niosomal suspension and niosomal film followed the Higuchi diffusion model. Moreover, the in vivo study in rabbits showed significantly higher rate and extent of Ketoconazole absorption from sublingual fast dissolving niosomal film compared to that from oral commercial tablets. Consequently, the absolute bioavailability of the drug following sublingual administration was significantly higher than that after oral tablet administration. These results indicated that the prepared sublingual fast dissolving niosomal film could have potential as an efficient delivery system to enhance the bioavailability and prolong the therapeutic effect of Ketoconazole, thus improving the patient compliance by eliminating the need for frequent dosing of the drug.

Keywords: Ketoconazole, Niosomal film, cholesterol, span 60.


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