Optimization of In Vitro Bioadhesion Time For Improved Stay of Omdds of Fluconazole

Pradnya Palekar Shanbhag, Anish Diwadkar, Atul Kadam, Sanika Rege, Neha Deolekar

Abstract: The present study focuses on the development of oral mucosal drug delivery system (OMDDS) of Fluconazole with extended hours of bioadhesion and optimization of in vitro bioadhesion time by using 22 factorial design. Fluconazole is a triazole antifungal effective in several systemic fungal infections. OMDDS were developed using hydroxypropylcellulose and sodium alginate chosen as two independent variables for 22 factorial design and in vitro bioadhesion time as the response parameter. The response data was fitted in the polynomial equation Y=B0+B1X1+B2X2+B12X1X2. Based on the generated polynomial equation, responses were predicted for various levels of the two variables. Developed OMDDS were assessed for in vitro bioadhesion time and effectiveness of factorial design was studied by comparing predicted and experimental response data. Factorial design can help in optimization of OMDDS with improved in vitro bioadhesion time in minimum experimental runs.
In formulation and process development, one of the two basic approaches is adopted which includes randomized approach (or experimentation) and factorial design (optimization). The randomized approach is time consuming, unreliable, costly and often unsuccessful whereas factorial design is a useful tool since various independent variables at different levels are evaluated against dependent variables to obtain maximum information in minimum number of runs and hence it is efficient and economical.
The aim of present work was to design and develop oral mucosal drug delivery systems (OMDDS) of Fluconazole as buccal tablets with good bioadhesion and improved stay with prolonged effect for 5 minutes (300 seconds). This can be achieved in minimum number of experimental runs using 22 factorial design. The objective of the study was to design OMDDS of Fluconazole and understand the practicality of optimization and application of factorial design as an optimization model. Fluconazole is an azole medicine used to treat fungal infections. It binds to the fungal p450 enzymes and stops the cells making ergosterol, the main component of the cell wall. Fluconazole is available as tablets: 50, 100, 150, 200 mg, oral suspension: 10 mg/ml and 40 mg/ml injection: 2 mg/ml.


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