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THE PHARMA REVIEW
(NOVEMBER 2009) |
Optimization of In Vitro
Bioadhesion Time For Improved Stay of Omdds of
Fluconazole
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Pradnya Palekar Shanbhag,
Anish Diwadkar, Atul Kadam, Sanika Rege, Neha Deolekar |
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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.
Introduction
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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