Abstract
Purpose: To develop and optimise some variables that influence fluoxetine orally disintegrating tablets (ODTs) formulation.
Methods: Fluoxetine ODTs tablets were prepared using direct compression method. Three-factor, 3-level Box-Behnken design was used to optimize and develop fluoxetine ODT formulation. The design suggested 15 formulations of different lubricant concentration (X-1), lubricant mixing time (X-2), and compression force (X-3) and then their effect was monitored on tablet weight (Y-1), thickness (Y-2), hardness (Y-3), % friability (Y-4), and disintegration time (Y-5).
Results: All powder blends showed acceptable flow properties, ranging from good to excellent. The disintegration time (Y-5) was affected directly by lubricant concentration (X-1). Lubricant mixing time (X-2) had a direct effect on tablet thickness (Y-2) and hardness (Y-3), while compression force (X-3) had a direct impact on tablet hardness (Y-3), % friability (Y-4) and disintegration time (Y-5). Accordingly, Box-Behnken design suggested an optimized formula of 0.86 mg (X-1), 15.3 min (X-2), and 10.6 KN (X-3). Finally, the prediction error percentage responses of Y-1, Y-2, Y-3, Y-4, and Y-5 were 0.31, 0.52, 2.13, 3.92 and 3.75 %, respectively. Formula 4 and 8 achieved 90 % of drug release within the first 5 min of dissolution test.
Conclusion: Fluoxetine ODT formulation has been developed and optimized successfully using Box-Behnken design and has also been manufactured efficiently using direct compression technique.