Development and optimization of fluoxetine orally disintegrating tablets using Box-Behnken design

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 (X₁), lubricant mixing time (X₂), and compression force (X₃) and then their effect was monitored on tablet weight (Y₁), thickness (Y₂), hardness (Y₃), % friability (Y₄), and disintegration time (Y₅). Results: All powder blends showed acceptable flow properties, ranging from good to excellent. The disintegration time (Y₅) was affected directly by lubricant concentration (X₁). Lubricant mixing time (X₂) had a direct effect on tablet thickness (Y₂) and hardness (Y₃), while compression force (X₃) had a direct impact on tablet hardness (Y₃), % friability (Y₄) and disintegration time (Y₅). Accordingly, Box-Behnken design suggested an optimized formula of 0.86 mg (X₁), 15.3 min (X₂), and 10.6 KN (X₃). Finally, the prediction error percentage responses of Y₁, Y₂, Y₃, Y₄, and Y₅ 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.