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Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
ISSN: 1596-5996
EISSN: 1596-9827
Vol. 15, No. 4, 2016, pp. 667-677
Bioline Code: pr16089
Full paper language: English
Document type: Research Article
Document available free of charge

Tropical Journal of Pharmaceutical Research, Vol. 15, No. 4, 2016, pp. 667-677

 en Development and optimization of fluoxetine orally disintegrating tablets using Box-Behnken design
Ali, Bahaa E.; Rabba, Abdullah K.; Fayed, Mohamed H.; El-Say, Khalid M.; Anwer, Mohammad Khalid; Ansari, Mohammad Javed; Al-Shdefat, Ramadan & Gabr, Gamal A.

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 (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.

Keywords
Box-Behnken experimental design; Direct compression; Magnesium stearate; Orally disintegrating tablets; Antidepressant; Mixing time

 
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