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.

Reliability of graphite furnace atomic absorption spectrometry as alternative method for trace analysis of arsenic in natural medicinal products

Purpose: To evaluate the comparative efficiency of graphite furnace atomic absorption spectrometry (GFAAS) and hydride generation atomic absorption spectrometry (HGAAS) for trace analysis of arsenic (As) in natural herbal products (NHPs). Method: Arsenic analysis in natural herbal products and standard reference material was conducted using atomic absorption spectrometry (AAS), namely, hydride generation AAS (HGAAS) and graphite furnace (GFAAS). The samples were digested with HNO3–H2O2 in a ratio of 4:1 using microwaveassisted acid digestion. The methods were validated with the aid of the standard reference material 1515 Apple Leaves (SRM) from NIST Results: Mean recovery of three different samples of NHPs, using HGAAS and GFAAS, ranged from 89.3 - 91.4 %, and 91.7 - 93.0 %, respectively. The difference between the two methods was insignificant. A (P= 0.5), B (P=0.4) and C (P=0.88) Relative standard deviation (RSD) RSD, i.e., precision was 2.5 - 6.5 % and 2.3 - 6.7 % using HGAAS and GFAAS techniques, respectively. Recovery of arsenic in SRM was 98 and 102 % by GFAAS and HGAAS, respectively. Conclusion: GFAAS demonstrates acceptable levels of precision and accuracy. Both techniques possess comparable accuracy and repeatability. Thus, the two methods are recommended as an alternative approach for trace analysis of arsenic in natural herbal products.