Application Of Box Behnken Experimental Design To Optimise Pharmaceutical Floating Tablet Formulations Of Synthetic Antibiotic Ofloxacin

Research Article
Sushil A. Kale and V. H. Bajaj
DOI: 
xxx-xxxxx-xxxx
Subject: 
science
KeyWords: 
QbD, DOE, Optimization, Box-Behnken, Analysis of Variance, Response Surface Design
Abstract: 

The aim of this study was to apply Box-Behnken design for the optimization of polymer concentration in effervescent floating tablets of antibiotic drug Ofloxacin. Mean dissolution time (MDT), time required to release 50% of drug (t50%), drug release at 2 hrs (R2hrs) and dissolution efficiency in 2 hrs (DE2hrs) were taken as target responses, whereas the quantity of different polymers such as carbopol 934P (viscoelastic agent), sodium carboxymethylcellulose (Sod.CMC) (swelling agent) and tablet thickness were considered as impacting factors. A second-order polynomial equation was determined by the multiple regression analysis of the experimental data. The design space was established targeting the successful operating ranges for the mean dissolution time (MDT), time required to release 50% of drug (t50%), drug release at 2 hrs (R2hrs) and dissolution efficiency in 2 hrs (DE2hrs) as 4.5-5.0 hrs., 5.0-5.5 hrs, 25.0-30.0 % and 15.0-18.0 % respectively. The design space illustrated that the available operation range is wide at the laboratory scale and thus ensuring the product quality. From the results of study it was concluded that successful application of Box-Behnken design of experiments is helpful to select grade and concentration of polymers cost effectively to reduce cost of goods which ultimately can improve profitability of pharmaceutical production unit.