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Screening of factors using plackett burman design in the preparation of capecitabine-loaded nano polymeric micelles
, Atmaram Pawar P.
Published in International Journal of Pharmacy and Pharmaceutical Science
2014
Volume: 6
   
Issue: 5
Pages: 489 - 496
Abstract
Objective: Quality is considered to be the major tool in pharmaceutical industry. Failures in the quality of upcoming new chemical entities have been seen in the recent years due to complications in the formulation process. Capecitabine (CTB), a anticancer pro-drug which orally shows fluctuation in plasma drug concentration and serious side effects. Purpose of this study is to understand the effect of variables on quality of the formulation. The aim of the present study was to develop CTB-loaded nano polymeric micelles (PMs) using Quality-by-Design (QbD) approach to screen the effect of eight formulation and process factors on the formulation. Methods: CTB-loaded nano PMs were prepared by organic solvent/water (o/w) emulsion technique. Plackett-Burman (PB) design was used to screen the effect of eight formulation and process factors to improve anticancer efficacy. The nano PMs were characterized by drug content (% DC), entrapment efficiency (% EE), particle size, zeta potential, TEM, PXRD, SEM and in-vitro drug release. Results: Particle Size and zeta potential of nano PMs were found to be in the range of 178 - 1572 nm and -10.9 to -36.1 mV respectively. Analysis of the Pareto chart revealed that the HP $\beta$-CD and Eudragit S100 significantly influences drug content and entrapment efficiency respectively. Nano PMs demonstrated sustained release of CTB. Conclusion: The study concludes that the statistical PB design could be useful to identify influencing variables such as HP $\beta$-CD and Eudragit S100 that can be used for further investigation.
About the journal
JournalInternational Journal of Pharmacy and Pharmaceutical Sciences
PublisherInternational Journal of Pharmacy and Pharmaceutical Science
ISSN09751491
Open AccessNo