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Design of experiment aided formulation development and optimization of nanostructured lipid carriers of asenapine maleate
5th International Conference on Nanotek & Expo
November 16-18, 2015 San Antonio, USA
Renuka S Managuli, M Sreenivasa Reddy and Srinivas Mutalik
Manipal University, India
Posters-Accepted Abstracts: J Nanomed Nanotechnol
Abstract:
Oral route is ideal and much preferred over other routes for antipsychotic drug administration because of improved patient compliance. Asenapine Maleate (ASPM) is a novel antipsychotic agent which undergoes extensive first pass metabolism making the oral route inconvenient using conventional dosage form. Therefore, the current study aims to prepare nanostructured lipid carriers (NLCs) of ASPM for intestinal lymphatic uptake to increase its oral bioavailability. Systematic screening of excipients was carried out followed by inclusion of statistical experimental design (DoE) approach for optimization of various process parameters. Placket-Burman design was employed in initial screening of significant independent factors followed by optimization of level of significant factors by Box-Behnken response surface methodology. NLCs of ASPM were prepared by ultrasound dispersion method and characterized for average particle size, polydispersity index (PDI) and zeta potential (ZP) (by Nano ZS, Malvern Instruments, UK), entrapment efficiency (EE) (by HPLC) and shape and surface morphology (by TEM). Drug release studies were conducted by dialysis method. Drug-excipient compatibility was investigated by DSC and FTIR and change in crystallinity was studied by DSC and XRD. The DoE approach was successful in optimization of parameters and the optimized NLCs formulation showed an average size of 84.91±2.14 nm, PDI of 0.222±0.026, ZP of -4.83±0.29 mV and EE of 86.9±1.8%. DSC and XRD studies indicated the amorphized nature of ASPM in lipid matrix. In vitro release study indicated the sustained release from NLCs (88.4% in 48 h) compared to plain drug solution (96.3% in 4 h).