Characterization Of Nifedipine/Soluplus/Kollidon SR Solid Dispersion

This study investigated the characterization primarily by means of FT-IR Spectroscopy in the solid dispersions(SD)of Nifedipine/Soluplus/Kollidon SR.The SD samples were prepared by Hot Melt Extrusion,Solvent and melting methods,respectively.In order to distinguish the different SD samples,a combined analytical strategy by FT-IR Spectrum,Raman spectrum,N-H peak analysis and Computational approaches(PCA and HCA)were developed to investigate the spectral patterns of the solid dispersions.DSC,PXRD,SEM and dissolution test were employed as the reference characterization.The stability test under the accelerated condition was carried out to investigate the physical stability of the SDs.The results showed that,for the three prepared SDs,the evident differences on the dissolution behaviors and the trend of aging was observed.By means of the combined analytical strategy,the samples could be successfully identified in terms of their preparing techniques.The strength of hydrogen bonding interaction between NF and polymers decreased in the order of HMESD>SESD>FCSD.The results of the stability test indicated that the similarity factor f2 value of dissolution profile decreased in the order of HMESD>SESD>FCSD.HMESD exhibited a tendency of minimal changing on both dissolution behavior and spectral patterns.The combined strategy suggested the possibility for identification of specific SDs in quality control and prediction of their trends on the aging.