화학공학소재연구정보센터
Powder Technology, Vol.270, 27-38, 2015
Solubility enhancement using poly(meth)acrylate based solid dispersions
The present study investigated the usage of poly(meth)acrylates for solubility enhancement of nifedipine via spray drying based solid dispersion technology. Solvent casting method was used for selection of suitable poly(meth)acrylates. A 2(3) full factorial design of experiment was undertaken to study the effect of spray drying process parameters like inlet temperature, feed rate and feed concentration on various evaluation parameters like %yield, mean particle size, %LOD and % in-vitro drug release at 20 min. Spray dried solid dispersion was characterized by different thermal methods and in-vitro dissolution. Based on preliminary screening of different poly(meth)acrylates using solvent casting trials, EUDRAGIT (R) E PO (cationic polymer) was chosen as an appropriate polymer for solubility enhancement. In-vitro dissolution showed more than 90% of drug releases within 20 min for spray dried solid dispersion while pure drug exhibited about 12% drug release after 20 min. SEM images showed changes in the surface morphology of processed nifedipine from crystalline shape to spherical uniform particles. DSC and XRD confirmed that crystalline drug was converted into amorphous form which was stable even after 3 months of storage. Particle size analysis confirmed uniform particle size distribution. FT-IR revealed no significant interaction between drug and polymer. Outcome of process parameter indicates that feed rate has significant effect on in-vitro dissolution and % LOD while solid content has the major effect on the process yield. (C) 2014 Elsevier BM All rights reserved.