Development of hot-melt extrusion as a novel technique for the ...
Development of hot-melt extrusion as a novel technique for the ...
Development of hot-melt extrusion as a novel technique for the ...
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CHAPTER 2: DISSOLUTION ENHANCEMENT OF POORLY WATER-SOLUBLE APIs PROCESSED BY HOT-MELT EXTRUSION (HME) USINGHYDROPHILIC POLYMERS1.0 Introduction ..................................................................................................................192.0 Materials and methods ...................................................................................................202.1 Materials .................................................................................................................202.2 Drug-polymer miscibility study by Hansen solubility parameters () ...................202.3 Preparation <strong>of</strong> <strong>for</strong>mulation blends ..........................................................................212.4 Hot <strong>melt</strong> <strong>extrusion</strong> process .....................................................................................222.5 Thermal analysis ....................................................................................................222.6 X-ray powder diffraction (XRPD) .........................................................................222.7 Particle size morphology and distribution .............................................................232.8 In vitro drug rele<strong>as</strong>e study ......................................................................................232.9 HPLC analysis ........................................................................................................243.0 Results and discussion ...................................................................................................243.1 Miscibility studies using calculating solubility parameters () ..............................243.2 Particle morphology and particle size analysis ......................................................273.3 X-ray powder diffraction (XRPD) .........................................................................283.4 Differential scanning calorimetry (DSC) ...............................................................303.5 In vitro dissolution studies .....................................................................................354.0 Conclusions ...................................................................................................................385.0 References .....................................................................................................................38vii | P a g e