Characterization of hot-melt extruded drug delivery systems for onychomycosis.

摘要: Abstract The objectives of this investigation were to study the physico-chemical properties hot-melt extruded (HME) films for onychomycosis and determine stability model antifungal drug incorporated within these films. influence etching instrument variables on bioadhesion delivery systems human nail was also studied. Six 250 g batches (F1–F6) hydroxypropyl cellulose (HPC) and/or poly(ethylene oxide) containing ketoconazole (20%) using a Killion extruder (Model KLB-100). thermal HME investigated differential scanning calorimetry (DSC). Scanning electron microscopy (SEM) used examine surface morphology X-ray diffraction (XRD) investigate crystalline drugs, physical mixtures as well Stability studies performed stored at 25 °C/60%RH. bioadhesive (ex vivo) Texture Analyzer ® . samples tested either non-treated (control) or treated with an gel. parameters measured peak adhesion force (PAF) area under curve (AUC). Hansen solubility parameter calculated combination Hoy Hoftyzer/Van Krevelen methods estimate likelihood drug–polymer miscibility. SEM provided direct evidence state theoretical post-extrusion content remaining in six film ranged from 90.3% (±2.2) 102.4% (±9.0) up 6 months 83.9% (±3.6) 91.6% (±3.0) 12 months. Bioadhesion HPC ‘etched’ nails recorded significantly higher PAF AUC than that ‘control’ nails. Ketoconazole found be relatively stable during extrusion process. Melting points corresponding drugs not observed processed predicted miscibility between polymers drug. predictions agreement DSC, XRD results. measurements substrate generally etched control