pps proceeding - Abstract Preview
pps proceeding
Symposium: S06 - Injection Molding and Extrusion
Oral Presentation
 
 

Manufacturing and characterisation of lidocaine films prepared by hot melt extrusion.

Nair Karthik (1)*, Coates Phil (1), Whiteside Ben (1), Kelly Adrian (1), Korde Sachin (1), Wellings Simon (1), Paradkar Anant (1)

(1) University of Bradford - Bradford - UnitedKingdom

The aim of this study was to evaluate the influence of the hydrophilic carriers such as, PEO (polyethylene oxide), HPC (hydroxypropyl cellulose), and PVA (polyvinyl alcohol) on lidocaine mucoadhesive films manufactured via hot-melt extrusion. Polymer films loaded with 5% lidocaine processed by XploreŽ (conical twin-screw extruder) were investigated for solid state characterisation, surface roughness, drug-polymer miscibility and molecular interactions, bioadhesion study, mechanical properties, drug release characteristics, and stability studies. The Hansen solubility parameters predicted a high miscibility between lidocaine and all three polymers. DSC and PXRD confirmed the conversion of the drug to the amorphous state. Lidocaine was found to increase the surface roughness of all the films except for PVA. Tensile testing showed the addition of lidocaine led to an increase in percentage strain at break, and a decrease in tensile strength, reflecting higher flexibility and ductility. FT-IR analysis of the extruded films showed no shifts in lidocaine bands in case of PEO whereas a total absence of lidocaine peaks was found in HPC and PVA due to the low incorporated amount of the drug (5%). All three extruded films demonstrated good adhesion ability, with PEO having the highest value. They also achieved immediate drug-release and were stable at 40°C/ 75% RH for one month with no detected recrystallisation of lidocaine. Overall, this study signified the suitability of a new XploreŽ (pharma grade twin screw) extruder in producing thin and stable lidocaine mucoadhesive films. Keywords: hot-melt extrusion, lidocaine, mucoadhesive films and XploreŽ