RESUMO
The body of work described in this research paper outlines the use of PEO/PCL blends in the production of monolithic matrices for oral drug delivery. Several batches of matrix material were prepared with carvedilol used as the active pharmaceutical ingredient. The matrices were prepared using various extrusion parameters to investigate the effect of screw speed and barrel temperature on the properties of the drug delivery devices. The resultant extrudate was characterised using steady state parallel plate rheometry, differential scanning calorimetry (DSC) and dissolution testing. Higher screw speeds were observed to result in slightly lower matrix melt viscosity when compared with matrices compounded using lower screw speeds. Dissolution testing showed that the incorporation of the hydrophobic PCL polymer into a PEO matrix results in a retarded drug release profile.
Assuntos
Carbazóis/química , Poliésteres/química , Propanolaminas/química , Tecnologia Farmacêutica/métodos , Administração Oral , Varredura Diferencial de Calorimetria , Carbazóis/administração & dosagem , Carvedilol , Preparações de Ação Retardada , Propanolaminas/administração & dosagem , Reologia , Solubilidade , TemperaturaRESUMO
The use of supercritical fluids as plasticisers in polymer processing has been well documented. The body of work described in this research paper outlines the use of a supercritical CO(2) assisted extrusion process in the preparation of a hot melt extruded monolithic polymer matrix for oral drug delivery. Several batches of matrix material were prepared with Carvedilol used as the active pharmaceutical ingredient (API). These batches were subsequently extruded both with and without supercritical CO(2) incorporation. The resultant matrices were characterised using steady-state parallel plate rheometry, differential scanning calorimetry (DSC), atomic force microscopy (AFM), micro-thermal analysis (microTA) and dissolution testing. Dissolution analysis showed that the use of supercritical CO(2) during the extrusion process resulted in a faster dissolution of API when compared with unassisted extrusion. The supercritical CO(2) incorporation also resulted in reduced viscosity during processing, therefore allowing for quicker throughput and productivity. The results detailed within this paper indicate that supercritical fluid assisted hot melt extrusion is a viable enhancement to conventional hot melt extrusion for the production of monolithic dosage forms.