The incorporation of an organically modified layered silicate in monolithic polymeric matrices produced using hot melt extrusion

The body of work described in this research paper outlines the use of nanoclay particles as a novel filler material in 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. An organically modified layered silicate was used as the filler material at various levels of inclusion. The resultant matrices were characterised using steady state parallel plate rheometry, differential scanning calorimetry (DSC), atomic force microscopy (AFM), mechanical testing, and dissolution testing. The mechanical analysis indicated that the nanoclay filler incorporation resulted in an increase in all of the mechanical properties of the matrix. Dissolution analysis showed that the presence of the filler particles resulted in a slower release rate of API than for the matrix alone. The results detailed within this paper indicate that nanoclay materials are an interesting prospect for use as filler materials for extended release hot melt produced dosage forms.