Novel controlled release polymer-lipid formulations processed by hot melt extrusion

Maniruzzaman, Mohammed and Islam, Muhammad T. and Halsey, Sheelagh and Amin, Devyani and Douroumis, Dennis (2016) Novel controlled release polymer-lipid formulations processed by hot melt extrusion. AAPS PharmSciTech, 17 (1). pp. 191-199. ISSN 1530-9932

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Abstract

The aim of the study was to investigate the effect of novel polymer/lipid formulations on the dissolution rates of the water insoluble indomethacin (INM), co-processed by hot melt extrusion (HME). Formulations consisted of the hydrophilic hydroxypropyl methyl cellulose polymer (HPMCAS) and stearoyl macrogol-32 glycerides—Gelucire 50/13 (GLC) were processed with a twin screw extruder to produce solid dispersions. The extrudates characterized by X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC) and hot stage microscopy (HSM) indicated the presence of amorphous INM within the polymer/lipid matrices. In-line monitoring via near-infrared (NIR) spectroscopy revealed significant peak shifts indicating possible interactions and H-bonding formation between the drug and the polymer/lipid carriers. Furthermore, in vitro dissolution studies showed a synergistic effect of the polymer/lipid carrier with 2-h lag time in acidic media followed by enhanced INM dissolution rates at pH > 5.5.