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To produce mini-matrix using hot-melt extrusion and to evaluate the effects of matrix composition and manufacturing temperature on the sustained release behavior.Mini-matrixes were prepared by hot-melt extrusion at different temperatures using quetiapine fumarate (QF) as model drug and ethyecellulose (EC) as matrix carrier.Poly(vinylpyrrolidone-co-vinyl acetate) (PVP VA64) was used as release modifiers at different weight ratios to the matrix carrier.The obtained mini-matrices were characterized by DSC, XRPD, Raman spectroscopy and SEM, and the drug content was determined by HPLC.The dissolution test was performed in deionized water with apparatus Ⅰ per CP 2010 combined with UV analysis.Through hot-melt extrusion, 99%-102% of crystalline QF was found uniformly dispersed in the EC based mini-matrix as detected by DSC, XRPD and Raman spectroscopy.Partial of the crystalline drug transferred to the amorphous form during the hot-melt extrusion.Raman spectroscopy indicated that QF was distributed uniformly in the entire matrices.The EC-drug mini-matrix showed 4% of drug release after 24 h in water With addition of 20%-40% PVP VA64, the drug release was increased to 50%-100% after 24 h.As the manufacturing temperature increased, the dissolution rate was decreased due to the decreasing free volume, the smaller pore radius and a more tortuous pore network.The release rate showed good fit with the Ritger-Peppas model with the values of the release exponent 0.45
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