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    The Influence of PVAP on the Stability of Amorphous Solid Dispersions of Itraconazole Produced using Hot Melt Extrusion Technology

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    Genre
    Thesis/Dissertation
    Date
    2014
    Author
    Young, Cara
    Advisor
    Fassihi, Reza
    Canney, Daniel J.
    Committee member
    Lebo, David
    Wong, Ho-Lun
    Wunder, Stephanie L.
    Department
    Pharmaceutical Sciences
    Subject
    Pharmaceutical Sciences
    Chemistry, Polymer
    Amorphous
    Itraconazole
    Melt Extrusion
    Polymer
    Polyvinyl Acetate Phthalate
    Solid Dispersions
    Permanent link to this record
    http://hdl.handle.net/20.500.12613/4082
    
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    DOI
    http://dx.doi.org/10.34944/dspace/4064
    Abstract
    The purpose of this study was to improve the melt extrusion processability of polyvinyl acetate phthalate (PVAP) and investigate its use as a stabilizing polymer for supersaturated solutions of itraconazole (ITZ) in neutral pH aqueous media and in the solid-state during storage over time. Polyvinyl pyrrolidone vinyl acetate (PVPVA) was incorporated into PVAP as a carrier matrix with the aim of lowering the melt viscosity and increasing the plasticity of PVAP while maintaining its high glass transition temperature (Tg). Amorphous solid dispersions of ITZ (40% w/w) in a 30:70% w/w PVAP:PVPVA mixture were produced by melt extrusion. Solid-state analyses of the composition were performed using differential scanning calorimetry and X-ray diffraction. Dissolution analysis was conducted using a pH-change method. Solid-state analyses demonstrated that the extruded composition was entirely amorphous and ITZ was largely distributed in PVAP- and PVPVA-rich portions of the ternary dispersion. Dissolution analysis revealed that PVAP functioned to prolong the release of supersaturated levels of ITZ from the dispersion following an acidic-to-neutral pH transition. In the solid state, ITZ remained in its amorphous form throughout 6 months of storage. The results of this study suggest that substantial improvements in melt extrusion with PVAP can be achieved by incorporating PVPVA and that the PVAP-PVPVA polymer combination can stabilize amorphous ITZ.
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