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@ARTICLE{Mller:905082,
      author       = {Müller, Martin and Platten, Florian and Dulle, Martin and
                      Fischer, Björn and Hoheisel, Werner and Serno, Peter and
                      Egelhaaf, Stefan and Breitkreutz, Jörg},
      title        = {{P}recipitation from amorphous solid dispersions in
                      biorelevant dissolution testing: {T}he polymorphism of
                      regorafenib},
      journal      = {International journal of pharmaceutics},
      volume       = {603},
      issn         = {0378-5173},
      address      = {New York, NY [u.a.]},
      publisher    = {Elsevier},
      reportid     = {FZJ-2022-00381},
      pages        = {120716 -},
      year         = {2021},
      note         = {post-print leider nicht verfügbar},
      abstract     = {AbstractAmorphous Solid Dispersions (ASDs) are a major drug
                      formulation technique to achieve higher bioavailability for
                      poorly water-soluble active pharmaceutical ingredients. So
                      far, dissolution tailoring and supersaturation enhancement
                      have been studied in detail, whereas less is known about the
                      importance of formed precipitates with amorphous or
                      crystalline states at the site of drug
                      absorption.Regorafenib monohydrate (RGF MH), a multikinase
                      inhibitor drug categorized as Biopharmaceutics
                      Classification System (BCS) class II compound, was
                      formulated with povidone K25 and hypromellose acetate
                      succinate (HPMCAS) as an ASD. Here, for the first time, the
                      RGF precipitation process as well as the physicochemical
                      properties of the arising precipitates are investigated. The
                      formed precipitates from biorelevant dissolution showed
                      varying drug content and were analyzed offline by scanning
                      electron microscopy (SEM), differential scanning calorimetry
                      (DSC), confocal Raman microscopy (CRM), X-ray powder
                      diffraction (XRPD), and small angle X-ray scattering (SAXS).
                      In addition to different crystalline RGF precipitates, an
                      amorphous co-precipitate of RGF and HPMCAS was identified,
                      which was suppressed in the presence of PVP. Wide angle
                      X-ray scattering (WAXS) and isothermal calorimetry (ITC)
                      were used to track the precipitation process of RGF in-situ.
                      From calorimetric data, the precipitation profile was
                      calculated. RGF forms precipitates in multiple polymorphic
                      states dependent on the environmental conditions, i.e.,
                      dissolution media composition and chosen excipients. The
                      engineered formation of defined amorphous structures in-vivo
                      may be a promising future drug formulation strategy.},
      cin          = {IBI-4},
      ddc          = {610},
      cid          = {I:(DE-Juel1)IBI-4-20200312},
      pnm          = {5241 - Molecular Information Processing in Cellular Systems
                      (POF4-524)},
      pid          = {G:(DE-HGF)POF4-5241},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {34015382},
      UT           = {WOS:000663093900004},
      doi          = {10.1016/j.ijpharm.2021.120716},
      url          = {https://juser.fz-juelich.de/record/905082},
}