title: Perphenazine solid dispersions for orally fast-disintegrating tablets: physical stability and formulation.
abstract: OBJECTIVE
  The aim of this study was to prepare an orally fast-disintegrating tablet (FDT) by direct compression, containing a poorly soluble drug (perphenazine, PPZ) formulated as a stable solid dispersion.
  
  
  METHODS
  The stability studies of the fast dissolving 5/1, 1/5, 1/20 (w/w), PPZ/polyvinylpyrrolidone K30 (PVP) or polyethylene glycol 8000 (PEG)) solid dispersions, and amorphous PPZ were conducted with differential scanning calorimetry, X-ray powder diffraction, Fourier-transform infrared spectroscopy, small-angle X-ray scattering, and dissolution rate studies.
  
  
  CONCLUSIONS
  It was found that 1/5 PPZ/PEG was the most stable dispersion under elevated temperature and/or humidity. FDTs containing 60% of mannitol, 15% of calcium silicate, 15% of crospovidone, and 10% of 1/5 PPZ/PEG solid dispersion exhibited fast disintegration times (37 +/- 3), sufficient hardness (1.28 +/- 0.06 MPa), and fast onset of drug dissolution (34% of PPZ dissolved in 4 minutes), and these properties were found to be retained with storage. Thus, by optimizing the drug/excipient ratio of the solid dispersion and tablet composition, it was possible to produce FDTs that possessed fast disintegration and satisfactory drug dissolution in addition to adequate tensile strength, so that they can be handled and packed normally.
authors: Department of Pharmaceutics, University of Kuopio, Kuopio, Finland. riikka.laitinen@uef.fi
authors: Riikka
authors: R
authors: Laitinen
authors: Eero
authors: E
authors: Suihko
authors: Mikko
authors: M
authors: Bjorkqvist
authors: Joakim
authors: J
authors: Riikonen
authors: Vesa-Pekka
authors: VP
authors: Lehto
authors: Kristiina
authors: K
authors: Jarvinen
authors: Jarkko
authors: J
authors: Ketolainen
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards; D010546:Perphenazine / Q000008:administration & dosage / Q000737:chemistry* / Q000493:pharmacokinetics*; D012995:Solubility; D013607:Tablets; D013997:Time Factors
chemical_list: D013607:Tablets; D010546:Perphenazine