Wednesday, October 14, 2015

Abstract-Estimation of Crystallinity of Nifedipine–Polyvinylpyrrolidone Solid Dispersion by Usage of Terahertz Time-Domain Spectroscopy and of X-Ray Powder Diffractometer

  1. Issei Takeuchi1
  2. Kemmaro Shimakura1,
  3. Hideki Kuroda2
  4. Takehisa Nakajima3,4,
  5. Satoru Goto1,3,4 and
  6. Kimiko Makino1,3,4,*
Article first published online: 13 OCT 2015
DOI: 10.1002/jps.24671;jsessionid=BFC9CF37EA66E2A43381239E3BF5B3A3.f02t03?userIsAuthenticated=false&deniedAccessCustomisedMessage=

Crystalline state of pharmaceutical materials is of great importance in preparation of pharmaceutics, because their physicochemical properties affect bioavailability, quality of products, therapeutic level and manufacturing process. In this study, we have estimated time-dependent changes of nifedipine in nifedipine–polyvinylpyrrolidone (PVP) solid dispersion by measuring terahertz time-domain spectroscopy (THz-TDS) and by X-ray powder diffractometry (XRPD), and compared their correlativity. Crystallinity of nifedipine–PVP solid dispersion was changed by storing the amorphous sample at 25°C–75°C and relative humidity of over 80% for 0.25–24.00 h. To compare the results of two types of measurements, we have used a general method of linear regression analysis. Crystallinities estimated using THz-TDS were plotted on the x-axis and that of XRPD were on the y-axis. From the result of the calculation, the correlativity of them was confirmed. THz-TDS has the capability of becoming the replacement of XRPD. 
© 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci

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