Stability evaluation of amorphous solid dispersions (ASDs) of felodipine during storage and biphasic dissolution.

  • Ashish Sarode(1,2), Swapnil Malekar(1), Catherine Cote(3), David R. Worthen (1,2)

Research

Characterization of ASDs:

  • Poorly water soluble drug: felodipine (FLD) and polymers: HPC-SSL and PVP-VA were used.
  • ASDs with 30:70 drug-polymer ratio were manufactured by hot melt mixing (HMM).
  • ASDs were stored at 5, 25, and 40 °C and 75 % relative humidity (RH).
  • ASDs were characterized using DSC, PXRD, HPLC, and FTIR analysis.
  • Molecularly dispersed and chemically stable ASDs were produced using both the polymers.
  •  Drug-polymer hydrogen bonding interactions were detected for both the systems.
  • FLD was chemically stable over the stability period at all the temperatures.
  • Late phase separation and early re-crystallization occurred at lower and higher storage temperatures, respectively, for HPC-SSL ASDs.
  • Early phase separation even at lower storage temperature was noted for PVP-VA ASDs.

Related People: David Worthen

(1)Department of Biomedical and Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI 02881
(2)Department of Chemical Engineering, College of Engineering, University of Rhode Island, Kingston, RI 02881
(3)Nisso America, Inc, New York, NY 10006.