title: Use of bicarbonate buffer systems for dissolution characterization of enteric-coated proton pump inhibitor tablets.
abstract: OBJECTIVE
  The aim of this study was to assess the effects of buffer systems (bicarbonate or phosphate at different concentrations) on the in vitro dissolution profiles of commercially available enteric-coated tablets.
  
  
  METHODS
  In vitro dissolution tests were conducted using an USP apparatus II on 12 enteric-coated omeprazole and rabeprazole tablets, including innovator and generic formulations in phosphate buffers, bicarbonate buffers and a media modified Hanks (mHanks) buffer.
  
  
  RESULTS
  Both omeprazole and rabeprazole tablets showed similar dissolution profiles among products in the compendial phosphate buffer system. However, there were large differences between products in dissolution lag time in mHanks buffer and bicarbonate buffers. All formulations showed longer dissolution lag times at lower concentrations of bicarbonate or phosphate buffers. The dissolution rank order of each formulation differed between mHanks buffer and bicarbonate buffers. A rabeprazole formulation coated with a methacrylic acid copolymer showed the shortest lag time in the high concentration bicarbonate buffer, suggesting varied responses depending on the coating layer and buffer components.
  
  
  CONCLUSIONS
  Use of multiple dissolution media during in vitro testing, including high concentration bicarbonate buffer, would contribute to the efficient design of enteric-coated drug formulations.
authors.affiliation: National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.
authors.forename: Hiroko
authors.initials: H
authors.lastname: Shibata
authors.affiliation: National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yoshida
authors.affiliation: National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Izutsu
authors.affiliation: National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Goda
mesh_terms: D001639:Bicarbonates / Q000737:chemistry*; D002021:Buffers; D004339:Drug Compounding; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007700:Kinetics; D009853:Omeprazole / Q000737:chemistry*; D054328:Proton Pump Inhibitors / Q000737:chemistry*; D064750:Rabeprazole / Q000737:chemistry*; D012995:Solubility; D013608:Tablets, Enteric-Coated; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D001639:Bicarbonates; D002021:Buffers; D054328:Proton Pump Inhibitors; D013608:Tablets, Enteric-Coated; D064750:Rabeprazole; D009853:Omeprazole
keywords: bicarbonate buffer; biorelevant media; dissolution; enteric-coated tablets