title: In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets.
abstract: BACKGROUND
  Considering that bitter taste of drugs incorporated in orally disintegrating tablets (ODTs) can be the main reason for avoiding drug therapy, it is of the utmost importance to achieve successful taste-masking. The evaluation of taste-masking effectiveness is still a major challenge.
  
  
  OBJECTIVE
  The objective of this study was to mask bitter taste of the selected model drugs by drug particle coating with Eudragit®E PO, as well as to evaluate taste-masking effectiveness of prepared ODTs using compendial dissolution testing, dissolution in the small-volume shake-flask assembly and trained human taste panel.
  
  
  METHODS
  Model drugs were coated in fluidized bed. Disintequik™ ODT was used as a novel co-processed excipient for ODT preparation. Selected formulations were investigated in vitro and in vivo using techniques for taste-masking assessment.
  
  
  CONCLUSIONS
  Significantly slower drug dissolution was observed from tablets with coated drug particles during the first 3 min of investigation. Results of in vivo taste-masking assessment demonstrated significant improvement in drug bitterness suppression in formulations with coated drug. Strong correlation between the results of drug dissolution in the small-volume shake-flask assembly and in vivo evaluation data was established (R ≥ 0.970).
  
  
  CONCLUSIONS
  Drug particle coating with Eudragit®E PO can be a suitable approach for bitter taste-masking. Strong correlation between in vivo and in vitro results implicate that small-volume dissolution method may be used as surrogate for human panel taste-masking assessment, in the case of physical taste-masking approach application.
authors: a Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia.
authors: Milica
authors: M
authors: Drašković
authors: a Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia.
authors: Djordje
authors: D
authors: Medarević
authors: a Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia.
authors: Ivana
authors: I
authors: Aleksić
authors: a Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia.
authors: Jelena
authors: J
authors: Parojčić
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004339:Drug Compounding / Q000379:methods; D065546:Drug Liberation / Q000187:drug effects; D005079:Excipients / Q000737:chemistry; D005260:Female; D006801:Humans; D008297:Male; D011109:Polymethacrylic Acids / Q000737:chemistry*; D012995:Solubility; D013607:Tablets / Q000737:chemistry*; D013649:Taste / Q000187:drug effects*; D055697:Taste Perception / Q000187:drug effects*; D055815:Young Adult
chemical_list: D005079:Excipients; D011109:Polymethacrylic Acids; D013607:Tablets; C518398:Eudragit E PO
keywords: Taste-masking; drug particle coating; in vitro–in vivo correlation; small-volume shake-flask assembly; trained human taste panel