title: Comparative study on novel test systems to determine disintegration time of orodispersible films.
abstract: OBJECTIVE
  Orodispersible films (ODFs) are a promising innovative dosage form enabling drug administration without the need for water and minimizing danger of aspiration due to their fast disintegration in small amounts of liquid. This study focuses on the development of a disintegration test system for ODFs.
  
  
  METHODS
  Two systems were developed and investigated: one provides an electronic end-point, and the other shows a transferable setup of the existing disintegration tester for orodispersible tablets. Different ODF preparations were investigated to determine the suitability of the disintegration test systems. The use of different test media and the impact of different storage conditions of ODFs on their disintegration time were additionally investigated.
  
  
  RESULTS
  The experiments showed acceptable reproducibility (low deviations within sample replicates due to a clear determination of the measurement end-point). High temperatures and high humidity affected some of the investigated ODFs, resulting in higher disintegration time or even no disintegration within the tested time period.
  
  
  CONCLUSIONS
  The methods provided clear end-point detection and were applicable for different types of ODFs. By the modification of a conventional test system to enable application for films, a standard method could be presented to ensure uniformity in current quality control settings.
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Düsseldorf, Germany.
authors.forename: Maren
authors.initials: M
authors.lastname: Preis
authors.forename: Dorothee
authors.initials: D
authors.lastname: Gronkowsky
authors.forename: Dominik
authors.initials: D
authors.lastname: Grytzan
authors.forename: Jörg
authors.initials: J
authors.lastname: Breitkreutz
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004304:Dosage Forms; D004339:Drug Compounding / Q000379:methods*; D006813:Humidity; D015203:Reproducibility of Results; D013607:Tablets / Q000737:chemistry*; D013696:Temperature; D013997:Time Factors; D014867:Water / Q000737:chemistry
chemical_list: D004304:Dosage Forms; D013607:Tablets; D014867:Water
keywords: disintegration time; oral soluble films; orodispersible films; oromucosal preparations; wafer