title: Oromucosal film preparations: classification and characterization methods.
abstract: BACKGROUND
  Recently, the regulatory authorities have enlarged the variety of 'oromucosal preparations' by buccal films and orodispersible films. Various film preparations have entered the market and pharmacopoeias. Due to the novelty of the official monographs, no standardized characterization methods and quality specifications are included.
  
  
  METHODS
  This review reports the methods of choice to characterize oromucosal film preparations with respect to biorelevant characterization and quality control. Commonly used dissolution tests for other dosage forms are not transferable for films in all cases. Alternatives and guidance on decision, which methods are favorable for film preparations are discussed. Furthermore, issues about requirements for film dosage forms are reflected.
  
  
  CONCLUSIONS
  Oromucosal film preparations offer a wide spectrum of opportunities. There are a lot of suggestions in the literature on how to control the quality of these innovative products, but no standardized tests are available. Regulatory authorities need to define the standards and quality requirements more precisely.
authors.affiliation: Heinrich Heine University of Düsseldorf, Institute of Pharmaceutics and Biopharmaceutics, Germany. maren.preis@hhu.de
authors.forename: Maren
authors.initials: M
authors.lastname: Preis
authors.forename: Christina
authors.initials: C
authors.lastname: Woertz
authors.forename: Peter
authors.initials: P
authors.lastname: Kleinebudde
authors.forename: Jörg
authors.initials: J
authors.lastname: Breitkreutz
mesh_terms: D000278:Administration, Buccal; D001682:Biological Availability; D004339:Drug Compounding; D016503:Drug Delivery Systems; D006801:Humans; D009061:Mouth Mucosa / Q000187:drug effects* / Q000378:metabolism; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry; D016062:Porosity; D012995:Solubility; D013499:Surface Properties; D013718:Tensile Strength
chemical_list: D004364:Pharmaceutical Preparations; D011108:Polymers