title: Advances in orodispersible films for drug delivery.
abstract: BACKGROUND
  Orodispersible films for oral delivery are gaining popularity. Whereas breath-fresheners and over-the-counter products have already become quite common in the US, the first prescription drug films were introduced into the EU and US markets only very recently. Already considered as a unique Rx (prescription drug) dosage form by the FDA (oral soluble film), such products are not substitutable by conventional oral dosage forms. The official term defined by the European Medicines Agency is orodispersible film (ODF).
  
  
  METHODS
  This review gives an overview on the benefits of ODFs, typical excipients and products already available on the market. ODFs are defined and differentiated from other films and dosage forms. Possible manufacturing methods are described. As ODFs are not yet listed in one of the pharmacopoeias, possible methods for characterization and quality control are discussed. Required characteristics, advantages and disadvantages are elaborated. Biopharmaceutical considerations are provided because such films can also be used to enhance bioavailability of a drug.
  
  
  CONCLUSIONS
  The magnitude of variants of ODF technology and the advantages over conventional dosage forms promise more applications and more marketed products with ODFs in the near future. Therefore, the authorities have to publish a monograph for ODFs as soon as possible to standardize characterization methods and quality specifications.
authors.affiliation: Heinrich Heine University, Institute of Pharmaceutics and Biopharmaceutics, Universitätsstr. 1, 40225 Düsseldorf, Germany.
authors.forename: Eva Maria
authors.initials: EM
authors.lastname: Hoffmann
authors.forename: Armin
authors.initials: A
authors.lastname: Breitenbach
authors.forename: Jörg
authors.initials: J
authors.lastname: Breitkreutz
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D016503:Drug Delivery Systems / Q000379:methods*
chemical_list: D004304:Dosage Forms