title: Oromucosal film preparations: points to consider for patient centricity and manufacturing processes.
abstract: BACKGROUND
  According to the European Pharmacopoeia, oromucosal films comprise mucoadhesive buccal films and orodispersible films. Both oral dosage forms receive considerable interest in the recent years as commercially available pharmaceutical products and as small scale personalized extemporaneous preparations.
  
  
  METHODS
  In this review, technological issues such as viscosity of the casting liquid, mechanical properties of the film, upscaling and the stability of the casting solution and produced films will be discussed. Furthermore, patient-related problems like appearance, mucosal irritation, taste, drug load, safety and biopharmaceutics are described. Current knowledge and directions for solutions are summarized.
  
  
  CONCLUSIONS
  The viscosity of the casting solution is a key factor for producing suitable films. This parameter is amongst others dependent on the polymer and active pharmaceutical ingredient, and the further excipients that are used. For optimal patient compliance, an acceptable taste and palatability are desirable. Safe and inert excipients should be used and appropriate packaging should be provided to produced films. Absorption through the oral mucosa will vary for each active compound, formulation and patient, which gives rise to pharmacokinetic questions. Finally, the European Pharmacopoeia needs to specify methods, requirement and definitions for oromucosal film preparations based on bio-relevant data.
authors.affiliation: a Institute of Pharmaceutics and Biopharmaceutics , Heinrich-Heine-University Düsseldorf , Düsseldorf , Germany.
authors.forename: Raphael
authors.initials: R
authors.lastname: Krampe
authors.affiliation: b Department of Pharmaceutical Technology and Biopharmacy , University of Groningen , Groningen , The Netherlands.
authors.forename: J Carolina
authors.initials: JC
authors.lastname: Visser
authors.affiliation: b Department of Pharmaceutical Technology and Biopharmacy , University of Groningen , Groningen , The Netherlands.
authors.forename: Henderik W
authors.initials: HW
authors.lastname: Frijlink
authors.affiliation: a Institute of Pharmaceutics and Biopharmaceutics , Heinrich-Heine-University Düsseldorf , Düsseldorf , Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Breitkreutz
authors.affiliation: b Department of Pharmaceutical Technology and Biopharmacy , University of Groningen , Groningen , The Netherlands.
authors.forename: Herman J
authors.initials: HJ
authors.lastname: Woerdenbag
authors.affiliation: a Institute of Pharmaceutics and Biopharmaceutics , Heinrich-Heine-University Düsseldorf , Düsseldorf , Germany.|c Pharmaceutical Sciences Laboratory, Faculty of Science and Engineering , Åbo Akademi University , Turku , Finland.
authors.forename: Maren
authors.initials: M
authors.lastname: Preis
mesh_terms: D000278:Administration, Buccal; D001696:Biomechanical Phenomena; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D055118:Medication Adherence; D009061:Mouth Mucosa / Q000187:drug effects* / Q000378:metabolism*; D065568:Oral Mucosal Absorption; D055697:Taste Perception; D014783:Viscosity
keywords: Buccal film; manufacturing; oral soluble film; orodispersible film; oromucosal preparations; patient acceptance; viscosity