title: Mechanical strength test for orodispersible and buccal films.
abstract: There are no test procedures, definitions and specifications available how to determine mechanical strength of orodispersible or buccal films. Aim of the study was to develop an appropriate and discriminating method to feature the evaluation of marketed and newly developed film products covering well-known and new approaches. The limits for mechanical strength were set starting from a puncture strength of 0.06 N/mm(2) according to the obtained results from marketed products. Furthermore, elongation to break of the marketed films (1.03-6.54%) and prepared film samples (4.51-33.17%) offered information on the film properties. The developed mechanical strength test method was suitable for all film types without the need of a pre-defined specimen. A mechanical strength threshold could be specified for future orodispersible film development.
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Universitätsstr. 1, 40225 Düsseldorf, Germany. Electronic address: maren.preis@hhu.de.
authors.forename: Maren
authors.initials: M
authors.lastname: Preis
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Universitätsstr. 1, 40225 Düsseldorf, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Knop
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Universitätsstr. 1, 40225 Düsseldorf, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Breitkreutz
mesh_terms: D000278:Administration, Buccal; D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D016503:Drug Delivery Systems; D011108:Polymers / Q000737:chemistry*; D013718:Tensile Strength
chemical_list: D011108:Polymers
keywords: Elongation to break; Mechanical strength; Oral soluble film; Orodispersible film; Oromucosal preparations; Puncture strength