Mechanical strength test for orodispersible and buccal films

Maren Preis; Klaus Knop; Jörg Breitkreutz

doi:10.1016/j.ijpharm.2013.11.033

Mechanical strength test for orodispersible and buccal films

Int J Pharm. 2014 Jan 30;461(1-2):22-9. doi: 10.1016/j.ijpharm.2013.11.033. Epub 2013 Nov 26.

Authors

Maren Preis¹, Klaus Knop², Jörg Breitkreutz²

Affiliations

¹ Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Universitätsstr. 1, 40225 Düsseldorf, Germany. Electronic address: maren.preis@hhu.de.
² Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Universitätsstr. 1, 40225 Düsseldorf, Germany.

PMID: 24291075
DOI: 10.1016/j.ijpharm.2013.11.033

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.

Keywords: Elongation to break; Mechanical strength; Oral soluble film; Orodispersible film; Oromucosal preparations; Puncture strength.

MeSH terms

Administration, Buccal
Administration, Oral
Chemistry, Pharmaceutical / methods*
Drug Delivery Systems*
Polymers / chemistry*
Tensile Strength

Substances

Polymers