Orodispersible films – characteristics of quality assessment methods

Abstract

Orodispersible films (ODF) are defined in the European Pharmacopoeia as “single or multilayered sheets of suitable materials, to be placed in the mouth where they disperse rapidly”. They are indicated as an appropriate form of medicine for pediatric and geriatric patients suffering from mental disorders, as well as bedridden or uncooperative patients. ODFs should be characterized by good mechanical properties and short disintegration time, as well as appropriate pharmaceutical availability of the active pharmaceutical ingredient (API). In addition, they should have a smooth surface, as well as appropriate taste and texture that do not cause an unpleasant sensation in the mouth. For this reason, during research and development, special attention is paid to disintegration time, mechanical properties, size, texture, mouthfeel after application and disintegration, as well as taste. Due to the lack of pharmacopoeial guidelines on how to assess the quality of ODF films, different standards and tests proposed in the literature are used. The disintegration time of the ODFs is indicated as key factor affecting patients’ acceptability of this dosage form. So far, many in vivo methods have been developed to assess this parameter. Among them, commonly methods, i.e. a Petri dish, a slide frame, a slide frame and ball, a pharmacopoeial apparatus, as well as novel methods, i.e. using a model of the oral cavity and a tribometer are utilized. Ensuring appropriate mechanical properties of ODFs are crucial during developing this dosage form. According to the pharmacopoeial definition, the ODFs should “possess suitable mechanical strength to resist handling without being damaged”. In order to assess the mechanical properties of ODF films, tensile strength, puncture test and tear resistance tests are carried out. The aim of this study is to present and characterized the research methods which are applied to assess the quality of ODFs, with particular emphasis on methods used for disintegration time and mechanical properties assessing.

Keywords

• mechanical properties
• tribology
• disintegration time
• orodispersible films (odf)
• quality assessment of odfs