Title:Trends in the Characterization Methods of Orodispersible Films
Volume: 18
Issue: 7
Author(s): Garba M. Khalid, Francesca Selmin, Umberto M. Musazzi, Chiara G.M. Gennari, Paola Minghetti and Francesco Cilurzo*
Affiliation:
- Department of Pharmaceutical Sciences, Universita degli Studi di Milano, 20133 Milan,Italy
Keywords:
Orodispersible films, non-destructive assay, quality control, mechanical properties, personalized therapy, therapy
pharmaco.
Abstract: The recent increased interest in orodispersible films (ODF) stems from their ideal potential
to circumvent several pharmacotherapy-related problems, such as improved medication compliance
and adherence, especially in children, elderly and uncooperative patients. Their administration
is well accepted by the majority of patients because ODF dissolve upon contact with the saliva
in the oral cavity without the need for water intake. ODF application in personalized pharmacotherapy
is currently being exploited. Moreover, innovative preparation methods and characterization
technologies have been evolving in recent years, highlighting a promising future both from the technological
and clinical standpoints. However, the key obstacles to the attainment of full potential of
ODF in the pharmaceutical field is the lack of harmonized and well-defined quality characterization
procedures, standard evaluation parameters, guidance on appropriate final product properties
and specifications. This review provides an appraisal on the ODF characterization methods from
slurries to the finished medicinal products with a specific focus on the technologies suitable for
identification, quantification, and quality evaluation of extemporaneously prepared ODF on small
batches in individualized pharmacotherapy. Generally, there is a paradigm shift from the use of the
conventional quality evaluation tools and/or protocols for oral solid dosage forms to characterize
ODF to more specific equipment and procedures that suit the peculiarities of the ODF.