Title:Trends in the Characterization Methods of Orodispersible Films
VOLUME: 18
Author(s):Garba M. Khalid, Francesca Selmin, Umberto M. Musazzi, Chiara G.M. Gennari, Paola Minghetti and Francesco Cilurzo*
Affiliation:Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, 71, 20133 Milan,, Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, 71, 20133 Milan,, Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, 71, 20133 Milan,, Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, 71, 20133 Milan,, Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, 71, 20133 Milan,, Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, 71, 20133 Milan
Keywords:Orodispersible films, None-destructive assay, Quality control, Mechanical properties, Personalized therapy.
Abstract:The recent increased interest in orodispersible films (ODF) stems from their ideal potential to circumvents 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 in
contact with the saliva in the oral cavity without need of 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 promising future both from the technological and clinical standpoints. However, the key
obstacles to the attainment of full potentials 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.
