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.

Trends in the characterization methods of orodispersible films / G.M. Khalid, F. Selmin, U.M. Musazzi, C. Gennari, P. Minghetti, F. Cilurzo. - In: CURRENT DRUG DELIVERY. - ISSN 1567-2018. - 18:7(2021), pp. 941-952. [10.2174/1567201818999201210212557]

Trends in the characterization methods of orodispersible films

G.M. Khalid
Primo
;
F. Selmin
Secondo
;
U.M. Musazzi;C. Gennari;P. Minghetti
Penultimo
;
F. Cilurzo
Ultimo
2021

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.
mechanical properties; none-destructive assay; orodispersible films; personalized therapy; quality control;
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
10-dic-2020
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/798734
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