Oral films: Current status and future perspectives

Abstract

Polymers are the most common excipients used in pharmaceutical dosage forms, and often new applications and innovative polymers appear aiming to overcome unmet needs in the drug formulation field. Orodispersible dosage forms based on polymeric matrices have currently demonstrated their prominence in accordance with the actual market requirements and patients' demands. The versatility of the polymeric oral films had proven their high value as suitable technological platforms for extension and adjustment to different delivery routes and promising markets. These are the main reasons for the increasing investment of several companies in this technology and their applicability in different therapeutic segments. This pharmaceutical form with a blustering beginning as a breath freshener had an emergent entrance in the Rx market proving its reliable value. This review describes and explores the oral film technology from its main component, the polymeric matrices, to the new and possible market applications, highlighting all the critical and important points of its development.

Orodispersible films: Towards drug delivery in special populations

“…Other ODF features such as flexibility, portability, and stability can confer superiority to other dosage forms like orodispersible tablets or liquids (Borges et al, 2015a) (Borges at al., 2015 vol I). Delivering actives via ODFs through oral mucosa, can lead to rapid dissolution and fastest onset of action (Ashraf and Sayeed, 2014;Choudhary et al, 2013).…”

“…Some examples of ODF products are commercially available for Alzheimer's disease (Donepezil -Labtech, Kyukyu Pharmaceuticals, Hexal Pharmaceuticals), emesis (Ondansetron -Monosol, Labtech, Aavishkar), schizophrenia (Olanzapine -Labtech, Hexal Pharmaceuticals), migraine (Zolmitriptan -Monosol, Labtech, NAL Pharma) etc. (Borges et al, 2015a). The readers are referred to a recent review by Borges et al for a comprehensive product list of oro-mucosal film based products that are registered, launched, under (pre-) clinical development or withdrawn/ discontinued.…”

“…ODF products are conventionally manufactured via film casting of solution, suspension or melt using diverse technologies such as solvent casting, semisolid casting, rolling, coating and hot melt sheet extrusion (Borges et al, 2015a;Krampe et al, 2015). In these cases, the API(s) is/are dispersed in a feedstock with the suitable excipients, formulation and/or process aids and processed to yield films of desired dimensions and mechanical properties.…”

Formulation Optimization and <i>in Vitro</i> Characterization of Orally Disintegrating Films Using a Factorial Design and Mathematical Modeling for Drug Release

“…PEG, glycerol, diethyl phthalate, triethyl citrate, tributyl citrate, and propylene glycol (PG) are common plasticizers. 18) There are critical quality attributes (CQAs) of ODFs that should be carefully considered during their development. These properties are inherent to the formulation but are also significantly influenced by the manufacturing process.…”

“…The most reliable tests available for this evaluation are the disintegration time and the dissolution profiles. 18) Stability, residual water content, organoleptic characteristics, and dose uniformity should also be considered during the development.…”