Oromucosal film preparations: points to consider for patient centricity and manufacturing processes

Introduction: According to the European Pharmacopoeia, oromucosal films comprise mucoadhesive

buccal films and orodispersible films. Both oral dosage forms receive considerable interest in

the recent years as commercially available pharmaceutical products and as small scale personalized

extemporaneous preparations.

Areas covered: In this review, technological issues such as viscosity of the casting liquid,

mechanical properties of the film, upscaling and the stability of the casting solution and

produced films will be discussed. Furthermore, patient-related problems like appearance, mucosal

irritation, taste, drug load, safety and biopharmaceutics are described. Current knowledge and

directions for solutions are summarized.

Expert opinion: The viscosity of the casting solution is a key factor for producing suitable films.

This parameter is amongst others dependent on the polymer and active pharmaceutical ingredient,

and the further excipients that are used. For optimal patient compliance, an acceptable

taste and palatability are desirable. Safe and inert excipients should be used and appropriate

packaging should be provided to produced films. Absorption through the oral mucosa will vary

for each active compound, formulation and patient, which gives rise to pharmacokinetic questions.

Finally, the European Pharmacopoeia needs to specify methods, requirement and definitions

for oromucosal film preparations based on bio-relevant data.