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Oral Soluble Films: Attributes of the Polymeric Material and Critical Process Parameters for Designing Good Quality Films



Soluble films prepared using polymeric matrices have gained prominence in
drug delivery because of its multifarious merits. They are emerging as a momentous technology for
designing precision medicines using printing technology, wherein the drugs, proteins/peptides and
hormones in printing ink solution can be printed on placebo films targeted for specific age group
dosage administration. Advances made in 3D printing technology in biomanufacturing for sophisticated
tailor-made scaffolds of bone and tissue have further given impetus to digitally-controlled depositing
of materials to create freeform geometries in the field of dosage form development.



The patent expiry of a significant number of existing chemical entities is an encouraging
factor for the possible market potential of these films as a novel drug delivery system through the
oral route, topical route and ocular route. Most prominent amongst them is the oral route simply because
of its substantial advantages over other pre-existing oral dosage forms.



Oral soluble films can be tailored for both local action in the buccal cavity as well as for
systemic action to other parts of the body by direct absorption into the systemic circulation through
the buccal mucosa. Depending upon the material attributes of its polymeric components, they can be
targeted for buccal, sublingual, ocular or topical administration and can also be loaded inside hard
gelatin capsule shells for administration into the gastrointestinal tract. Polymeric oral film technology
has been exploited to address gaps in varied therapeutic segments including pain and inflammation
management to provide instant relief, anti-emesis following chemotherapy, central nervous system
disorders due to ease of administration to the caregivers and patient compliance, cardiovascular diseases
due to faster onset of action, cancer therapy with enhanced safety and efficacy due to direct
systemic absorption bypassing the first pass metabolism effect.



This review summarizes the research works done to address gaps in varied therapeutic
areas with an emphasis on critical material attributes of its polymeric components and the critical
process parameters to be considered for manufacturing robust good quality medicinal films.
