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

Abstract

Background:: 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. Objective: 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. Method: 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. Conclusion: 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.