Abstract

MS. Dhruvi Darji, Dr. Neelam D. Patel

ABSTRACT

Oral drug delivery is the most preferred route for medication due to its convenience,cost-effectiveness, and ease of administration. However, approximately 28% of thepopulation experience difficulty swallowing conventional solid dosage forms,which affects patient compliance. Fast dissolving oral films (FDOFs), also knownas mouth dissolving films (MDFs), offer an innovative solution by disintegratingquickly in the oral cavity without the need for water, thereby enhancing patientadherence. These ultra-thin films (50–150 μm) are composed of hydrophilicpolymers, plasticizers, sweeteners, flavoring agents, saliva stimulants, andcolorants, with active pharmaceutical ingredients (APIs) incorporated up to 30%w/w. The films are designed to dissolve within seconds, facilitating rapidabsorption through the highly vascularized oral mucosa, offering highbioavailability and bypassing first-pass hepatic metabolism. Various manufacturingtechniques include solvent casting, hot- melt extrusion, solid dispersion, semisolidcasting, and rolling methods. The choice of polymer and excipients plays a criticalrole in the film’s mechanical strength, disintegration time, and drug release profile.While MDFs offer advantages such as pain-free administration, portability, andrapid onset of action, limitations include moisture sensitivity, dosage uniformity,and incompatibility with high-dose or mucosa-irritating drugs. Overall, mouthdissolving films present a promising alternative dosage form, particularly forpediatric, geriatric, and non-cooperative patients.