FAST DISSOLVING ORAL FILM: OVERVIEWAbstract
The purpose of the current review is to enlighten the present and the future perspective on oral fast dissolving films (OFDFs) as a drug delivery system as they are gaining interest as a substitute of fast dissolving tablets. Tablets/capsules to modified release tablets/capsules to oral disintegrating tablet to wafer to the recent development of fast dissolving oral films. Fast dissolving drug delivery systems were first invented in the late 1970s to overcome swallowing difficulties associated with tablets and capsules for pediatric and geriatric patients. Also, solid oral delivery systems do not require sterile conditions and are therefore less expensive to manufacture, but oral drug delivery systems still need some advancements to be made because of their drawbacks related to particular class of patients which includes geriatric, pediatric and dysphagia patients associated with many medical conditions as they have difficulty in swallowing or chewing solid dosage forms. Many pediatric and geriatric patients are unwilling to take solid preparations due to fear of choking because of tablet appearance, and patients experienced difficulty in swallowing tablets. Even fast dissolving tablets, there is a fear of choking due to its tablet type appearance. For the last two decades, there had been an enhanced demand for patient-compliant dosage forms. Research and development in the oral drug delivery segment had led to the transition of dosage form from simple conventional tablets/capsules to modified release tablets/capsules too. The oral disintegrating tablet (ODT) to wafer to the recent development of oral dissolving film, “a thin film that is prepared using hydrophilic polymers that rapidly dissolves on the tongue or buccal cavity.” Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. It improves the efficacy of APIs by dissolving within a minute in the oral cavity after the contact with saliva without chewing and no need of water for administration. It gives quick absorption, and instant bioavailability of drugs due to high blood flow, and permeability of oral mucosa is 4-1000 times greater than that of skin. Fast dissolving oral films are fast disintegrating thin films having an area ranging from 5 to 20 cm2 in which drug is incorporated in the form of a matrix using hydrophilic polymer. The active pharmaceutical ingredient can be incorporated up to 15 mg along with other excipients, i.e., plasticizers, colorants, sweeteners, taste masking agents, etc. Plasticizer increases workability, spreadability, and flexibility of films, thereby reducing the glass transition temperature of polymers. Fast dissolving films are very similar to an ultra-thin strip of a postage stamp in their shape, size and thickness. They quickly disintegrate and dissolve, and there is no need for water for their administration, making them suitable for pediatric and geriatric patients. The solvent casting method is commonly used for OFDFs preparation. Films prepared should be evaluated for organoleptic properties, thickness, tackiness, tensile strength, folding endurance, disintegration, and in-vitro drug release.