An Overview of Fast Dissolving Oral Film

Abstract

Taste-masking techniques are applied to mask or overcome the bitter or unpleasant taste of active pharmaceutical ingredients/drugs to achieve patient acceptability and compliance. Oral administration of bitter or unpleasant tasting drugs is often the biggest barrier for patient groups, such as pediatrics and geriatrics [1, 2]. Unless the active ingredient is tasteless or does not have any unpleasant taste, taste-masking plays a key role in the success of a final solid oral dosage form. The efficiency of taste-masking is often a key determinant for the success of specialized dosage forms like orally disintegrating tablets and films, and chewable tablets [2]. The mechanisms of taste-masking techniques often rely on two major approaches: the first is to add sweeteners, flavors, and effervescent agents to mask the unpleasant taste, and the second is to avoid the contact of bitter/unpleasant drugs with taste buds. In the past few years, significant progress has been made in the area of taste-masking by applying novel strategies and techniques, such as hot-melt extrusion and microencapsulation.[1,3] The following presents an overview and current status of the industrial approaches and platforms used for taste-masking in oral dosage forms. [1, 2, 4] Many pharmaceutical companies are switching their products from tablets to fast dissolving oral thin films (OTFs).[6,7] Films have all the advantages of tablets (precise dosage, easy administration) and those of liquid dosage forms (easy swallowing, rapid bioavailability). Statistics have shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosages forms. Pediatric, geriatric, bedridden, emetic patients and those with Central Nervous System disorders, have difficulty in swallowing or chewing solid dosage forms.[7,8] Many of these patients are non-compliant in administering solid dosage forms due to fear of choking.[9] OTFs when placed on the tip or the floor of the tongue are instantly wet by saliva. This technology provides a good platform for patent non- infringing product development and for increasing the patent life-cycle of the existing products. [10, 11]