FAST DISSOLVING FILMS: A NOVEL APPROACH TO ORAL DRUG DELIVERY

Amongst the plethora of avenues explored for rapid drug releasing products, oral strip technology (OST) is gaining much attention. Dissolvable oral thin films (OTFs) evolved over the past few years from the confection and oral care markets in the form of breath strips and became a novel and widely accepted form by consumers. Fast-dissolving oral films are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking water or chewing. These drug delivery systems allow the medication to bypass the first pass metabolism thereby making the medication more bioavailable. The sublingual and buccal delivery of a drug via thin film has the potential to improve the onset of action, lower the dosing and eliminate patient’s fear of chocking. Formulation of oral films involves the application of both aesthetic and performance characteristics such as plasticized hydrocolloids, active pharmaceutical ingredient, taste masking agent being laminated by solvent casting or hot melt extrusion. Solvent casting being the most preferred offers great uniformity of thickness and films have fine gloss and better physical properties. Oral strips are evaluated for various attributes such as thickness, folding endurance, disintegration and dissolution time. This review describes about the formulation methodology, evaluation parameters and the future aspects of oral fast dissolving films. KeywordsOral fast dissolving films, solvent casting, rapid disintegration INTRODUCTION Among the delivery routes, Oral route is the most preferred route for the delivery of the drugs till date due to ease of ingestion, pain avoidance and versatility (to accommodate various types of drug candidates). 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 some drawbacks related to particular class of patients which includes geriatric, pediatric and dysphasic 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. Even with fast dissolving tablets there is a fear of choking due to its tablet type appearance. One study showed that 26% of 1576 patients experienced difficulty in swallowing tablets. The most common complaint was tablet size, followed by surface form and taste. For the last two decades, there has been an enhanced demand for more patient-compliant dosage forms. “Research and development in the oral drug delivery segment has led to transition of dosage forms from simple conventional tablets/capsules to modified release tablets/capsules to oral disintegrating tablet (ODT) to wafer to the recent development of oral strip (OS), a thin film that is prepared using hydrophilic polymers that rapidly dissolves on the tongue or buccal cavity”. Fast-dissolving drug-delivery systems were first developed in the late 1970s as an alternative to tablets, capsules and syrups for pediatric and geriatric patients who experience difficulties swallowing traditional oral solid-dosage forms. The novel technology of oral fast-dispersing dosage forms is known as fast dissolve, rapid dissolve, rapid melt and quick disintegrating tablets. By definition, a solid dosage form typically the size of a postage stamp that dissolves or disintegrates quickly in the oral cavity resulting in solution or suspension without the need for the administration of water is known as an oral fast-dispersing dosage form. Today, OTFs are a proven and accepted technology for the systemic delivery of APIs for over-the-counter (OTC) medications and are in the early to mid development stages for prescription drugs. Special Features Of Oral Thin Films