wjpmr, 2019,5(7), 116-127 SJIF Impact Factor: 4.639 WORLD JOURNAL OF PHARMACEUTICAL Review Article Rao et al. World Journal of Pharmaceutical and Medical Research AND MEDICAL RESEARCH ISSN 2455-3301 www.wjpmr.com WJPMR FAST DISSOLVING ORAL FILMS: A COMPREHENSIVE REVIEW Priyanka Gupta, Amrita Bisht and Dr. N. G. Raghavendra Rao* Dept of Pharmacy, GRD [PG] Institute of Management and Technology, 214, Rajpur, Dehradun - 248009, Uttarakhand India. *Corresponding Author: Dr. N. G. Raghavendra Rao Dept of Pharmacy, GRD [PG] Institute of Management and Technology, 214, Rajpur, Dehradun - 248009, Uttarakhand India. Article Received on 07/05/2019 Article Revised on 28/05/2019 Article Accepted on 18/06/2019 ABSTRACT In the late 1970s, rapid disintegrating drug delivery system was developed as an alternative to capsules, tablets and syrups for geriatric and pediatric patients having problems in swallowing. To overcome the need, number of orally disintegrating tablets which disintegrate within one minute in mouth without chewing or drinking water were commercialized. Then later, oral drug delivery technology had been improved from conventional dosage form to modified release dosage form and developed recently rapid disintegrating films rather than oral disintegrating tablets. Orally fast dissolving films (OFDFs) have been introduced in the market recently as they provide convenience and ease of use over other dosage forms such as orally disintegrating tablets. This technology 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, so OFDFs are gaining the interest of large number of pharmaceutical industries. Orally fast dissolving film is the type of drug delivery system which when placed in the oral cavity, disintegrate or dissolve within few seconds without the intake of water. OFDFs are very similar to postage stamp in their shape, size and thickness. These films have a potential to deliver the drug systemically through intragastric, sublingual or buccal route of administration and also has been used for local action. This type of technology offer a convenient way of dosing medication, not to special population groups like pediatric, geriatric, bedridden patients, mentally ill patients, but also to the general population. Some companies introduced more robust forms of fast- dissolving drug delivery the film is placed on the top or the floor of the tongue. When put on the tongue, this film dissolves instantaneously, releasing the drug which dissolves in the saliva. Some drugs are absorbed from the mouth, pharynx and esophagus as the saliva passes down into the stomach. In such case is enhancing drug bioavailability, No risk of chocking, Provide good mouth feel. The present review provides an account of various formulation considerations, method of preparation and quality control of the OFDFs. KEYWORDS: Fast dissolving films, Oral strips, Tensile strength. INTRODUCTION disease, head and neck radiation therapy and other neurological disorders as well as encephalopathy.[6] The Oral route is a most preferred route of drug most common complaint with tablet is size, fear of administration for systemic effect due to its ease of chocking. The problem of swallowing tablets is more administration, non-invasiveness, adaptability, patient evident in geriatric and pediatric patients, as well as compliance and acceptability.[1,2] Tablet is the most travelling patients who may not have ready access to preferred dosage form due to ease of manufacturing, water.[7] To overcome this Oral fast disintegrating drug transportation and more patient compliance.[3] Generally delivery systems were developed, these systems were geriatric, pediatric, nauseous, bed ridden and initially developed within the late Seventies as an noncompliance patients experience difficulties in alternative to tablets, capsules and syrups for pediatric & swallowing the conventional oral dosage form and do not geriatric patients who experience difficulties in take their medicines as prescribed. It is estimated that 50 swallowing traditional oral solid dosage forms. These % of the population was affected by this problem, which dosage forms either dissolve or disintegrate generally finally results in a higher chance of noncompliance & within a 3 minute in mouth, without need of water. Oral ineffective therapy.[4] The elderly constitute a major fast Disintegrating dosage form have started gaining portion of today’s population mainly because of popularity & acceptance as new drug delivery system increased life expectancy of individuals.[5] Dysphagia or due to better patient compliance.[8] difficulty in swallowing is common problem, this disorder is coupled with several medical conditions including stroke, AIDS, thyroidectomy, Parkinson’s www.wjpmr.com 116 Rao et al. World Journal of Pharmaceutical and Medical Research Oral fast disintegrating dosage form consists of mouth administration of water. The delivery system consists of dissolving tablets & fast dissolving films. Mouth a very thin oral strip which is simply placed on the dissolving tablets associated with many problems like patient’s tongue or any other oral mucosal tissue and leave residues in mouth which causes feeling of instantly gets wetted by saliva.[14] The film rapidly grittiness in mouth; there is a fear of choking, difficulty hydrates onto the site of application. It then rapidly in swallowing tablets. To beat the issues of mouth dissolves and disintegrates to release the medication for dissolving tablets, a new drug delivery system for the oro-mucosal absorption. Fast dissolving oral thin films oral delivery of the drugs, was investigated which is are widely accepted by patients and also to the caregiver known as Fast dissolving films/oral dispersible film/ for their ease-of-delivery, portability and accurate dosing mouth dissolving films / oral disintegrating film/ oral [15]. The robustness of the film depends upon the type and dissolving film.[9] Fast dissolving oral film was amount of polymer used and general dissolution time for developed based on the technology of the transdermal orally dissolving film is 5–20 min. as per patches for oral delivery of drugs.[10] The delivery system pharmacopoeia.[16,17] They also provide quick onset of consists of a thin film of the size of a postage stamp, action within few seconds as the oro-mucosal absorption which is placed on the patient’s tongue or mucosal of the drug occurs directly from the site of administration tissue, where it instantly hydrates by absorbing saliva; to the systemic circulation avoiding the first-pass the film then rapidly disintegrates and dissolves to metabolism to produce the desired effect.[18] release the drug for oral mucosal absorption. This fast dissolving action is primarily due to the large surface Anatomy of oral cavity area of the film, which wets quickly when exposed to the The structure and anatomy of oral cavity is studied for moist oral environment.[11] understanding the environment provided for delivering drugs [Fig. 1]. The oral mucosa allows direct access of Fast dissolving drug delivery system drug to the systemic circulation and avoids first pass Fast dissolving drug delivery system is a new generation metabolism. The epithelium of the oral cavity is quite delivery system also known as fast similar to that of the skin, with slight differences with dissolving/disintegrating film for the oral delivery of the regard to keratinization, protective and lubricant mucous drugs which came into existence in the late 1970's as an which is spread across its surface.[19] The permeability of alternative to tablets, capsules, syrups and other oral mucosa is 4–1000 times greater than that of the skin. formulations for pediatric and geriatric patients who The oral cavity is divided into two regions: outer being experience difficulties in swallowing traditional solid the oral vestibule bounded by the lips and cheeks; the dosage forms which combines both the advantages of hard and soft palates, the floor of the mouth and conventional tablet and of liquid formulation.[12] FDDS is tonsils.[20] Oral drug delivery has been known for easy to administer and provides better patient compliance decades as the most widely utilized route of in the elderly, pediatric, mentally retarded, nauseated and administration among all the routes that have been uncooperative patients.[13] This delivery system consists explored for the systemic delivery of drugs via various of the solid dosage forms that dissolve quickly i.e. within pharmaceutical products of different dosage forms.[21] a matter of seconds in the oral cavity without the www.wjpmr.com 117 Rao et al. World Journal of Pharmaceutical and Medical Research Flow Chart for the Development of Oral Solid Dosage Special Features of Fast Dissolving Oral Films[22,23] Limitations of Fast Dissolving Oral Films 1. Thin elegant film 1. High doses cannot be incorporated. 2. Available in various size and shapes 2. Excessive bitter drugs are not feasible. 3. Unobtrusive 3. Dose uniformity is a technical challenge. 4. Excellent mucoadhesion 4. They require special packaging for the products 5. Fast disintegration and dissolution stability and safety. 6. Rapid drug release 5. Drugs which irritate the oral mucosa cannot be 7. Bypasses first pass effect administered by this route. Advantage of Orally Fast Dissolving Oral Films[24-27] The Ideal Characteristics of Drug To Be 1. No need of water for administration. Selected.[24,27,28] 2. Convenient for pediatric, geriatric and dysphasic 1. The drug should have pleasant taste. The drug patients having difficulty in swallowing. should have small molecular size and low molecular 3. Rapid disintegrating and dissolution in the oral weight. cavity due to larger surface area of films. 2. The drug should have good solubility and stability in 4. Rapid onset of action with increased bioavailability water as well as in saliva. due to bypassing hepatic first pass effect. 3. It should be partially unionized at the pH of oral 5. Reduce dose, enhances the efficacy and safety cavity. profile of the drug with reduced side effects.