RECENT UPDATE ON ORAL FILMS: A BENCH TO MARKET POTENTIAL Review Article RENUKA R. TIWARI 1 , UMASHANKAR M. S. 1* , DAMODHARAN N. 1 1 Received: 24 Jul 2018, Revised and Accepted: 04 Sep 2018 Department of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science and Technology, Tamilnadu, India Email: umashankarms269@gmail.com ABSTRACT Oral films are gaining a lot of attention as a substitute approach to the conventional dosage form. Over the past few years, many of the pharmaceutical scientists throughout the world are focusing their research on oral films, trying to see the sights of oral films as a novel drug delivery system. The oral films are convenient to swallow for geriatric and pediatric patients, are self-administrable, used for systemic and local action and rapid release of a drug, which makes it an excellent system of drug delivery. This review article mainly discusses the manufacturing aspects of films and their characterization, applications and the constraints in the development of oral films along with highlights of market potential. Keywords: Oral films, Formulation, Evaluation, Drawbacks, Market © 2018 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open-access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ijap.2018v10i6.28725 INTRODUCTION An oral film as drug delivery is emerging as an advanced alternative to the traditional oral methods of drug administration. Oral film delivery system is a solid dosage form which dissolves in a short span when administered without chewing or drinking water. Oral films containing active drugs are designed for oral administration, allowing the drug to bypass the first pass metabolism in the liver thus enhancing the bioavailability. Upon dissolution, medication enters bloodstream enterically, buccally and sublingually. Making an oral film involves the use of a hydrophilic polymer as a vital ingredient that rapidly dissolves in the buccal cavity thus delivering medication into systemic circulation. This advanced innovation in the formulation was first invented by Richard and Joseph Fuisz, Garry Myers and Robert Yang. They have contributed over 30 patents in this field [1]. The most favoured route of drug administration is oral route due to cost efficiency and ease of administration which lead to high patient compliance for the pediatric and geriatric group, but it is still challenging route due to swallowing difficulty for pediatric and geriatric patients. The development of novel and safer drug delivery such as oral strips, buccal films are the result of patient convenience and compliance-oriented research. In recent times, an oral film drug delivery system has gained lots of popularity and acceptance [1, 2]. Oral film technology was first invented in the late 1970s just to overcome swallowing difficulties related to tablets and capsules faced by geriatric and pediatric patients but now is trending in pharma industry due to less fragility than other oral dosage forms, dosage accuracy, rapid release, ease of administration. These oral films are also known as oral strips, buccal strips or films. A variety of bioadhesive mucosal dosage form has been developed such as adhesive tablets, gels, ointments, patches and currently polymeric film for buccal delivery is known as mouth dissolving films. Oral films have a shelf life of 2-3 y depending upon the active pharmaceutical ingredient but are unusually sensitive to environmental moisture [3]. The following review was focused on elaborating the manufacturing aspects of films and their characterization, market potential, applications and the constraints in development of oral films. Review and research article on oral films and its market potential that are available in journal databases such as Science Direct, PubMed, Springer, Pharmatutor from the year 2000-2017 were studied and in- depth knowledge of oral films in present market was produced. Very few articles before the year 2000 were also considered. Keywords used to search: formulation, methods of preparation, market potential, patented oral films. An ideal oral film possesses following properties such as high stability, transportability, ease of handling and administration, no water necessary for application and pleasant taste. Therefore, they are very suitable for pediatric and geriatric patients, bedridden patients; or patients suffering from dysphagia, Parkinson's disease, mucositis or vomiting. Oral films were first introduced to the market as breath fresheners and personal care products such as dental care strips and soap strips. These oral dosage forms were introduced in the United States and European pharmaceutical markets for therapeutic benefits. The first oral strip was developed by Pfizer named as Listerine pocket packs which were used as mouth freshener [1]. Advantages • Pleasing and fresh mouthfeel. • No risk of choking. • Easy application-no swallowing and chewing difficulties. • To avoid first pass metabolism. • Administering of an accurate dose is possible. • For improved patient compliance, small size is available. • Rapid onset of action. • It helps in enhancing stability [4]. • It masks the bitter taste. • Available in various sizes and shapes. • Reduce gastrointestinal irritation. Disadvantages • Sometimes show the fragile and granular property. • Hygroscopic in nature thus must be stored in a dry place. • Require special packaging for the product stability and safety. • The high dose cannot be incorporated into an oral film. • Eating and drinking may be restricted. • Drug unstable at buccal pH cannot be administered. • A drug with nauseous odour cannot be administered [5] International Journal of Applied Pharmaceutics ISSN- 0975-7058 Vol 10, Issue 6, 2018