Review Article ISSN 2277-3657 Available online at www.ijpras.com International Journal of Volume 2, issue 1 (2013),14-24 Pharmaceutical Research & Allied Sciences Fast Dissolving Films: An Innovative Drug Delivery System Kaur Mandeep*,A.C. Rana, Seth Nimrata Department of Pharmaceutics, Rayat Institute of Pharmacy, S.B.S.Nagar-144533(Punjab) India *Email id: [email protected] Subject: Pharmaceutics Abstract In the recent years, many of the pharmaceutical groups are focusing their research on rapid dissolving technology. Amongst the plethora of avenues explored for rapid drug releasing product, Fast Dissolving Films technology is gaining much attention. Fast Dissolving Films 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 for delivering vitamins and personal care products. These are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking water or chewing. This technology has been used for local action, rapid release products. The oral films are formulated using polymers, plasticizer, flavors, colors and sweeteners. This review describes about the formulation methodology, evaluation parameters and the future aspects of fast dissolving films. Keywords: Fast Dissolving Films, Solvent casting technique, Rapid disintegrating, Patented technologies Introduction Oral route of administration is the most delivery markets [2,3]. Pharmaceutical convenient and preferred route of companies and consumers alike have embraced administration among the various other FDFs as a practical and accepted alternative to delivery system. More than 70% of drugs are traditional OTC medicines, such as liquids, available in the market in the form of oral drug tablets and capsules, because of the various delivery system due to pain avoidance and benefits of the films. FDFs offer fast, accurate versatility (to accommodate various types of dosing in a safe, efficacious format that is drug candidates) [1]. Dysphagia is commonly convenient and portable, without requiring the found among all age groups. Due to this use of water or a spoon. A variety of polymers problem, approximately 50% of population, are available for preparation of RDFs. The mainly pediatric and geriatric patients, tend to polymers can be used alone or in combination avoid taking oral solid dosage preparations due to obtain the desired film properties. The films to fear of choking. To overcome various obtained should be tough enough so that they problems related to swallowing, Fast are not damaged while handling or during dissolving Tablets (FDTs) were designed in transportation. On the other hand, Mouth early 19 th century, which slowly led to their dissolving films should have the property to further advancement and thus Fast Dissolving dissolve within seconds when placed in mouth Films (FDFs) were developed. Fast dissolving and deliver the drug to the oral cavity dosage form has become increasingly instantaneously. The excipients employed in important because of their unique properties. FDFs are preferably hydrophilic in nature They quickly disintegrate and dissolve, and whereas drug may be either hydrophilic or can be administered without water, making hydrophobic. As the film forming polymer them particularly suitable for pediatrics and (which forms the platform for the RDFs) and geriatric patients. Fast dissolving films (FDFs), plasticizer are the most essential and major have gained popularity not only in breath strips component of the FDFs, at least 40-50 % w/w but also in personal care, food and drug of polymer and upto 20% (total weight of 14 Available online at www.ijpras.com polymer) of plasticizer should generally be • The drug to be incorporated should have present based on the total weight of dry RDFs. low dose upto 40 mg. Technology Catalysts forecasts the market for • The drugs with smaller and moderate drug products in oral thin film formulations molecular weight are preferable. was valued of $500 million in 2007 and could • Good solubility in water as well as in reach $2billion in 2012. Based on upward saliva and also good stability. global growth trends of the past decade, the Classification of Oral Films [6] fast dissolving dosage market could produce There are three different subtypes of oral revenues of $13billion by 2015[4]. The FDFs films: technology continues to be viewed as an i. Flash release alternative for FDT products that would afford ii. Mucoadhesive melt-away wafer a superior barrier to generic entry and product iii. Mucoadhesive sustained-release wafers differentiation to over ‐the ‐counter brands. Types of oral films and their properties From the marketing perspective, a patented are described in Table 1 ODF technology would be beneficial. The grant of marketing exclusivity to the new dosage form would help to gain more revenue. Classification of Fast Dissolving The various synonyms used for FDFs include Technology mouth dissolving films (MDFs), orally For ease of description, fast-dissolve disintegrating films (ODFs), melt in-mouth films, technologies can be divided into three oro-dispersible, quick dissolving and rapid broad groups: disintegrating films.[4,5] i. Lyophilized systems: The technology Advantages of Fast Dissolving Films [6] around these systems involves taking a • No risk of choking and obstruction. suspension or solution of drug with other • No need of water has led to better structural excipients, through the use of a acceptability amongst the dysphagic mould or blister pack, forming tablet- patients shaped units. The units or tablets are then • Improved oral bioavailability of drugs frozen and lyophilized in the pack or • Taste masking mould. The resulting units have a very high porosity, which allows rapid water • Enhanced stability or saliva penetration and very rapid • Improved patient compliance disintegration. • Oral films are flexible and they are not as ii. Compressed tablet-based systems: This fragile as most of the ODTs system is produced using standard tablet • Reduction in first pass metabolism may technology by direct compression of lead to reduction in the dose excipients. Depending on the method of • The oral or buccal mucosa is highly manufacture, the tablet technologies have vascularized, hence drugs can be different levels of hardness and friability. absorbed directly and can enter the The speed of disintegration for fast- systemic circulation without undergoing dissolve tablets compared with a standard first-pass hepatic metabolism tablet is achieved by formulating using Ideal Properties of Fast Dissolving either water soluble excipients, super- Films disintegrant or effervescent components, • It should have an acceptable taste. to allow rapid penetration of water into • It should give a pleasing mouth feel. the core of the tablet. • It should be less friable and have good iii. Thin film strips: Oral films, also called mechanical strength to withstand the post oral wafers, evolved over the past few manufacturing handling. years from the confection and oral care • It should be stable in environmental markets in the form of breath strips and conditions. became a novel and widely accepted form • Subsequent to oral administration, it by consumers for delivering vitamins and should leave least or no residue in mouth. personal care products. Today, FDFs are a • It should quickly dissolve to release drug proven and accepted technology for the instantaneously in mouth. systemic delivery of APIs for over-the- counter (OTC) medications and are in the • It should be compatible with the other early- to mid development stages for ingredients. prescription drugs. This has been Drug Selection Criteria for Fast attributed to the success of the breath Dissolving Films[7] freshener products by consumers such as • The drug should have pleasant taste. Listerine Pocket Paks in the US consumer 15 Available online at www.ijpras.com market. Such systems use a variety of iii. Plasticizers: Plasticizer is a vital ingredient hydrophilic polymers to produce a 50- of the oral films. The selection of plasticizer 200 mm film. The film is manufactured depends upon its compatibility with the as a large sheet and then cut into polymer and also the type of solvent employed individual dosage units for packaging in a in the casting of film. It helps to improve the range of pharmaceutically acceptable flexibility of the film and reduces the formats. brittleness of the film . Plasticizer significantly improves the strip properties by reducing the Formulation Aspects for Fast Dissolving glass transition temperature of the polymer. Films [7] Typically the plasticizers are used in the 1) Drug Category concentration of 1 - 20%w/w of dry polymer 2) Film Forming Polymers weight. Examples include: Glycerol, Propylene 3) Plasticizers glycol, Low molecular weight polyethylene 4) Sweetening Agents glycols, Citrate derivatives like triacetin, acetyl 5) Saliva Stimulating Agents citrate, Phthalate derivatives like dimethyl, 6) Cooling Agent diethyl, dibutyl derivatives, Castor oil etc. 7) Flavoring Agent iv. Sweetening agents: Sweeteners have 8) Coloring Agent become the important part of the food products 9) Surfactants as well as pharmaceutical products intended to 10) Stabilizing and thickening agents be disintegrated or dissolved in the oral cavity. Formulation of FDFs involves the intricate The sweet taste in formulation is more application of aesthetic and performance important in case of pediatric