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Journal ArticleDOI

Orally disintegrating films: A modern expansion in drug delivery system.

TL;DR: Orally disintegrating films have potential for business and market exploitation because of their myriad of benefits over orally disintegrating tablets and the market prospect of this innovative dosage form is also targeted.
Abstract: Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for existing drugs. Out of those, drug delivery system being very eminent among pediatrics and geriatrics is orally disintegrating films (ODFs). These fast disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability. This drug delivery system has numerous advantages over conventional fast disintegrating tablets as they can be used for dysphasic and schizophrenic patients and are taken without water due to their ability to disintegrate within a few seconds releasing medication in mouth. Various approaches are employed for formulating ODFs and among which solvent casting and spraying methods are frequently used. Generally, hydrophilic polymers along with other excipients are used for preparing ODFs which allow films to disintegrate quickly releasing incorporated active pharmaceutical ingredient (API) within seconds. Orally disintegrating films have potential for business and market exploitation because of their myriad of benefits over orally disintegrating tablets. This present review attempts to focus on benefits, composition, approaches for formulation and evaluation of ODFs. Additionally, the market prospect of this innovative dosage form is also targeted.
Citations
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Journal ArticleDOI
TL;DR: The aim of this review is to provide an overview of the critical factors affecting the formulation of thin films, including the physico-chemical properties of polymers and drugs, anatomical and physiological constraints, as well as the characterization methods and quality specifications to circumvent the difficulties associated with formulation design.

332 citations


Cites background from "Orally disintegrating films: A mode..."

  • ...a thin film with less water vapor barrier due to hydrophilic nature which aids in water retention [15]....

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  • ...Among different routes, the use of thin films for delivering medicine into sublingual or buccal mucosa has drawn immense interest in recent years [15]....

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  • ...duced in late 1970 to overcome swallowing difficulties exhibited by tablets and capsules [15]....

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Journal ArticleDOI
TL;DR: The current strides of ODF technology and some of its unmet quality and manufacturing aspects are reviewed, which highlights opportunities and limitations of inkjet printed ODF as a population-specific drug delivery.

73 citations

Journal ArticleDOI
TL;DR: The present study concluded that glycerol is suitable plasticizer compared to others for manufacturing pullulan based oral films.

72 citations

Journal ArticleDOI
TL;DR: This work provides an insight of the novel approaches in drug delivery covering the critical comparison between traditional and novel “advanced-designed” systems.

72 citations

Journal ArticleDOI
TL;DR: This study successfully formulated personalised warfarin ODFs using a modified TIJ printer, widening the range of applications for TIJ printing to formulate narrow therapeutic index drugs.

65 citations


Cites methods from "Orally disintegrating films: A mode..."

  • ...There have been many attempts at modelling in vivo conditions to evaluate ODF disintegration, such as the Petri dish method and the slide frame method (Irfan et al., 2016)....

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References
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Journal ArticleDOI
TL;DR: This work aimed to study maltodextrins (MDX) with a low dextrose equivalent as film forming material and their application in the design of oral fast-dissolving films, and the MDX/plasticizer interactions were investigated by ATR-FTIR spectroscopy.

267 citations


"Orally disintegrating films: A mode..." refers methods in this paper

  • ...A water insoluble drug (piroxicam) was incorporated into fast dissolving films prepared using maltodextrins (MDX) and equivalent low dose dextrose (Cilurzo et al., 2008)....

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Journal ArticleDOI
TL;DR: As the drug is directly absorbed into systemic circulation, degradation in gastrointestinal tract and first pass effect can be avoided, these points make this formulation most popular and acceptable among pediatric and geriatric patients and patients with fear of choking.
Abstract: Recently, fast dissolving films are gaining interest as an alternative of fast dissolving tablets. The films are designed to dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for additional liquid. This convenience provides both a marketing advantage and increased patient compliance. As the drug is directly absorbed into systemic circulation, degradation in gastrointestinal tract and first pass effect can be avoided. These points make this formulation most popular and acceptable among pediatric and geriatric patients and patients with fear of choking. Over-the-counter films for pain management and motion sickness are commercialized in the US markets. Many companies are utilizing transdermal drug delivery technology to develop thin film formats. In the present review, recent advancements regarding fast dissolving buccal film formulation and their evaluation parameters are compiled.

219 citations


"Orally disintegrating films: A mode..." refers background in this paper

  • ...The concentration of plasticizer usually ranges from 0% to 20% w/w. Common examples of plasticizers are PEG, glycerol, diethyl phthalate, triethyl citrate, tributyl citrate, etc. (Bala et al., 2013)....

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Journal ArticleDOI
TL;DR: Eugenol containing films improved the acceptability of TC-Poloxamer 407 films with respect to taste masking and mouth freshening without compromising the in vivo dissolution time.
Abstract: The present investigation was undertaken with the objective of formulating TC containing fast dissolving films for local delivery to oral cavity. Various film forming agents, film modifiers and polyhydric alcohols were evaluated for optimizing the composition of fast dissolving films. The potential of poloxamer 407 and hydroxypropyl-β- cyclodextrin (HPBCD) to improve solubility of TC was investigated. Fast dissolving films containing hydroxypropyl methylcellulose (HPMC), xanthan gum, and xylitol were formulated. Use of poloxamer 407 and HPBCD resulted in significant improvement in the solubility of TC. Fast dissolving films containing TC-HPBCD complex and TC-Poloxamer 407 were formulated and were evaluated for the in vitro dissolution profile and in vitro microbiological assay. Films containing TC-Poloxamer 407 exhibited better in vitro dissolution profile and in vitro antimicrobial activity as compared to the films containing TC-HPBCD complex. Effect of incorporation of eugenol on the in vivo performance of TC-Poloxamer 407 containing films was evaluated in human volunteers. Eugenol containing films improved the acceptability of TC-Poloxamer 407 films with respect to taste masking and mouth freshening without compromising the in vivo dissolution time.

198 citations


"Orally disintegrating films: A mode..." refers methods in this paper

  • ...The development of fast dissolving film of triclosan prepared by using different grades of HPMC indicated that Methocel E15 Premium LV resulted into the films with appropriate properties (Dinge and Nagarsenker, 2008)....

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01 Jan 2011
TL;DR: The oral thin-film technology is still in the beginning stages and has bright future ahead because it fulfils all the need of patients, and for future growth point of view the oral thin film sector is well-positioned.
Abstract: Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. It improve the efficacy of APIs by dissolving within minute in oral cavity after the contact with less saliva as compared to fast dissolving tablets, without chewing and no need of water for administration. The FDOFs place as an alternative in the market due to the consumer's preference for a fast- dissolving product over conventional tablets / capsules. The oral thin-film technology is still in the beginning stages and has bright future ahead because it fulfils all the need of patients. Eventually, film formulations having drug/s will be commercially launched using the oral film technology. However, for future growth point of view the oral thin film sector is well-positioned. In US market the OTC films of pain management and motion sickness are commercialized. More importantly, prescription OTFs have now been approved in US, EU and Japan which are the three major regions. These approved Rx films, have potential to dominate over other oral dosage forms of the same drugs. It seems that the value of the overall oral thin film market will grow significantly.

157 citations


"Orally disintegrating films: A mode..." refers background in this paper

  • ...Often, polaxamer 407 is used due to its many advantages (Siddiqui et al., 2011)....

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  • ...Neotame and Alitame are 2000–8000 times sweeter than sucrose (Siddiqui et al., 2011)....

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  • ...Some commonly used saliva stimulating agents are citric acid, malic acid, tartaric acid, ascorbic acid and lactic acid (Siddiqui et al., 2011)....

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  • ...Apart from titanium dioxide, a full range of colors are available including FD and C, natural and custom pantone-matched colors (Siddiqui et al., 2011)....

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  • ...Any US-FDA approved flavor can be used such as sweet, sour or mint flavor (Siddiqui et al., 2011)....

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Journal ArticleDOI
TL;DR: This article attempts at discussing the patents relating to orally disintegrating systems with respect to the use of different formulation ingredients and technologies.
Abstract: Orally disintegrating systems have carved a niche amongst the oral drug delivery systems due to the highest component of compliance they enjoy in patients especially the geriatrics and pediatrics. In addition, patients suffering from dysphagia, motion sickness, repeated emesis and mental disorders prefer these medications because they cannot swallow large quantity of water. Further, drugs exhibiting satisfactory absorption from the oral mucosa or intended for immediate pharmacological action can be advantageously formulated in these dosage forms. However, the requirements of formulating these dosage forms with mechanical strength sufficient to with stand the rigors of handling and capable of disintegrating within a few seconds on contact with saliva are inextricable. Therefore, research in developing orally disintegrating systems has been aimed at investigating different excipients as well as techniques to meet these challenges. A variety of dosage forms like tablets, films, wafers, chewing gums, microparticles, nanoparticles etc. have been developed for enhancing the performance attributes in the orally disintegrating systems. Advancements in the technology arena for manufacturing these systems include the use of freeze drying, cotton candy, melt extrusion, sublimation, direct compression besides the classical wet granulation processes. Taste masking of active ingredients becomes essential in these systems because the drug is entirely released in the mouth. Fluid bed coating, agglomeration, pelletization and infusion methods have proven useful for this purpose. It is important to note that although, freeze dried and effervescent disintegrating systems rapidly disintegrate in contact with fluids, they do not generally exhibit the required mechanical strength. Similarly, the candy process cannot be used for thermolabile drugs. In the light of the paradoxical nature of the attributes desired in orally disintegrating systems (high mechanical strength and rapid disintegration), it becomes essential to study the innovations in this field and understand the intricacies of the different processes used for manufacturing these systems. This article attempts at discussing the patents relating to orally disintegrating systems with respect to the use of different formulation ingredients and technologies.

143 citations


"Orally disintegrating films: A mode..." refers background in this paper

  • ...No expensive lyophilization, high mechanical strength, rapid disintegration, and reduced choking risks are the quality attributes of ODFs (Arya et al., 2010; Preis et al., 2012; Goel et al., 2008)....

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