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Orally Disintegrating Films: a Modern Expansion in Drug Delivery System

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Orally Disintegrating Films: a Modern Expansion in Drug Delivery System Accepted Manuscript Review Orally disintegrating films: A modern expansion in drug delivery system Muhammad Irfan, Sumeira Rabel, Quratulain Bukhtar, Muhammad Imran Qadir, Farhat Jabeen, Ahmed Khan PII: S1319-0164(15)00062-6 DOI: http://dx.doi.org/10.1016/j.jsps.2015.02.024 Reference: SPJ 400 To appear in: Saudi Pharmaceutical Journal Received Date: 30 January 2015 Accepted Date: 28 February 2015 Please cite this article as: Irfan, M., Rabel, S., Bukhtar, Q., Qadir, M.I., Jabeen, F., Khan, A., Orally disintegrating films: A modern expansion in drug delivery system, Saudi Pharmaceutical Journal (2015), doi: http://dx.doi.org/ 10.1016/j.jsps.2015.02.024 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Review Article Orally disintegrating films: A modern expansion in drug delivery system Muhammad Irfan1, Sumeira Rabel1, Quratulain Bukhtar1, Muhammad Imran Qadir2, Farhat Jabeen3, Ahmed Khan4 1 Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, GC University Faisalabad, Pakistan 2Institute of Molecular Biology and Biotechnology, Bahauddin Zakariya University, Multan, Pakistan 3Department of Zoology, Wildlife & Fisheries, GC University Faisalabad, Pakistan 4Department of Pharmacy, Quaid-i-Azam University Islamabad, Pakistan *Corresponding Author: Muhammad Irfan Department of Pharmaceutics, Faculty of Pharmaceutical Sciences GC University Faisalabad, Pakistan E mail: [email protected] Phone: 0092-320-6504412 1 Introduction .........................................................................................................................3 2 Formulation .........................................................................................................................5 2.1 Active pharmaceutical ingredient ..................................................................................5 2.2 Hydrophilic Polymers ...................................................................................................5 2.3 Plasticizers ....................................................................................................................7 2.4 Surfactants ....................................................................................................................7 2.5 Flavor ...........................................................................................................................7 2.6 Sweetening agents .........................................................................................................7 2.7 Saliva stimulating agent ................................................................................................8 2.8 Coloring agents .............................................................................................................8 3 Conventional approaches for manufacturing of orodispersible films .....................................8 3.1 Solvent casting method .................................................................................................8 3.2 Semi-solid casting method ............................................................................................9 3.3 Hot melt extrusion.........................................................................................................9 3.4 Solid dispersion extrusion .............................................................................................9 3.5 Rolling method ........................................................................................................... 10 3.6 Spray technique........................................................................................................... 10 4 Characterization and Evaluation ......................................................................................... 10 4.1 Organoleptic evaluation .............................................................................................. 10 4.2 Mechanical properties ................................................................................................. 10 4.2.1 Thickness test ...................................................................................................... 10 4.2.2 Dryness test/Tack test .......................................................................................... 11 4.2.3 Tensile strength .................................................................................................... 11 4.2.4 Percent elongation ................................................................................................ 11 4.2.5 Tear resistance ..................................................................................................... 11 4.2.6 Young’s modulus ................................................................................................. 12 4.2.7 Folding endurance ................................................................................................ 12 4.3 Swelling property ........................................................................................................ 12 4.4 Transparency .............................................................................................................. 13 4.5 Contact angle .............................................................................................................. 13 4.6 Content uniformity ...................................................................................................... 13 4.7 Disintegration time ...................................................................................................... 14 4.7.1 Slide frame method: ............................................................................................. 14 4.7.2 Petri dish method: ................................................................................................ 14 4.8 In-vitro dissolution test ............................................................................................... 14 4.9 Visual inspection and surface morphology .................................................................. 14 4.10 Surface pH .................................................................................................................. 15 4.11 Moisture uptake and moisture loss .............................................................................. 15 5 Packaging of orally disintegrating films ............................................................................. 15 6 Conclusion ......................................................................................................................... 16 7 References ......................................................................................................................... 16 Abstract Over the past few decades, tendency towards 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 towards 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. Keywords: ODFs, novel drug delivery, formulation parameters, manufacturing techniques 1 Introduction Oral route of drug administration is a most preferred route due to its ease of administration, non- invasiveness, adaptability, patient compliance and acceptability. Regarding oral route of drug administration, many substitutes have continuously been presented by using recent novel technologies for pediatrics, geriatrics, nauseous and non-compliance patients. Bioadhesive mucosal dosage forms including adhesive tablets, gels and patches are outcomes of technological development. Among various dosage forms, the use of polymeric films for delivering medication into buccal cavity has developed great potential in recent era (Arya et al., 2010). Orally disintegrating films (ODFs), when placed on tongue, immediately hydrates by soaking saliva following disintegration
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