mouth dissolving film

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mouth dissolving film,oral film,oral dissolving thin film,foremulation and evalution of mouth dissolving film,evaluation of thin film,mouth dissolving tablet,oral dispersible tablet,film, strip http://www.irjponline.com/admin/php/uploads/1347_pdf.pdf

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DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL FILM Guided by Mrs. Vijayalaxmi Chavan Department of Quality Assurance, SBCOP,Aurangabad . Presented by Mr. Udhan Ravi R. M.Pharm (QAII SEM) Shri Bhagwan College Of Pharmacy Aurangabad, 1

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Contents Introduction Review of literature Objective Justification Novelty Feasibility Plan of work References

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Introduction Fast dissolving film are most advanced form of solid dosage form due to more flexibility and comfort. It improves the efficacy of API dissolving within minute in oral cavity after the contact with less saliva as compared to fast dissolving tablet .

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Advantages Availability of larger surface area . Reduced hepatic first pass effect. No need of water or a spoon . Destructive acidic environment of stomach can be avoided. Delivery can also be terminated relatively easily if required. Site specific action and local action. Rapid onset of action. Patent life extension Disadvantages Large dose can not be incorporated

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Flow Chart for the Development of Oral Solid Dosage Form

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Formulation Drug and Excipient Concentration ( %w/w) Example Drug 5-30 Water Soluble Polymer 45 HPMC,Pullulan,CMC,Maltodextrin,Eudragit Surfactant q. s Polaxamer 407,Tweens,SLS Plasticizer 0-20 Glycerol, Polyethylene Glycol, Dibuty Pthalate Sweetening Agent 3-6 Sucrose ,Dextrose, Fructose, Manitol, Sorbitol Saliva Stimulating Agent 2-6 Citric Acid,Malic and Ascorbic acid Coloring agent q. s US FDA approved Flavoring Agent q. s

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Manufacturing Method Solvent casting Semisolid casting Hot melt extrusion Solid dispersion extrusion Rolling

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Solvent Casting Method

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Solvent Casting Method

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Semisolid Casting Method

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Solvent Casting Method

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Rolling Method : In this method a solution or suspension containing drug is rolled on a carrier. The solvent is mainly water and mixture of water and alcohol. The film is dried on the rollers and gives desired shape and size .

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Evaluation

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Review of literature

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Patent no date Country Drug Use 5948430 7dep199 us methanol,Kallidol brath freshener breath freshner 6159498 12de200 us tagacanth,cellulose,pectin muth sore 6596298 22-Jul-03 us listerine mouth wash, antiseptic 6824829b2 30-Nov-04 us developed procedure 7132113 7-Nov-06 us Klucel EF flavoured film 7182964b2 27-Feb-07 us xanthone nutraceutical 7267718 11-Sep-07 us cosmetics 7347985b2 25-Mar-08 us Magnolia bark extract breath frshner,oral ceaning agent 17407669 5-Aug-08 us thymol,eukalyptol kiling germ Patents

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759019b2 25-Aug-09 us carrier device adhesive 768712b2 19-Jan-10 us taste masking- dextromethorphan antitussive 7946296b2 24-May-11 us tobaco smikeless tobaco 4136145 23-Jan-79 us carrier carrier 6592887 15-Jul-03 us breath freshner 7067116 27-Jun-06 us dextromethorphan anttitussive 0198873a1 7-Sep-06 us nicotine tobaco abuse 47330 19-Feb-09 us sildenafil citrate erectile dysfunctioning 256215 7-Oct-10 us melatonin hormone sleep disease Patent no D ate Country Drug Use Patents

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Author Drug Polymer Conclusion Vijaykumar A gahorwada et al Montelukast sodium HMC good solubility, Narsimha Rao et al Etophylline HPMC more dissolution time Gupta M.M Meclizine HCL B-cycliodextrin good moth feel, Sandip S aini etal levocetrizine HCL MDX,HPMCE15. decreased disintegration time S.Raju metaclopromide Hpmc Drug release 99.55% Renuka S harma et al valdecoxib Eudragit,HPMC Synergistic effect of eudragit and glycerine 18

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Author Drug Polymer Conclusion H.Plim et al Acetaminophene PEG,HPMC 18 min dist. prabhakara Prabhu et al levocetrizine HCL PEG,HPMC 10S,95% YOSHUFUMI Murata et al Dexmethasone Pullulan presence of drug affect fil aditya Dinge et al Tricloson polaxomer407 eugenol for human voluntaries Francesco Reddyet al Nicotine MDX,HPMCE15. TMA &NHT affect tensile strength Renuka mishra et al Cetrizine HCL Pullulan Methanol along with aspartate suitable for TMA. 19

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Sandeep Saini et al Fast dissolving film of levocetrizine dihydrochloride were prepared by solvent casting method by using Maltodextrin & HPMC E15 as the main film forming polymers . To decrease the disintegration time, concentration of maltodextrin & HPMC E15 were optimized be using 22 factorial design. Disintegration time, drug release pattern, mouth dissolving time and content uniformity were also evaluated . Compatibility between drug and recipients were studied by means of DSC analysis . S. Raju et al Moth dissolving film of metoclopramide hydrochloride was prepared for pediatric use. The metoclopramide use as anti emetic drug. The drug release was found to be 99.40%. Research

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Renuka Sharma et al Developed taste masked film of Valdecoxib by using Eudragit and HPMC as polymer . She found that Eudragit and Glycerol which used as plasticizer give synergistic effect. The glycerol play important role in the increasing the flexibility of the film. The drug loading was 10 mg for the 4 cm2 film. Francesco Cilurzo et al He performed the feasibility study of maltodextrin film Paracetamol is used as Model because the bioavailability of paracetamol can easily determined when absorbed orally. The film is prepared by Hot melt extrusion technology by using glycerin as plasticizer. The drug loading capacity is 16 mg. Research

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Prabhakara prabhu et al Formulated and evaluated the moth dissolving film of levocitrizine dihydrochloride by solvent casting method the polymer used are HPMC and polyvinyl alcohol. He found that the disintegration time of this film is more that the conventional tablet. The disintegration found to be 10 second and percentage drug release 95.45%. Yoshifumi Murata et al Fast-dissolving films (FDFs) were prepared from natural polysaccharides , such as pullulan , without heating, controlling the pH, or adding other materials. The release profiles of model drugs from the films were investigated. In the absence of a drug, the casting method and subsequent evaporation of the solvent resulted in the polysaccharide forming a circular film. The presence of drugs (both their type and concentration) affected film formation. The thickness of the film was controllable by adjusting the concentration of the polysaccharide, Research

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Aditya Dinge et al Mouth dissolving film of Triclosan formulated and evaluated. The potential of poloxamer 407 and hydroxypropyl -β- cyclodextrin (HPBCD) to improve solubility of TC was investigated. 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. Francesco Cilurzo et al Nicotine fast dissolving film of Maltodextrine was formulated and evaluated. MDX with two different dextrose equivalents (DEs), namely DE 6 and DE 12, were selected in order to evaluate the effect of polymer molecular weight on film tensile properties . Nicotine used as Nicotine hydrogen tartarate salt. Among the tested TMA,the milk and mint flavors resulted particularly suitable to mask the taste of NHT. . Research

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Renuka Mishra et al Formulation and evaluation of mouth dissolving film of cetrizine hydrochloride using Pullulan as film forming agent are done. Pullulan is a water soluble polysaccharide produced from yeast Aureobasidium pullulans . Solvent casting was the method used for formation of rapidly dissolving films. The disintegration time was found to be 10 s And 20 second for another batch. The methanol alone was unaccepted for the taste Masking .It is observed that methanol along with the aspartate is suitable for taste masking . The plasticizer used is PEG400. Research Nidhi P. Sapkal et al The mouth dissolving film of ambroxol hydrochloride was prepared by using Polymer HPMC, PEG400,TEEN 80. Ambroxol hydrochloride used as mucolytic agent.Maximum drug release is about 97.40%.

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Objective/Justification To develop analytical method for given drug To formulate mouth dissolving film To study the effect of polymers on release pattern

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Novelty/justification Till date no formulation available on …… drug Disintegration and dissolution within second . Patent oriented. 26 Sr .No Marketed Product Manufactured By 1 Doneprezil,Ondansetron Labtec Pharma 2 Life Saving Rota-Virus to Infant John Hopkings undergraduate Biomedical Engineering students 3 Methylcobalamine,Dextromethorphan,Folic acid,Caffieine Hughes medical corporation 4 Cinnamon strip, Benzocaine strip Dow Chemical Company

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Feasibility Task Feasibility Manufacturing Method Yes Dissolution Yes Tensile strength Length measurement Other evaluation parameter yes

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Plan of work

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References

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Kulkarni P.K ,Dixit M.,formulation and evauation of moth dissolving fil containing Rofecoxib,IRJPonline,273-278 2.Renika Mishra and Avani Amin,formulation and characterisation of mouth dissolving fil of cetrizine hydrochloride,Indian jornal of pharmaceutical education and research71-77 3.Narasimha Rao R.,formulation and evaluation of rapidly dissolving buccal patches, International journal of pharmacy and biological science145-159 4.Vijaykumar Ghorwade,development and evaluation of moth dissolving film of monteleukast sodium,world journal of medical pharmaceuticaland biological science, 06-12 5.Kulkarni A.S,Exploration of different polymers for use in the formulation of oral fast dissolving strips , Journal of Current Pharmaceutical Research , 33-35 6.Francesco Cilurzo , Nicotine Fast Dissolving Films Made of Maltodextrins : A Feasibility Study, AAPS PharmSciTech,1511-1517 7. AAPS PharmSciTech , Formulation and Evaluation of Fast Dissolving Films for Delivery of Triclosan to the Oral Cavity,349-356 8. Renuka Sharma,development of taste masked film of valdecoxib for oral use, IJPSONLINE,320-322 9. Francesco Cilurzo,maltodextrin fast dissolving film a feasibility study, www.technova.srl.it. 10. Nidhi P. Sapkal , Development of fast dissolving oral thin films of ambroxol hydrochloride, Journal of Advanced Pharmaceutical Research, 102-109

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10. S. Raju , Flash release oral films of metoclopramide hydrochloride for pediatric use,indian journal of pharmaceutical and chemical research,636-646 011. Sandeep Saini , Formulation, Development & Evaluation of Oral Fast Dissolving, Anti-Allergic Film of Levocetrizine Dihydrochloride ,journal of pharmaceutical science and research,1322-1325 12. Yoshifumi Murata, Preparation of Fast Dissolving Films for Oral Dosage from. Natural Polysaccharides,MDPI,4291-4295 13. Gupta M.M,Enhancement of dissolution rate of rapidly dissolving oral film of meclizine hydrochloride by complexation of Meclizine ydrochloride with b- cyclodextrin,journal of applied pharmaceutical science,150-153 14. Arun Arya , Fast Dissolving Oral Films: An Innovative Drug Delivery System and Dosage Form, International Journal of ChemTech Research,576-583 15. M.D. Nehal Siddiqui , A Short Review on “A Novel Approach in Oral Fast Dissolving Drug Delivery System and Their Patents”, mAdvances in Biological Research 5 (6): 291-303, 2011 16 Rajni Bala , ORALLY FAST-DISPERSING DRUG DELIVERY SYSTEM – A REVIEW,american journal of pharmatech research,10-32 17. Vishawkarma D.K, REVIEW ARTICLE ON MOUTH DISSOLVING FILM, Journal of Global Pharma Technology,1-8 18. BASANI GAVASKAR, OVERVIEW ON FAST DISSOLVING FILMS, International Journal of Pharmacy and Pharmaceutical Sciences,1-5

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19.Aggarwal Jyoti,fast dissolving film a noel approach to oral drug delivery,International research journal of pharmacy,69-74 20. Priyanka Nagar, Insights into Polymers: Film Formers in Mouth Dissolving Films , Drug Invention Today, 2011, 3(12), 280-289 21. Honey Goel , Orally Disintegrating Systems: Innovations in Formulation and Technology, Recent Patents on Drug Delivery & Formulation 2008, 2, 258-274 22. Apoorva Mahajan , Formulation and Characterization of Fast Dissolving Buccal Films:A Review, cholars Research Library, Der Pharmacia Lettre , 2011, 3(1): 152-165 23. R.P. Dixit, Oral strip technology: Overview and future potential,science direct, Journal of Controlled Release 139 (2009) 94–107 24.Soluble thin film formulation for oral targeted drug delivery,johns hopkings technology transfer,c10078 25. Gajare G. G.,moth dissolving tablet an overview IJPRD, 2011; Vol 3(6): August 2011 (280 - 296)

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