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Oro dispersible films

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a brief review on oro dispersible films

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Oro dispersible films

  1. 1. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 1 VIGNAN PHARMACY COLLEGE (Approved by AICTE, PCI-New Delhi & Affiliated to JNTUK- Kakinada) Vadlamudi (V), Chebrolu (M), Guntur (Dt.) – 522 213
  2. 2.  Introduction  Applications  Formulation development  Evaluation  Market potential  FDA approved drugs  Commercially available marketed products  Conclusion  References 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 2 .
  3. 3. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 3 Oro-dispersible film drug-delivery systems were first developed in the late 1970s as based on the technology of the transdermal patch. An alternative to tablets, capsules, and syrups for paediatric and geriatric patients who experienced difficulties in swallowing traditional oral solid-dosage forms.
  4. 4. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 4 A solid dosage form that dissolves or disintegrates quickly in the oral cavity, resulting in solution or suspension without need for the administration of water, is known as Oral Fast-dispersing dosage form. These are also called as: Orally dissolving films Flash release wafer Wafer Quick dissolving film Soluble or Buccal film- Preferred by FDA European Medicines Agency using Oro-Dispersible films Definition:
  5. 5. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 5 ADHESIVE LAYER INTERMEDIATE LAYER BACKING LAYER Contains API Or Adhesion purpose only Contains API Drug dissolution Or Shielded between layers Permanent Or Dissolvable 5
  6. 6. • Thin elegant film • Available in various sizes and shapes • Less fragile when compared to ODT • Excellent mucoadhesion • Dosage accuracy • Rapid release • Can be administered without water • Most acceptable dosage form for dysphagic patients 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 6
  7. 7. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 7 • Thickness ranges from 2-500mm & it’s surface area is 1-20 cm². • Its low dry tack allows for ease of handling & application. • Its rapid hydration rate facilitates fast softening & absorption. • 2mm thickness of film will take 5-10sec to start its disintegration.
  8. 8. ADVANTAGES: 1. Improved oral absorption 2. Faster onset of action 3. Minimized first – pass effect 4. Improved bio availability 5. Accurate dosing 6. No special training is required for administration 7. Reduced gastrointestinal irritation DISADVANTAGES: 1. High dose can't be incorporated 2. Drug unstable in buccal pH can’t be administrated 3. Need special packing has they must be protected from water 4. Drugs with obnoxious odor can not be given 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 8
  9. 9. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 9 Topical application: Feasible in delivery of active agents like analgesics or anti-microbial agents Gastro retentive dosage systems: Poorly water soluble and high molecular weight molecules incorporated into films, dissolution triggered by PH or enzymatic secretions Diagnostic devices: Multiple agents can be incorporated in the film for timed release in diagnostic device
  10. 10. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 10 Comparison between fast dissolving tablets and films Fast dissolving Tablets Fast dissolving Films Lesser dissolution due to less surface area Greater dissolution due to large surface area Less durable as compared with oral films Better durable than oral disintegrating tablets Less patient compliance than films More patient compliance High dose can be incorporated Low dose can only be incorporated It has fear of chocking No risk of chocking
  11. 11. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 11 1. Flash release wafers 2. Mucoadhesive melt away wafers 3. Mucoadhesive sustained release wafers PROPERTIES FLASH RELEASE WAFERS MUCO-ADHESIVE MELT AWAY WAFERS MUCO-ADHESIVE SUSTAINED WAFERS Area(cm2) 2-8 2-7 2-4 Thickness(mm) 20-70 50-500 50-250 Structure Single layer system Single or multilayer Multilayer system Excipients Soluble hydrophilic polymer Soluble hydrophilic polymer Low/non-soluble polymer Drug phase Solid solution Solid solution or suspended solution Suspension and/or solid solution Dissolution 60 sec Few min Max 8-10 hrs Application Tongue Gingival or buccal region Gingival (other region in oral cavity) Classification of Oral thin films:
  12. 12. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 12 Category Conc(%) Examples Drug 1-25 NSAIDS, Antiemetic, Anti asthmatic, Snoring agents, Erectile dysfunction drugs Hydrophilic Polymers 40-50 Pullulan, Gelatin, Starch, Sodium alginate, Pectin, Maltodextrin, HPMC, HPC, PEO, Kollicoat, PVA, PVP. Novel film forming polymer: Rosin Plasticizer 25-35 PEG,PG, PHTHALATE Derivatives Saliva secreting agents 2-6 Citric acid, Malic acid, Tartaric acid Sweetener 2-10 Sucrose, Glucose,Fructose Aspartame, Sucralose Flavor 2-5 Peppermint, vanilla,cofee, chocalate, Strawberry, Lemon
  13. 13. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 13 • Mouth dissolving film can be prepared by five methods: 1. Solvent casting method 2. Semisolid casting method 3. Hot melt extrusion 4. Solid dispersion technique. 5. Rolling method • Generally Solvent casting method is most preferred for the manufacture of mouth dissolving film. 13
  14. 14. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 14 SOLVENT CASTING METHOD 1. • In solvent casting method excipients are dissolved in water. Then water soluble polymers and in last drug is added. 2. • Solutions are stirred with the help of magnetic stirrer for 5 mins. to form a homogenous solution 3. • Finally casted in to the Petri plate and dried at 40°C temp in hot air oven. 14
  15. 15. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 15 Finally the melt is shaped in films by the dies Extruders having heaters melts the mixture The drug is mixed with carrier in solid form 15 HOT – MELT EXTRUSION
  16. 16. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 16 Drug is dissolved in a suitable liquid solvent Then solution is incorporated into the melt of polyethylene glycol, obtainable below 700c Solid dispersions are shaped into the films by means of dies. 16 SOLID DISPERSION EXTRUSION
  17. 17. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 17 In this method firstly solutions or suspension of the drug is prepared Either water or mixture of water and alcohol are mainly used Suspension or solution containing drug is rolled on the carrier Films are dried on the rollers and cut in to desired shapes and sizes 17 ROLLING METHOD
  18. 18. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 18 MORPHOLOGY STUDY Scanning electron microscope Visual inspection THICKNESS Micrometer screw gauge WEIGHT VARIATION Digital vernier callipers . TENSILE STRENGTH (Load at failure * 100) FOLDING ENDURANCE A typical folding endurance for a film is 100 – 150 TRANSPARENCY Transperancy=(logT600)/b=-€c (Strip thickness * Strip width)
  19. 19. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 19 PERCENTAGE ELONGATION (Increase in length of strip / initial length of strip) * 100 SWELLING PROPERTY (Wt – W0) / W0 SURFACE PH OF FILM PH meter MOISTURE CONTENT Karl Fischer titration method or weight variation (Wt – W0) / W0 PERMEATION STUDIES Franz diffusion cell DISINTEGRATION TIME Typical disintegration time for film is 30s Tests: Slide frame method Petri dish method CONTACT ANGLE Goniometer DISSOLUTION USP Type I or Type II
  20. 20. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 20 Packaging for oral thin films includes foil paper or plastic pouches, single pouch, aluminum pouch, blister packaging with multiple units and barrier films. Barrier films are most commonly used for those drugs which are extremely moisture sensitive . The films are manufactured by Rapid film technology developed by Labtec GmbH describes primary packaging made of a sealing pouch affords enough space for logos, codes, instructions or other information. Barrier films were prepared by a laminating process and packaging costs are comparable to tablets
  21. 21. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 21 • With the reference to Research and Market : Oral Thin Films Market ,2015-2025:jan 2015 1. As per the market projection study for 2015-2025, owns a good prospective of growth as a upcoming technology of drug delivery. 2. 10 oral films are in market and another 29 are in the stage of various clinical and pre clinical trials. 3. Around 10 proprietary technologies like PharmFilm, RapidFilm, Bio- FX, etc are coming up which has 38% of the market. 4. Thus there is a potential ground of research in this technology.
  22. 22. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 22 Drug Year Company Versafilm(Rizatriptan) Feb /4 /2014 IntelGenx and RedHill Biopharma Suboxone (Buprinorphine or Naloxone) 31/08/2010 Reckitt Benckiser Pharmaceuticals Inc. Zulpenz January 2010 Pharmfilm technology Ondansetron 23rd march 2010 APR Applied Pharma research s.a (“APR”) and Labtech GmbH(“Labtech”) Zelapar October 2005 Valent Pharmaceuticals Interanational Inc
  23. 23. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 23 Brand Distributor Drug BenadrylR Allergy quick dissolve strips McNeil-PPC Diphenhydramine HCL Gas –XR thin strips Novartis consumer health Simethicone Risperidon HEXALR SF Schmelzfilm Hexal AG Risperidone SudafedR quick dissolve strips McNeil-PPC Phenylephrine HCL TherafluR Thin strips long acting cough Novartis consumer health Dextromethorphan HBr ZulpenzTM Sativa Pharmaceuticals Ondansetron
  24. 24. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 24 Brand Distributor Drug ChlorasepticR Sore Throat Relief Strips Prestige brands Benzocaine OrajelR Kids Sore Throat Relief Strips Church & Dwight Co. Pectin Snoreez Oral Strips Passion For Life Healthcare Peppermint oil, vitamin E, sodium hyaluronate, guar gum
  25. 25. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 2525
  26. 26. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 26
  27. 27. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 27 The brief review on oral films concludes with the note that they are considered as a most promising and important drug delivery system because of their rapid disintegration include dissolution properties especially with pediatrics and geriatrics patients. Even though most of the formulations today are developed as ODTs, oral films has gained more popularity because of their easy portability, improved patient compliance and easy of administration.
  28. 28. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 28 They can be applied by both oral and buccal routes. apart from being used as medicament films(local anesthetic ,vitamins supplements and cold allergy remedies). They can also be used for refreshing the breath. This technology is growing in fast pace challenging most of the pharmaceutical companies to develop oral films for a wide range of active pharmaceutical ingredients.
  29. 29. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 29 REFERENCES  Arya A, Chandra A, Sharma V, (2010). Fast Dissolving Oral Films: An Innovative Drug. International Journal of ChemTech Research. 2 (1), 576-583.  Varma S N, Sharma P K, (2014). Buccal Film: An Advance Technology for Oral Drug Delivery. Advances in Biological Research. 8 (6),260-267.  Jain N.K., (2005). Controlled and Novel Drug Delivery. 1st ed. New Delhi: CBS Publishers and Distributers. pp- 52-56.  Tarjani et.al,(2014)Evaluation of mouth dissolving films:physical and chemical methods.Eijppr 4(1):62-65.  Chonkar ankita D. Et al,(2015) an overview on fast dissolving oral films.www.asiapharmaonline.org,5(3):129-137. 2 9
  30. 30. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 30 Eva maria et al.,(2011), Advances in orodispersible films for drug delivery.informa health care 8(3):299-316 Alpesh R.Patel et al.,(2010), fast dissolving films as new venture in fast dissolving dosage forms.International journal of drug development and research , 2(2):232-246 Muhammad irfan et al.,(2015),orally disintegrating films A modern expansion in drug delivery systems.Saudi pharmaceutical journal Udhan ravindra radha kisan et ai.,(2012),Mouth dissolving films and their overview.International research journal of pharmacy,3(9):39-42 Yogyata S. Pathare ew al., (2013), Polymers used for Fast Disintegrating Oral Films: Review, International Journal Of Pharmaceutical Sciences Review And Research.,21(1):169-178
  31. 31. 3/12/2017 vignan pharmacy college , dep. of pharmaceutics 31

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