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Edit Comment Close Premium member Presentation Transcript ORAL STRIP TECHNOLOGY: ORAL STRIP TECHNOLOGY Presented By Yogesh A.Shirsath Guided by Dr.C.R.Kokare Department of Pharmaceutics Sinhgad Technical Education Society’s Sinhgad Institute of Pharmacy, Narhe , Pune-41 25 Apr 2011 1 Oral Strip TechnologyCONTENTS: CONTENTS Introduction. Overview of the oral mucosa. Advantages & disadvantages. Strip forming agents. Plasticizers. Active pharmaceutical ingredients(API). Sweetening agents. Saliva stimulating agents. Stabilizing and thickening agents. Permeation enhancers. Manufacturing & production of strips. Quality control tests. Case study. Applications. 25 Apr 2011 2 Oral Strip TechnologyINTRODUCTION: INTRODUCTION Oral film It is relatively a new dosage form in which thin film is prepared using hydrophilic polymers rapidly dissolves on tongue or buccal cavity. 25 Apr 2011 3 Oral Strip TechnologyOVERVIEW OF THE ORAL MUCOSA: OVERVIEW OF THE ORAL MUCOSA 25 Apr 2011 Oral Strip Technology 4 Buccal cavity comprises of stratified squamous epithelium which is essentially separated from the underlying tissue of lamina propria and submucosa by an basement membrane. Epithelia of oral cavity are also composed of an intercellular ground substance called as mucus which basically consists of proteins and carbohydrates.ADVANTAGES: ADVANTAGES Rapid Disintegration. Films are flexible easy for transportation and handling and storage. First pass effect can be avoided. Reduction in side effects associated with the drug. Precision in administration of dose. Useful for patient suffering from diseases like Motion sickness Mental disorder Repeated emesis. Better acceptance. 25 Apr 2011 5 Oral Strip TechnologyDISADVANTAGES: DISADVANTAGES Drugs which are unstable at buccal pH cannot be administered. Drugs which irritate the mucosa or have a bitter or unpleasant taste or an obnoxious odor cannot be administered by this route. Drug with small dose requirement can be administered. Drugs which are absorbed by passive diffusion can be administered by this route. Eating and drinking may become restricted. 25 Apr 2011 6 Oral Strip Technology STRIP FORMING AGENTS : STRIP FORMING AGENTS At least 45%w/w of polymer should present based on the total weight of dry OS Should show fast disintegration. Polymers used for OS should have good shelf life. Should not cause secondary infections in the oral mucosa or dental regions. Should be non-toxic, non-irritant and devoid of leachable impurities Should have good wetting and spreadability property. Should exhibit sufficient peel, shear and tensile strengths. Should be readily available and should not be very expensive. 7 25 Apr 2011 7 Oral Strip TechnologyCOMMON STRIP FORMING POLYMERS: COMMON STRIP FORMING POLYMERS Hydroxyl propyl methyl cellulose Hydroxy Propyl cellulose Starch and modified starch Pullunan Pectin Gelatin Carboxy methyl cellulose PVP+Cross linked PVP 25 Apr 2011 8 Oral Strip TechnologyMUCOADHESIVE POLYMERS: MUCOADHESIVE POLYMERS Polycarbophil . Cellulose derivatives like hydroxy propyl methylcellulose, sodium carboxy -methyl cellulose, hydroxyl ethyl cellulose, hyaluronic acid. Xanthan gum, locust bean gum, guar gum, carrageenan , sodium alginate, chitosan . Polyphosphazenes, Second generation mucoadhesive polymers include thiolated polymers. 25 Apr 2011 9 Oral Strip TechnologyPLASTICIZERS: PLASTICIZERS Improves the flexibility of the strip and reduces the brittleness of the strip. Inappropriate use of plasticizer may lead to film cracking, splitting and peeling of the strip Plasticizers are used in the concentration up to 20%w/w of dry polymer weight of OS. Commonly used Plasticizers-Glycerol, Propylene glycol, low molecular weight polyethylene glycols, phthalate derivatives- dimethyl , diethyl and dibutyl phthalate, Citrate derivatives- tributyl , triethyl , acetyl citrate, triacetin and castor oil. 25 Apr 2011 10 Oral Strip TechnologyACTIVE PHARMACEUTICAL INGREDIENTS(API): ACTIVE PHARMACEUTICAL INGREDIENTS(API) High dose molecules are difficult to be incorporated in OS. 5%w/w to 30%w/w of active pharmaceutical ingredients can be incorporated in the OS. Multivitamins incorporate up to 10% w/w of dry film weight. Bitter taste can be reduced by- complexation, polymeric coating, conversion into microparticles/microcapsules, coated particles or coated granules technologies. 25 Apr 2011 11 Oral Strip TechnologySWEETENING AGENTS : SWEETENING AGENTS Natural sweeteners as well as artificial sweeteners are used to improve the palatability of the formulations. Sucrose, Dextrose, Fructose, Glucose, Polyhydric alcohols- sorbitol , Mannitol , Isomalt and maltitol . Fructose is perceived rapidly in the mouth as compared to sucrose and dextrose. Fructose is sweeter than sorbitol and mannitol and thus used widely as a sweetner . Artificial sweeteners- Saccharin, cyclamate, aspartame, Acesulfame -K, Sucralose Alitame, Neotame. 25 Apr 2011 12 Oral Strip TechnologySlide 13: SALIVA STIMULATING AGENT- Concentration up to 2-6%w/w of strip. Increase the rate of production of saliva & faster disintegration of strip formulations. Citric acid, Malic acid, Lactic acid, Ascorbic acid,Tartaric acid. FLAVORING AGENT- The amount of flavor needed to mask the taste depends on the flavor type and its strength. Up to 10%w/w flavors are added in the OS formulations. Geriatric population-mint or orange flavors Younger generation-punch, raspberry Other flavors- Pippermint , Cinnamon oil, Vanilla,Coffee,Chocalate 25 Apr 2011 13 Oral Strip TechnologySlide 14: COLORING AGENTS- Concentration up to10%w/w of strip. Pigments such as titanium dioxide & FD & C approved coloring agents used. STABILIZING AND THICKENING AGENTS It improves the viscosity & consistency. Natural gums like Xanthan gum, Locust bean gum, Carrageenan . And Cellulose derivatives can be used in the concentration up to 5%w/w as thickening agents . 25 Apr 2011 14 Oral Strip TechnologyPERMEATION ENHANCERS: PERMEATION ENHANCERS Permeation enhancers are pharmaceutical ingredients included in a formulation in order to improve the permeation characteristics of the drug. Permeation through the buccal epithelium occurs either by the transcellular or by the paracellular route overall process governed by passive diffusion. 25 Apr 2011 Oral Strip Technology 15 Permeation enhancer Examples Surfactants Sodium dodecyl sulfate Sodium lauryl sulfate Bile salts Sodium glycocholate Sodium taurocholate , sodium glycodeoxycholate , and sodium taurodeoxycholate Fatty acids Oleic acid ChitosanMANUFACTURE AND PRODUCTION OF ORAL STRIPS: MANUFACTURE AND PRODUCTION OF ORAL STRIPS 1.HOT MELT EXTRUSION METHOD- In the extrusion process the API and other ingredients are mixed in dry state, subjected to heating process and then extruded out in molten state. In this process, solvents are completely eliminated. The strips are further cooled and cut to the desired size. The high temperature used in this process may degrade thermolabile APIs. 25 Apr 2011 16 Oral Strip Technology2. SOLVENT CAST METHOD: 2. SOLVENT CAST METHOD Process consists of at least six steps: Preparation of the casting solution, Deareation of the solution, Transfer of the appropriate volume of solution into a mold, Drying the casting solution, Cutting the ﬁnal dosage form to contain the desired amount of drug, Packaging. 25 Apr 2011 17 Oral Strip TechnologySOLVENT CAST METHOD: SOLVENT CAST METHOD Citation-R.P. Dixit, S.P. Puthli , Oral strip technology: Overview and future potential, Journal of Controlled Release 139 (2009) 94–107 25 Apr 2011 18 Oral Strip Technology B.Strip cutting a, Reservoir for film forming materials b.deaerater c.roller D.printing E.cuttingQUALITY CONTROL TESTS : QUALITY CONTROL TESTS 1.THICKNESS The thickness of strip can be measured by micrometer screw gauge at different strategic locations. This is essential to assure uniformity in the thickness of the ﬁlm as this is directly related to the accuracy of dose. 25 Apr 2011 19 Oral Strip Technology2.TENSILE STRENGTH: 2.TENSILE STRENGTH Tensile strength is the maximum stress applied to a point at which the strip specimen breaks. It is calculated by the applied load at rupture divided by the cross-sectional area of the strip as given in the equation below: Load at failure × 100 Strip thickness × Strip width Tensile strength = 25 Apr 2011 20 Oral Strip Technology3.PERCENT ELONGATION: 3.PERCENT ELONGATION When stress is applied, a strip sample stretches and this is referred to as strain. Strain is basically the deformation of strip divided by original dimension of the sample. Generally elongation of strip increases as the plasticizer content increases Increase in length of strip × 100 Initial length of strip % elongation = 25 Apr 2011 21 Oral Strip Technology 4.TEAR RESISTANCE: 4.TEAR RESISTANCE Tear resistance of plastic ﬁlm or sheet is a complex function of its resistance to rupture. Basically very low rate of loading 51 mm (2 in.)/min is employed and is designed to measure the force to initiate tearing. The maximum stress or force (that is generally found near the onset of tearing) required to tear the specimen is recorded as the tear resistance value in Newton (or pounds-force). 25 Apr 2011 22 Oral Strip Technology5.YOUNG'S MODULUS: 5.YOUNG'S MODULUS Young's modulus or elastic modulus is the measure of stiffness of strip. It is represented as the ratio of applied stress over strain in the region of elastic deformation Slope of stress-strain curve × 100 Strip thickness × cross-head speed Young’s modulus = 25 Apr 2011 23 Oral Strip Technology6. FOLDING ENDURANCE: 6. FOLDING ENDURANCE Folding endurance is determined by repeated folding of the strip at the same place till the strip breaks. The number of times the ﬁlm is folded without breaking is computed as the folding endurance value. 25 Apr 2011 24 Oral Strip Technology7.DISSOLUTION TEST: 7.DISSOLUTION TEST Dissolution testing can be performed using the standard basket or paddle apparatus described in any of the pharmacopoeia. The dissolution medium will essentially be selected as per the sink conditions. Many times the dissolution test can be difficult due to tendency of the strip to ﬂoat on to the dissolution medium when the paddle apparatus is employed . 25 Apr 2011 25 Oral Strip TechnologySlide 26: 8.DISINTEGRATION TIME Although, no official guidance is available for films strips. Pharmacopoeial disintegrating test apparatus may be used for this study. Typical disintegration time for strips is 5–30 s 9.CONTENT UNIFORMITY- Determined by any standard assay method of API in any standard pharmacopoeia. Limit of content uniformity is 85–115 percent 25 Apr 2011 26 Oral Strip TechnologyCASE STUDY: CASE STUDY ORAL PATCH TREATMENT HEALS CANKER SORES Study Conducted at: Department of Dermatology, C. Sheba Medical Center, Huzot Clinic, Clalit Health Services, Ashkelon, School of Pharmacy, Faculty of Medicine, The Hebrew University, Jerusalem, Israel. The study evaluated the efficacy and tolerability of two topical medications for the treatment of canker sores ( aphthous stomatitis ), Canker Cover, an oral patch and Kanka , a benzocaine based oral solution.. 25 Apr 2011 27 Oral Strip TechnologyCANKER SORES: CANKER SORES Canker sores are shallow, painful sores on the inside of the lips, the inside of the cheeks, or on the gums. They begin as small, reddish swellings. Then they burst, and the ruptured sores are covered with a white or yellow membrane. The edges of the sores are still red, and look like a painful red hole. Without treatment, canker sores heal in 2 to 3 weeks. Causes Stress, vitamin B12 or iron deficiencies, menstruation, hormonal changes, and food allergies are all suspected. 25 Apr 2011 28 Oral Strip TechnologyDETAIL OF STUDY: DETAIL OF STUDY 48 patients were enrolled to the study. 7 patients left due to personal reasons. 23 patients were treated with the oral patch containing citrus oil, a carnelite mineral blend and menthol And 20 were treated with the oral solution containing benzocaine and benzoine . 25 Apr 2011 29 Oral Strip Technology SUMMARY OF STUDY: SUMMARY OF STUDY Observation Canker Cover(Patch) Oral Solution ( Kanka ) 1.Side effects 43% of the Canker Cover users reported side effects but they stopped within the first hour. 100% of the benzocaine users reported one or more minor side effects. 2.Difficulty swallowing after treatment 4% of Canker Cover users difficulty swallowing after treatment. 35% of those treated with the oral solution had difficulty swallowing after treatment. 3. Product use in future 87% of those treated with Canker Cover would use the product again 50% of the benzocaine users would use it again 4. Pain levels Lower after 12 hours. Lower after 24 hours. 5. Complete resolution of the canker sore 24 hours. 120 hours. 25 Apr 2011 30 Oral Strip TechnologyAPPLICATION: APPLICATION Product category Ingredients applications 1. Bioﬁlm Energy boosters Caffeine, green tea extract and guarana The product maintains the energy levels. 2. Male vitality strip Maca root extract and Siberian ginseng extract, herbs which enhance libido, It acts as an aphrodisiac. 3. Vitamins and food supplements Various vitamins, minerals and supplements For the people who do not like to use the tablets or soluble supplements. 4. Labtec GmbH Ondansetron Rapidﬁlm ® Ondansetron Prevention of chemotherapy and radiation-induced nausea and vomiting 5.Donezepil Rapidﬁlm ® Donepezil Hydrochloride Dementia of the Alzheimer's type. 25 Apr 2011 31 Oral Strip TechnologyAPPLICATION(cont.): APPLICATION(cont.) Observation Ingredients applications 6. Breath freshener strip, (Antibacterial strip) Contain mint favor and antibacterial agent, Mouth freshener and to stop bad breath. 7. Smoking cessation Nicotine To reduce the smoking habit 8. Suppress™ Cough strips with Dextromethorphan Dextromethorphan hydrobromide Suppresses coughs due to minor throat and bronchial irritation 9. Loratidine strip Loratidine Non sedative antihistaminic agent used to treat the allergy. 10. Diphenhydramine strip Diphenhydramine Antihistaminic, sedative, hypnotic and antiemetic 11. Listerine pocketpaks Available in cool mint®, Fresh Citrus, Cinnamon,& fresh burst Strips dissolve instantly and kill 99% of bad breath germs 25 Apr 2011 32 Oral Strip TechnologyCONCLUSION: CONCLUSION Oral strip is consumer friendly alternative to oral disintegrating tablets. Hepatic first pass metabolism effect is avoided and showing less side effect. It is easy to fabricate and reduce the overall cost. The use of penetration enhancers in buccal films not hinders the manufacturing capability nor imposes mucosal irritation or toxicity. Many companies are developing oral strip and have pipeline of molecules for shifting their existing tablet preparations into oral strips. 25 Apr 2011 Oral Strip Technology 33REFERENCES: REFERENCES 1. R.P. Dixit, S.P. Puthli , Oral strip technology: Overview and future potential, Journal of Controlled Release 139 (2009) 94–107. 2. Francesco Cilurzo , Irma E. Cupone, Paola Minghetti, Francesca Selmin, Luisa Montanari, Fast dissolving films made of maltodextrins, European Journal of Pharmaceutics and Biopharmaceutics 70 (2008) 895-900 3. Javier O. Morales, Jason T. McConville , Manufacture and characterization of mucoadhesive buccal films, European Journal of Pharmaceutics and Biopharmaceutics 77 (2011) 187–199 4. Viralkumar F. Patel a, Fang Liu a, Marc B. Brown, Advances in oral transmucosal drug delivery, Journal of Controlled Release (2011)Article in press. 5. Hiroyoshi Shimoda , et al. Preparation of a fast dissolving oral thin film containing dexamethasone:A possible application to antiemesis during cancer chemotherapy, European Journal of Pharmaceutics and Biopharmaceutics 73 (2009) 361–365 6. Avner Shemer , MD, Boaz Amichai , MD, Henri Trau , MD, Boaz Mizrahi, MSc , Abraham J. Domb , Ph.D , Nir Nathansohn , MD, MHA , Drugs in R&D 9, (2008),29-35(7), Adis International . 7. Basani Gavaskar , Subash Vijaya Kumar, Guru Sharan , Y.Madhusudan Rao , Overview On Fast Dissolving Films, International Journal of Pharmacy and Pharmaceutical Sciences, 2(2010). 8. Aditya Dinge , Mangal Nagarsenker , Formulation and Evaluation of Fast Dissolving Films for Delivery of Triclosan to the Oral Cavity, AAPS PharmSciTech , 9 (2008 ). 9. Mona Semalty , A. Semalty , G. Kumar,Formulation and Characterization of Mucoadhesive Buccal Films of Glipizide,Indian Journal of Pharmaceutical Science,70(2010). 25 Apr 2011 34 Oral Strip TechnologySlide 35: 25 Apr 2011 Oral Strip Technology 35 THANK YOU You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.