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SEMINAR ONBUCCAL DRUG DELIVERY SYSTEM CONTENTS INTRODUCTION OF BUCCAL MUCOSA.APPROACHES OF BUCCAL DOSAGE FORMIDEAL DRUG CANDIDATESMETHODS TO INCREASE DRUG DELIVERY VIA BUCCAL ROUTEEVALUATIONSADVANTAGES.LIMITATIONSMARKETED PRODUCTS REFERENCESMARKETED PRODUCTS CONCLUSIONS. REFERENSES INTRODUCTION Administration of drug via buccal mucosa linings of cheek and area between upperand lower lips to the systemic circulation . Potential route for typically large hydrophilic and unstable proteins oligonucleotides and poly saccharides For local and systemic drug delivery Most buccal formulations are designed to.provide sustained release of activeingredients BUCCAL MUCOSA Within the oral mucosal cavity delivery of drugs is classified into.three categories i sublingual delivery ii buccal delivery iii local Within the oral mucosal cavity the.buccal region offers an attractive4 63 route of administration for systemic STRUCTURE OF ORAL MUCOSA The oral mucosa is composed of an outermost layer ofstratified squamous epithelium Below this lies a.basement membrane a lamina propria followed by thesubmucosa as the innermost layer A Buccal Epithelium The buccal epithelium is composed of 40 to 50 layersof nonkeratinized stratifiedsquamous cells It is 500 to.800 m in thickness with varying degrees of maturity The uppermost superficial layer of cells is comprisedof flattened compact differentiatedcells of about150 m in thickness PERMEABILITY. oral mucosae is leaky epithelia intermediate betweenthat of epidermis and intestinal mucosa permeability is4 4000 times greater than that of skin B Lamina Propria The lamina propria consists of collagen.fibrils a supporting layer of connectivetissue blood vessels and smooth muscle The structure of the lamina propria is notdense and it is not a barrier to drugpermeation. C Submucosa The submucosa is a relatively denseconnective tissue that contains a fewaccessory salivary glands mucus acinusMucus acini are surrounded by.myoepithelial cells that aid in the secretionof saliva Mucosal Environment The cells of the oral epithelia are surrounded byan intercellular ground substance mucus the.principle components of which are complexesmade up of proteins and carbohydrates The mucus is also believed to play a role inbioadhesion of mucoadhesive drug delivery the presence of saliva produced by the salivary.glands Saliva is the protective fluid for alltissues of the oral cavity It protects the softtissues from abrasion by rough materials andfrom chemicals BUCCAL ROUTE OF DRUG.ABSORPTION There are two permeation pathways forpassive drug transport across the oralmucosa paracellular and transcellular TRANSCELLULAR PERMEATION. Drug permeation through the epithelialcells involves transport across the apicalcell membrane the intracellular space and the basolateral membrane PARACELLULAR PERMEATION. Drug permeation through the epithelial9 63 cells also involves transport through the APPROACHES OF BUCCAL DRUG DELIVERY1 MATRIX TYPE CONVENTIONAL BUCCAL TABLETS . NOVEL BUCCAL ADHESIVE TABLETS 2 RESERVIOUR TYPE BUCCAL PATCHES3 BUCCAL FILMS 4 BUCCAL MUCOADHESIVE HYDROGEL .5 BUCCAL SPRAY 6 FAST DISSOLVING BUCCAL TABLETS 7 BUCCAL WAFERS 8 BUCCAL MICROSPHERE DESIGN OF BUCCAL DOSAGE FORM.I MATRIX TYPE 1 CONVENTIONAL BUCCAL TABLETS 2 NOVEL BUCCAL ADHESIVEHydrophilic and Hydrophobic matrices have been used For moderatly water soluble drugs hydrophilic matrices ofAre widely used to conrol release . Sodium carboxy methyl cellulose SCMC Hydroxypropyl methyl cellulose HPMC sodium alginate andguar gum as mucoadhesive polymers The carbopol 934 is used as a primary polymer becauseof its excellent mucoadhesive property and secondary.polymers like HPMC SCMC and guar gum were used EX A polymeric matrix system containingpectin HPMC and diltizem HCL prepared bydirect compression further two externallayer are applied Geomatrix tri layer tablets . the two external layer control rate ofdehydration of core there by restrictingsurface area available for diffusion Ideal buccal adhesive system maintain it s position in mouth . release the drug in controlled Provide drug release in unidirection Example mucoadhesive buccaltablet of diltiazem HCL Ex verapamil buccal.tablets sumatriptan succinatebuccal tablets ii RESERVIOUR TYPE Contains cavity for drug and additivesseparate from adhesive . Impermiable backing controlsdirection reduce patch deformation anddisintegration BUCCAL ADHESIVE PATCHES Buccal adhesive patches are modified.release dosage form that have potential toprovide controlled drug delivery from 1 to They adhere to buccal mucosa forextended period of time They consists of solid matrix non .dissolvable or slowly dissolvable They may be Unidirectionally bidirectionally 63 multidirectionally . a bidirectional release from adhesive patch bydissolution or diffusion b unidirectional release from patch embedded inan adhesive Shield c bidirectional release from a laminated patch . d unidirectional release from a laminated patch Adhesive polymer itself act as drug carrieror adhesive layer link between drug loadedlayer and mucosa Size generally 1 16 cm2. But 1 3 cm2 used Large sized patches are placed at centralposition of buccal mucosa Two methods used to prepare adhesivepatches include solvent casting and direct.milling In the solvent casting method theintermediate sheet from which patches arepunched is prepared by casting the solutionof the drug and polymer onto a backing18 layer sheet and subsequently allowing the.solvent to evaporate Three basic type of bucccal patches toachieve targeted drug release i monolithic matrix for multidirectionii a multilayer matrix having semi.permeable backing layer iii multilayer matrix havingimpermeable layer over back and side of E g 1 MUCO ADHESIVE BUCCAL PATCHESCONTAINING VERAPAMIL HCL . 2 BUCO ADHESIVE BUCCAL PATCHES OFCARVEDILOL63 B uccal patches prepared from chitosan with BUCCAL FILMS Thin film drug delivery has emerged as an.advanced alternative to the traditionaldosage form placing the strip on or under the tongueor along the inside of the cheek As the strip dissolves the drug can enter.the blood stream buccally or sublingually Buccal mucosa preferred over sub lingual It consists of film forming polymer Plasticizer . Stabilizing and thickning agents BUCCAL FILM E g buccal film of salbutamol MARKETED PRODUCT ONSOLIS FANTANYL BUCCALSOLUBLE FILM .WHICH IS USED IN MANAGEMENT OF SEVERE PAIN OF MUCOADHESIVE HYDROGEL These are hydrophilic matrices that arecapable of swelling when placed inaqueous media . Hydrogels which release the drug byswelling and thereby allowing drugtransport through the spaces in thepolymer network are beingwidelystudied for their use in.bioadhesive gels Polyacrylic basedhydrogels have alsobeen extensivelystudied An example of a commerciallyavailable device is theOTS oraltransmucosal system TheraTech which. MUCOADHESIVE HYDROGEL mainlyused for local action Various polymers are used to preparedmucoadhesive hydrogel such aschitosan and its derivatives . To obtain mucoadhesive hydrogel twoproperties have to be optimised 1 polarity of polymer surface 2 molecular mobility of polymer BUCCAL SPRAYS . GENEREX BIO TECHNOLOGY haveintroduced insulin spray which is used fortype 1 diabetes patients Generex Biotechnology has completed aproof of concept study on buccal delivery of.heparin using their oral spray platformtechnology This technology is being used to develop aformulation for buccal delivery of insulin forthe treatment of diabetes. Buccal spray delivers a mist of fine dropletsonto mucosal membrane probably ontomucin layer The solvent either is absorbed throughmembrane or it is diluted by saliva . The drug substance that in solvent and not63 immediately absorbed is diposited as athin Mucoadhesive poymers Mucoadhesion is defined as the ability of materialadheres to biological tissue for an extended period of.Ideal Characteristics of a Buccal Adhesive Polymer Polymer and its degradation products should be non toxic non irritant and free from leachable impuri ties Should have good spreadability wetting swellingand solubility and biodegradability properties . pH should be biocompatible and should possessgood viscoelastic properties Should adhere quickly to buccal mucosa and shouldpossess sufficient mechanical strength Should possess peel tensile and shear strengths at.the bioadhesive range Polymer shoud have following features suitable surface property for wetting mucus mucosal tissue sufficient flexiblity . predominantly anionic hydrophobicity withhydrogen bond forming groupsFactors to be considerations charge of polymers molecular wt . Fast Dissolving buccal Tablets Fast dissolving buccal tablets for administring a medicamentincludes active ingredients a lubricunt and water solublesugar Such as sorbitol combined such that buccal tabletsdissolves in about one minute .It includes buccally absorbable active ingredients a lubricant mg stearate sds soluble directly compressible excipients spray dried sorbitol such rapid delivery is useful for delivering a bolus dose to.achieve a rapid rise in blood level This is covered by patent U S patent no 5 073 374 BUCCAL WAFERS Buccal wafers are rapidly dissolving oral ORA VESCENT This drug delivery system have been designedto promote drug absorption through oral mucosa buccal . This may enable more rapid absorption of drug that have along Tmax In case where the patient is vomiting frequently Or in migrainegastric transit may be so severely compromised In suchcircumtance this delivery may be advantageous . However this technology is protected by patent Mechanism by means of CO2 release EX An ORA VESCENT fentanyl buccal tablet BUCCAL MICROSPHERE Bioadhesive microspheres offer unique carrier system.for many pharmaceuticals and can be tailored to adhereto any mucosal tissue The bioadhesive microspherescan be used not only for controlled release but also fortargeted delivery of the drugs to specific sites in body Recent advances development of polymeric drug.delivery systems for protein peptide drugs Bioadhesive microspheres exhibit a prolonged residencetime at site of application or absorption and facilitate anintimate contact with underlying absorption surface andthus contribute to improved and or better therapeutic.performance of drugs E g Bio adhesive polymer grafted starch microspherebearing isosorbide dinitrite for buccal delivery chemicalabstracts BUCCAL COVERED TABLET SYSTEM BCTS . This method restric disintegration from the sides of tablets The method involve sandwiching a slowly disintegration buccalmucoadhesive plain tablet between two poly ethylene sheets The upper sheets contained a hole that allowed tablet to absorbwater and disintegrate only through hole . The lower sheet contained adhesive to allow the delivery systemto adhere to gingiva for a long time LIQUID CRYSTALLINE PHASES OF GLYCERYL MONO OLEATE AS BDDS FOR PEPTIDE AND PROTEIN lyotrophic LCP cobic lamellar reversed micellar hexagonal phase . cubic type LCP have ability to incorporate various size of bothhydrophilic and hydrophobic drugs several innovative self actuated drug delivery devices designed foradministration of drugs to the tissue of the intraoral cavity and thebuccal mucosa are being developed including. aerosol sprays liquid pump sprays Activated mists i e RapidMist device needleless injectors i e PowderJect device These devices are being developed in multidose formats for a.variety of dugs requiring control of diabetes i e insulin pain e g fentanyl and morphine anticoagulants i e heparin flu vaccines i e influenza delivered noninvasively to the oral.cavity for buccal absorption The IntelliDrug device The IntelliDrug device represents arevolutionary method for delivering drugsfor long term chronic diseases through the.buccal mucosa according to the patientneeds in periods lasting days weeks orFormulation and evaluation of muco adhesive tablet of timololmaleate. Formulation and in vitro evaluation of mucoadhesivebuccal tablets of diltiazem. Study of various polymers in buccal drug delivery system.