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SticksEUROPEANPHARMACOPOEIA6.0whengentlepressureisappliedandcanbepeeledoffwithoutcausingappreciableinjurytotheskinordetachmentofthepreparationfromtheouter,supportinglayer.TESTSDissolution.Asuitabletestmayberequiredtodemonstratetheappropriatereleaseoftheactivesubstance(s),forexampleoneofthetestsdescribedinDissolutiontestfortransdermalpatches(2.9.4).01/2008:1154STICKSStyliAdditionalrequirementsforsticksmaybefound,whereappropriate,inothergeneralmonographs,forexampleNasalpreparations(0676).DEFINITIONSticksaresolidpreparationsintendedforlocalapplication.Theyarerod-shapedorconicalpreparationsconsistingofoneormoreactivesubstancesaloneorwhicharedissolvedordispersedinasuitablebasiswhichmaydissolveormeltatbodytemperature.Urethralsticksandsticksforinsertionintowoundsaresterile.PRODUCTIONInthemanufacture,packaging,storageanddistributionofsticks,suitablemeansaretakentoensuretheirmicrobialquality;recommendationsonthisaspectareprovidedinthetextonMicrobiologicalqualityofpharmaceuticalpreparations(5.1.4).Urethralsticksandothersterilesticksarepreparedusingmaterialsandmethodsdesignedtoensuresterilityandtoavoidtheintroductionofcontaminantsandthegrowthofmicro-organisms;recommendationsonthisaspectareprovidedinthetextonMethodsofpreparationofsterileproducts(5.1.1).Inthemanufactureofsticksmeansaretakentoensurethatthepreparationcomplieswithatestformassuniformityor,whereappropriate,atestforuniformityofcontent.TESTSSterility(2.6.1).Urethralsticksandsticksforinsertionintowoundscomplywiththetestforsterility.LABELLINGThelabelstates:—thequantityofactivesubstance(s)perstick,—forurethralsticksandstickstobeinsertedintowoundsthattheyaresterile.01/2008:0478TABLETSCompressiTherequirementsofthismonographdonotnecessarilyapplytopreparationsthatarepresentedastabletsintendedforuseotherthanbyoraladministration.Requirementsforsuchpreparationsmaybefound,whereappropriate,inothergeneralmonographs;forexampleRectalpreparations(1145),Vaginalpreparations(1164)andOromucosalpreparations(1807).Thismonographdoesnotapplytolozenges,oralpastesandoralgums.Wherejustifiedandauthorised,therequirementsofthismonographdonotapplytotabletsforveterinaryuse.DEFINITIONTabletsaresolidpreparationseachcontainingasingledoseofoneormoreactivesubstances.Theyareobtainedbycompressinguniformvolumesofparticlesorbyanothersuitablemanufacturingtechnique,suchasextrusion,mouldingorfreeze-drying(lyophilisation).Tabletsareintendedfororaladministration.Someareswallowedwhole,someafterbeingchewed,somearedissolvedordispersedinwaterbeforebeingadministeredandsomeareretainedinthemouthwheretheactivesubstanceisliberated.Theparticlesconsistofoneormoreactivesubstanceswithorwithoutexcipientssuchasdiluents,binders,disintegratingagents,glidants,lubricants,substancescapableofmodifyingthebehaviourofthepreparationinthedigestivetract,colouringmatterauthorisedbythecompetentauthorityandflavouringsubstances.Tabletsareusuallystraight,circularsolidcylinders,theendsurfacesofwhichareflatorconvexandtheedgesofwhichmaybebevelled.Theymayhavebreak-marksandmaybearasymbolorothermarkings.Tabletsmaybecoated.Whereapplicable,containersfortabletscomplywiththerequirementsformaterialsusedforthemanufactureofcontainers(3.1andsubsections)andcontainers(3.2andsubsections).Severalcategoriesoftabletsfororalusemaybedistinguished:—uncoatedtablets;—coatedtablets;—effervescenttablets;—solubletablets;—dispersibletablets;—orodispersibletablets;—gastro-resistanttablets;—modified-releasetablets;—tabletsforuseinthemouth;—orallyophilisates.PRODUCTIONTabletsareusuallypreparedbycompressinguniformvolumesofparticlesorparticleaggregatesproducedbygranulationmethods.Inthemanufactureoftablets,meansaretakentoensurethattheypossessasuitablemechanicalstrengthtoavoidcrumblingorbreakingonhandlingorsubsequentprocessing.Thismaybedemonstratedusingthetestsdescribedinchapters2.9.7.Friabilityofuncoatedtabletsand2.9.8.Resistancetocrushingoftablets.Chewabletabletsarepreparedtoensurethattheyareeasilycrushedbychewing.748Seetheinformationsectionongeneralmonographs(coverpages)EUROPEANPHARMACOPOEIA6.0TabletsSubdivisionoftablets.Tabletsmaybearabreak-markorbreak-marksandmaybesubdividedinparts,eithertoeasetheintakeofthemedicinalproductortocomplywiththeposology.Inthelattercase,subdivisionmustbeassessedandauthorisedbythecompetentauthority.Inordertoensurethatthepatientwillreceivetheintendeddose,theefficacyofthebreak-mark(s)mustbeassessedduringthedevelopmentoftheproduct,inrespectofuniformityofmassofthesubdividedparts.Eachauthoriseddosemustbetestedusingthefollowingtest.Take30tabletsatrandom,breakthembyhandand,fromallthepartsobtainedfrom1tablet,take1partforthetestandrejecttheotherpart(s).Weigheachofthe30partsindividuallyandcalculatetheaveragemass.Thetabletscomplywiththetestifnotmorethan1individualmassisoutsidethelimitsof85percentto115percentoftheaveragemass.Thetabletsfailtocomplywiththetestifmorethan1individualmassisoutsidetheselimits,orif1individualmassisoutsidethelimitsof75percentto125percentoftheaveragemass.Inthemanufacture,packaging,storageanddistributionoftablets,suitablemeansare