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外文翻译--混合性能单轴构件式搅拌机 英文版.pdf

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外文翻译--混合性能单轴构件式搅拌机 英文版.pdf

08855,BlenderAcetaminophenpowderSomeer.Iwithrespecttotwoaxesahorizontalaxistumblingmotion,andacentralsymmetryaxisspinningisconductedonmixingperformanceofpowdersandtheeffectofcriticalinametallthelongativeltypeisthetumblingblender,wheregrainsflowbydevice,mixingandsegregationmechanismsinthesedevicesarenotmicronizedAcetaminophen.WeuseextensivesamplingtocharacterPowderTechnology19620091–7ContentslistsavailableatScienceDirectPowderTechnologysfullyunderstoodandthedesignofblendingequipmentislargelybasedonempiricalmethods.Tumblersarethemostcommonbatchmixersinindustry,andalsofinduseinmyriadofapplicationasdryers,kilns,coaters,millsandgranulators4–8.Whilefreeflowingmaterialsinrotatingdrumshavebeenextensivelystudied9,10,cohesivegranularflowsinthesesystemsarestillnotcompletelyunderstood.LittleisknownabouttheeffectoffundamentalparamizemixingbytrackingtheevolutionofAcetaminophenhomogeneityusingaNearInfraredspectroscopydetectionmethod.AftermaterialsandmethodsaredescribedinSection2,resultsarepresentedinSection3,followedbyconclusionsandrecommendations,whicharepresentedinSection4.eterssuchasblendergeometry,speed,filllevloadingpatternandaxisofrotationoncohesivepowdersorthescalingrequirementsHowever,conventionaltumblers,rotatingallshareanimportantcharacteristicwhile⁎Correspondingauthor.Tel.17324453357fax1Emailaddressmuzziosol.rutgers.eduF.J.Muzzio.00325910/–seefrontmatter©2009ElsevierB.V.Alldoi10.1016/j.powtec.2009.06.008acombinationofgravityisaverycommonrotationonthemixingperformanceofafreeflowingmatrixofFastFlolactoseandAvicel102,containingamoderatelycohesiveAPI,andvesselrotation.Althoughthetumblingblender1.IntroductionParticleblendingisarequiredstepspanningtheceramic,food,glass,pharmaceuticalsindustries.Despitemixingorperhapsbecauseofit,comparmechanismsinvolved1–3.Acommonandaxisofrotation.InthisworkAcetaminophenisusedastheactivepharmaceuticalingredientandtheformulationcontainscommonlyusedexcipientssuchasAvicelandLactose.Themixingefficiencyischaracterizedbyextractingsamplesafterpredeterminednumberofrevolutions,andanalyzingthemusingNearInfraredSpectroscopytodeterminecompositionaldistribution.Resultsshowtheimportanceofprocessvariablesincludingtheaxisofrotationonhomogeneityofpowderblends.©2009ElsevierB.V.Allrightsreserved.varietyofapplicationsurgical,polymers,andhistoryofdrysolidsylittleisknownoftheofbatchindustrialmixerdirectionofrotationisfast,mediatedbyaconvectivemixingprocess,mixinginthehorizontalaxialdirection,drivenbyadispersiveprocess,isoftenmuchslower.Inthispaper,weexperimentallyinvestigateanewtumblingmixerthatrotateswithrespecttotwoaxesahorizontalaxistumblingmotion,andacentralsymmetryaxisspinningmotion.Weexaminetheeffectsoffilllevel,mixingtime,loadingpatternandaxisofRelativestandarddeviationNIRfundamentalparametersincludingblendergeometry,speed,filllevel,presenceofbaffles,loadingpattern,Mixermotion.AdetailedstudyComparingmixingperformanceofuniaxialAmitMehrotra,FernandoJ.Muzzio⁎DepartmentofChemicalandBiochemicalEngineering,RutgersUniversity,Piscataway,NJ,abstractarticleinfoArticlehistoryReceived17February2009Receivedinrevisedform30May2009Accepted14June2009Availableonline27June2009KeywordsPowdermixingCohesionThedynamicsinvolvedintheorystillremainsunderdeveInmanyindustries,includingmixers.Tumblingmixersaresomenumberofrevolutions.coneblendersandbinblenders.mediatedbyaconvectivemixingprocess,isoftenmuchslowjournalhomepagewww.elel,presenceofbaffles,mixingperformanceofofthedevices.aroundahorizontalaxis,homogenizationinthe7324452581.rightsreserved.andbiaxialbinblendersUnitedStatesmixingremainsatopicofinterestformanyresearchershowevertheloped.Mostofthemixersarestilldesignedandscaleduponempiricalbasis.pharmaceutical,themajorityofblendingisperformedusingtumblinghollowcontainerswhicharepartiallyloadedwithmaterialsandrotatedforcommonexamplesincludehorizontaldrummixers,vblenders,doubleInallthesemixerswhilehomogenizationinthedirectionofrotationisfast,process,mixinginthehorizontalaxialdirection,drivenbyadispersiventhispaper,weexperimentallyinvestigateanewtumblingmixerthatrotatesevier.com/locate/powtec2.MaterialsandmethodsThematerialsusedinthestudyarelistedinTable1,alongwiththeirsizeandmorphology.Acetaminophenisblendedwithcommonlyusedexcipientsandisusedasatracertoevaluatethedegreeofhomogeneityachievedasafunctionofnumberofrevolutions.Acetaminophenisoneofthedrugsmostwidelyusedinmixingstudies,andAvicelandLactosearecommonlyusedpharmaceuticalTheexperimentalplanusedinthisstudyisasfollowsFilllevelblender1–60Filllevelblender2–60,70,80Loadingpatternblender1side–sideloading,top–bottomloadingLoadingpatternblender2side–sideloading,top–bottomloadingSpeedblender1–15rpm,20rpm,25rpmSpeedblender2rotational/spinning15/7.5rpm,20/10rpm,30/15rpmSamplingtimeblender1,blender2–7.5,15,30,60,120revolutions3.ResultsThehomogeneityindexusedistheRSD,whereCistheconcentrationofeachindividualsample,C_istheaverageconcentrationofallsamplesandnisthetotalnumberofsamplesobtainedatagivensamplingtime.RSDSCwhereSffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffinPC2−PCðÞ2nn−1ðÞsWeexaminetheeffectoffilllevelonmixingperformance.2A.Mehrotra,F.J.Muzzio/PowderTechnology19620091–7excipients.IntheinterestofbrevitytheirSEMimagesarenotincludedinthispaper,butcanbefoundinHandbookofPharmaceuticalexcipients.2.1.NearinfraredspectroscopyAcetaminophenhomogeneitywasquantifiedusingnearinfraredspectroscopy.Acalibrationcurvewasconstructedforapowdermixturecontaininginaverage35avicelPH102,62lactoseand3acetaminophen.NearinfraredNIRspectroscopycanbeausefultooltocharacterizeacetaminophen.SamplesarepreparedbykeepingtheratioofAviceltolactoserandomizedinordertominimizeeffectsofimperfectblendingofexcipientsduringtheactualexperimentsontheaccuracyoftheresults.TheRapidContentAnalyzerinstrumentmanufacturedbyFOSSNIRSystemsSilverSpring,MDandVisionsoftwareversion2.1isusedfortheanalysis.Thesamplesarepreparedbyweighing1gofmixtureintoseparateopticalscintillationvialsKimbleGlassInc.Vineland,NJusingabalancewithanaccuracyof±0.01mg.NearIRspectraarecollectedbyscanningintherange1116–2482nminthereflectancemode.PartialleastsquarePLSregressionisusedincalibrationmodeldevelopmentusingthesecondderivativemathematicalpretreatmenttominimizetheparticlesizeeffects.AsshowninFig.1,excellentagreementisachievedbetweenthecalibratedandpredictedvalues.2.2.BinblendersusedinthisstudyuniaxialblenderBlender1,biaxialblenderBlender2Duetoitswidespreaduse,acylindricalblender1withacapacityof30Lischosenasareferenceblenderinthestudy.AsshowninFig.2,thisblenderhasacircularcrosssectionandtapersatthebottom.Itcanbeusedwithorwithoutbaffles,whicharemountedonaremovablelid.Inthisstudyalltheexperimentsareconductedwithouttheuseofbaffles.Mixingperformanceinthisdeviceisusedtoprovideabaselineforevaluatingthemixingperformanceofanewlydevelopedblender2withacapacityof40L,whichisalsocylindrical,inordertodeterminetheeffectofdualaxisofrotationonmixingperformance.TheblendershowninFig.2bhastwoaxisofrotation.Thespinningrateofprecessionrelativetothecentralaxisofsymmetryisgearedtobehalfofthatoftherateofrotationaroundthehorizontalaxis.2.3.ExperimentalmethodTwotypesofinitialpowderloadingusedintheexperimentstop–bottomloadingandside–loading,whichareschematicallyrepreTable1Materialsstudiedinthispaper.NameSizeandmorphologyVendor,City,StateFastFloLactose∼100μ,sphericalForemostfarms,Newark,NJAvicelPH102Microcrystallinecellulose∼90μ,needlelikeFMC,Rothschild,WIAcetaminophen∼40μ,needlelikeMallinckrodt,StLouis,MOsentedinFig.3.Toavoidagglomeration,theAPI,acetaminophen,wasdelumpedpriortoloadingitintotheblenderbypassingitthrougha35meshscreen.Inordertocharacterizemixingperformance,agroovesamplerwasusedtoextractsamplesfromtheblendersat7.5,15,30,60,120revolutions.Thethiefwascarefullyinsertedinthebin,andacorewasextractedateachpointofinsertioneachstabminimizingperturbationtothepowderbedremainingintheblender.Approximately7samplesaretakenfromeachthiefstab,andatotaloffivestabsareusedateachsamplingtime,asshowninFig.4soatotalof∼35samplesaretakenateachsamplingpoint.PreviouslytherehavebeenstudiesontheeffectoffilllevelintheBohlebinblender,GallaybinblenderandVblenderanddoubleconeblender11–13.Alltheaforementionedblendershaveonlyoneaxisofrotation,thereforetheobjectiveofthisstudyistoexaminehowdualaxisimpactmixingperformancesathighfilllevels.Toavoidrepetition,studiesforfilllevelarenotconductedforbinblender1.ResultsavailablefromapreviousstudyusingMgStasatracershowedthatmixinginauniaxialblendersloweddownquitedramaticallyasthefilllevelexceeded70.Moreover,resultsforacetaminophencanbeassumedtobesimilartothoseobtainedinpreviousworkbyMuzzioetal.11,13,forasingleaxisrectangularbinblender11,whichhaveshownthatevenafterfewhundredrevolutionshomogeneityachievedwitha80filllevelisverypoorascomparedto60filllevel.Toexaminetheeffectoffilllevelinadualaxisblender,experimentswereperformedinblender2withthetopbottomloadingpatternforarotationalspeedof15rpmandwithspinningspeedof7.5rpm.Thefilllevelsexaminedare60,70and80respectivelyandsamplesaretakenafter7.5,15,30,60,120revolutions.TypicalresultsareshowninFig.5,whichshowstheRSDvs.numberofblenderrevolutions.Asexpectedfornonagglomeratingmaterials,thecurvesFig.1.NearInfraredNIRspectroscopyvalidationcurve.Theequationusedtopredictacetaminophenconcentrationisvalidatedbytestingsampleswithknownamountsofacetaminophenconcentration.Theyaxisrepresentstheconcentrationcalculatedfromtheequationandthexaxisrepresentstheactualconcentration.Thusaperfectlystraightlineat45°wouldrepresentthebestcalibrationmodel.Eachpointonthegraphrepresentsasinglesample.Theconcentrationofacetaminophenexaminedhererangesfrom0to8.Fig.2.Pictorialrepresentationofabinblender1andbbinblender2showingthecorrespondingaxisofrotation.Fig.3.Schematicoftheloadingpatternusedinthestudy.Intop–bottomloading,AvicelisloadedfirstintotheblenderfollowedbyLactoseontopofitandfinallyAcetaminophenisuniformlysievedover.Inside–sideloadingavicelisplacedatthebottomandthenAcetaminophenisonlysievedonlyinhalfpartoftheblenderandissandwichedbetweenlactoseandAvicel.Fig.4.aThiefsamplerbtopviewofthesamplingpositionscheme.Fig.5.Mixingcurvesfordifferentfilllevelsinblender2.TheRSDofacetaminophenisplottedasafunctionofnumberofrevolutions.Theloadingpatternintopbottomandtheblenderrotationalspeedis15rpmwithspinningspeedof7.5rpm.3A.Mehrotra,F.J.Muzzio/PowderTechnology19620091–7d4A.Mehrotra,F.J.Muzzio/PowderTechnology19620091–7showarapidlydecayingregion.Theslopeofthecurvesinthisregion,insemilogarithmiccoordinates,isusedtodefinethemixingrate.Thecurvesthenlevelofftoaplateauthatindicatesthemaximumdegreeofhomogeneitythatisachievableintheblenderforagivematerial.Similartopreviousstudieswithothertumblingblendersweobservethatblendingperformanceisadverselyaffectedbyincreasingfilllevels.AsshowninFig.5,thecurvefor80fillperformsmorepoorlythanthosefor60and70fillasfilllevelincreases,RSDcurvesdecaymoreslowly,signifyingaslowermixingprocess.However,theeffectisnotaspronouncedasinotherbinblendersandafteraboutonly100revolutions,thesameplateauthesameasymptoticblendhomogeneityisachievedforallthreefilllevels.Next,theeffectofrotationalspeedisinvestigatedintheblender1Fig.6.Mixingcurvesfortopbottomloadingexperimentswith60filllevel.RSDisplotteblender1,whilesolidlinesrepresentdatapointsfromtheblender2.withoneaxisofrotationandiscomparedtotheblender2withdualrotationaxis.Experimentswereconductedforbothblenderswithtopbottomandsidesideloading.ExperimentswereperformedatFig.7.Mixingcurvesforside–sideloadingexperimentswith60filllevel.RSDisplottedasafunctionwhilesolidlinesrepresentdatapointsfromtheblender2.60filllevelandtherotationspeedsconsideredforblender1are15rpm,20rpmand25rpmrespectively.AsshowninFigs.6and7,whenplottedasafunctionofblenderrevolutions,thereisnotmuchofaneffectofrotationspeedonthehomogeneityindexRSDofacetaminophenat60filllevel.Itisobservedthatmixingperformanceat20rpmand25rpmisslightlybetterthanat15rpm,howeverthedifferencesintheperformanceoftheblenderunderdifferentspeedsareprobablytoosmalltobesignificant.RSDcurvesdecaywiththesameslope,indicatingsimilarmixingrates.Inthestudyreportedhere,thefilllevelisonly60,andalltherotationalspeedsareenoughtoachievehomogenization.Theaforementionedstudieswereconductedat85filllevel.Forsuchahighfilllevel,atlowspeeds,astagnantcoreisknowntooccuratthecenterofmanyblenders,asafunctionofnumberofrevolutions.Dottedlinescorrespondtoexperimentsintherequiringhighershearstressperunitvolumetoachievehomogenization.Moreover,theflowpropertiesofMgStareknowntobestronglydifferentthanthoseofmostmaterials,andareknowntohaveadeepofnumberofrevolutions.Dottedlinescorrespondtoexperimentsintheblender1,

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