4/1/2015

SigmaPlot:FittingControlledReleaseandDissolutionData
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FITTINGCONTROLLEDRELEASEANDDISSOLUTIONDATA

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Introduction
Theparametersderivedfromfittingmodelsofcontrolledreleasemechanismstoexperimentaldatamaybeusedtocharacterizethe
releaseproperties(1).Someofthesameequationsmaybeusedtofitdissolutionprofilesandpairwisecomparisonsmadeusing
confidenceintervals(2).Acustomcurvefitlibrary,Release.jfl,wascreatedinSigmaPlottofitfivepublishednonlinearmodelsforthe
controlledreleaseofpharmaceuticals(1).Thedifferentmodelsrepresentdifferentencapsulationgeometriesanddifferentrelease
mechanisms.The"rightclick,FitCurve"featureofSigmaPloteasilyallowsrapidfittingofallfivemodelstodataforcomparison.
DownloadtheselfextractingfileRelease.zipanddoubleclickonittoobtainthecustomcurvefitlibraryandgraphexample.Anexample
ofthefitofthismodeltopublisheddata(3)isshowninthegraphabove.

SmoothingRoutines
SystatLicensingOptions
TrainingOnSigmaPlot
Updates
UpgradeComparisons

TheCustomFitLibrary
TheequationsimplementedinRelease.jflareshowninthetablebelow.Fisthepercentageofdrugreleasedattimet.
Name

SigmaStatIntegration

Equation

Parameters

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BakerandLonsdale
(4)

Peppas(5)

k,
n

HixonandCrowell
(6)

HiguchiSquareRoot
ofTime(7)

FirstOrder(8)

Support

ThemodeldevelopedbyBakerandLonsdaleisanimplicitfunction.Twowaystoapproachanimplicitfunctionfitaredescribed.First,inan
approximatebutneverthelessaccurateapproach,TableCurve2Dwasusedto"invert"thisfunctiontoprovideanexplicitfunction
approximationaccurateto0.03%.Automaticinitialparameterestimationfunctionsareusedforeachoftheseequations.Aparticularly
cleverapproach,usingtheape()functionfortheBaker&Lonsdaleequationisdescribedhere.Second,SigmaPlotcannowfitimplicit
functionsusingthenewimplicit()transformcommand.Sotheproblemcannowbesolveddirectlywithoutapproximation.Thefitcommands
forfittingtheimplicitBaker&Lonsdaleequationaredescribedhere.
FittingEquations
Itiseasytofitthefivemodelstodataandcomparetheresults.Yousimplyrightclickonagraphdatapointforthedatatobefitted,selectthe
equationandclickFinish.Thenrepeatthisforeachequation.ThefirsttimeyoufitacurveyouwillneedtoclicktheBackbuttonandBrowse
fortheRelease.jflfitlibrary.ThisproducestheControlledReleaseequationlibrarywiththefivemodelsshowninthefollowingdialog.

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SigmaPlot:FittingControlledReleaseandDissolutionData

ThefitofthefivemodelstoShakulaandPrice'stheophyllinemicrospheredataisshowninthefollowingfigure.Thenumbersinthelegend
arethesumsofsquaresoftheresiduals.TheBakerandLonsdaleequationprovidesthebestfitbyfar.EventhePeppasequationwithits
extradegreeoffreedom(twoparameters)fitslesswell.

ReplicateMeasurements
DatawithreplicatemeasurementscanbegraphedandfitusingthereplicatedataformatX,YReplicate.Datawithtime(X)incolumn1and
12replicate%releasedatavalues(YReplicate)incolumns2through13isgraphedusingsymbolvaluescomputedfromRowMeansand
StandardDeviationfortheerrorcalculation.Thereplicatesareenteredrowwiseforeachtimevalue.

Theresultingmeanpluserrorbargraphisshownbelow.ThisdatacanthenbefitusingthesameX,YReplicateformatintheRegression
Wizard.TodothisrightclickononeofthesymbolsinthegraphandselectFitCurve.SelecttheBakerandLonsdaleequationandother
optionsintheRegressionWizard.SinceyourightclickedonagraphthathasbeenformattedusingX,YReplicate,thisformatwillbe
automaticallyselectedforthecurvefit.BesuretoselectExtendFittoAxestostartthefitlineattheorigin.

Summary
TheRegressionWizarddesignofSigmaPlotallowsthecreationofcustomcurvefitlibraries.Theprocedureforcreatingacontrolledrelease
libraryforanalyzingdatafromdrugdissolutiontestswasshowntobeastraightforwardmodificationofequationsintheSigmaPlotFit
Library.TheregressionlibraryRelease.jflwascreatedusingtheproceduredescribed.Oncethelibraryhasbeencreatedthedifferent
functionscanberapidlyfittedtodatabyrightclickingonadatapointandselectingFitCurve.
References

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SigmaPlot:FittingControlledReleaseandDissolutionData
Lu,D.R.,AbuIzza,K.,andMao,F.,NonlinearDataFittingforControlledReleaseDevices:AnIntegratedComputerProgram,
Internat.J.Pharmaceutics129(1996)243251.
Polli,J.E.andRekhi,G.S.,Methodstocomparedissolutionprofiles,DrugInformationJournal,30,(1996),11131120.
Shukla,A.J.andPrice,J.C.,Effectofdrugloadingandmolecularweightofcelluloseacetatepropionateontherelease
characteristicsoftheophyllinemicrospheres.Pharm.Res.,8(1991)13691400.
Baker,R.W.,andLonsdale,H.S.,Controlledreleased:mechanismsandrates.InTanquary,A.C.andLacey,R.E.(Ed.),Controlled
ReleaseofBiologicallylActiveAgents,PlenumPress,NewYork,1974,pp.1571.
Peppas,N.A.,AnalysisofFickianandnonFickiandrugreleasefrompolymers.Pharm.ActaHelv.,60(1985)110111.
Hixon,A.W.andCrowell,J.H.,Dependenceofreactionvelocityuponsurfaceandagitation:ITheoreticalcondideration.Ind.Eng.
Chem.,23(1931)923931.
Higuchi,T.,Rateofreleaseofmedicamentsfromointmentbasescontainingdrugsinsuspension.J.Pharm.Sci.,50(1961)874875.
Shah,M.V.,DeGennaro,M.D.andSuryakasuma,H.,Anevaluationofalbuminmicrocapsulespreparedusingamultipleemulsion
technique.J.Microencapsul.,4(1987)223238.

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