Application of defin让ive screening design to quantify the effects of process parameters on key granule characteristics and optimize operating parameters in pulsed-spray fluid-bed granulation

(整期优先)网络出版时间:2019-02-12
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Thepulsed-sprayfluid-bedgranulation(PSFBG)processwasinvestigatedandoptimizedusingdefinitivescreeningdesign,arecentlyproposednewclassofthree-leveldesignofexperimentmethod.Suchadesignenabledquadraticmodelstobeestablishedthatdescribedtheeffectofsixinputprocessparameters-inletairtemperature,inletairhumidity,bindersprayrate,atomizationpressure,pulseperiod,andpulsewidth-onthegranulequalityinaPSFBGprocess.Mathematicalmodelsofthemeanparticlesize,relativesizedistributionwidth,productionyield,andporosityweredevelopedtoquantifytherelationshipsbetweentheinfluencingfactorsandcriticalqualityattributes.Onthebasisofconstraintsonthedesiredgranuleproperties,adesignspaceforPSFBGwasdeterminedandrangesoftheoperatingparametersweredefined.Anacceptabledegreeofpredictionwasconfirmedbyvalidationexperiments,demonstratingthereliabilityandeffectivenessofusingdefinitivescreeningdesigntostudythePSFBGprocess.Thismethodcanacceleratescreeningandoptimizationofthisprocesswithinalargemultidimensionaldesignspace.