Transcription of PARTICLE SIZE
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PARTICLE SIZE
PARTICLE SIZEDISTRIBUTIONDrugDeliveryTechnologyMa y2009 Vol9No5xxINTRODUCTIO NThe need for par ticl e size control in the manufactureofpharmaceuticalsis becomingincreas ingl y apparen t asthe pharmaceuticalindust ry at tem pts to capi talize onsome APIs with less -than-i deal sol ubili ty ,signif icant advancesin drug del ivery have been made inwhich a finely di vi ded API, wit h the concom itantincr ease in specific surface area, has res ulted inincr eased bioav ailabi lit y. Preci se parti cle size controltechnolo gies hav e al so ass is ted in the de velopm ent ofdrug delivery platfor ms for the del ivery of amedi cament to the lung. As thes e trends have occu rred,the need for highly reproducible part icle sizeassessmenttechniqueshas grown si gnificantly in thepast decade. The int eres t in part icle size meas urementswil l remain high, part icul arly in view of FDA trendstoward recommending more thoroughdescript ions ofpart icle size distributions in subm is si ons in which theemphasisof a drug product clai m is bas ed in a tightlycontrolledparticle si PA RIS ON OF ME THOD S TOME AS URE PARTICLESI ZEDI STRI BUTIO NParti cle sizing of di spers ion can be accomplishedusing laser scatteringor diffract ion techniquesor bydisc centrifugetechni ques if high res olution
PARTICLE SIZE DISTRIBUTION D r u g D e l i v e r y T e c h n o l o g y M a y 2 0 0 9 V o l 9 N o 5 xx whichthismethodwasdeveloped,norforrelatingparticlesizetoother ...
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