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1、Narrowingthegapbetweenclinicalcapsuleformulationsandcommercialfilm-coatedtabletsBasedonformulationsimplicityandblindingcapability,hardgelatincapsulesarepreferrablecomparedwithotheroralsoliddosageforms,includingtablets,intheearlyclinicalphasesofdrugdevelopment.However,asa
2、resultofeconomicandothermarketingconsiderations,mostoralsoliddosageformsonthemarkettodayaretablets.Theauthorssuggestthattimecouldbesavedinformulationdevelopmentifrelativelysimple,commonformulations,suitableforuseinbothcapsuleandtabletdosageforms,canbedevelopedintheprecli
3、nicalphase.Fourcasestudies,withformulaecontainingmodeldrugsofvaryingdoseandwatersolubility,weredevelopedtoillustratetheconcept.Ineachcase,comparativedissolutionprofilesofcapsulesandcorrespondinguncoatedandfilm-coatedtabletsshowedequivalencein vitro.NgocDoThegoalofearlycl
4、inicaltrialsistoestablishWhilehardgelatincapsuleformulationsforJasonHansellthesafetyandproof-of-conceptefficacyearly-phasestudieshavemanydesirablefeatures,ThomasP.FarrellofanewAPI.1LimitedamountsoftheAPIandtheyarenotcommerciallyviablemostofthetime.3,4PEERColorconInc.REVI
5、EWEDaggressivedevelopmenttimelines,however,oftenThereasonforthisisthatthemanufactureofearlyforceformulatorstodevelopsimplehardgelatinclinicalformulationscannotusuallybetransferredtoPEERcapsuleformulationsforearly-phaseclinicallarge-scaleproductionequipmentand,assuch,theR
6、EVIEWEDuse;2thecompositionofwhichcouldbetheAPIdevelopmentofaseconddrugproductforlate-phasealone,orasimplepowderblendoftheAPIandclinicalstudiesthatcanbemanufacturedonaafiller.Notonlyaretheyusefulforsimplifyinglarge-scaleandischemicallycompatible,stableandformulations,hard
7、gelatincapsulesarealsousefulbioavailable,isnecessary.Basedoneconomicandformaskingthetasteandodouroftheactivecertainmarketingconsiderations,tabletsaremostblendaswellasforblindingmarketedproducts.oftenformulatedforlate-stageclinicaltrialsandThepositivecomparatorscaneasilyb
8、eblindedascommercialization;theyaremoretamper-resistanttablets-in-capsulesorcapsule-in-capsules.thanhar
