(
(51)InternationalPatentClassification:
A61K9/00(2006.01)A61P37/06(2006.01)G01N15/02(2006.01)A61P7/06(2006.01)G01N15/10(2006.01)A61P37/04(2006.01)(21)InternationalApplicationNumber:
PCT/US2019/025420(22)InternationalFilingDate:
02April2019(02.04.2019)
(25)FilingLanguage:(26)PublicationLanguage:(30)PriorityData:
62/661,929
24April2018(24.04.2018)
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(84)DesignatedStates(unlessotherwiseindicated,forevery
kindofregionalprotectionavailable).ARIPO(BW,GH,GM,KE,LR,LS,MW,MZ,NA,RW,SD,SL,ST,SZ,TZ,UG,ZM,ZW),Eurasian(AM,AZ,BY,KG,KZ,RU,TJ,TM),European(AL,AT,BE,BG,CH,CY,CZ,DE,DK,EE,ES,FI,FR,GB,GR,HR,HU,IE,IS,IT,LT,LU,LV,MC,MK,MT,NL,NO,PL,PT,RO,RS,SE,SI,SK,SM,TR),OAPI(BF,BJ,CF,CG,Cl,CM,GA,GN,GQ,GW,KM,ML,MR,NE,SN,TD,TG).
EnglishEnglish
US
(71)Applicant:AMGENINC.[US/US];LawDepartment-PatentOperations,OneAmgenCenter,ThousandOaks,California91320(US).(72)Inventors:SPASOFF,AndrewPhillip;7105OldGate
Road,Rockville,Maiyland20852(US).ATKINSON,Su-sanneTherese;4RathmichaelWoods,Shankill,Dublin,D18C7P2(IE).BENNIS,Adrian;48BallyroanCrescent,Rathfarnham,Dublin,16(IE).FREUND,Erwin;12059PraderaRoad,Camarillo,California93012(US).(74)Agent:ChenghuaLuo;AmgenINC.,LawDepartment
-PatentOperations,OneAmgenCenter,ThousandOaks,California91320(US).(81)DesignatedStates(unlessotherwiseindicated,forevery
kindofnationalprotectionavailable):AE,AG,AL,AM,AO,AT,AU,AZ,BA,BB,BG,BH,BN,BR,BW,BY,BZ,CA,CH,CL,CN,CO,CR,CU,CZ,DE,DJ,DK,DM,DO,DZ,EC,EE,EG,ES,FI,GB,GD,GE,GH,GM,GT,HN,HR,HU,ID,IL,IN,IR,IS,JO,JP,KE,KG,KH,KN,KP,
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patent(Rule4.17(H))
—astotheapplicant'sentitlementtoclaimthepriorityofthe
earlierapplication(Rule4.17(iii))Published:
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(54)Title:METHODFORMAKINGINJECTABLEPHARMACEUTICALCOMPOSITIONS
Figure1
(57)Abstract:Theinventionrelatestomethodsformakingin?jectablepharmaceuticalcompositionswhereinparticlespresentinthecompositionsaredetectedandanalyzedandtheacceptance
alhe
METHODFORMAKINGINJECTABLEPHARMACEUTICALCOMPOSITIONS
Cross-ReferencetoRelatedApplications
ThisapplicationclaimsthebenefitofU.S.ProvisionalApplicationNo.62/661,929,filedon
April24,2018,whichisherebyincorporatedbyreference.
FieldoftheInvention
[0001]
Theinventionrelatestomethodsformakinginjectablepharmaceuticalcompositions.
Inparticular,theinventionrelatestomethodsfordetectingandanalyzingparticlesinaninjectablepharmaceuticalcompositionanddeterminingwhetherthecompositionisacceptable.
BackgroundoftheInvention
[0002]
Injectablepharmaceuticalcompositionsincludesolutionssuitableforintravenous,
intramuscularandsubcutaneousadministration.Manufactureprocessesformakingthesecompositionsmayintroduceparticlestothecompositionsfromextrinsicsourcessuchasthemanufacturingenvironment,equipmentandpackaging,and/orintrinsicsourcessuchastheexcipientsusedformakingthecompositions.Duetopotentialhealthrisksthatparticlesmayhaveonpatients(e.g.,injectionsitereactions),particlecontrolstrategieshavebeenimplementedin
manufacturingprocessesbasedoncurrentregulatoryexpectations.Theseincludeimplementingparticlecontrolapproachestoreduceparticlecontaminationduringmanufactureaswellasinspectingandanalyzingforthepresenceofparticlesininjectablepharmaceuticalcompositionsattheendofmanufacturingprocesses.
[0003]
Particlecontrolapproachesincludereducingparticlesfrommanufacturingequipment
andmanufacturingenvironments.Thearthasdevelopedandadoptedinspectionandquality
controlstrategiestoensureinjectablepharmaceuticalcompositionsmeetacceptableparticle
levels.Onceinjectablepharmaceuticalcompositionsaremanufactured,theyareinspectedforthepresenceofparticles.Thearthasalsoadoptedstandardsforacceptableparticlelevels.Forexample,theUSPharmacopeiarecommendsthatparticlesmaybeobservedinnomorethanaspecifiednumberofdrugproductunits,asdeterminedbyastaticallyjustifiedsamplingplan,wheninspectedunderspecificconditions.However,currentparticlecontrolandinspectionstrategiesdonottakeintoconsiderationthesafetyortoxicologyinformationassociatedwith
WO2019209473A1制备可注射药物组合物的方法[专利] - 图文
