Sarfaraz K. Niazi - Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 2_ Uncompressed Solid Products (2009)资料下载.pdf

Sarfaraz K. Niazi - Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 2_ Uncompressed Solid Products (2009)资料下载.pdf

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UncompressedSolidProductsVolume3HandbookofPharmaceuticalManufacturingFormulations:

LiquidProductsVolume4HandbookofPharmaceuticalManufacturingFormulations:

SemisolidProductsVolume5HandbookofPharmaceuticalManufacturingFormulations:

Over-the-CounterProductsVolume6HandbookofPharmaceuticalManufacturingFormulations:

SterileProductsSPHSPHFM-sampleIHBK039-Niazi-FMMay26,200922:

25CharCount=InformaHealthcareUSA,Inc.52VanderbiltAvenueNewYork,NY10017C?

2009byInformaHealthcareUSA,Inc.InformaHealthcareisanInformabusinessNoclaimtooriginalU.S.GovernmentworksPrintedintheUnitedStatesofAmericaonacid-freepaper10987654321InternationalStandardBookNumber-10:

1-4200-8116-0（Volume1;

Hardcover）InternationalStandardBookNumber-13:

978-1-4200-8116-9（Volume1:

Hardcover）InternationalStandardBookNumber-10:

1-4200-8118-7（Volume2;

978-1-4200-8118-3（Volume2;

1-4200-8123-3（Volume3;

978-1-4200-8123-7（Volume3;

1-4200-8126-8（Volume4;

978-1-4200-8126-8（Volume4;

1-4200-8128-4（Volume5;

978-1-4200-8128-2（Volume5;

1-4200-8130-6（Volume6;

978-1-4200-8130-5（Volume6;

Hardcover）Thisbookcontainsinformationobtainedfromauthenticandhighlyregardedsources.Reprintedma-terialisquotedwithpermission,andsourcesareindicated.Awidevarietyofreferencesarelisted.Reasonableeffortshavebeenmadetopublishreliabledataandinformation,buttheauthorandthepublishercannotassumeresponsibilityforthevalidityofallmaterialsorfortheconsequenceoftheiruse.Nopartofthisbookmaybereprinted,reproduced,transmitted,orutilizedinanyformbyanyelectronic,mechanical,orothermeans,nowknownorhereafterinvented,includingphotocopying,microfilming,andrecording,orinanyinformationstorageorretrievalsystem,withoutwrittenpermissionfromthepublishers.Forpermissiontophotocopyorusematerialelectronicallyfromthiswork,please（http:

/contacttheCopyrightClearanceCenter,Inc.（CCC）222RosewoodDrive,Danvers,MA01923,978-750-8400.CCCisanot-for-profitorganizationthatprovideslicensesandregistrationforavarietyofusers.FororganizationsthathavebeengrantedaphotocopylicensebytheCCC,aseparatesystemofpaymenthasbeenarranged.TrademarkNotice:

Productorcorporatenamesmaybetrademarksorregisteredtrademarks,andareusedonlyforidentificationandexplanationwithoutintenttoinfringe.LibraryofCongressCataloging-in-PublicationDataNiazi,Sarfaraz,1949Handbookofpharmaceuticalmanufacturingformulations/SarfarazK.Niazi.2nded.p.;

cm.Includesbibliographicalreferencesandindex.ISBN-13:

978-1-4200-8106-0（set）（hardcover:

alk.paper）ISBN-10:

1-4200-8106-3（set）（hardcover:

alk.paper）ISBN-13:

978-1-4200-8116-9（v.1）（hardcover:

1-4200-8116-0（v.1）（hardcover:

alk.paper）etc.1.DrugsDosageformsHandbooks,manuals,etc.I.Title.DNLM:

1.DrugCompoundingHandbooks.2.DosageFormsHandbooks.3.FormulariesasTopicHandbooks.4.Technology,PharmaceuticalHandbooks.QV735N577h2009RS200.N532009615?

.19dc222009009979ForCorporateSalesandReprintPermissioncall212-520-2700orwriteto:

SalesDepartment,52VanderbiltAvenue,16thfloor,NewYork,NY10017.VisittheInformaWebsiteandtheInformaHealthcareWebsiteSPHSPHFM-sampleIHBK039-Niazi-FMMay26,200922:

25CharCount=tothememoryofTakeruHiguchiSPHSPHFM-sampleIHBK039-Niazi-FMMay26,200922:

25CharCount=PrefacetotheSeriesSecondEditionThescienceandtheartofpharmaceuticalformulationkeepsevolvingasnewmaterials,methods,andmachinesbecomereadilyavailabletoproducemorereliable,stable,andrelease-controlledformulations.Atthesametime,globalizationofsourcingofrawandfinishedpharmaceuticalsbringschal-lengestoregulatoryauthoritiesandresultsinmorefrequentrevisionstothecurrentgoodmanufacturingpractices,regu-latoryapprovaldossierrequirements,andthegrowingneedforcostoptimization.Sincethepublicationofthefirsteditionofthisbook,alothaschangedinalloftheseareasofimpor-tancetopharmaceuticalmanufacturers.Thesecondeditionbuildsonthedynamicnatureofthescienceandartoffor-mulationsandprovidesanevermoreusefulhandbookthatshouldbehighlywelcomedbytheindustry,theregulatoryauthorities,aswellastheteachinginstitutions.Thefirsteditionofthisbookwasagreatsuccessasitbroughtunderoneumbrellathemyriadofchoicesavailabletoformulators.Thereaderswereveryresponsiveandcom-municatedwithmefrequentlypointingouttotheweaknessesaswellasthestrengthsofthebook.Thesecondeditiontotallyrevisedattemptstoachievethesebymakingmajorchangestothetext,someofwhichinclude:

1.Complete,revisederrorscorrectedandsubjectmatterreorganizedforeasyreference.WhereasthisserieshassixvolumesdifferentiatedonthebasisofthetypeofdosageformandaseparateinclusionoftheU.S.OTCproducts,ideallytheentirecollectionisneededtoben-efitfromthemyriadoftopicsrelatingtoformulations,regulatorycompliance,anddossierpreparation.2.Totalnumberofpagesisincreasedfrom1684to2726.3.Totalnumberofformulationsisexpandedbyabout30%withmanynewlyapprovedformulations.4.Novelformulationsarenowprovidedforavarietyofdrugs;

thesedataarecollectedfromthemassiveintellec-tualpropertydataandsuggesttowardthefuturetrendofformulations.WhilesomeoftheseformulationsmaynothavebeenapprovedintheUnitedStatesorEurope,thesedoprovideadditionalchoices,particularlyfortheNDApreparation.Asalways,itistheresponsibilityofthemanufacturertoassurethattheintellectualpropertyrightsarenotviolated.5.Asignificantchangeinthiseditionistheinclusionofcommercialproducts;

whilemostofthisinformationisculledoutfromtheopensourcesuchastheFOIA（http:

/www.fda.gov/foi/default.htm）,Ihavemadeat-temptstoreconstructthecriticalportionsofitbasedonwhatIcallthegenerallyacceptablestandards.Thedrugcompaniesareadvisedtoassurethatanyintellec-tualpropertyrightsarenotviolatedandthisappliestoallinformationcontainedinthisbook.Thefreedomofinformationact（FOIA）isanextremelyusefulconduitforreliableinformationandmanufacturersarestronglyurgedtomakeuseofthisinformation.Whereasthisin-formationisprovidedfreeofcharge,theprocessofob-tainingtheinformationmaybecumbersome,inwhichcase,commercialsourcesofthesedatabasescanproveuseful,particularlyforthenon-U.S.companies.6.AlsoincludedarethenewGoodManufacturingGuide-lines（2007）withamendments（2008）fortheUnitedStatesandsimilarupdatesforEuropeanUnionandWHO;

itisstronglyurgedthatthecompaniesdiscontinueusingallolddocumentsastherearesignificantchangesinthere-visedform,andmanyofthemarelikelytoreducethecostofGMPcompliance.7.Detailsondesignofcleanroomsisanewentrythatwillbeofgreatusetosterileproductmanufacturers;

whereasthedesignandflowofpersonnelandmaterialflowisofcriticalnature,regulatoryagenciesviewthesedifferentlyandthemanufacturerisadvisedalwaystocomplywithmoststringentrequirements.8.Additionofaself-auditingtemplateineachvolumeoftheseries.WhilethecGMPcomplianceisacomplexis-sueandtherequirementsdiversifiedacrosstheglobe,thebasiccomplianceremainsuniversal.IhavechosentheEuropeanUnionguidelines（asthesearemoreintunewiththeICH）toprepareaself-auditmodulethatIrec-ommendthateverymanufactureradoptasaroutinetoassureGMPcompliance.InmostinstancesreadingthetemplatebythoseresponsibleforcompliancewithkeepthemsensitivetotheneedsofGMP.9.OTCproductscross-referencedinothervolumeswhereappropriate.Thiswasnecessarysincetheregulatoryau-thoritiesworldwidedefinethisclassofdrugdifferently.Itisimportanttoiteratethatregardlessoftheprescrip-tionortheOTCstatusofaproduct,therequirementsforcompliancewiththecGMPapplyequally.10.OTCmonographstatusisanewsectionaddedtotheOTCvolumeandthisshouldallowmanufacturerstochoseap-propriateformulationsthatmaynotrequireafilingwiththeregulatoryagencies;

itisimportanttoiteratethatanapprovedOTCmonographincludesdetailsofformula-tionincludingthetypesandquantitiesofactivedrugandexcipients,labeling,andpresentation.Toqualifytheex-emption,themanufacturermustcomplywiththemono-graphinitsentirety.However,subtlemodificationsthataremerelycosmeticinnatureandwherethereisanevi-dencethatthemodificationwillnotaffectthesafetyandefficacyoftheproductscanbemadebutrequirepriorapprovaloftheregulatoryagenciesandgenerallytheseapprovalsaregranted.11.Expandeddiscussiononcriticalfactorsinthemanufac-turingofformulationsprovided;

frombasicshortcutstosmartmodificationsnowextendtoalldosageforms.Pharmaceuticalcompoundingisoneoftheoldestpro-fessionsandwhereastheartofformulationshasbeenvSPHSPHFM-sampleIHBK039-Niazi-FMMay26,200922:

25CharCount=viPrefacetotheSeriesSecondEditionrelegatedtomoreobjectivepar