Sarfaraz K. Niazi - Handbook of Pharmaceutical Manufacturing Formulations, Second Edition_ (Six-Volume Set) (2009).pdf
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HowtogotoyourpageThiseBookcontainstwovolumes.Eachvolumehasitsownpagenumberingscheme,consistingofavolumenumberandapagenumber,separatedbyahyphen.Forexample,togotopage5ofVolume1,typev1-5inthe“page#”boxatthetopofthescreenandclick“Go.”Togotopage5ofVolume2,typev2-5inthepage#boxandsoforth.SarfarazK.NiaziPharmaceuticalScientist,Inc.Deerfield,Illinois,USAVOLUMEONESecondEditionHandbookofPharmaceuticalManufacturingFormulationsCompressedSolidProductsNiazi_978-1420081169_TP.indd25/26/0912:
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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:
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Productorcorporatenamesmaybetrademarksorregisteredtrademarks,andareusedonlyforidentificationandexplanationwithoutintenttoinfringe.LibraryofCongressCataloging-in-PublicationDataNiazi,Sarfaraz,1949Handbookofpharmaceuticalmanufacturingformulations/SarfarazK.Niazi.2nded.p.;cm.Includesbibliographicalreferencesandindex.ISBN-13:
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21CharCount=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-turingofformulation