Handbook of Pharmaceutical Excipients - GBV

1 Handbook ofPharmaceutical ExcipientsFIFTH EDITIONE dited byRaymond C RoweBPharm, PhD, DSc, FRPharmS, CChem,FRSC, CPhys, MlnstPChief ScientistIntelligensys LtdBillingham, UKPaul J SheskeyBSc, RPhTechnical Services LeaderThe Dow Chemical CompanyMidlandMl, USASian C OwenBSc, MADevelopment EditorRoyal Pharmaceutical Society of Great BritainLondon, UKAPhA(RP)London Chicago Pharmaceutical PressContentsInternational Steering Committee ixEditorial Staff ixContributors xAbout the Editors xiiNew Monographs xiiiRelated Substances xivPreface xviArrangement xviiAcknowledgments xixNotice to Readers xixBibliography xxAbbreviations xxUnits of Measurement xxiiMonographsAcaciaAcesulfame PotassiumAcetic Acid.

2 GlacialAcetoneAcetyltributyl CitrateAcetyltriethyl CitrateAgarAlbuminAlcoholAlginic AcidAliphatic PolyestersAlitameAlmond OilAlpha TocopherolAluminum Hydroxide AdjuvantAluminum OxideAluminum Phosphate AdjuvantAluminum StearateAmmonia SolutionAmmonium AlginateAscorbic Acid146810121416182124283032363840424446 48 Ascorbyl PalmitateAspartameAttapulgiteBentoniteBe nzalkonium ChlorideBenzethonium ChlorideBenzoic AcidBenzyl AlcoholBenzyl BenzoateBoric AcidBronopolButylated HydroxyanisoleButylated HydroxytolueneButylparabenCalcium AlginateCalcium CarbonateCalcium Phosphate, Dibasic AnhydrousCalcium Phosphate, Dibasic DihydrateCalcium Phosphate, TribasicCalcium StearateCalcium SulfateCanola OilCarbomerCarbon DioxideCarboxymethylcellulose CalciumCarboxymethylcellulose SodiumCarrageenanCastor OilCastor Oil, HydrogenatedCellulose, MicrocrystallineCellulose, PowderedCellulose.

3 Silicified MicrocrystallineCellulose AcetateCellulose Acetate PhthalateCeratoniaCetostearyl Alcohol515356586164666972747679818386899 3961001021051081111161181201241281301321 36139142145148150 VIContentsCetrimideCetyl AlcoholCetylpyridinium ChlorideChitosanChlorhexidineChlorobutan olChlorocresolChlorodifluoroethane (HCFC)Chlorofluorocarbons (CFC)ChloroxylenolCholesterolCitric Acid MonohydrateColloidal Silicon DioxideColoring AgentsCopovidoneCorn OilCottonseed OilCresolCroscarmellose SodiumCrospovidoneCyclodextrinsCyclometh iconeDenatonium BenzoateDextratesDextrinDextroseDibutyl PhthalateDibutyl SebacateDiethanolamineDiethyl PhthalateDifluoroethane (HFC)

4 DimethiconeDimethyl EtherDimethyl PhthalateDimethyl SulfoxideDimethylacetamideDisodium EdetateDocusate SodiumEdetic AcidErythorbic AcidErythritolEthyl AcetateEthyl LactateEthyl Maltol1521551571591631681711741761801821 8518819220120420620821121421722222422622 8231234236238240242244246248250253255257 260264266268270272 Ethyl OleateEthyl VanillinEthylcelluloseEthylene Glycol PalmitostearateEthylene Vinyl AcetateEthylparabenFructoseFumaric AcidGelatinGlucose, LiquidGlycerinGlyceryl BehenateGlyceryl MonooleateGlyceryl MonostearateGlyceryl PalmitostearateGlycofurolGuar GumHectoriteHeptafluoropropane (HFC)HexetidineHydrocarbons (HC)

5 Hydrochloric AcidHydroxyethyl CelluloseHydroxyethylmethyl CelluloseHydroxypropyl CelluloseHydroxypropyl Cellulose, Low-substitutedHydroxypropyl StarchHypromelloseHypromellose Acetate SuccinateHypromellose PhthalateImidureaInulinIron OxidesIsomaltIsopropyl AlcoholIsopropyl MyristateIsopropyl PalmitateKaolinLactic AcidLactitolLactose, AnhydrousLactose, MonohydrateLactose, Spray-DriedLanolin2742762782832852872902 9329529930130430630831131331531832132332 5328330334336341344346350354359362364366 371374376378381383385389396399 ContentsVIIL anolin AlcoholsLanolin, HydrousLaurie AcidLecithinLeucineLinoleic AcidMacrogol 15 HydroxystearateMagnesium Aluminum SilicateMagnesium CarbonateMagnesium OxideMagnesium SilicateMagnesium StearateMagnesium TrisilicateMalic AcidMaltitolMaltitol SolutionMaltodextrinMaltolMaltoseMannito lMedium-chain TriglyceridesMeglumineMentholMethylcellu loseMethylparabenMineral OilMineral Oil.

6 LightMineral Oil and Lanolin AlcoholsMonoethanolamineMonosodium GlutamateMonothioglycerolMyristic AcidNeohesperidin DihydrochalconeNitrogenNitrous OxideOctyldodecanolOleic AcidOleyl AlcoholOlive OilPalmitic AcidParaffinPeanut OilPectinPetrolatum402404406409412414416 4184224264284304344364384404424454474494 5445745946246647147447647848048248448648 8490492494496498501503505507509 Petrolatum and Lanolin AlcoholsPhenolPhenoxyethanolPhenylethyl AlcoholPhenylmercuric AcetatePhenylmercuric BoratePhenylmercuric NitratePhosphoric AcidPolacrilin PotassiumPoloxamerPolycarbophilPolydextr osePolyethylene GlycolPolyethylene OxidePolymethacrylatesPolyfmethyl vinyl ether/maleic anhydride)

7 Polyoxyethylene Alkyl EthersPolyoxyethylene Castor Oil DerivativesPolyoxyethylene Sorbitan Fatty Acid EstersPolyoxyethylene StearatesPolyvinyl Acetate PhthalatePolyvinyl AlcoholPotassium AlginatePotassium BenzoatePotassium BicarbonatePotassium ChloridePotassium CitratePotassium HydroxidePotassium MetabisulfitePotassium SorbatePovidonePropionic AcidPropyl Gal latePropylene CarbonatePropylene GlycolPropylene Glycol AlginatePropylparaben2-PyrrolidoneRaffin oseSaccharinSaccharin SodiumSaponiteSesame OilShellac512514517519521524526530532535 5395425455515535615645725805855895925945 9659860060360560760961161761962262462762 9633635638641644646649 VIIIC ontentsSimethiconeSodium AcetateSodium AlginateSodium AscorbateSodium BenzoateSodium BicarbonateSodium BorateSodium ChlorideSodium Citrate DihydrateSodium CyclamateSodium HyaluronateSodium HydroxideSodium LactateSodium Lauryl SulfateSodium MetabisulfiteSodium Phosphate, DibasicSodium Phosphate.

8 MonobasicSodium PropionateSodium Starch GlycolateSodium Stearyl FumarateSodium SulfiteSorbic AcidSorbitan Esters (Sorbitan Fatty Acid Esters)SorbitolSoybean OilStarchStarch, PregelatinizedStarch, Sterilizable MaizeStearic AcidStearyl AlcoholSucraloseSucroseSugar, CompressibleSugar, Confectioner'sSugar SpheresSulfobutylether P-CyclodextrinSulfuric AcidSunflower OilSuppository Bases, Hard FatTalcTartaric AcidTetrafluoroethane (HFC)ThaumatinThimerosal6526546566596626 6566967167567868168368568769069369669970 1705708710713718722725731734737740742744 748750752754758760762767770772775777 ThymolTitanium DioxideTragacanthTrehaloseTriacetinTribu tyl CitrateTriethanolamineTriethyl CitrateVanillinVegetable Oil, HydrogenatedWaterWax, Anionic EmulsifyingWax, CarnaubaWax, Cetyl EstersWax, MicrocrystallineWax, Nonionic EmulsifyingWax, WhiteWax, YellowXanthan GumXylitolZeinZinc AcetateZinc StearateAppendix 1: Suppliers' Directory 835 Appendix II: List of Excipient 'E' Numbers 882 Appendix III.

9 List of Excipient 'EINECS' NumbersAppendix IV: List of Excipient Molecular WeightsIndex 8897807827857887907927947967988008028078 09811813815817819821824828830832884886