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HydroxypropylStarch

时间:2013-1-16 9:25:27 作者:118.244.254.207 来源:Hy 阅读:1997次
HydroxypropylStarch
HydroxypropylStarch
1NonproprietaryNames
Noneadopted.
2Synonyms
E1440;hydroxylpropylstarch.
3ChemicalNameandCASRegistryNumber
Hydroxypropylstarch[113894-92-1]
4EmpiricalFormulaandMolecularWeight
Hydroxypropylstarchisaderivativeofnaturalstarch;itis
describedintheJPE2004asahydroxypropyletherofcornstarch.
5StructuralFormula
See Section4.
6FunctionalCategory
Bindingagent;disintegrant;emulsifyingagent;thickeningagent;
viscosity-increasingagent.
7ApplicationsinPharmaceuticalFormulationor
Technology
Hydroxypropylstarchisamodifiedstarchandhasbeenusedin
combinationwithcarrageenanintheproductionofsoftcapsules.
(1)
Hydroxypropylstarchhasbeenusedexperimentallyinhydrophilic
matrices,whereitwasshowntobeaneffectivematrixfortablets
designedforcontrolled-releasedrugdeliverysystems.
(2)
Ithasalso
beenusedexperimentallyintheproductionofhydrophilicmatrices
bydirectcompression.
(3)
Itisusedinantisepticsandisusedwidelyincosmetics.Itisalso
usedanalyticallyasabioseparationaqueous-phase-formingpoly-
mer.
(4)
8Description
Hydroxypropylstarchoccursasafree-flowingwhitetooff-white
coarsepowder.
9PharmacopeialSpecifications
See Section18.
10TypicalProperties
Acidity/alkalinity pH=4.5–7.0(10%w/vaqueousdispersion)
Solubility Practicallyinsolubleinwater,ethanol(95%),andether.
11StabilityandStorageConditions
Hydroxypropylstarchisstableathighhumidityandisconsidered
tobeinertundernormalconditions.Itisstableinemulsionsystems
atpH3–9.
12Incompatibilities
See Section18.
13MethodofManufacture
Hydroxypropylstarchisproducedindustriallyfromnaturalstarch,
usingpropyleneoxideasthemodifyingreagentinthepresenceof
alkali,addinghydroxypropyl(CH(OH)CH2CH3)groupsatthe
OHpositionsbyanetherlinkage.
14Safety
Hydroxypropylstarchiswidelyusedincosmeticsandfood
products.Itisalsousedinoralpharmaceuticalformulations.The
WHOhassetanacceptabledailyintakeforhydroxypropylstarch
at ‘notlimited’ sinceitwaswelltoleratedonoralconsumption.
(5)
LD50 (rat,oral):0.218g/kg(6)
15HandlingPrecautions
Observenormalprecautionsappropriatetothecircumstancesand
quantityofmaterialhandled.
16RegulatoryStatus
GRASlisted.AcceptedforuseasafoodadditiveinEurope.
17RelatedSubstances

18Comments
Hydroxypropylstarch–methylmethacrylate(HS-MMA)hasbeen
usedexperimentallyinhydrophilicmatricesproducedbydirect
compression.
(4)
Pregelatinizedhydroxypropylstarchhasbeen
showntoexhibitgooddisintegratingproperties,andcanbeused
asabinderinwetgranulation.
(7)
Althoughitisnotcurrentlyincludedinthepharmacopeias,a
specificationforhydroxypropylstarchisincludedinthe Japanese
PharmaceuticalExcipients (JPE); see TableI.
(8)
Hydroxypropylstarchiscompatiblewithcationicingredients
(monovalent,divalent),oils,emollients,andsilicone.
TheEINECSnumberforhydroxypropylstarchis232-679-6.
ThePubChemCompoundID(CID)forhydroxypropylstarchis
24847857.
TableI: JPE2004specificationforhydroxypropylstarch.
Test JPE2004
Description þ
Identification þ
pH 5.0–7.5
Chloride 40.142%
Heavymetals 420ppm
Arsenic 45ppm
Lossondrying 415.0%
Residueonignition 40.5%
Contentofhydroxypropylgroup
afterdrying
2.0–7.0%
19SpecificReferences
1DraperPR etal.Filmformingcompositionscomprisingmodified
starchesandiota-carrageenanandmethodsformanufacturingsoft
capsulesusingthesame.InternationalPatentWO013677;1999.
2GoniI etal.Synthesisofhydroxypropylmethacrylate/polysaccharide
graftcopolymersasmatricesforcontrolledreleasetablets. DrugDev
IndPharm 2002; 28(9):1101–1115.
3FerreroMC etal.Drugreleasefromafamilyofgraftcopolymersof
methylmethacrylate.I. IntJPharm 1997; 149:233–240.
H
3254VenacioA etal.Evaluationofcrudehydroxypropylstarchasa
bioseparationaqueous-phase-formingpolymer. BiotechnolProg 1993;
9(6):635–639.
5FAO/WHO.FifteenthreportoftheJointFAO/WHOExpertCommittee
onFoodAdditives. WorldHealthOrganTechRepSer 1972;No.488.
6LewisRJ,ed. Sax’sDangerousPropertiesofIndustrialMaterials,11th
edn.NewYork:Wiley,2004;2054.
7VisavarungrojN,RemonJP.Anevaluationofhydroxypropylstarchas
disintegrantandbinderintabletformulation. DrugDevIndPharm
1991; 17(10):1389,1396.
8JapanPharmaceuticalExcipientsCouncil. JapanesePharmaceutical
Excipients2004. Tokyo:YakujiNippo,2004;425–427.
20GeneralReferences

21Authors
SAShah,DThassu.
22DateofRevision
8October2008.
Hypromellose
1NonproprietaryNames
BP:Hypromellose
JP:Hypromellose
PhEur:Hypromellose
USP:Hypromellose
2Synonyms
BenecelMHPC;E464;hydroxypropylmethylcellulose;HPMC;
hypromellosum; Methocel;methylcellulosepropyleneglycolether;
methylhydroxypropylcellulose; Metolose;MHPC; Pharmacoat;
Tylopur; TyloseMO.
3ChemicalNameandCASRegistryNumber
Cellulosehydroxypropylmethylether[9004-65-3]
4EmpiricalFormulaandMolecularWeight
ThePhEur6.3describeshypromelloseasapartlyO-methylatedand
O-(2-hydroxypropylated)cellulose.Itisavailableinseveralgrades
thatvaryinviscosityandextentofsubstitution.Gradesmaybe
distinguishedbyappendinganumberindicativeoftheapparent
viscosity,inmPas,ofa2%w/waqueoussolutionat208C.
HypromellosedefinedintheUSP32specifiesthesubstitutiontype
byappendingafour-digitnumbertothenonproprietaryname:e.g.
hypromellose1828.Thefirsttwodigitsrefertotheapproximate
percentagecontentofthemethoxygroup(OCH3).Thesecondtwo
digitsrefertotheapproximatepercentagecontentofthehydro-
xypropoxygroup(OCH2CH(OH)CH3),calculatedonadried
basis.Itcontainsmethoxyandhydroxypropoxygroupsconforming
tothelimitsforthevarioustypesofhypromellose; see Section9.
Molecularweightisapproximately10000–1500000.
5StructuralFormula
whereRisH,CH3,orCH3CH(OH)CH2
6FunctionalCategory
Bioadhesivematerial;coatingagent;controlled-releaseagent;
dispersingagent;dissolutionenhancer;emulsifyingagent;emulsion
stabilizer;extended-releaseagent;film-formingagent;foaming
agent;granulationaid;modified-releaseagent;mucoadhesive;
release-modifyingagent;solubilizingagent;stabilizingagent;
suspendingagent;sustained-releaseagent;tabletbinder;thickening
agent;viscosity-increasingagent.
7ApplicationsinPharmaceuticalFormulationor
Technology
Hypromelloseiswidelyusedinoral,ophthalmic,nasal,andtopical
pharmaceuticalformulations.
Inoralproducts,hypromelloseisprimarilyusedasatablet
binder,
(1)
infilm-coating,
(2–7)
andasamatrixforuseinextended-
releasetabletformulations.
(8–12)
Concentrationsbetween2%and
5%w/wmaybeusedasabinderineitherwet-ordry-granulation
processes.High-viscositygradesmaybeusedtoretardthereleaseof
drugsfromamatrixatlevelsof10–80%w/wintabletsand
capsules.Hypromelloseisalsousedinliquidoraldosageformsasa
suspendingand/orthickeningagentatconcentrationsrangingfrom
0.25–5.0%.
(13)
Dependingupontheviscositygrade,concentrationsof2–20%
w/wareusedforfilm-formingsolutionstofilm-coattablets.Lower-
viscositygradesareusedinaqueousfilm-coatingsolutions,while
H
326 Hypromellose1997
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