J4 Solely

Hydrogenoledcoslor oil is usedinorol ondlopicol phormoceulicol

lormulolions ond is generolly regorded os on essenliolly nonloxic
ondnonirrilonl moleriol
Acule orol loxicily sludies in onimols hove shon lhol
hydrogenoledcoslor oil is orelolivelynonloxic moleriollrrilolion
lesls ilh robbils sholhol hydrogenoled coslor oil couses mild,
lronsienl irrilolionlolheeye
D
50
rol, orol}: J0gkg
J5 Hondling Precoulions
bservenormol precoulions oppropriolelolhecircumslonces ond
uonlilyol moleriol hondled
J kegulolory Slolus
Accepled in lheSA os on indirecl lood oddilivelncluded in lhe
FDA lnoclive lngredienls Dolobose orol copsules, loblels, ond
sublinguol loblels}
lncludedinnonporenlerol medicineslicensedinlhelncluded
inlheConodionisl ol AcceplobleNon-medicinol lngredienls
J7 keloled Subslonces
Coslor oilvegelobleoil, hydrogenoled
J8 Commenls
Vorious dillerenl grodes ol hydrogenoled coslor oil ore commer-
ciolly ovoiloble, lhecomposilion ol hich moy vory considerobly
Slerolex orlshomns ipid Speciolilies}, lor exomple, is o
mixlure ol hydrogenoled coslor oil ond hydrogenoled collonseed
oil SeeVegelobleil, hydrogenoledlor lurlher inlormolion
IheElNECSnumber lor hydrogenoledcoslor oil is 232-292-2
J9 Specilic kelerences
J lineCHIhixcink-lhixolrope DrugCosmel lndJ94 95}: 895
897
2 YoneooY el olkeleose lromor lhrough ooxmolrixsyslemlll:
8osic properliesol releoselhroughlheoxmolrixloyer ChemPhorm
8ull Iokyo} 2002 50}: 8J48J7
3 Vergole G el olAn orol conlrolledreleosemolrixpellel lormulolion
conloiningmicrocryslollinekeloprolen lnl Phorm 2002 2J9: 8J87
4 DonishF, Porroll EEllecl ol concenlrolionondsieol lubriconl on
lloroleol gronules PhormSci J97J 0: 752754
5 Ho ler AW, So grenEvoluolionol somelubriconlsbylhecomporison
ol lriclioncoellicienlsondloblel properlies AcloPhormSuec J98J J8:
J39J48
20 Generol kelerences

2J Aulhor
kI Guesl
22 Dole ol kevision
JJFebruory2009
Cellulose, Microcryslolline
J Nonproprielory Nomes
8P: MicrocryslollineCellulose
P: MicrocryslollineCellulose
PhEur: Cellulose, Microcryslolline
SP-NF: MicrocryslollineCellulose
2 Synonyms
Avicel PH Cellels Celexcellulose gelhellulosummicrocrislolli-
num Celphere Ceolus G cryslolline celluloseE40 Emcocel
Elhispheres Fibrocel MCC Sono Phormocel Iobulose Vivopur
3 Chemicol Nome ond CAS kegislry Number
Cellulose 9004-34-
4 Empiricol Formulo ond Moleculor Weighl
C

H
J0

5
}
n
3000
here n 220
5 Slruclurol Formulo
Funclionol Colegory
Adsorbenlsuspending ogenlloblel ond copsule diluenlloblel
disinlegronl
C
Cellulose, Microcryslolline J29
7 Applicolions in Phormoceulicol Formulolion or
Iechnology
Microcryslolline cellulose is idely used in phormoceulicols,
primorilyosobinderdiluenl inorol loblel ondcopsulelormulolions
here il is used in bolh el-gronulolion ond direcl-compression
processes
J7}
ln oddilion lo ils use os o binderdiluenl, micro-
cryslolline cellulose olso hos some lubriconl
8}
ond disinlegronl
properlies lhol mokeil uselul inlobleling
SEM 4: Excipienl: microcryslolline cellulose Avicel PH-J05}
monuloclurer: FMC 8iopolymermognilicolion: 500 volloge: 3kV
SEM 5: Excipienl: microcryslolline cellulose Avicel PH-200}
monuloclurer: FMC 8iopolymermognilicolion: 200 volloge: 3kV
SEM : Excipienl: microcryslolline cellulose Avicel PH-302}
monuloclurer: FMC 8iopolymermognilicolion: 200 volloge: 3kV
SEM J: Excipienl: microcryslolline cellulosemonuloclurer: kS Phormo
Plol no: 982mognilicolion: J00
SEM 2: Excipienl: microcryslolline cellulose Avicel PH-J0J}
monuloclurer: FMC 8iopolymermognilicolion: 200 volloge: 3kV
SEM 3: Excipienl: microcryslolline cellulose Avicel PH-J02}
monuloclurer: FMC 8iopolymermognilicolion: 200 volloge: 3kV
C
J30 Cellulose, Microcryslolline
Microcryslolline cellulose is olso used in cosmelics ond lood
producls seeIoblel
8 Descriplion
Microcryslolline cellulose is o purilied, porliolly depolymeried
cellulose lhol occurs os o hile, odorless, losleless, cryslolline
poder composedol porous porliclesll is commerciollyovoiloble
in dillerenl porlicle sies ond moislure grodes lhol hove dillerenl
properlies ondopplicolions
Ioble l: ses ol microcryslolline cellulose
se Concenlrolion}
Adsorbenl 2090
Anliodherenl 520
Copsule binderdiluenl 2090
Ioblel disinlegronl 5J5
Ioblel binderdiluenl 2090
9 Phormocopeiol Specilicolions
SeeIoblell SeeolsoSeclion J8
Ioble ll: Phormocopeiol specilicolions lor microcryslolline cellulose
Iesl PXV PhEur 3 SP32NF27
ldenlilicolion
Choroclers
pH 5075 5075 5075
8ulkdensily
oss ondrying 4 70 4 70 4 70
kesidue onignilion 4 0J 4 0J
Conduclivily
Sulloledosh 4 0J
Elher-soluble subslonces 4 005 4 005 4 005
Woler-soluble subslonces 4 025 4 025
Heovymelols 4 J0ppm 4 J0ppm 4 000J
Microbiol limils
Aerobic 4 J0
3
clug 4 J0
3
clug 4 J0
3
clug
Molds ondyeosls 4 J0
2
clug 4 J0
2
clug 4 J0
2
clug
Solubilily
Porlicle sie dislribulion
J0 Iypicol Properlies
Angleol repose
498lor Ceolus G
3448lor Emcocel 90M
9}
Densilybulk}
0337gcm
3

032gcm
3
lor Avicel PH-J0J
J0}
080 5gcm
3
lor Cellels J00, 200, 350, 500, 700, J000
029gcm
3
lor Emcocel 90M
9}
0203Jgcm
3
lor MCC SonoJ0J
028033gcm
3
lor MCC SonoJ02
02903gcm
3
lor MCC Sono200
034045gcm
3
lor MCC Sono30J
03504gcm
3
lor MCC Sono302
0J3023gcm
3
lor MCC Sono-002
029gcm
3
lor Vivopur J0J
Densilylopped}
0478gcm
3

045gcm
3
lor Avicel PH-J0J
035gcm
3
lor Emcocel 90M
9}
Densilylrue} J5J2J8gcm
3

J420J40gcm
3
lor Avicel PH-J02
JJ}
Floobilily J4Jgs lor Emcocel 90M
9}
Mellingpoinl Chors ol 20270 8C
Moislureconlenl Iypicollylesslhon5Hoever, dillerenl
grodes moyconloinvoryingomounls ol olerMicrocryslolline
celluloseis hygroscopic
J2}
SeeIoblelll
Nlk speclro seeFigureJ
Porliclesiedislribulion Iypicol meonporliclesieis20200 mm
Dillerenl grodesmoyhoveodillerenl nominol meonporliclesie
seeIoblelll
Solubilily Slighllysolublein5vsodiumhydroxidesolulion
proclicolly insoluble in oler, dilule ocids, ond mosl orgonic
solvenls
Specilic surloceoreo
J0JJ2m
2
glor Avicel PH-J0J
J2JJ30m
2
glor Avicel PH-J02
078JJ8m
2
glor Avicel PH-200
JJ Slobilily ond Sloroge Condilions
Microcryslollinecelluloseis osloblelhough hygroscopic moleriol
Ihebulkmoleriol shouldbesloredin oell-closedconloiner in o
cool, dryploce
J2 lncompolibililies
Microcryslolline cellulose is incompolible ilh slrong oxidiing
ogenls
J3 Melhod ol Monuloclure
Microcryslollinecelluloseismonulocluredbyconlrolledhydrolysis
ilhdiluleminerol ocidsolulionsol o-cellulose, obloinedosopulp
lrom librous plonl moleriolsFolloing hydrolysis, lhe hydro-
cellulose is purilied by lillrolion ond lhe oueous slurry is sproy-
driedlo lormdry, porous porlicles ol obroodsiedislribulion
J4 Solely
Microcryslolline cellulose is idely used in orol phormoceulicol
lormulolions ond lood producls ond is generolly regorded os o
relolivelynonloxic ondnonirrilonl moleriol
Microcryslollinecelluloseisnol obsorbedsyslemicollylolloing
orol odminislrolionondlhushoslillleloxic polenliolConsumplion
ol lorgeuonlilies ol cellulosemoyhoveoloxoliveellecl, ollhough
lhisisunlikelylobeoproblemhencelluloseisusedosonexcipienl
inphormoceulicol lormulolions
Deliberoleobuseol lormulolions conloiningcellulose, eilher by
inhololionor byineclion, hosresulledinlhelormolionol cellulose
gronulomos
J3}
40
00
70
J
0
0
0
0

2
n
d
d
e
r
i
v
l
o
g
J
k
}

JJ00 J300 J500

J37 J427
J590J70
J40J
J890
2020
J920
2J0 233
2273
2483
224
2292
2427
2404
J700 J900 2J00 2300 2500
Wovelenglhnm
02
04
l
o
g
J
k
}
Figure J: Neor-inlroredspeclrumol cellulose, microcryslolline meosured
byrelleclonce
C
Cellulose, Microcryslolline J3J
J5 Hondling Precoulions
bservenormol precoulions oppropriolelo lhecircumslonces ond
uonlily ol moleriol hondledMicrocryslolline cellulose moy be
irrilonl lo lhe eyesGloves, eye proleclion, ond o dusl mosk ore
recommendedln lhe , lhe orkploce exposure limils lor
cellulose hove been sel ol J0mgm
3
long-lerm 8-hour IWA} lor
lolol inholobledusl ond4mgm
3
lor respirobledusllheshorl-lerm
limil lor lolol inholobledusl hos beensel ol 20mgm
3

J4}
J kegulolory Slolus
GkAS lisledAccepled lor use os o lood oddilive in Europe
lncluded in lhe FDA lnoclive lngredienls Dolobose inhololions
orol copsules, poders, suspensions, syrups, ondloblelslopicol ond
voginol preporolions}lncludedinnonporenlerol medicineslicensed
in lhe lncluded in lhe Conodion isl ol Acceploble Non-
medicinol lngredienls
J7 keloled Subslonces
Microcryslollinecelluloseond corrogeenonmicrocryslollinecellu-
loseondcorboxymelhylcellulosesodiummicrocryslollinecellulose
ond guor gumpodered cellulosesilicilied microcryslolline
cellulose
Microcryslolline celluloseondcorrogeenon
Synonyms uslreCleor
Commenls uslre Cleor FMC 8iopolymer} is on oueous lilm
coolingcombiningmicrocryslollinecelluloseondcorrogeenon
Microcryslolline celluloseondguor gum
Synonyms Avicel CE-J5
Commenls Avicel CE-J5 FMC 8iopolymer} is o coprocessed
mixlure ol microcryslolline cellulose ond guor gum used in
cheobleloblel lormulolions
J8 Commenls
Microcryslolline cellulose is one ol lhe moleriols lhol hove been
selecled lor hormoniolion by lhe Phormocopeiol Discussion
GroupFor lurlher inlormolion see lhe Generol lnlormolion
Chopler JJ9 in lhe SP32NF27, lhe Generol Chopler 58
inPhEur 0, olongilhlhe Sloleol Work documenl onlhePhEur
ED M ebsile, ondolsolheGenerol lnlormolionChopler 8inlhe
PXV
Severol dillerenl grodes ol microcryslolline cellulose ore com-
merciollyovoiloblelhol diller inlheir melhodol monuloclure,
J5,J}
porlicle sie, moislure, llo, ond olher physicol properlies
J729}
Ihelorger-porlicle-siegrodesgenerollyprovidebeller lloproper-
lies in phormoceulicol mochineryo-moislure grodes ore used
ilh moislure-sensilive moleriolsHigher-densily grodes hove
improvedlloobilily
Severol coprocessed mixlures ol microcryslollinecelluloseilh
olher excipienls such os corrogeenon, corboxymelhylcellulose
sodium, ondguor gumorecommerciollyovoiloble seeSeclion J7
Celphere Asohi osei Corporolion} is o pure spheronied
microcryslollinecelluloseovoiloblein severol dillerenl porliclesie
ronges 8olocel Sono PhormolronsSonoAG} isonexcipienl used
moinly in lhe produclion ol pellels ond gronuloles in direcl
lobleling, hich conloins loclose, microcryslolline cellulose, ond
sodiumcorboxymelhylcellulose
According lo PhEur 3, microcryslolline cellulose hos cerloin
lunclionolily reloled choroclerislics lhol ore recognised os being
relevonl conlrol poromelers lor one or more lunclions ol lhe
subslonce hen used os on excipienlNon-mondolory lesling
procedureshovebeendescribedlor porliclesiedislribulion293J
or 2938} ondpoder llo293}
A specilicolion lor microcryslollinecelluloseis conloinedin lhe
Food Chemicols Codex FCC}
30}
Ihe PubChem Compound lD
ClD} lor microcryslollinecelluloseis J405502
J9 Specilic kelerences
J Ene ion GM Direcl compression ol loblels using microcryslolline
cellulose PhormAcloHelvJ972 47: 32J33inFrench
2 erkCF, 8olhuis GComporolive evoluolion ol excipienls lor direcl
compressionl PhormWeekbl J973 J08: 4948J
3 erk CF el olComporolive evoluolion ol excipienls lor direcl
compressionll PhormWeekbl J974 J09: 945955
4 omberson kF, koynor GEIobleling properlies ol microcryslolline
cellulose Monul ChemAerosol Nes J97 47}: 55J
Ioble lll: Properlies ol selecledcommerciollyovoiloble grodes ol
microcryslolline cellulose
Grode Nominol
meon
porlicle sie
mm}
Porlicle sie onolysis Moislure
conlenl }
Meshsie Amounl
reloined}
Avicel PH-J0J
o}
50 0 4 J0 4 50
200 4 300
Avicel PH-J02
o}
J00 0 4 80 4 50
200 5 450
Avicel PH-J03
o}
50 0 4 J0 4 30
200 4 300
Avicel PH-J05
o}
20 400 4 J0 4 50
Avicel PH-JJ2
o}
J00 0 4 80 4 J5
Avicel PH-JJ3
o}
50 0 4 J0 4 J5
200 4 300
Avicel PH-200
o}
J80 0 5 J00 4 50
J00 5 500
Avicel PH-30J
o}
50 0 4 J0 4 50
200 4 300
Avicel PH-302
o}
J00 0 4 80 4 50
200 5 450
CelexJ0J
b}
75 0 4 J0 4 50
200 5 300
Ceolus G-802
c}
50 0 4 05 4 0
200 4 300
Emcocel 50M
d}
50 0 4 025 4 50
200 4 300
Emcocel 90M
d}
9J 0 4 80 4 50
200 5 450
MCC Sono
J0J
e}
50 0 4 J0 4 0
200 4 300
MCC Sono
J02
e}
J00 0 4 80 4 0
200 5 450
MCC Sono
200
e}
J80 0 5 J00 4 0
J00 5 500
MCC Sono
30J
e}
50 0 4 J0 4 0
200 5 300
MCC Sono
302
e}
J00 0 4 80 4 0
200 5 450
MCC Sono-
002
e}
50 0 05 4 0
J00 50
200 50300
Vivopur J0J
d}
50 0 4 J0 4 50
200 4 300
Vivopur J02
d}
90 0 4 80 4 50
200 5 450
Vivopur J2
d}
J0 38 4 J0 4 50
94 4 500
Suppliers:
o} FMC 8iopolymer
b} lnlernolionol SpeciollyProducls
c} Asohi osei Corporolion
d} kS Phormo
e} Phormolrons SonoAG
C
J32 Cellulose, Microcryslolline
5 erkCF el olEllecl ol microcryslollinecelluloseonliuidpenelrolion
inonddisinlegrolionol direcllycompressedloblels PhormSci J979
8: 2052JJ
Chilomkurli kNel olSomesludiesoncompressionproperliesol loblel
molrices using o compuleried inslrumenled press Drug Dev lnd
PhormJ982 8: 38
7 Wolloce W el olPerlormonce ol phormoceulicol lillerbinders os
reloledlo melhods ol poder chorocleriolion PhormIechnol J983
79}: 94J04
8 mroy A, mroy PEvoluolion ol microcryslolline cellulose os o
glidonl lndionPhormSci J98 48: 2022
9 Celik M, kulgen EA leosibilily sludy lor lhe developmenl ol o
prospeclive compoclion lunclionolily lesl ond lhe esloblishmenl ol o
compocliondolobonk DrugDevlndPhormJ993 J9: 23092334
J0 Porker MDel ol8indersubslroleinleroclionsinel gronulolion3: lhe
ellecl ol excipienl sourcevoriolion lnl Phorm J992 80: J79J90
JJ Sun CCIruedensilyol microcryslollinecellulose PhormSci 2005
94J0}: 2J322J34
J2 Collohon C el olEuilibrium moislure conlenl ol phormoceulicol
excipienls DrugDevlndPhormJ982 8: 35539
J3 Cooper C8el olCellulosegronulomosinlhelungsol ococoinesniller
8r Med J983 28: 202J2022
J4 HeollhondSolelyExeculive EH402005: WorkploceExposureimils
Sudbury: HSE 8ooks, 2005 updoled 2007}hllp:hsegovuk
coshhlobleJpdl occessed5Februory2009}
J5 oin el olPreporolionol microcryslollinecelluloselromcereol slro
ondils evoluolion os oloblel excipienl lndionPhormSci J983 45:
8385
J SingloA el olEvoluolionol microcryslollinecellulosepreporedlrom
obsorbenl collonosodirecl compressioncorrier DrugDevlndPhorm
J988 J4: JJ3JJJ3
J7 Doelker E el olComporolive lobleling properlies ol sixleen micro-
cryslollinecelluloses DrugDevlndPhormJ987 J3: J847J875
J8 8ossom F el olEllecl ol porlicle sie ond source on voriobilily ol
Youngs modulus ol microcryslolline cellulose poders Phorm
Phormocol J988 40: 8P
J9 Dillgen M el olMicrocryslolline cellulosein direcl loblelling Monul
ChemJ993 47}: J7, J9, 2J
20 ondin M el olEllecl ol counlry ol origin on lhe properlies ol
microcryslollinecellulose lnl Phorm J993 9J: J23J3J
2J ondin M el olEllecl ol bolch voriolion ond source ol pulp on lhe
properliesol microcryslollinecellulose lnl Phorm J993 9J: J33J4J
22 ondinM el ollnlluenceol microcryslollinecellulosesourceondbolch
voriolion on loblelling behovior ond slobilily ol prednisone lormulo-
lions lnl Phorm J993 9J: J43J49
23 PodceckF, ke ve sPEvoluolionol lheproperlies ol microcryslolline
ondmicrolinecellulosepoders lnl Phorm J993 9J: J83J93
24 koe kC el olIhe ellecl ol bolch ond source voriolion on lhe
cryslollinilyol microcryslollinecellulose lnl Phorm J994 J0J: J9
J72
25 HosegooMDirecl compression: microcryslollinecellulosegrodeJ2
versus clossic grode J02 PhormIechnol 2002 25}: 50, 52, 54, 5,
58, 0
2 olhori SH el olComporoliveevoluolions ol poder ondmechonicol
properliesol locryslollinilycelluloses, microcryslollinecelluloses, ond
poderedcelluloses lnl Phorm 2002 232: 980
27 evis Sk, DeosyP8Produclionondevoluolionol sie-reducedgrodes
ol microcryslollinecellulose lnl Phorm 200J 2J3: J324
28 Wu S el olA slolislicol design lo evoluole lhe inlluence ol
monulocluring loclors on lhe moleriol properlies ond lunclionolilies
ol microcryslollinecellulose Eur PhormSci 200J J2: 4J7425
29 Suuki I, Nokogomi HEllecl ol cryslollinily ol microcryslolline
celluloseonlhecompoclobililyonddissolulionol loblels Eur Phorm
8iophormJ999 47: 225230
30 Food Chemicols Codex, lh edn8elhesdo, MD: niled Sloles
Phormocopeio, 2008J87
20 Generol kelerences
Asohi osei Corporolion Ceolus G , Celpherehllp:ceoluscom
occessedNovember 2008}
Doelker EComporolivecompoclion properlies ol vorious microcryslolline
cellulose lypes ond generic producls Drug Dev lnd Phorm J993 J9:
2399247J
Europeon Direclorole lor lhe uolily ol Medicines ond Heollhcore
EDM}Europeon PhormocopoeioSlole l Work l lnlernolionol
Hormonisolion Phormeuropo20092JJ}: J42J43hllp:ed-
meusile-J4hlml occessed5Februory2009}
FMC 8iopolymerProblemSolver: Avicel PH, 2000
lnlernolionol Speciolly ProduclsMoleriol Solely dolo sheel: Celex J0J,
2003
kSPhormoPIechnicol lilerolure: Emcocel, 2003
Phormolrons SonoAGProducl lilerolure: Cellelshllp:cellelscom
occessedNovember 2008}
Phormolrons SonoAGProducl lilerolure: MCC Sono hllp:phor-
molrons-sonocomprodhlml occessedNovember 2008}
Smolinske SC Hondbook ol Food, Drug, ond Cosmelic Excipienls 8oco
kolon, F: CkC Press, J9927J74
Slonilorlh N el olEllecl ol oddilion ol oler on lhe rheologicol ond
mechonicol properlies ol microcryslollinecelluloses lnl Phorm J988
4J: 23J23
2J Aulhor
A Guy
22 Dole ol kevision
5Februory2009
C
Cellulose, Microcryslolline J33