Eudragit and its Pharmaceutical Significance

Satish Singh Kadian*, S.L. Harikumar

Roorkee College of Pharmacy
9
th
milestone, Roorkee-ehradun high!ay
Kishan"ur, Roorkee-#$%&&% '()*, +ndia
,mail- satish./attu0rediffmail.com
Abstract
1ne !ould al!ays like to ha2e an ideal drug deli2ery system that !ill "ossess three main
"ro"erties- 'a* +t !ill /e a single dose for the !hole duration of treatment. '/* +t !ill deli2er
the acti2e drug directly at the site of action. 'c* +t !ill "ossess "ossi/le fe!er side effects.
)/o2e a""roaches are achie2ed !ith the hel" of suita/le choice of "olymer. 3his re2ie!
focuses on recent literature regarding use of ,udragit "olymer in different drug deli2ery
systems !ith s"ecial attention to used in its fa/rication along !ith their "hysiochemical
"ro"erties.
Introduction
) "olymer, natural or synthetic is a su/stance that is com/ined !ith a drug or other acti2e
agent to release drug in a "re-designed manner
4
. 3he de2elo"ment of 5S has /een made
"ossi/le /y the 2arious com"ati/le "olymers to modify the release "attern of drug
#,6
.

Choice
of "olymers al!ays suffering from the "ro/lems of non-/iocom"ati/le, non-/iodegrada/le
and e7"ensi2e and this "ro/lem can sol2e !ith a "olymer of different "ro"erties. 3he /asic
o/8ecti2e of controlled drug release is to achie2e more effecti2e thera"ies /y eliminating
the "otential for /oth under- and o2erdosing. 1ther ad2antages are the maintenance of drug
concentration !ithin a desired range, fe!er administrations, o"timal drug use and increased
"atient com"liance
$
.
,udragit is trademark of Rohm 9m/H : Co. K9. armstadt in 9ermany, first
marketed in 49;<s. ,udragit "re"ared /y the "olymeri=ation of acrylic and methacrylic
acids or their esters, e.g., /utyl ester or dimethylaminoethyl ester. ,udragit introduced in
(SP5>, ?P, Ph,ur, Hand /ook of "harmaceutical e7ci"ients
;
. 3he eudragit acrylic
"olymers ha2e a long history of use, the indi2idual ty"es and grades /eing introduced in the
follo!ing chronological order-
Table:1
Table:2 Countries with regular imports of Eudragit
Year of introduction Eudragit rade
49;$ ,udragit L 4#.;
,udragit S 4#.;
49;9 ,udragit , 4#.;
49&4 ,udragit , 4<<
49&@ ,udragit RL 4<<
,udragit RS 4<<
49%# ,udragit 5, 6< 'formerly ,udragit , 6< *
,udragit L 6< -;; 'formerly ,udragit L 6< *
,udragit RS P1
,udragit RL P1
49%% ,udragit L 4<<
49@6 ,udragit 5, $<
49@; ,udragit L 4<<-;;
49@& ,udragit RL 6<
,udragit RS 6<
4999 ,udragit , P1
,udragit >S 6<
!estern
Europe
Eastern
Europe
"ear East America Africa Asia#Pacific
)ustria
?elgium
enmark
>inland
>rance
9ermany
9reat ?ritain
9reece
+reland ',ire*
+celand
+taly
Liechtenstein
Lu7em/ourg
Aalta
5etherlands
5or!ay
Portugal
S!eden
S!it=erland
S"ain
3urkey
?ulgaria
Croatia
C=ech Re"u/lic
,stonia
Hungary
Lat2ia
Lithuania
Aa=edonia
Poland
Romania
Russia
Slo2akia
Slo2enia
(kraine
Cy"rus
+ran
+srael
Bordan
Ku!ait
Le/anon
Saudi )ra/ia
Syria
(.).,.
)rgentina
?oli2ia
?ra=il
Canada
Chile
Colom/ia
Costa-Rica
ominican
Re"u/lic
,cuador
9uatemala
Honduras
Ae7ico
Panama
Paraguay
Peru
(ruguay
(S)
Cene=uela
,gy"t
Kenya
Aorocco
5igeria
South )frica
3unisia
)ustralia
?angladesh
China, P.R.
China, Hong
Kong
+ndia
+ndonesia
Ba"an
Aalaysia
5e"al
5e! Dealand
Pakistan
Phili""ines
Singa"ore
South Korea
Sri Lanka
3ai!an
3hailand
Cietnam
lass transition temperature $Tg%:
3he glass transition tem"erature is an im"ortant factor for descri/ing the "hysical
"ro"erties of "olymers. 1n a macrosco"ic le2el it descri/es the solidification of an
anisotro"ic "olymer melt. 3he glass transition tem"erature has far-reaching conseEuences,
e.g. for film formation, melt "rocessing and storage of finished "harmaceutical dosage
forms. Plastici=ers, sol2ents or residual sol2ents 'including !ater* that act as "lastici=ers
usually cause a reduction in glass transition tem"erature, !hich is s"ecifically e7"loited in
a""lication formulations. Aost common "lastici=er for ,(R)9+3 "olymers is triethyl
citrate '3,C*.
Table: & lass transition inter'als of different grades
S( "o( Eudragit grade T
g)m
*iaC+
4. ,udragit

, 4<< F , P1 $@
#. ,udragit

L 4<<-;; F L 6< -;; 44<
6. ,udragit

>S 6< $@
$. ,udragit

RL 4<< F RL P1 %<
;. ,udragit

RS 4<< F RS P1 &;
&. ,udragit

5, 6< 9
%. ,udragit

5A 6< 44
Table:, Ph-sical and Chemical Properties :
Trade "ame
.
Solubilit-
.
/escription Applications
.
,udragit , 4<< Solu/le in gastric fluid- to
"H ;
Cationic, Gello! in
colour
;
>ilm coating
,udragit , 4#.; Solu/le in gastric fluid- to
"H ;
Cationic, Gello! in
colour
;
>ilm coating
,udragit 5, 6< S!ella/le, "ermea/le Cationic, Gello! in
colour
;
Sustained release
,udragit L 4<< Solu/le in intestinal- fluid
from "H &
)nionic, !hite free-
flo!ing "o!ders
;
,nteric coatings
,udragit L 4#.; Solu/le in intestinal- fluid
from "H &
)nionic, !hite free-
flo!ing "o!ders
;
,nteric coatings
,udragit L 4#.; P Solu/le in intestinal- fluid
from "H &
)nionic, !hite free-
flo!ing "o!ders
;
,nteric coatings
,udragit L 6< -;; Solu/le in intestinal- fluid
from "H ;.;
)nionic, !hite free-
flo!ing "o!ders
;
,nteric coatings
,udragit L 4<<-;; Solu/le in intestinal- fluid
from "H ;.;
)nionic, !hite free-
flo!ing "o!ders
;
,nteric coatings
,astacryl 6< Solu/le in intestinal- fluid
from "H ;.;
- ,nteric coatings
Kollicoat A), 6< Solu/le in intestinal- fluid
from "H ;.;
)nionic, Ailky Hhite,
Lo! Ciscosity
&
.
,nteric coatings
Kollicoat A), 6<
P
Solu/le in intestinal- fluid
from "H ;.;
0 ,nteric coatings
,udragit S 4<< Solu/le in intestinal-fluid
from "H %
)nionic, !hite free-
flo!ing "o!ders
;
,nteric coatings
,udragit S 4#.; Solu/le in intestinal-fluid
from "H %
)nionic, !hite free-
flo!ing "o!ders
;
,nteric coatings
,udragit S 4#.; P Solu/le in intestinal- fluid
from "H %
)nionic, !hite free-
flo!ing "o!ders
;
,nteric coatings
,udragit RL 4<< High "ermea/ility Cationic, non-
/iodegrada/le
%
Sustained release
,udragit RL P1 High "ermea/ility Cationic, non-
/iodegrada/le
%
Sustained release
,udragit RL 6< High "ermea/ility Cationic, non-
/iodegrada/le
%
Sustained release
,udragit RL 4#.; High "ermea/ility Cationic, non-
/iodegrada/le
Sustained release
,udragit RS 4<< Lo! "ermea/ility Cationic,

non-
/iodegrada/le
%
Sustained release
,udragit RS P1 Lo! "ermea/ility Cationic, non-
/iodegrada/le
%
Sustained release
,udragit RS 6< Lo! "ermea/ility Cationic, non-
/iodegrada/le
%
Sustained release
,udragit RS 4#.; Lo! "ermea/ility Cationic, non-
/iodegrada/le
%
Sustained release

1ig: 1 /ifferent grades of Eudragit in oral solid dosage formulation
rug Release Aechanism-
1ral "re"aration for controlled release can /e su/ di2ided in systems !here drug release
from the dosage form is go2erned /y the follo!ing "rinci"les-
issolution
iffusion
1smotic Pressure
+on-,7change
1ther Princi"le
@
/issolution controlled dosage forms can be di'ided into reser'oir and matri2
s-stem( 3eser'oir principle is gi'en b- a controlled release formulation
comprising ,44mg .0ASA within an acr-lic resin coat) eudragit S
5
(
6echanism of drug release from pellets coated with pol-mer eudragit E &4 /)
was go'erned b- diffusion through water0filled pores in the film coat
14
(
The release of propanolol 7C8 from a monolithic matri2 $Eudragit "E &4 /%
b- a combination of diffusion through the pol-mer and pores or chanels
11
(
) desira/le release "rofile of di"henhydramine !as achie2ed /y incor"orating
,udragit L in a carnau/a !a7 matri7. 3he drug release from these "olymer-!a7
matrices is descri/ed /y a com/ination diffusionFerosion mechanism
4#
.
,udragit RS P1 release the car/ama=e"ine drug /y com"le7 mi7ture of diffusion
and erosion mechanism
46
(
,udragit RS 6< -coated theo"hylline /eads "ro2ed ion e7change to /e the
res"onsi/le mechanism of controlling "olymer "ermea/ility as a function of anionic
s"ecies and concentration
4$
.

)""lications of ,udragit "olymers-
9phthalmic /rug /eli'er-:
) ma8or "ro/lem /eing faced in ocular thera"eutics is the attainment of an o"timal
concentration at the site of action. Poor /ioa2aila/ility of drugs from ocular dosage forms
is mainly due to the tear "roduction, non-"roducti2e a/sor"tion, transient residence time,
and im"ermea/ility of corneal e"ithelium. ,udragit e7hi/its fa2ora/le /eha2ior, such as no
to7icity, "ositi2e charge and controlled release "rofile this make them suita/le for o"thalic
a""lication
4;
.
/uarte et( al. used ,udragit RS 4<< and RL 4<< as a drug carrier. 3he release /eha2iour
of aceta=olamide from the "re"ared micro"articles !as studied and most "roducts e7hi/ited
a slo!er release than the single drug
4&
.
Pignatello et( al( !ere "re"ared from inert "olymer resins ',udragit RS4<<, RS, and
RL4<<, RL*. 3hey !ere Successful to )2oid of any irritant effect on cornea, iris, and
con8uncti2a u" to #$ h after a""lication
4%
.
:hopade et( al( ,udragit RLPA and RSPA !ere used as carrier materials. ,udragit RSPA
sho!ed com"arati2ely longer release than ,udragit RLPA nanosus"ensions, e7cellent
enca"sulation efficiency of a/out 9$-9@I
4@
.
;ucolo et( al( 3he results indicated that the dis"ersion of cloricromene !ithin ,udragit
RL4<< "olymer nano"articles increased its ocular /ioa2aila/ility and enhanced the
/io"harmaceutical "rofile
49
.
;uccal and Sublingual /rug /eli'er-:
3he oral mucosae in general is a some!hat leaky e"ithelia intermediate /et!een that of the
e"idermis and intestinal mucosa. +t is estimated that the "ermea/ility of the /uccal mucosa
is $-$<<< times greater than that of the skin
#<
. +n general, the "ermea/ilities of the oral
mucosae decrease in the order of su/lingual greater than /uccal, and /uccal greater than
"alatal
#4
. )t "hysiological "H the mucus net!ork carries a negati2e charge 'due to the
sialic acid and sulfate residues* !hich may "lay a role in mucoadhesion. )t this "H mucus
can form a strongly cohesi2e gel structure that !ill /ind to the e"ithelial cell surface as a
gelatinous layer
##
. Aa8or limitation of the /uccal route of administration is the lack of
dosage form retention at the site of a/sor"tion. ConseEuently, /ioadhesi2e "olymers ha2e
e7tensi2ely /een em"loyed in /uccal drug deli2ery systems. Polymers !hich can adhere to
either hard or soft tissue ha2e /een used for many years in surgery and dentistry. i2erse
classes of "olymers ha2e /een in2estigated for their "otential use as mucoadhesi2es. 3hese
include synthetic "olymers such as monomeric a cyanoacrylate, "olyacrylic acid
#6
, and "oly
methacrylate deri2ati2es. )n ideal /uccal film should /e fle7i/le, elastic, and soft yet
strong enough to !ithstand /reakage due to stress from acti2ities in the mouth. Aoreo2er,
it must also "ossess good mucoadhesi2e strength so that it is retained in the mouth for the
desired duration. 3o "re2ent discomfort, s!elling of the film should not /e too e7tensi2e.
3he mechanical, /ioadhesi2e, and s!elling "ro"erties of /uccal films are critical and must
/e e2aluated. Carious mucoadhesi2e de2ices, including ta/lets
#$
, films
#;
, "atches
#&
, disks
#%
,
stri"s
#@
, ointments
#9
, and gels
6<
, ha2e recently /een de2elo"ed. ,udragit "ro2iding good
drug release /arier !ith good adhesi2e strength.
Ashwini 6adgul<ar et( al( Solid dis"ersion of itracona=ole !ith ,udragit ,4<< "re"ared a
ta/let /y s"ray-drying method in the ratio of 4-# sho!ed 4<<I drug release !ithin 6 h
64
.
loria 3ui= et( al( also used ,udragit RL P1 to "re"are mucoadhesi2e ta/let
6#
. 6ona
Semalt-

et(al( Here "re"ared mucoadhesi2e /uccal films of gli"i=ide !ith ,udragit
RL-4<<
66
.
astrointestinal /rug /eli'er-:
3he need for gastroretenti2e dosage forms has led to e7tensi2e efforts in /oth academia and
industry to!ards the de2elo"ment of such drug deli2ery systems. 3hese efforts resulted in
gastroretenti2e dosage forms that !ere designed, in large "art, /ased on the follo!ing
a""roaches,Lo! density form of the dosage form that causes /uoyancy in gastric fluid,
High density dosage form that is retained in the /ottom of the stomach, ?ioadhesion to
stomach mucosa, Slo!ed motility of the gastrointestinal tract /y concomitant
administration of drugs or "harmaceutical e7ci"ients, ,7"ansion /y s!elling or unfolding
to a large si=e !hich limits em"tying of the dosage form through the "yloric s"hincter

. )ll
these techniEues !e can achie2ed !ith different grades of eudragit
6$
.
:ale et al( 3he micros"heres of eudragit S4<< !ere found to float continuously in the
acidic solution and successfully release drug in a "redetermined rate
6;
.
loria et al( >ormulate /ioadhesi2e t!o layers controlled release ta/lets !ith com/ination
of Carrageenan 96$ and ,udragit RL P1 in 4-4 ratio. 3he drug release !as 9&.6I in
"hos"hate /uffer "H %.$J ;9.4I in <.4 5 HCl and $&.$I in distilled !ater
66
.
Intestinal /rug /eli'er-:
Sustained intestine deli2ery of drugs !as de2elo"ed that could /y"ass the stomach and
release the loaded drug for long "eriods into the intestine /y coating of eudragit "olymer.
,udragit L : ,udragit S are t!o forms of commercially a2aila/le enteric acrylic resins.
?oth of them "roduce films resistant to gastric fluid. ,udragit L : S are solu/le in
intestinal fluid at "H & : % res"ecti2ely. ,udragit L is a2aila/le as an organic solution
'+so"ro"anol*, solid or aEueous dis"ersion. ,udragit S is a2aila/le only as an organic
solution '+so"ro"anol* and solid. Rahman et. al. "re"ared sodium "ara aminosalicylate
Pellets !ere coated !ith ,udragit L 6< -;; using fluidi=ed /ed "rocessor and e2aluated
for in vitro dissolution /eha2ior in <.4 5 HCl for t!o hours and then media !as changed to
"hos"hate /uffer "H &.@. ) &<I !F! coating le2el of ,udragit L6< ;; has "roduced the
most acce"ta/le results against the gastric attack
6&
.
Colon /rug /eli'er-:
Colonic drug deli2ery is a relati2ely recent a""roach for the treatment of diseases like
ulcerati2e colitis, CrohnKs disease, and irrita/le /o!el syndrome. "H-sensiti2e "olymers
that dissol2e, or a/o2e "H % used for colonic drug deli2ery
6%
.3egaserod maleate !as used
as a drug for irrita/le /o!el syndrome, !hereas ,udragit L 4<< and S4<< mi7ture '4-4, 4-#,
and 4-6* !ere used
6@
.
Transdermal /rug /eli'er-:
3he mechanical "ro"erties of casted ,udragit ,-4<< films !ere tested for the com/ined
effect of t!o cohesion "romoters 'succinic or citric acid* and triacetin as a "lastici=er. 3he
"re"ared films !ere elastic, self-adhesi2e, trans"arent and "ale yello! in colour. ,udragit
,4<< "olymer !as found to result in !rinkle-free trans"arent films !ith good adhesion to
skin. Release kinetics from transdermal thera"eutic system !as o/ser2ed due to erosion of
hydro"hilic ,udragit ,4<< "olymer, and 4<<I release !as o/ser2ed !ithin #< minutes
69
.
>aginal /rug /eli'er-:
,udragit RS4<< 2aginal su""ositories containing sildenafil, and other e7ci"ients gi2e
adeEuate release
$<
. +ntra2aginal ta/let !ere "re"ared !ith 4-4 ratio of lactic acid to ,udragit
,-4<<, ta/lets disintegrating into a gelform at "hysiological range of 6.@-$.$ "H. 3hese gels
"ossess an acid reser2e that might /e a/leto neutralise the e7cess of alkali "resent in se2ere
2aginal infections
$4
.
ene /eli'er-
3he course of many hereditary diseases could /e re2ersed /y gene deli2ery. +n addition,
many acEuired diseases such as multigenetic disorders and those diseases caused /y 2iral
genes could /e treated /y genetic thera"y
$#
. 5ano"articles "re"ared /y /lending PL9)
!ith methacrylate co"olymer ',udragit'R* ,4<<* can efficiently and safely deli2er "lasmid
5) encoding mouse interleukin-4< leading to "re2ention of autoimmune dia/etes
$6
. 5e!
)nionic nano"articles !ere "re"ared /y ,udragit L4<<F;; "ro2ide a 2ersatile "latform for
"rotein surface adsor"tion and a "romising deli2ery system "articularly !hen the
maintenance of the /iologically acti2e conformation is reEuired for 2accine efficacy
$$
.
)ntisense oligodeo7ynucleotides !ere successfully deli2ered /y nano"articles "re"ared /y
,udragit RL4<<, RS4<<
$;
.
>accine /eli'er-
)nionic surfactant-free "olymeric core-shell nanos"heres and micros"heres !ere "re"ared
/y ,udragit L4<<-;;. Caccines !ere administered /y different routes, including
intramuscular, su/cutaneous or intranasal and the results !ere com"ared to immuni=ation
!ith 3at alone or !ith 3at deli2ered !ith the alum ad8u2ant. 3he data demonstrate that the
nano- and micros"heresF3at formulations are safe and induce ro/ust and long-lasting
cellular and humoral res"onses in mice after systemic andFor mucosal immuni=ation
$&
.
Height ratio of 5o2eon and ,udragit S-4<< had a significant effect on adhesion time of
/ilayer films. Postloaded "lasmid 5) and /eta-gal remained sta/le after /eing released
from /ilayer films 'release of -&<-@<I in # h for /oth*. ?uccal immuni=ation using no2el
/ilayer films '4<9 LF- &-microm thickness* containing "lasmid 5) led to com"ara/le
antigen-s"ecific +g9 titer to that of su/cutaneous "rotein in8ection. )ll ra//its immuni=ed
!ith "lasmid 5) 2ia the /uccal route /ut none /y the su/cutaneous route !ith "rotein
antigen demonstrated s"lenocyte "roliferati2e immune res"onses
$%
.
Table: . Taste 6as<ing /rug /eli'er- S-stem:
Sr(
"o(
/rug#Acti'e
Agent
Techni?ue Pol-mer 3eference
4 +/u"rofen )ir-sus"ension Aethacrylic acid co"olymer $@
coating ',udragit*
# )cetamino"hen Coating Cellulose acetate, cellulose
acetate /utyrate, HPCFcellulose
acetate, ,udragit , 4<<, PCP
$9,;<
6 Aor"hine HCl Coating Cellulose, ,udragit 5, 6< ;4
$ Ro7ithromycin 9ranulation and
coating
P,9, ,udragit L 4<<M;; ;#
; 5i=atidine S"ray drying ,udragit , 4<< ;6
& Cetra7ate HCl Aelt granulation
and coating
Corn starch, Aacrogol-&<<<,
,udragit S-4<<
;$
% Ci"roflo7acin Aicroenca"sulatio
n
,udragit 5, 6<, HPC ;;
@ +/u"rofen S"ray coating ,udragit L6<<, "ro"ylene
glycol, mannitol, and fla2or
;&
9 ?ifemelane HCl Coating and
s"raying
9lycerin monostearate,
,udragit L6<--;;, P,9,
sucrose
;%
4< Cefuro7ime a7etil ,mulsion-sol2ent
e2a"oration
,udragit L-;; and RL ;@
44 Piren=e"ine and
17y/utynin
is"ersion
coating
,udragit ,-4<<, ACC, HPC ;9
4# Le2oflo7acin Coating ,udragit ,4<<, cellulose
acetate
&<
Conclusion
3he large 2ariety of a""lications as !ell as the steadily increasing num/er of research
!orkers engaged in studies of ,udragit "olymers due to their uniEue "ro"erties, ha2e made
significant contri/utions to many ty"es of formulations and suggest that the "otential of
,udragit as no2el and 2ersatile "olymer !ill /e e2en more significant in future.
3eference
4. Sint=e A.?., ?ernatche= S. >., 3a/ata/ay C. and 9urny R, ,ur. B. Pharm.
?io"harm, 499&, $#- 6;@M 6%$.
#. 5agai, 3., Aachida, G., Pharm. +nt. 49@;, &-49&-#<<.
6. ?odde, H.,., e Cries, A.,., and Bunginger, H.,., B. Control. Rel, 499<,
46-##;-#64.
$. Le ?ourlais C. )., 3reu"el-)car L., Rhodes C.3., Sado P. 3., Le2erge R., rug
e2. +nd. Pharm, 499;, #4- 49M ;9.
;. Ray C. Ro!e., Paul B. Sheskey., Paul B. Heller., Hand ?ook of Pharmaceutical
e7ci"ients, 6
rd
ed., )merican Pharmaceutical )ssociation Hashington C, (S) :
Pharmaceutical "ress, London (.K.
&. htt"-FF!!!.scri/d.comFdocF;&@#%@&FKollicoat-A),-grades.
%. Biao GG , (/rich 5, Hoffart C, Aarchand-)r2ier A, Cigneron C, Hoffman A,
Aaincent P., rug e2 +nd Pharm. #<<#, #@-4<66-$4.
@. Lerk C.>., Heek/l., 49@@, 4#6- ;99-&<;.
9. Riley, S.)., 3a2ares, +.)., ?ennett, ). Aani, C., ?r. B. clin. Pharmac., 49@@, #&-
4%6-4%%.
4<. 9he/er-Sellassie +., 9ordon R.H., 5es/itt R.(. >a!=i A.?., +nt. B. Pharm., 49@%,
6% -#44-#4@.
44. ?odmeier, R., Paeratakul 1., Pharmaceutical Research. Res., 49@9, &- %#;-%6<.
4#. Hua-Pin Huang, Surendra C. Aehta

, 9alen H. Rade/augh, Aahdi ?. >a!=i., B.
Pharm. Sci., #<<&, @6 -%9; M %9%.
46. )"ur/a Sarker )"u, )tiEul HaEue Pathan, ilashan Shrestha, 9olam Ki/ria and
Re=a- ul Balil., 3ro". B. Pharm. Res., #<<9, @- 4$;-4;#.
4$. Karl 9. Hagner., Bames H. Ac9inity(, B.Controlled Release, #<<#, @#- 6@;-69%.
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