Volume: 2: Issue-1: Jan-Mar -2011 ISSN 0976-4550

Review Paer
MOUTH DISSOLVING TABLETS AN INNOVATIVE TECHNOLOGY
Sagar A. Konapure
1
*, Prafulla S. Chaudhari
1
, Rajesh J. Oswal
2
, Sandip S. Kshirsagar
2
,
Rishikesh . An!re
2
, "rushal . Chorage
#


1
$epar!%en! of Phar%a&eu!i&s, JSP'(s Charak College of Phar%a&) * Resear&h,
+agholi, Pune,-122./.
2
$epar!%en! of Phar%a&eu!i&al Che%is!r), JSP'(s Charak College of Phar%a&) *
Resear&h, +agholi, Pune,-122./.
1
$epar!%en! of Phar%a&ognos), JSP'(s Charak College of Phar%a&) * Resear&h,
+agholi, Pune,-122./

ABSTRACT: 'ou!h dissol0ing !a1le!s are disin!egra!ing and dissol0e rapidl) in !he sali0a
wi!hou! !he need for wa!er. So%e !a1le!s are designed !o dissol0e in sali0a re%arka1l) fas!, wi!hin
a few se&onds, and are !rue fas!,dissol0ing !a1le!s. O!hers &on!ain agen!s !o enhan&e !he ra!e of
!a1le! disin!egra!ion in !he oral &a0i!), and are %ore appropria!el) !er%ed fas!,disin!egra!ing
!a1le!s, as !he) %a) !ake up !o a %inu!e !o &o%ple!el) disin!egra!e. Oral deli0er) is &urren!l) !he
gold s!andard in !he phar%a&eu!i&al indus!r) where i! is regarded as !he safes!, %os! &on0enien!
and %os! e&ono%i&al %e!hod of drug deli0er) ha0ing !he highes! pa!ien! &o%plian&e. 2as!, or
%ou!h dissol0ing !a1le!s ha0e 1een for%ula!ed for pedia!ri&, geria!ri&, and 1edridden pa!ien!s and
for a&!i0e pa!ien!s who are 1us) and !ra0eling and %a) no! ha0e a&&ess !o wa!er.
Keywords: 'ou!h dissol0ing !a1le!s, superdisin!egran!s, e0alua!ion of %ou!h dissol0ing !a1le!s.

34"RO$5C"3O4
Oral rou!es of drug ad%inis!ra!ion ha0e wide a&&ep!an&e up !o 6.,7.8 of !o!al dosage for%s.
Solid dosage for%s are popular 1e&ause of ease of ad%inis!ra!ion, a&&ura!e dosage, self,
%edi&a!ion, pain a0oidan&e and %os! i%por!an!l) !he pa!ien! &o%plian&e. "he %os! popular solid
dosage for%s are 1eing !a1le!s and &apsules9 one i%por!an! draw1a&k of !his dosage for%s for
so%e pa!ien!s, is !he diffi&ul!) !o swallow
1
. $rinking wa!er pla)s an i%por!an! role in !he
swallowing of oral dosage for%s. Of!en !i%es people e:perien&e in&on0enien&e in swallowing
&on0en!ional dosage for%s su&h as !a1le! when wa!er is no! a0aila1le, in !he &ase of !he %o!ion
si&kness ;kine!osis< and sudden episodes of &oughing during !he &o%%on &old, allergi& &ondi!ion
and 1ron&hi!is. 2or !hese reason, !a1le!s !ha! &an rapidl) dissol0e or disin!egra!e in !he oral &a0i!)
ha0e a!!ra&!ed a grea! deal of a!!en!ion. Orodispersi1le !a1le!s are no! onl) indi&a!ed for people
who ha0e swallowing diffi&ul!ies, 1u! also are ideal for a&!i0e people
2
.
In!erna!ional Journal o" #lie$ %iolo&' an$ P(arma)eu!i)al *e)(nolo&' Pa&e:496
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Mou! d"sso#$"%& '(#e
"his is an inno0a!i0e !a1le! !e&hnolog) where !he dosage for% &on!aining a&!i0e phar%a&eu!i&al
ingredien!s disin!egra!es rapidl), usuall) in a %a!!er of se&onds, wi!hou! !he need for wa!er,
pro0iding op!i%al &on0enien&e !o !he pa!ien!.
"he =uropean Phar%a&opoeia defines Orodisperse as a !a1le! !ha! &an 1e pla&ed in !he %ou!h
where i! disperses rapidl) 1efore swallowing. Resear&hers ha0e for%ula!ed O$" for 0arious
&a!egories of drugs, whi&h are used for !herap) in whi&h rapid peak plas%a &on&en!ra!ion is
re>uired !o a&hie0e desired phar%a&ologi&al response. "hese in&lude neurolep!i&s, &ardio0as&ular
agen!s, analgesi&s, an!i,allergi& and drugs for ere&!ile d)sfun&!ion.
Su)erd"s"%e&r'%s
$isin!egra!ing agen!s are su1s!an&es rou!inel) in&luded in !he !a1le! for%ula!ions !o aid in !he
1reakup of !he &o%pa&!ed %ass when i! is pu! in!o a fluid en0iron%en!. "he) pro%o!e %ois!ure
pene!ra!ion and dispersion of !he !a1le! %a!ri:. 3n re&en! )ears, se0eral newer agen!s ha0e 1een
de0eloped known as ?Superdisin!egran!s@. "hese newer su1s!an&es are %ore effe&!i0e a! lower
&on&en!ra!ions wi!h grea!er disin!egra!ing effi&ien&) and %e&hani&al s!reng!h. On &on!a&! wi!h
wa!er !he superdisin!egran!s swell, h)dra!e, &hange 0olu%e or for% and produ&e a disrup!i0e
&hange in !he !a1le!. =ffe&!i0e superdisin!egran!s pro0ide i%pro0ed &o%pressi1ili!), &o%pa!i1ili!)
and ha0e no nega!i0e i%pa&! on !he %e&hani&al s!reng!h of for%ula!ions &on!aining high,dose
drugs.
Me*!'%"s+ o, su)erd"s"%e&r'%s
Swe##"%&
Perhaps !he %os! widel) a&&ep!ed general %e&hanis% of a&!ion for !a1le! disin!egra!ion is
swelling. "a1le!s wi!h high porosi!) show poor disin!egra!ion due !o la&k of ade>ua!e swelling
for&e. On !he o!her hand, suffi&ien! swelling for&e is e:er!ed in !he !a1le! wi!h low porosi!). 3! is
wor!hwhile !o no!e !ha! if !he pa&king fra&!ion is 0er) high, fluid is una1le !o pene!ra!e in !he
!a1le! and disin!egra!ion is again slows down.
-oros"y '%d *')"##'ry '*"o% ./"*0"%&1
$isin!egra!ion 1) &apillar) a&!ion is alwa)s !he firs! s!ep. +hen we pu! !he !a1le! in!o
sui!a1le a>ueous %ediu%, !he %ediu% pene!ra!es in!o !he !a1le! and repla&es !he air
adsor1ed on !he par!i&les, whi&h weakens !he in!er%ole&ular 1ond and 1reaks !he !a1le!
in!o fine par!i&les. +a!er up!ake 1) !a1le! depends upon h)drophili&i!) of !he drug
Ae:&ipien!s and on !a1le!ing &ondi!ions. 2or !hese !)pes of disin!egran!s %ain!enan&e of
porous s!ru&!ure and low in!erfa&ial !ension !owards a>ueous fluid is ne&essar) whi&h
helps in disin!egra!ion 1) &rea!ing a h)drophili& ne!work around !he drug par!i&les.
In!erna!ional Journal o" #lie$ %iolo&' an$ P(arma)eu!i)al *e)(nolo&' Pa&e:497
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Sa&ar e! al ISSN 0976-4550
Due o d"s"%e&r'"%& )'r"*#e2)'r"*#e re)u#s"$e ,or*es
Ano!her %e&hanis% of disin!egran!s a!!e%p!s !o e:plain !he swelling of !a1le! %ade wi!h
Bnonswella1le( disin!egran!s. Cu)o!,Der%ann has proposed a par!i&le repulsion !heor) 1ased on
!he o1ser0a!ion !ha! nonswelling par!i&le also &ause disin!egra!ion of !a1le!s. "he ele&!ri&
repulsi0e for&es 1e!ween par!i&les are !he %e&hanis% of disin!egra!ion and wa!er is re>uired for
i!. Resear&hers found !ha! repulsion is se&ondar) !o wi&king.
Due o de,or+'"o%
$uring !a1le! &o%pression, disin!egra!ed par!i&les ge! defor%ed and !hese defor%ed par!i&les ge!
in!o !heir nor%al s!ru&!ure when !he) &o%e in &on!a&! wi!h a>ueous %edia or wa!er.
O&&asionall), !he swelling &apa&i!) of s!ar&h was i%pro0ed when granules were e:!ensi0el)
defor%ed during &o%pression. "his in&rease in siEe of !he defor%ed par!i&les produ&es a 1reakup
of !he !a1le!. "his %a) 1e a %e&hanis% of s!ar&h and has onl) re&en!l) 1egun !o 1e s!udied
1,1-
.
Ad$'%'&es o, +ou! d"sso#$"%& '(#es
=ase of ad%inis!ra!ion !o pa!ien!s who &anno! swallow, su&h as !he elderl), s!roke 0i&!i%s
and 1edridden pa!ien!s9 pa!ien!s who should no! swallow, su&h as renal ailure pa!ien!s9
and who refuse !o swallow, su&h as pedia!ri&s, geria!ri& and ps)&hia!ri& pa!ien!s.
Pa!ien!(s &o%plian&e for disa1led 1edridden pa!ien!s and for !ra0elling and 1us) people
who do no! ha0e read) a&&ess !o wa!er.
Cood %ou!h feel proper!) of '$$$S helps !o &hange !he 1asi& 0iew of %edi&a!ion
drugs.
Con0enien&e of ad%inis!ra!ion and a&&ura!e dosing as &o%pared !o li>uid for%ula!ions.
Fenefi! of li>uid %edi&a!ion in !he for% of solid prepara!ion.
'ore rapid drug a1sorp!ion fro% !he pre,gas!ri& area i.e. %ou!h, phar)n: and esophagus
whi&h %a) produ&e rapid onse! of a&!ion.
Pregas!ri& a1sorp!ion &an resul! in i%pro0ed 1ioa0aila1ili!), redu&ed dose and i%pro0ed
&lini&al perfor%an&e 1) redu&ing side effe&!s.
4ew 1usiness oppor!uni!iesG produ&! differen!ia!ion, line e:!ension and life,&)&le
%anage%en!, e:&lusi0i!) of produ&! pro%o!ion and pa!en!,life e:!ension
16,17
.
Ide'# )ro)er"es o, +ou! d"sso#$"%& '(#es
1. 4o! re>uire wa!er !o swallow and should dissol0e or disin!egra!e in !he %ou!h wi!hin few
se&onds.
2. Allow high drug loading.
#. Fe &o%pa!i1le wi!h !as!e %asking and o!her e:&ipien!s.
-. Da0e a pleasing %ou!h feel.
6. Hea0e %ini%al or no residue in !he %ou!h af!er oral ad%inis!ra!ion.
7. Da0e suffi&ien! s!reng!h !o wi!hs!and !he rigors of !he %anufa&!uring pro&ess and pos!
%anufa&!uring handling.
/. =:hi1i! low sensi!i0i!) !o en0iron%en!al &ondi!ions su&h as hu%idi!) and !e%pera!ure.
I. Fe adap!a1le and a%ena1le !o e:is!ing pro&essing and pa&kaging %a&hiner).
J. Allow !he %anufa&!ure of !a1le!s using &on0en!ional pro&essing and pa&kaging
e>uip%en!s a! low &os!.
1.. =:hi1i! low sensi!i0i!) !o en0iron%en!al &ondi!ion
1/,1I
.
In!erna!ional Journal o" #lie$ %iolo&' an$ P(arma)eu!i)al *e)(nolo&' Pa&e:49.
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Sa&ar e! al ISSN 0976-4550
E$'#u'"o% o, +ou! d"sso#$"%& '(#es
Ge%er'# A))e'r'%*e
"he general appearan&e of a !a1le!, i!s 0isual iden!i!) and o0er all Kelegan&eK is essen!ial for
&onsu%er a&&ep!an&e. 3n&lude in are !a1le!Ls siEe, shape, &olour, presen&e or a1sen&e of an odour,
!as!e, surfa&e !e:!ure, ph)si&al flaws and &onsis!en&) and legi1ili!) of an) iden!if)ing %arking.
S"3e '%d S!')e
"he siEe and shape of !he !a1le! &an 1e di%ensionall) des&ri1ed, %oni!ored and &on!rolled.
/e"&! $'r"'"o%
2. !a1le!s were sele&!ed rando%l) fro% !he lo! and weigh!ed indi0iduall) !o &he&k for
weigh! 0aria!ion. +eigh! 0aria!ion spe&ifi&a!ion as per 3.P. is shown in !a1le
1J
.
T'(#e No4 54 /e"&! $'r"'"o% s)e*","*'"o% 's )er I-
Ass'y
"wen!) !a1le!s fro% ea&h 1a!&h were weighed a&&ura!el) and powdered powder e>ui0alen! !o 1..
%g drug was shaken wi!h 1.. %l of ..14 D)dro&hlori& a&id in 1.. %l a%1er &olored 0olu%e!ri&
flask and fro% !his 1. %l was pipe!!e ou! and !hen dilu!e up !o 1.. %l. 2ro% s!andard solu!ion
again 1. %l pipe!!e ou! and dilu!ed up !o 1.. %l in %l
2.,21
.
T'(#e !'rd%ess
"he s!reng!h of !a1le! is e:pressed as !ensile s!reng!h ;KgA&%
2
<. "he !a1le! &rushing load, whi&h is
!he for&e re>uired !o 1reak a !a1le! in!o hal0es 1) &o%pression .3! was %easured using a !a1le!
hardness !es!er ;PfiEer Dardness "es!er<
1I
.
Co%e% u%",or+"y
2i0e !a1le!s were powdered and !he 1lend e>ui0alen! !o - %g of "iEanidine D&l was weigh! and
dissol0ed in sui!a1le >uan!i!) of pD 1.2 solu!ions. Solu!ion was fil!ered and dilu!ed and drug
&on!en! anal)Eed spe&!ropho!o%e!ri&all) a! 22I n%
22
.
In!erna!ional Journal o" #lie$ %iolo&' an$ P(arma)eu!i)al *e)(nolo&' Pa&e:499
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Me'sur+e% o, '(#e e%s"#e sre%&!
"he !a1le! !ensile s!reng!h is !he for&e re>uired !o 1reak a !a1le! 1) &o%pressing i! in !he radial
dire&!ion and is %easured using a !a1le! hardness !es!er. 2or %easuring !he hardness of !he !a1le!s,
!he plunger of !he hardness !es!er is dri0en down a! a speed of 2. %%A%in. "ensile s!reng!h for
&rushing ;"< is &al&ula!ed using e>ua!ionG
E64 T7 89 2 :d
+here 2 is !he &rushing load, and d and ! deno!e !he dia%e!er and !hi&kness of !he !a1le!,
respe&!i0el)
2#
. "hough, !his is a widel) used and a&&ep!ed %e!hod for hardness !es!ing, i! is no!
appli&a1le !o 0er) deli&a!e !a1le!s prepared 1) H)ophiliEa!ion !e&hni>ue wherein !he li>uid
suspension of drug and e:&ipien!s is freeEe dried in !he 1lis!er po&ke! and !he dried !a1le!s are
finall) sealed in !he 1lis!er. Spe&ial alu%inu% 1lis!ers wi!h peel off 1lis!er &o0ers are used as
pa&kaging %a!erial for !hese !a1le!s. 2lash dose !a1le!s prepared 1) &o!!on &and) pro&ess are also
poor &andida!es for !his !es!
1J,2.
. "his !es! is 1es! sui!ed for !a1le!s prepared 1) dire&! &o%pression
and %oulding %e!hods. Dowe0er, !he !ensile s!reng!h of !hese !a1le!s is alwa)s kep! low whi&h
needs !o 1e &o%pro%ised !o keep !he disin!egra!ion !i%e as %ini%u% as possi1le.
9r"'("#"y
"he phar%a&opoeial li%i! of fria1ili!) !es! for a !a1le! is no! %ore !han 18 using !a1le! fria1ili!)
appara!us, &arried ou! a! 26 rp% for - %in ;1.. ro!a!ions<. Dowe0er, i! 1e&o%es a grea! &hallenge
for a for%ula!or !o a&hie0e fria1ili!) wi!hin !his li%i! for '$" produ&! keeping hardness a! i!s
lowes! possi1le le0el in order !o a&hie0e a %ini%u% possi1le disin!egra!ion !i%e. "his !es! is
again no! appli&a1le for l)ophiliEed and flash dose !a1le!s, 1u! is alwa)s re&o%%ended for !a1le!s
prepared 1) dire&! &o%pression and %olding !e&hni>ues !o ensure !ha! !he) ha0e enough
%e&hani&al s!reng!h !o wi!hs!and !he a1rasion during shipping and shelf life
1I,2#
.
Mo"sure u)'0e sudy
'$"s usuall) &on!ain high &on&en!ra!ion of h)drophili& e:&ipien!s wi!h !he %ini%u% possi1le
hardness whi&h !oge!her &on!ri1u!es !o !heir in&reased sus&ep!i1ili!) !o %ois!ure up!ake. 3n order
!o %ain!ain !heir ph)si&al in!egri!) and surfa&e !e:!ure, spe&ial a!!en!ion is re>uired during !he
s!orage and pa&kaging of !hese dosage for%s. "herefore, %ois!ure 5p!ake s!udies are s!rongl)
re&o%%ended for '$"s. "he !es! &an 1e &arried ou! 1) keeping !en !a1le!s along wi!h &al&iu%
&hloride in a desi&&a!ors %ain!ained a! #/ MC for 2- hrs !o ensure &o%ple!e dr)ing of !he !a1le!s.
"he !a1le!s are !hen weighed and e:posed !o /68 RD, a! roo% !e%pera!ure for 2 weeks. "he
re>uired hu%idi!) &an 1e a&hie0ed 1) keeping sa!ura!ed sodiu% &hloride solu!ion in !he
desi&&a!ors for 2- hrs. "he !a1le!s are reweighed and !he per&en!age in&rease in weigh! is
re&orded. 3f !he %ois!ure up!ake !enden&) of a produ&! is high, i! re>uires spe&ial dehu%idified
area for %anufa&!uring and pa&king. "he %a!erials wi!h high %ois!ure resis!an! proper!ies should
1e used for pa&kaging for e.g. alu s!rip pa&k, alu,alu 1lis!er or pol)e!h)lene sealing on 1lis!er. "he
use of appropria!e >uan!i!) of desi&&an! in D$P= 1o!!le pa&ks wi!h %ini%u% head spa&e is highl)
re&o%%ended !o ensure s!a1ili!) of !he produ&! during i!s shelf life
2-,2/
.

In!erna!ional Journal o" #lie$ %iolo&' an$ P(arma)eu!i)al *e)(nolo&' Pa&e:500
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Sa&ar e! al ISSN 0976-4550
/e"%& "+e '%d w'er '(sor)"o% r'"o
A s!ud)
2-
on we!!ing !i%e and wa!er a1sorp!ion ra!io repor!ed !he use of a pie&e of dou1le folded
!issue paper pla&ed in a pe!ridish &on!aining 7 %l ;Ph 7.I< of wa!er. One !a1le! was pla&ed on !his
paper and !he !i%e for &o%ple!e we!!ing of !a1le! was no!ed as we!!ing !i%e. "he we!!ed !a1le!
was !hen weighed and !he wa!er a1sorp!ion ra!io, R, was de!er%ined a&&ording !o e>ua!ionG
E64 R 7 5;; ./'4/(12/(
+here +1 and +a are !he weigh!s of !a1le! 1efore and af!er wa!er a1sorp!ion, respe&!i0el)
D"s"%e&r'"o% "+e
"he %e!hods for e0alua!ion of in,0i0o disin!egra!ion !i%e had 1een e:plained in li!era!ure
2I,#.
.
Dowe0er, !he resul!s fro% !his !)pe of !es! !)pi&all) re0eal unsa!isfa&!or) reprodu&i1ili!) and are
no! relia1le as !he differen&e in disin!egra!ion !i%e is few se&onds in %os! &ases. 3n addi!ion, !he
in,0i0o disin!egra!ion !es! has i!s own li%i!a!ion of issues rela!ed !o e!hi&s and !he safe!) of !he
0olun!eers.
A! presen!, !he disin!egra!ion !i%e of '$"s is %easured using !he disin!egra!ion !es! for
&on0en!ional !a1le!s !ha! is des&ri1ed in !he Phar%a&opoeias. =P has se! !he li%i! of # %ins for
disin!egra!ion !i%e of '$"s using &on0en!ional disin!egra!ion appara!us. Dowe0er, no spe&ial
appara!us is %en!ioned in !he phar%a&opoeias for disin!egra!ion !es! of '$"s and !he
&on0en!ional %e!hod a0aila1le see%s !o 1e inappropria!e for '$"s. "his is 1e&ause of !he
e:!re%e opera!ing &ondi!ions in !he disin!egra!ion appara!us whi&h fails !o pro0ide a signifi&an!
dis&ri%ina!ion a%ong !he rapidl) disin!egra!ing !a1le!s. 2ur!her%ore, !he &on0en!ional !es!
e%plo)s a rela!i0el) huge 0olu%e of !es! solu!ion ;J.. %l< &o%pared !o !he 0olu%e of sali0a in
hu%an 1u&&al &a0i!), whi&h is less !han 7 %l.
D"s"%e&r'"o% es w"! ro'ry s!', +e!od
3n ano!her s!ud), proposed a 1e!!er disin!egra!ion %e!hod for '$"s. 3n !he e:peri%en!al %e!hod,
!he '$" was pla&ed on !he wire gauEe ;$<, sligh!l) i%%ersed in !he %ediu%, and !hen
&o%pressed 1) a ro!ar) shaf! ;=< whi&h was e%plo)ed !o pro0ide %e&hani&al s!ress on !he !a1le!
1) %eans of i!s ro!a!ion and weigh!. Purified wa!er a! !e%pera!ure #/ MC was used as !he %ediu%.
"he &ri!i&al para%e!ers of !he proposed %e!hod were !he ro!a!ion speed and !he %e&hani&al s!ress.
5sing !his new %e!hod, i! would 1e possi1le !o predi&! a %ore realis!i& disin!egra!ion ra!e in
hu%an. "he &o%pression for&e &an 1e easil) adjus!ed using !he weigh! ;A<. "he ro!ar) shaf!
&rushes !he '$" whi&h disin!egra!es in!o !he %ediu%. "he endpoin! was %easured 0isuall)
using a s!opwa!&h.
"he 1elow %en!ioned appara!us was %odified 1) Darada e!
#1
al 1) pla&ing a sponge a! !he surfa&e
of shaf! weigh! !o in&rease fri&!ion wi!h !he '$". "herefore, !he weigh! !rans%i!s !he !or>ue of
!he ro!a!ing shaf! !o !he O$" and grinds i! on !he s!ainless s!eel perfora!ed pla!e whi&h is used in
pla&e of wire gauge. "he ele&!rodes are a!!a&hed on ea&h side of !he pla!e. "he ro!a!ion speed and
weigh! were op!i%iEed !o se! !he %e&hani&al pressure. +hen !he weigh! %akes &on!a&! wi!h
separa!ed pla!es, !he ele&!ri& sensor &on0e)s a signal !ha! indi&a!es !he end poin! of !he
disin!egra!ion !es! of !he O$"
#2
.
In!erna!ional Journal o" #lie$ %iolo&' an$ P(arma)eu!i)al *e)(nolo&' Pa&e:501
#vaila+le online a! www,i-a+!,)om
Sa&ar e! al ISSN 0976-4550
D"s"%e&r'"o% es e<ure '%'#y3er
3n ano!her s!ud), a !e:!ure anal)sis appara!us was used !o %easure !he s!ar! and end !i%e poin!s of
!a1le! disin!egra!ion. A &ons!an! pene!ra!ion for&e was applied !o !a1le!s 0ia a &)lindri&al fla!,
ended pro1e. "he !a1le!, under &ons!an! for&e, is i%%ersed in a defined 0olu%e of dis!illed wa!er
and !he !i%e is plo!!ed agains! !he dis!an&e, whi&h !he pro1e !ra0elled in!o !he !a1le!. ")pi&al
!i%eNdis!an&e profiles, genera!ed 1) !he !e:!ure,anal)sis sof!ware, ena1led !he &al&ula!ion of !he
s!ar!ing and ending !i%e of disin!egra!ion
##,#-
.
D"s"%e&r'"o% es us"%& e#e*ro ,or*e =5;;
An ins!ru%en! ?=le&!ro 2or&eO #1..@ has re&en!l) 1een designed 1) !he Fose Corpora!ion wi!h
an o1je&!i0e !o si%ula!e !he disin!egra!ion &ondi!ion of !he '$"s in %ou!h. 3! is 1ased on
appli&a!ion of low for&e !o %easure s%all displa&e%en!s and disin!egra!ion ra!e as a fun&!ion of
%anufa&!uring pro&ess of a 0arie!) of '$"s. "he ins!ru%en! !)pi&all) &onsis!s of a lower pla!e !o
hold !he !a1le! on whi&h a for&e of a1ou! 1. %4 is applied followed 1) addi!ion of appro:i%a!el)
6 %l of wa!er %ain!ained a! #/ MC. 3! has !he ad0an!age of pro0iding 1e!!er resolu!ion !han !hose
a0aila1le ins!ru%en!s wi!h %odera!e !o high for&e !es!
#1
. "his is !he firs! e>uip%en! of i!s !)pe
whi&h is a0aila1le in !he %arke! for e0alua!ion of O$". "his !a1le!op s)s!e% &an 1e used 1) !he
%anufa&!urers and regula!or) agen&ies !o %oni!or and e0alua!e !he differen! fa1ri&a!ion
!e&hnologies of '$"s.
D"sso#u"o% es"%& o, +ou! d"sso#$"%& '(#es
"he &on0en!ional %e!hod of dissolu!ion &ould 1e e:!ended !o in,0i!ro e0alua!ion of '$" "he
dissolu!ion &ondi!ions for !he referen&e lis!ed drugs a0aila1le in 5SP &an 1e u!iliEed for
preli%inar) in,0i!ro s!udies !o %i%i& 1e!!er in,0i0o &ondi!ions. Apar! fro% !he a1o0e, %ul!i%edia
dissolu!ion s!udies in 0arious 1uffer solu!ions of differen! pD 0iE. ..1 4 DCl9 pD -.6 and 7.I
1uffers should 1e &arried ou! for in!erpre!a!ion of !heir in,0i0o perfor%an&e and phar%a&eu!i&al
e>ui0alen&e. 5SP appara!us 33 ;paddle< wi!h a speed of 6. rp% see%s !o 1e %os! sui!a1le and
&o%%on &hoi&e wi!h appropria!e dissolu!ion %edia 0olu%e !o %ain!ain sink &ondi!ion.
E$'#u'"o% o, e,,e*"$e%ess o, es +'s0"%&
"he for%ula!ion(s organolep!i& proper!ies like !as!e, %ou!h,feel and appearan&e are of
&onsidera1le i%por!an&e in differen!ia!ing produ&!s in !he %arke! and &an ul!i%a!el) de!er%ine
!he su&&ess of a produ&!.
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#vaila+le online a! www,i-a+!,)om
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In!erna!ional Journal o" #lie$ %iolo&' an$ P(arma)eu!i)al *e)(nolo&' Pa&e:50/
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