Result

& Discussion
6. RESULTS AND DISCUSSION
6.1 PREFORMULATION STUDIES
6.1. a) Identification test for Traado! "C!
a) Me!tin# $oint% The melting point of the Tramadol HCl was found to be 180
0
C-184
0
C,
which complies with melting point reported ones.
b) Infrared a&sor$tion s$ectro$'otoetr(% All the prominent and primar pea!s were
obser"ed in #T$% spectrum of Tramadol HCl (Fig. 6.1)
450 600 750 900 1050 1200 1350 1500 1650 1800 1950 2100 2400 2700 3000 3300 3600 3900
1/cm
7.5
15
22.5
30
37.5
45
52.5
60
67.5
75
82.5
%T
Tramadol Hcl
#igure &.1' #T$% (pectrum of drug sample
Sr. No.
Frequency (cm
-1
) Assignment
1 3305.26 N-H
2 2929.60 C-H
3 1606.59 C=O
4 1542.45 OH
5 1288.36 C=O
6 1045.37 Pri. Alcohol
7 777.20 C-Cl
c) U) Scannin#% The )
ma*
of Tramadol was found to be +,1nm , which complies with the
specification of -. +00, (Figure 6.2).
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
#igure &.+' (canning of Tramadol HCl in 1.+ .H
6.1. &) STANDARD CALI*RATION CUR)E OF TRAMADOL "C!
6.1.i) Standard ca!i&ration c+r,e of Traado! "C! in disti!!ed -ater%
a) .+a!itati,e identification% /0 0g1ml solution of Tramadol HCl was prepared in
distilled water and was sub2ected to scanning under 34 "isible spectrophotometer,
between +00-400 nm. The )
ma*
was found to be at +,1 nm.
#igure &./' (canning of Tramadol HCl in distilled water.
&) Pre$aration of standard ca!i&ration c+r,e in disti!!ed -ater% The standard
calibration cur"e was prepared for concentration of 50g1m6 to /00g1m6 at +,1 nm. The
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
graph of absorbance "1s concentration was plotted and data were sub2ected to linear
regression analsis. The data of absorbance is as shown in Table 6.1. The standard
calibration cur"e of drug in distilled water was as depicted in Figure 6.4. The data had
correlation coefficient of 0.777 and e8uation of regressed line is,
y ( ).))*+ , ).)))
-a#le No. ..1: Absorbanc !al"s #or s$an%ar% calibra$ion c"r!
&ra'a%ol HCl in %is$ill% (a$r

#igure &.4'
(tandard
calibration
cur"e of
Tramadol HCl
in distilled water
The calibration
cur"e for
Tramadol HCl
in distilled water
in the concentration range of 59g1ml to /09g1ml was a straight line. The absorbance
increased with the increase in concentration. Thus the standard cur"e followed the -eer-
6ambert:s 6aw.
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Sr .No. /onc . A#sor#anc
e
1 0
0
2 5
0.029
3 10
0.06
4 15
0.091
5 20
0.116
6 25
0.147
7 30 0.176
Result
& Discussion
6.1.ii) Standard ca!i&ration c+r,e of Traado! "C! in '(droc'!oric acid
&+ffer $" 1./%
a) .+a!itati,e identification% /0 0g1ml solution of Tramadol HCl was prepared in
HCl buffer pH 1.+ and was sub2ected to scanning under 34 "isible
spectrophotometer, between +00-400 nm. The )
ma*
was found to be at +,1 nm.
(Figure 6.5).
#igure &.5' (canning of Tramadol HCl in hdrochloric acid buffer pH 1.+
&) Pre$aration of standard ca!i&ration c+r,e in '(droc'!oric acid &+ffer $" 1./%
The standard calibration cur"e was prepared for concentration of
50g1ml to /00g1ml at +,1 nm. The graph of absorbance "1s concentration was
plotted and data were sub2ected to linear regression analsis. The data of
absorbance is as shown in Table 6.2. The standard calibration cur"e of drug in HCl
buffer pH 1.+ was as depicted in Figure 6.6.The data had correlation coefficient of
0.777 and e8uation of regressed line is,
y ( ).)).+ , ).)))
Table ;o. &.+' Absorbance "alues for standard calibration cur"e of
Tramadol HCl in hdrochloric acid buffer pH 1.+
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
#igure &.&' (tandard calibration cur"e of Tramadol HCl in pH 1.+ buffer
The calibration cur"e for Tramadol HCl in pH 1.+ buffer in the concentration range
of 59g1ml to /09g1ml was a straight line. The absorbance increased with the increase in
concentration. Thus the standard cur"e followed the -eer-6ambert:s 6aw.
6.1.iii) Standard ca!i&ration c+r,e of Traado! "C! in $'os$'ate &+ffer $" 6.0%
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Sr. No.
/oncentration
(0g1ml)
A#sor#ance
1 0
0
2 5
0.03
3 10
0.061
4 15
0.092
5 20
0.122
6 25
0.151
7 30
0.181
Result
& Discussion
a< .+a!itati,e identification% /0 0g1ml solution of Tramadol HCl was prepared in
phosphate buffer pH &.8 and was sub2ected to scanning under 34 "isible
spectrophotometer, between +00-400 nm. The )
ma*
was found to be at +,1 nm.
(Figure 6.7).
#igure &.,' (canning of Tramadol HCl in phosphate buffer pH &.8
b< Pre$aration of standard ca!i&ration c+r,e in $'os$'ate &+ffer $" 6.0% The
standard calibration cur"e was prepared for concentration of 50g1ml to /00g1ml at
+,1 nm. The graph of absorbance "1s concentration was plotted and data were
sub2ected to linear regression analsis. The data of absorbance is as shown in Table
6.3. The standard calibration cur"e of drug in phosphate buffer pH &.8 was as
depicted in Figure 6.8. The data had correlation coefficient of 0.778 and e8uation
of regressed line is,
y ( ).)).+, ).)))
Table ;o. &./' Absorbance "alues for standard calibration cur"e of Tramadol HCl in
phosphate buffer pH &.8
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
Fi#+re 6.0% (tandard calibration cur"e of Tramadol HCl in pH&.8 buffer
6./. TASTE MAS1IN2 *3 ION4E5C"AN2E RESINS
6./.1. Moist+re content deterination of t'e resin
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
(r. ;o.
Concentration
=9g1ml<
Absorbance
1 6
6
/ 7
6.68
8 16
6.669
9 17
6.6:
7 /6
6.1/7
6 /7
6.17
; 86
6.10:
Result
& Discussion
%esults of moisture content determination of the resin are shown in Table No. 6.4,
which complies with the prescribed specifications.
Table ;o. &.4' >oisture content determination of the resin
%esin
>a*. limit of
moisture content
>oisture content
Compliances with the
specifications
Indion /89 < 7= 8.8= 3es
6././. Pre$aration of Dr+#% Resin co$!e>
?rug-resin comple*es were prepared b batch method. 3sing different ratios of
resins to determine which ratio would gi"e ma*imum percent drug comple*ation.
Ta&!e No. 6.7% %atio of drug' resin selected for comple*ation

-atch process is simple and 8uic!er process. Comple*ation between the drug and resin is
essentiall a process of diffusion of ions between the resin and surrounding drug solution.
As comple*ation is an e8uilibrium phenomenon, ma*imum efficac is best achie"ed in
batch process in less period of time. @8uilibration time was shorter due to thinner barrier
for diffusion of ions, as it is in continuous motion. Also, higher swelling efficienc in the
batch process results in more surface area for ion e*change. Hence, the batch process is
suitable for smaller particles.
6.8. EFFECT OF DIFFERENT PROCESS )ARIA*LES ON PERCENT
COMPLE5ATION OF DRU2 ?IT" RESIN
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Resins Ratios of Dr+#% Resin @= -A-)
Indion /89
1:1 1:2 1:3
Result
& Discussion
6.8.1. Effect of Ratio of Dr+#% resin on $ercent dr+# co$!e>ation%
Attempts were made to optimiAe the drug loading process b carring out loading at
different drug' resin concentration. The basis of selection for the comple* was binding
efficienc and good taste mas!ed properties. The results obtained are gi"en in the Table
No.6.6
Ta&!e No. 6.6% .ercent drug comple*ed in "arious ratios of drug resin comple*
#igure ;o. &.7' .ercent drug comple*ed in "arious ratios of resin $ndion +/4
-%e #asis o! selection !or t%e comle+ 2as as !ollo23
-inding efficienc should be greater than 75B.
The resinate obtained should ha"e good taste mas!ed properties.
Thus based on the final criteria for the selection comple*es, comple*es of drug'
$ndion +/4 in the ratio of 1'/ was selected for further studies.
6.8./. Effect of Acti,ation of ion e>c'an#e resin on $ercent dr+# co$!e>ation%
Ta&!e No. 6.;% @ffect of Acti"ation of ion e*change resin on percent drug
comple*ation
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Time
=>in<
B ?rug Comple*ation
C
1'1 1'+ 1'/
17 +7.+7D0.4& /4.58D0./, /8.,/D0,/8
86 44.+4D0.47 54.7&D0.5, &0.,7D0./1
97 57.7+D0.4& &&.77D0.4& ,8.08D0./,
66 ,5.84D0.47 8&.01D0.4& 7&.+4D0.4&
:6 ,/./D0.44 81./0D0.4& 88.80D0.4&
Acti"ation >edia
B ?rug comple*ationC
1'/
None
8&.88D0.&5
1N "C!
70.54D0.5&
1N NaO"
,/./,D0.&5
Result
& Discussion

Highest drug binding on resin was achie"ed when acti"ated with 1; HCl.
Acti"ation e*posed the e*changeable groups producing rapid drug e*change and hence
higher drug loading
6.8.8. Effect of concentration of !oadin# so!+tion on co$!e>ation%
Table ;o. &.8' @ffect of concentration of loading solution on comple*ation

[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Conc. of !oadin# so!+tion = Dr+# co$!e>ationB
Dr+# % Indion /89
1%8
/.7 #A! 85.47D0.4&
7.6 #A! 8,.48D0.+8
;.7 #A! 70.,+D0.75
16 #A! 75.,0D0.4&
1/.7 #A! 7/.,,D0.47
Result
& Discussion
#igure ;o. &.10' @ffect of concentration of loading solution on comple*ation
At lower concentrations percent comple*ation is less, it ma be because at lower
concentration, e8uilibrium shifts towards the sol"ent phase.
6.8.9. . Effect of i>in# tie on $ercent dr+# co$!e>ation%
Table ;o. &.7 ' @ffect of mi*ing time on percent drug comple*ation
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Time =min< B ?rug comple*ationC
17 /8.+/D0./8
86 &0.71D0.4&
97 ,/.&8D0.&5
66 7/.,&D0.5&
1/6 87./D0.+8
Result
& Discussion
#igure ;o.&.11' @ffect of mi*ing time on percent drug comple*ation
Comple*ation between drug and resin increases up to optimum time and then
remains almost constant. As ion e*change is an e8uilibrium phenomenon it re8uires
specific time for optimum percent comple*ation of drug with resin. Comple*ation was
found to be optimum in &0 min of mi*ing.
6.8.7 Effect of s-e!!in# tie of resin on = dr+# co$!e>ation%
Comple*ation between drug and resin increases with increase in swelling time of
resins from 10 to /0 min, in case of wea! cation e*change resin.
Table ;o. &.10' @ffect of time of swelling of resin on comple*ation
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Time =min< B ?rug comple*ationC
16 77.98 C 1. ;9
/6 ;9.11 C 1.0/
86 :/.6/ C 1.98
96 0;.88 C1./9
76 07.81 C 1.;0
Result
& Discussion
#igure ;o. &.1+' @ffect of time of swelling of resin on comple*ation
$n un-swollen resin matri*, the e*changeable groups are latent and coiled towards
the bac!bone, hence less drug- loading efficienc. Thus drug- loading efficienc increases
after swelling of resin.
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
6.9 E,a!+ation st+dies of so!id dr+#% resin co$!e>
6.9.1 FT4IR S$ectrosco$(%
450 600 750 900 1050 1200 1350 1500 1650 1800 1950 2100 2400 2700 3000 3300 3600 3900
1/cm
7.5
15
22.5
30
37.5
45
52.5
60
67.5
75
82.5
%T
Tramadol Hcl
Figure No. ..143 )&*+ ,-c$r"' o# &ra'a%ol HCl
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
500 750 1000 1250 1500 1750 2000 2250 2500 2750 3000 3250 3500 3750 4000
1/cm
19.5
21
22.5
24
25.5
27
28.5
30
31.5
33
%T
Drug+Resi
#igure ;o.&.14' FTIR S$ectr+ of Indion /89
450 600 750 900 1050 1200 1350 1500 1650 1800 1950 2100 2400 2700 3000 3300 3600 3900
1/cm
8
10
12
14
16
18
20
22
24
26
%T
DR!
Fi#+re No. 6.17% #T$% (pectrum of ?rug' %esin comple* =%esinate<
The infrared spectra of Tramadol HCl, $ndion +/4 and drug' resin comple*
shown in figure 8.1/, 8.14 and 8.15 respecti"el. ?rug spectrum shows prominent pea!s at
//05.,& cm
-1
, +7+7.&0 cm
-1
, 1&0&.57 cm
-1
,154+.45 cm
-1
,
,,,.+0 cm
-1
corresponding to the
-;H stretching, -CH stretching, CEF, FH and C-Cl stretching respecti"el =#igure 8.1/<.
$ndion +/4 shows a characteristic pea! at 1&&0 cm
-1
, at 1,&0 cm
-1
corresponding to GCEF
stretching of arl acids, and at 1&10 cm
-1
due to aromatic CEC stretching =#igure 8.14<.
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
?rug' resin comple* spectrum =#igure 8.15< shows absence of characteristic drug pea!s at
//05.,& cm
-1
. (ubtraction spectrum did not show the characteristic pea! of drug at //05.,&
cm
-1
corresponding to G;H stretching. This indicates interaction of amine group of drug
with $ndion +/4
6.9./. Taste E,a!+ation of So!id Dr+#% Resin Co$!e>%
%esults of taste e"aluation b panel method are shown in Table No.6.11.
Ta&!e No. 6.11% (ensor e"aluation data of drug- $ndion +/4 comple*es
Ratio of
Dr+#% resin
co$!e>
Scores #i,en &( different #ro+$ a&o+t taste of dr+#% Indion
/89 co$!e>
A,era#e
&itterness
,a!+e
2ro+$ I 2ro+$ II 2ro+$ III
1 / 8 1 / 8 1 / 8
.ure drug 5 5 5 5 5 5 5 5 5 5
1'1 / / / 4 / / / / 4 /.++
1'+ 1 + + + + 1 1 1 + 1.55
1'/ 1 1 1 1 1 1 1 1 1 1

%esults of taste e"aluation b panel method re"ealed that $ndion +/4 mas! the
bitter taste of drug effecti"el at 1'/ ratio, which shows satisfactor mas!ing of taste.
6.9.8. Assa( of Dr+#% Resin Co$!e>es%
%esults of comple*ed drug' resin comple* are shown in Table No. 6.12.
Ta&!e No. 6.1/3 Percent dr+# content of dr+#% resin co$!e>es
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
6.7 Pre4co$ression st+d( of ta&!et &!end
#or formulation of Frodispersible tablet the blend was prepared and sub2ected to
e"aluation. The composition of blend of each batch is gi"en in Table no. 5.3.
Ta&!e No. 6.18% P'(sica! $ro$erties of ta&!et &!end
-atch ;o.
-ul! densit
=g1ml<
Tapped densit
=g1ml<
Angle of %epose
=H<
Hausnser:s
%atio
B
Compressibilit
F1 0.51D0.01 0.&D0.0+ +7.5+D+.&8 1.15D0.04 1/.87D+.7+
F/ 0.5&D0.0+ 0.&+D0.0+ +7.01D1.&& 1.11D0.01 10.0+D1.50
F8 0.5/D0.0+ 0.&D0.0+ +7.&/D+.71 1.1+D0.0+ 11.&1D1.&4
F9 0.5+D0.0+ 0.&1D0.01 +7.70D/.44 1.1,D0.01 14.87D1.+1
F7 0.5+D0.01 0.&0D0.01 +7.8+D/.+8 1.15D0.0/ 1/./&D+.48
F6 0.54D0.0+ 0.&+D0.0+ +7.8&D/./& 1.15D0.01 1/.&/D0.+1
F; 0.5/D0.01 0.&+D0.01 +7.,8D/.+1 1.1,D0.01 15.14D1.07
F0 0.54D0.0+ 0.&/D0.0+ +7.&0D+.8/ 1.15D0.01 1/.,5D0.+1
F: 0.54D0.01 0.&+D0.01 +7.5&D+.,& 1.14D0.01 1+.8/D1.50
F16 0.5/D0.0+ 0.&+D0.0+ +7.+4D+.1+ 1.1,D0.01 14.+4D0.77
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
%atio of drug' resin
=Bw1w<
B ?rug content
1%8 ::.99
Result
& Discussion
The .re-compression stud of all batches of blend was e"aluated for
different deri"ed properties are' -
1 < Angle of repose =between +7 to /0<,
+ < -ul! densit =between 0.51 to 0.54 g1ml<,
/< Tapped ?ensit =-etween 0.& to 0., =g1ml< I
4< Compressibilit inde* =between 10 to 1&<.
The results angle of repose and compressibilit indicated that the flowabilit of
blend is significantl good. All the results pre-compression parameters are in acceptable
range.
6.6 Post4co$ression assessent of Oro4dis$ersi&!e ta&!ets
of Traado! "c!
Frodispersible tablets were prepare in batches #1 to #10 and e"aluated for tablet
properties li!e weight "ariation, hardness, thic!ness, friabilit, wetting time, water
absorption ratio, content uniformit, disintegration time and dissolution.
Table ;o. &.14' P'(sica! $ro$erties of ta&!et &!end
-atch ;o. Hardness
=Jg1cm
+
<
#riabilit
=B<
Thic!ness
=mm<
B Keight
"ariation
F1 /.,+D0.+1
0.,8
/.05D0.01 -/.55To L +.+7
F/ /.54D0.+0
0.5
/./&D0.04 -+.&/ To L4.7/
F8 /.&,D0.+8
0.&&
/.//D0.0/ -1.7, To L4.+8
F9 /.51D0./+
0.8/
/.+&D0.0/ -4.&, To L 5.00
F7 /.58D0.+1
0.,+
/.+/D0.05 -/./5 To L /.85
F6 /.&4D0.//
0.88
/.17D0.0+ -+.8/ To L /.//
F; /.44D0.+,
0.&1
/.+7D0.04 -+.,5 To L /.41
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
F0 /.54D0./0
0.,,
/.14D0.0+5 -+.81 To L /.&+
F: /.5,D0.+4
0.74
/.+5D0.0+ -+.&4 To L +.&4
F16 /./5D0.1+
0.8+
/.1,D0.04
-/./4 To L/.00

All the tablets passed weight "ariation test as the percent weight "ariation
was within the pharmacopoeias limits. Hardness was shown in the range of /.00 to 4.00
Jg1 cm
+
in all the formulations. The hardness of all tablets was !ept within the abo"e
mentioned range to compare the disintegration time between the formulations prepared
using different disintegrants and their "aring concentrations. The friabilit of all
formulations was determined. The friabilit "alues of none of the formulations e*ceeded
1B. The results of friabilit indicated that the tablets were mechanicall stable and can
withstand rigors of transportation and handling. Thic!ness of all tablets was between / to
/.5 mm showing fairl uniform tabletting.
Ta&!e No. 6.17% %esults for disintegration time ,wetting time ,B water absorption ratio
and B ?rug content
-atch ;o. ?isintegration
time
=(ec<
Ketting time
=(ec<
B Kater absorption
ratio
=(ec<
5
Drug
/ontents
F1
5+.//D1.15 57D1 104.5&D4.71
6..78
F/
4&.&&D1.5+ 51.//D1.5+ 10,.+&D4.0&
69.:8
F8
/&D1 4,D1 115.00D4.,8
66.88
F9
/7D1.15 41.&&D1.5+ 1+1.,1D4.+0
69.:8
F7
/5D1 /4.//D1.5+ 14,.4&D5.0,
1)1.)*
F6
+4D1 +5D1 1&8.7/D/.81
1)7..*
F;
4+.//D0.5, 5&.&&D1.5+ 118.5,D1.&,
69.:8
F0
/&.&&D1.5+ 40.//D1.5+ 14+.,8D0.50
1)1.)*
F:
47.&&D0.5, &&D+ 1+7.58D+.47
66.88
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
F16 1&+.00D0.0+ ,1.&&D1.5+ :9.44D7.*1
1)1.)*
The results of disintegration of all the tablets was found to be within prescribed
limits and satisfied the criteria of Fro-dispersible tablet. The "alue was found to be in the
range of +4 to 1&5 sec. The wetting time was acceptable in the range of +4 to ,5 (ec and
water absorption time was also in acceptable limit i.e. 104 to 1,0 sec.
6.; Disso!+tion st+d( of different &atc'es
$n the dissolution stud of following batches containing superdisintegrants in
the tablet. Ke chec!ed B ?rug released from the following batches that containing >CC
as diluents. Ke are "aries onl the concentration of superdisintegrants.
#irstl we done dissolution stud in .H &.8 and then .H 1.+

T'e Fo!!o-in# are res+!ts of P" 6.0

Table ;o. &.1& ' Cummulati"e B drug released in .H &.8
Time
=>in<
-atches Cummulati"e
B ?rug
%eleased
Time
=>in<
-atches Cummulati"e
B ?rug
%eleased
1 #1 1.8+D0.1, 1 #& +.1&D0.04
1 #+ +.1/D0.07 1 #, 1.,/D0.1/
1 #/ 1.78D0.05 1 #8 +.0/D0.05
1 #4 1.,8D0.14 1 #7 +.00D0.1&
1 #5 1.78D0.05 1 #10 1.88D0.0&

[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
Percent Dr+# Re!eased in P" 1./
$n-"itro release data of these formulations are gi"en as mean in Table No. 6.17
Ta&!e No. 6.1;% = dr+# re!ease fro ta&!ets of &atc'es F1 to F8
Containin# Sodi+ Starc' 2!(co!ate as s+$erdisinte#rants

0 3 6 9 12 15 18
0
20
40
60
80
100
"a#c$ %1 &&'1%
"a#c$ %2 &&' 2 %
"a#c$ %3 &&' 4 %
Time (min)
%
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#igure &.1&' In4,itro re!ease $rofi!e of ta&!ets of &atc'es F1 to F8 containin# Sodi+
Starc' 2!(co!ate as S+$er disinte#rants
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Time =>in<
Cumulati"e B drug release
#1 #+ #/
6
00 00 00
8
//.75D0.&/ /,.0/D+./1 //./,D1.,&
6
4/.8,D1./0 5+.+1D1.&1 48.8,D1.,4
:
&/./4D1.++ &&.5+D1.47 &&.1+D1./1
1/
,&.&1D1.0,0 ,,.0&D1.0+ ,5.&0D1.41
17
7/.4&D0.41+ 74.,4D0.50 7&.71D0.5/
10
7/.+5D0.51 74./0D0.&5 7&.&0D0.5/
Result
& Discussion
$n #1 to #/ .reparation #/ formulation gi"es the good B drug released As compared to #1
I #+
Ta&!e No. 6.10% C++!ati,e = dr+# re!ease fro ta&!ets of &atc'es F9 to F6
Containin# Cross Care!!ose Sodi+ as S+$erdisinte#rants


0 3 6 9 12 15 18 21 24
0
20
40
60
80
100
120
"a#c$ %4 !!(a 1%
"a#c$ % 5 !!(a 2%
"a#c$ %6 !!(a 4%
Time (min)
%

d
r
u
g

r
e
l
e
a
s
e

Fi#+re 6.1;% In4,itro re!ease $rofi!e of ta&!ets of &atc'es F9 to F6 containin# Cross
Care!!ose Sodi+ as S+$erdisinte#rants
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Time
=>in<
Cumulati"e B drug release
F9 F7 F6
6 0.000 0.000 0.000
8 /4.,1D+./+ /&.804D1.75 41.,48D1.&7
6 48./&D1./1 4,.840D1.+, 5+.44+D1.,4
: &&.1+D+.+& &4.5/D1.7/ &8.00+D1.+1
1/ ,8.,54D1.+7 ,,.,4+D1.0& 8+.0,D1.08
17 75.0+D0.5, 7,.1/D0.&8 77.41D0.45
10 74.,4D0.5& 7,./+D0.,/ 77.+7D0./8
Result
& Discussion
$n #4 to #& #ormulations the #& batch will gi"es good released as compared to #4 I
#5
Ta&!e 6.1:% In4,itro re!ease $rofi!e of ta&!ets of &atc'es F9 to F6 containin#
Indion 919 as S+$erdisinte#rant.

0 3 6 9 12 15 18 21 24
0
20
40
60
80
100
120
140
"a#c$ %7 )dio 1 %
"a#c$ %8 )dio 2 %
"a#c$ %9 )dio 4 %
Time (min)
%

d
r
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g

r
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l
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a
s
e
d
Fi#+re 6.10% In4,itro re!ease $rofi!e of ta&!ets of &atc'es F; to F: containin#
Indion 919 as S+$erdisinte#rants
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Time
=>in<
Cumulati"e B drug release
F; F0 F:
6 0.00 0.00 0.00
8 /8.48D1.&/ 40.&4+D0.75 41.,48D1.&7
6 48./&D1.44 51.5++D1.17 5+.44+D1.,4
: &/.45D1.4/ &8./4+D1.05 &8.00+D1.+1
1/ ,5./8D1.4& ,7.8++D1.5, 8+.0,0D1.08
17 7&./5D0./& 78.5+D0.00 75.5+D0.45
10 7&./8D0.41 78.58D0.50 75.84D0./8
Result
& Discussion
As abo"e mentioned here also in #, to #7 batches #8 batch gi"es more released than #, I
#7
6.0 Co$arison of o$tiiDed for+!ationE MarFeted Ta&!et and ta&!et -it'o+t
s+$erdisinte#rants
Comparision of $n-"itro release data with optimiAed formulations and >ar!eted
Tablet =Contramol ?T< .iramal:s ."t. 6td. 6ab<.

Ta&!e No. 6./6% C++!ati,e = re!ease of dr+# fro o$tiiDed for+!ationE MarFeted
ta&!et and ta&!et -it'o+t s+$erdisinte#rants
Time
=min<
Cumulati"e B
release from
optimiAed batch
Time =min< Cumulati"e B
release from
>ar!eted
Tablet
Tie
@in)
Cumulati"e B
release from
without
(uperdisintegrants
tablet
6
0.00
6
0.00
6 0.000
8
41.,4D1.&7
8
51.11D0.5/
8 18.0,D1.+0
6
5+.44D1.,4
6
&0.0/D0.&0
6 +1.,74D1.11
:
&8.00D1.+1
:
&8.+1D0.4,
: /,.,5+D1.07
1/
8+.0,D1.08
1/
80.85D0.,+
1/ 4,.74&D1.10
17
77.41D0.45
17
7,.1&D0.45
17 55.&1D0.8+
10
77.+7D0./8
1;
77.0,D0,/&
10 &+.1&8D0.70
/9 ,7.10D0.,+
/; 84.51D0.71
86 88.1/D0.,,
88 7&.14D0.+7
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age
Result
& Discussion
0 3 6 9 12 15 18 21 24 27 30 33 36
0
20
40
60
80
100
120
"a#c$ %6 !!(a 4%
*.%.
+i#$ ou# &.D.
Time (Min)
%

d
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a
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Fi#+re 6.1:% In4,itro re!ease $rofi!e of O$tiiDed for+!ationE MarFeted ta&!et and
ta&!et -it'o+t +sin# s+$er disinte#ratin# a#ent
1< The drug released from formulation batch no. #& , mar!eted formulation and tablet
without using superdisintegrants 77.+7 D 0./8 in 15 min , 77.0, D 0.0, in 1, min
and 7&.14 D 0.+7 in // min resp.
+< #rom abo"e it shows that the # & formulation shows good B drug released in less
time.
[Formulation develoment and evaluation o! "ro-disersi#le ta#let #y direct
comression $et%od& 'age