Experimental

5. EXPERIMENTAL
5.1 MATERIALS USED
Table No. 5.1: List of materials used and their suppliers
SR.
NO.
CHEMICALS & REAGENTS MANUFACTURES
1

Tramadol HCL Linchon Pharma Ltd., Ahmadabad
2 Sodium starch glycolate
Loba Chemie Laboratory Chemicals
Ltd.
Cosscaremellose sodium !aple "iotech P#t. Ltd
$ %ndion 2$
%on &'change (esin Ltd.
!umbai.
) %ndion $1$
*
!icrocrystalline cellulose
+A#icel PH,1-2.
Samar Chemicals +%ndia.
/ !agnesium Stearate
Loba Chemie Laboratory Chemicals
Ltd.
0 Hydrochloric acid !erc1 Chemicals
2 Sodium hydro'ide pellets (3CL LT4 5e6 4elhi
1-
Potassium dihydrogen
7rthophosphate
8ual9gens 3ine Chemicals,
5a#i !umbai
11 Potassium chloride
(anba'y 3ine Chemicals Ltd.,
5e6 4elhi
12
Potassium bromide +%(. 8ualigence Laboratories,
5a#i !umbai.
1 7range 3la#our Sapphire Life ScienceP#t. Ltd.
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 44

Experimental
5.1 INSTRUMENTS USED
Table No. 5.2: List of instruments used and their manufacturer
SR.
NO.
INSTRUMENTS/
EUIPMENTS
MANUFACTURES
1
(otary Press Tablet
Compression !achine
(%!&: !inipress,%,
:arna#ati &ngineering Ltd.,
!ehsana, ;u9arat.
2 4hona "alance 4hona %nstruments P#t. Ltd., :ol1ata.
4igital pH meter
!odel 5o. 5%; ,
5aina Solaris Ltd. %ndia.
$ !onsanto Hardness tester
Cadmach !achinery P#t. Ltd.,
Ahmedabad.
) (oche 3riabilator <SP =>%%%
!odel 5o. &3,1?,
&lectrolab P#t. Ltd., ;oregaon +&.,
!umbai.
* Sie#es Sethi Standard Test Sie#es
/
4ouble "eam
<>,Spectrophotometer
Techcomp <> 2--
0 4issolution Apparatus <SP =>%%%
!odel 5o. T4T @ -*P,
&lectrolab P#t. Ltd., ;oregaon +&.,
!umbai.
2 3T%( Spectrophotometer
!odel 5o. 0$-- S,
ShimadAu Asia Pacific P#t. Ltd.,
Singapore.
1- 4igital >ernier Caliper ASAH%, %ndia.
11 <ltrasonicator PCi, !umbai.
12 !agnetic stirrer
!odel 5o. 1!LH,
(emi, !umbai
5.1 SOFT!ARE USED
PCP 4%SS7 >, +Poona College of Pharmacy, Pune..
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 45

Experimental
;raph Pad Prism +>ersion ).-.
!icrosoft 7ffice 2--/
5! PREFORMULATION STUDIES
5.1.1 I"e#$%&%'a$%o# $e($ &o) T)a*a"ol HCl
a+ Mel$%#, -o%#$: The melting point of Tramadol HCl 6as determined by capillary
method and chec1ed, 6hether it complies 6ith the reported ones or not.
b+ I#&)a)e" ab(o)-$%o# (-e'$)o-.o$o*e$)/: Tramadol HCl 6as dried in hot air o#en
at )-
-
C for 2 hours. The sample 6as prepared by mi'ing it thoroughly 6ith
potassium bromide. This sample 6as compressed under pressure of 1- TonBnm
2
and
con#erted in a circular disc. This disc 6as then placed in the scanning slot of 3ourier
Transform %nfra,red +3T,%(. Spectrophotometer and scanned at range from $-- to
$--- cm
,1
to obtain the 3T%( of Tramadol HCl.
5.1.1 P)e-a)a$%o# o& ($o'0 (ol1$%o# o& T)a*a"ol HCl
Accurately 6eighed 1--.- mg of tramadol HCl and dissol#ed in 1--.-mL of
dilution media +respecti#e buffer solution.. The strength of solution 6as found to be 1
mgBmL. (especti#e dilutions 6ere prepared using stoc1 solution +A..
Then 1- mL of stoc1 solution +A. 6as accurately pipetted into a 1-- mL of
#olumetric flas1 and #olume 6as made 6ith the dilution media to get stoc1 solution
+". of strength 1-- gBmL. (especti#e dilutions 6ere prepared using stoc1 solution +"..
5.1.2 P)e-a)a$%o# o& ($a#"a)" 'al%b)a$%o# '1)2e
To ma1e dilutions of Tramadol HCl ranging from ) gBmL to - gBmL
appropriate #olumes of stoc1 solution +". i.e. ), 1-, 1), 2- ,2) and - mL 6as pipette
and #olume 6as made up to 1--.- mL 6ith the dilution media. The absorbance 6as
measured of the prepared dilution in <>,>isible spectrophotometer at 2/1 nm
6a#elength and Calibration cur#e bet6een absorbance and concentration 6as plotted.
Same procedure 6as repeated for acidic buffer P
H
1.2 and phosphate buffer
P
H
*.0 to prepare standard cur#e.
The reagents reCuired for preparation of pH 1.2 hydrochloric acid buffer and pH
*.0 phosphate buffer are gi#en as follo6sD
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 4"

Experimental
5.1.3 P)e-a)a$%o# o& Rea,e#$(
The reagents 6ere prepared as per %P.
a+ P)e-a)a$%o# o& 4.2M ./")o'.lo)%' a'%" 5HCl+ (ol1$%o#: Conc. HCl diluted 6ith
distilled 6ater so that final solution contains /.222 g of hydrochloric acid in 1---.-
mL to obtain -.2! hydrochloric acid solution.
b+ P)e-a)a$%o# o& 4.2M -o$a((%1* '.lo)%"e 56Cl+ (ol1$%o#: 4issol#ed 1$.211 g of
potassium chloride in distilled 6ater and diluted to 1---.- mL 6ith distilled 6ater
to obtained -.2! potassium chloride solution.
'+ P)e-a)a$%o# o& "%l1$%o# *e"%a 5-H 1.2 ./")o'.lo)%' a'%" b1&&e)+: ?eighed
accurately 2)-.- mL of -.2! potassium chloride solution 6as placed in a 1---.-
mL #olumetric flas1. To this, about $2).- mL of -.2! hydrochloric acid 6as added
and then #olume 6as ad9usted to 1--- mL 6ith distilled 6ater. Then prepared
solution 6as tested using pH meter. The pH of solution 6as ad9usted to pH 1.2 6ith
the help of -.2! hydrochloric acid.
"+ P)e-a)a$%o# 4.2M -o$a((%1* "%./")o,e# -.o(-.a$e (ol1$%o#: 2/.210 g of
potassium dihydrogen phosphate 6as dissol#ed in distilled 6ater and the #olume
6as then made up to 1---.- mL 6ith distilled 6ater. This gi#es solution of strength
-.2! of potassium dihydrogen phosphate.
e+ P)e-a)a$%o# 4.2M (o"%1* ./")o7%"e (ol1$%o#: Accurately 6eighed 0.- g of
sodium hydro'ide pellets 6as dissol#ed in distilled 6ater and the #olume 6as then
made up to 1---.- mL 6ith distilled 6ater to obtain the -.2! sodium hydro'ide
solution.
&+ P)e-a)a$%o# o& "%l1$%o# *e"%a 5-H 8.9 -.o(-.a$e b1&&e)+: 2)-.- mL of -.2!
Potassium dihydrogen phosphate solution 6as placed in a 1--- mL #olumetric
flas1. To this, about 112.- mL of -.2! Sodium hydro'ide solution 6as added and
then #olume 6as ad9usted to 1--- mL 6ith distilled 6ater. Then prepared solution
6as tested using pH meter. The pH of solution 6as ad9usted to *.0 6ith the help of
-.2! Sodium hydro'ide solution.
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 4#

Experimental
5.2+ TASTE MAS6ING :; USING ION EXCHANGE RESINS
5.2.1. Mo%($1)e 'o#$e#$ "e$e)*%#a$%o# o& $.e )e(%#
Accurately ?eighed 1 gm resin sample +%ndion 2$. 6as 1ept in o#en
+pre#iously heated to 1--
-
C. for 2$ hours and 6eighed. The difference in the 6eight
before and after drying gi#es moisture content.
5.2.2. P)e<$)ea$*e#$ o& $.e )e(%#
The resin 6as 6ashed 6ith deionised 6ater to remo#e the traces of any 6ater
soluble impurities. The resultant resin +%ndion2$. 6as dried and then again treated 6ith
alcohol to remo#e any organic sol#ents or impurities. Then resin 6as dried to remo#e
the sol#ent.
5.2.3. P)e-a)a$%o# o& D)1,: Re(%# 'o*-le7
%on e'change resin +6ea1 cation e'change resins %ndion 2$. 6as 6eighed
accurately +in the proportion of 1--, 2-- and -- gm .. %ndion 2$ resin 6as acti#ated
by stirring in 6ater for - min, using a magnetic stirrer. After - min, the accurately
6eighed Cuantity of drug 6as added in slurry of resin during stirring. The resultant
mi'ture of drug and ion e'change resin 6as stirred for 1 h. The solution 6as filtered off
and the filter ca1e 6as dried.
Solid comple'es of ion e'change resin 6ith drug 6ere prepared in #arious ratios,
1eeping the Cuantity of drug constant. %t is sho6n in Table 5o.0.)
5.3. EFFECT OF DIFFERENT PROCESS =ARIA:LES ON PERCENT
COMPLEXATION OF DRUG !ITH RESIN
5.3. a+ E&&e'$ o& Ra$%o o& D)1,: )e(%# o# -e)'e#$ ")1, 'o*-le7a$%o#:
3or optimiAation of drug to resin ratio 1-- mg, 2-- mg and -- mg of resin 6as
allo6ed to s6ell in 2) mL of distilled 6ater. Then 1-- mg of drug 6as added to each
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 4$

Experimental
slurry of resin that 6ere resulted in 1D1, 1D2 and 1D ratio of drug to resin. The percent
comple'ation 6as estimated at 2/1 nm. 4ata obtained is as sho6n in Table No. 6.6
5.3. b+. E&&e'$ o& A'$%2a$%o# o& %o# e7'.a#,e )e(%# o# -e)'e#$ ")1, 'o*-le7a$%o#:
"y 1eeping drugD resin ratio +1D. constant, %ndion 2$ 6as placed on a
?hatman filter paper in a funnel, 6as 6ashed 6ith distilled 6ater and subseCuently
6ith 15 HCl +1-- mL.. The resin 6as re6ashed 6ith 6ater until neutral pH 6as
reached and then resin 6as dried. 4rug resin comple' 6as prepared by placing 1--
mg to -- mg of acid,acti#ated resin in a bea1er containing 2) mL distilled 6ater.
Accurately 6eighed 1-- mg of Tramadol HCl 6as added to resin slurry 6ith
magnetic stirring. 7n filtration, the residue 6as 6ashed 6ith /) mL of distilled
6ater. Percent comple'ation 6as estimated at 2/1 nm using <>,Spectrophotometer.
Similarly, al1ali acti#ation of %ndion 2$ 6as performed, replaced 1 5 HCl
6ith 1 5 5a7H. The percent comple'ation 6as calculated at 2/1 nm using <>,
Spectrophotometer. The data obtained is sho6n in the Table No. 6.7
5.3. '+. E&&e'$ o& 'o#'e#$)a$%o# o& loa"%#, (ol1$%o# o# 'o*-le7a$%o#:
"y 1eeping drugD resin ratio +1D. constant, different Cuantities of drug resin
solution 6as prepared in bea1er by using the concentration of loading solution 6ere
#aried from 2.) mgBmL, ).- mgBmL, /.) mgBmL, 1- mgBmL and 12.) mgBmL The
drugD resin slurry 6as stirred for one hour inter#al on magnetic stirrer. The percent
comple'ation 6as estimated by using <>,Spectrophotometer at 2/1 nm. Similar
procedure 6as carried out 6ith different ratios. 4ata obtained is as sho6n in Table
No.6.8
5.3. "+. E&&e'$ o& *%7%#, $%*e o# -e)'e#$ ")1, 'o*-le7a$%o#:
"y 1eeping drugD resin ratio +1D. constant, -- mg of resin 6as stirred in 2) ml
of distilled 6ater for - min then add 1-- mg of Tramadol Hcl 6as added to it. Then
4rugD resin slurry 6as 1ept for 1), -, $), *-, 2- and 12- minutes inter#al on magnetic
stirrer. The percent comple'ation 6as estimated by using <>,Spectrophotometer at 2/1
nm. 4ata obtained is as sho6n in Table No. 6.9
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 4%

Experimental
5.3. e+. E&&e'$ o& $%*e o& (>ell%#, o& )e(%# o# 'o*-le7a$%o#:
"y 1eeping drugD resin ratio +1D. constant, -- mg of resin +%ndion 2$ . 6as s6elled
in 2) mL of distilled 6ater in a bea1er for 1-, 2-, - and $- minutes on
magnetic stirrer. 1-- mg of Tramadol Hcl 6as added to the slurry of resin during
stirring. 4rugD resin slurry 6as stirred for *- minutes on magnetic stirrer. The
percent comple'ation 6as estimated by using <>,Spectrophotometer at 2/1 nm.
4ata obtained is as sho6n in Table No. 6.10

5.? E2al1a$%o# ($1"%e( o& (ol%" ")1,: )e(%# 'o*-le7
5.?.1. FT<IR S-e'$)o('o-/:
3T,%( spectrum of the 4rug, %ndion,2$, and 4rugD %ndion,2$ +1D. 6as
recorded on ShimadAu 0$--S spectrophotometer using the :"r disc techniCue. The
spectrum of the 4rug, %ndion,2$, and 4rugD %ndion,2$ +1D. comple' is sho6n in
figure 0.1, 0.1$ and 0.1) respecti#ely.
5.?.2. Ta($e E2al1a$%o# o& Sol%" D)1,: Re(%# Co*-le7:
The sample of each drug resin comple' 6as sub9ected to sensory e#aluation by a
panel of nine members 6ith respect to bitter taste. "itterness 6as measured by
consensus of panel 6hich contain three group, each group contain three sub9ects The
e#aluation 6as performed by classifying bitter taste into follo6ing fi#e classes.
Le#el )D >ery strongly bitter taste is sensed.
Le#el $D strongly bitter taste is sensed.
Le#el D !oderately bitter taste is sensed.
Le#el 2D Slightly bitter taste is sensed.
Le#el 1D 5o bitter taste is sensed.
The pure drug 6ithout comple'ation 6ith ion e'change resin 6as used as a control
ha#ing an a#erage bitterness #alue of ).
A 6ritten consent of the members of the panel 6as ta1en and 6ere e'plained the
procedure in#ol#ed in testing the taste of comple'es. &ach of the members 6as gi#en
the control that is the pure drug and 6as as1ed to compare the bitterness of each of the
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 5&

Experimental
ratio of comple' 6ith that of the control and indicate the le#el of bitterness percei#ed by
them. The members of the panel 6ere as1ed to gargle. After complete remo#al of taste
sense of pre#ious sample then only the ne't sample 6as gi#en for taste analysis. The
a#erage bitterness #alue of each of the ratio 6as 6or1ed out based upon the le#el of
bitterness percei#ed by indi#idual member of the panel.
The a#erage bitterness #alue of each of the ion e'change resin comple' 6ith the
drug is sho6n in Table No. 5.12
5.?.3. A((a/ o& D)1,: Re(%# Co*-le7e(:
A comple' eCui#alent to )- mg 6as accurately 6eighed, in that 1- mL of 15 HCl
6as added to brea1 the drugD resin comple'. This 6as stirred on magnetic stirrer for
-min. Solution 6as filtered E dilutions 6ere made, and absorbance 6as measured at
2/1 nm using <>,Spectrophotometer. The data obtained is sho6n in Table No. 6.13
5.5+ Fo)*1la$%o# De(%,# :
Sele'$%o# o& (1-e)"%(%#$e,)a#$
A disintegrant is included in the formulation to ensure that the tablet, 6hen in
contact 6ith a liCuid, brea1s up into small fragments, 6hich promotes rapid drug
dissolution. %deally, the tablet should brea1 up into indi#idual drug particles in order to
obtain the largest possible effecti#e surface area during dissolution.
The disintegration process for tablet occurs into t6o steps. 3irst, the liCuid 6ets
the solid and penetrates the pores of the tablet. Thereafter, the tablet brea1s into smaller
fragments. A disaggregation directly into primary po6der particles 6ill set up
conditions for the possible dissolution of the drug.
The disintegration times of these tablets depend largely on the siAe of the dosage
form and hardness parameter. The basic approach used in the de#elopment of the
7rodispersible tablet is the use of superdisintegrants.
Preliminary study 6as carried out for screening of three superdisintegrants namely,
1. Sodium starch glycolate
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 5!

Experimental
2. Croscarmellose sodium
. %ndion $1$
4rug, mannitol, aspartame, orange fla#or, magnesium stearate,
aerosil, microcrystalline cellulose and #arious concentrations of superdisintegrants 6ere
ta1en and compressed. The 6eight of tablet in all batches 6as 1ept constant. All the
batches of tablets 6ere prepared by direct compression using 11, station rotary tablet
machine +(ime1 machineries Ltd..&feect of disintegrating agents and their
concentrations on #arious table properties and in , #itro dissolution characteristics 6ere
studied and discussed.
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 5'

Experimental
Na*e o&
%#,)e"%e#$(
1a#$%$/ %# *,
F1
1F
F2
2F
F3
$F
F?
1F
F5
2F
F8
$F
F@
1F
F9
2F
FA
$F
F14
<
4(CG 2-/.01 2-/.01 2-/.01 2-/.0
1
2-/.01 2-/.01 2-/.01 2-/.01 2-/.01 2-/.01
SS; ( " !' , , , , , , ,
CC5a , , , ( " !' , , , ,
%ndion $1$ , , , , , , ( " !' ,
4, !annitol - - - - - - - - - -
!CC )*.12 ).12 $/.12 )*.12 ).12 $/.12 )*.12 ).12 $/.12 )2.12
!g Stearate 1.) 1.) 1.) 1.) 1.) 1.) 1.) 1.) 1.) 1.)
7range
3la#our
1.) 1.) 1.) 1.) 1.) 1.) 1.) 1.) 1.) 1.)
To$al -- -- -- -- -- -- -- -- -- --
Table 5.3 Fo)*1la$%o# "e(%,# o& $able$(
, 4(CD 4rug (esin Comple' +1D.
, G 4rug resin comple' eCui#alent to )- mg of Tramadol HCl
, Tablets 6ere prepared in batch of )
5.8+ < P)e-a)a$%o# o& -o>"e) ble#" o& D)1, a#" E7'%-%e#$(:
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 5(

Experimental
3ast dissol#ingB disintegrating tablets of Tramadol Hydrochloride 6ere
Prepared using direct compression method after incorporating different
superdisintegrants such as, Crosscarmellose sodium +Ac,4i,Sol., Sodium starch
glycolate and %ndion $1$ in different concentrations. A#icel PH 1-1+!CC., !annitol as
directly compressible diluents, Ac,4i,Sol, sodium starch glycolate and %ndion $1$ 6ere
tried as superdisintegrants. the efficacy of these super disintegrants in any fast
dissol#ing H dosage forms depends upon its selection, concentration used, method of
incorporation and steps used for preparation of the formulation.
All the ingredients 6ere passed through *- mesh sie#e separately and then
ingredients 6ere 6eighed and mi'ed in a geometrical order. 3irst !CC, !annitol 6ere
6eighed and mi'ed together. 4rug comple' 6as then added and 6as mi'ed for 1-,1)
minutes. 3inally to this blend magnesium stearate 6as added and mi'ed further for 1-,
1) minutes. The tablet 6as then compressed by direct compression by using 1- mm siAe
punches to get a tablet of -- mg.
"efore tablet preparation, the mi'ture blend of all the formulation 6ere
sub9ected for compatibility studies %.(. and pre,compressible parameters li1e angle of
repose, bul1 density, tapped density, compressibility inde' and HauserIs ratio.
The 7ro,dispersible tablets prepared sub9ected to post compression parameters
li1e hardness, friability, 6eight #ariation, 6etting time, 6ater absorption ratio, in-vitro
disintegration and in-vitro dissolution. Tablet compression 6as carried out in rotary
compression machine. Compression force 6as 1ept constant throughout the study.
Compression 6as carried out using 1- mm flat faced punches. !ultiple Punch Single
(otary, (ime1 Tablet Compression !achine according to the 1,$,),*,.... a total number
of nine formulations 6ere prepared and 6eight of all tablets 1ept constant. i.e. -- mg
.
5.@ ASSESSMENT OF PREPARED PREFORMULATION
5.@. %+ P)e<'o*-)e((%o# a((e((*e#$ o& -./(%'al -a)a*e$e)( o& *%7$1)e ble#"
4ifferent physical properties of mi'ture blend 6ere e#aluated using follo6ing
methods.
5.@. a+ :1l0 "e#(%$/D

[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 54

Experimental
"ul1 density of po6der 6as determined by pouring gently 2 g of sample through
a glass funnel in to a 1- mL graduated cylinder. The #olume occupied by the sample
6as recorded. "ul1 density 6as calculated by the follo6ing formula

.
5.@. b+ Ta--e" "e#(%$/:

2 g po6der sample 6as poured gently through a glass funnel in to a 1-mL
graduated cylinder. The cylinder 6as tapped from height of 2 inches 6ith a time inter#al
of 2 seconds until the po6der bed #olume has reached minimum. >olume occupied by
the sample after tapping 6ere recorded and tapped density 6as calculated

.

5.@. ' + A#,le o& )e-o(e :

The angle of repose 6as determine by passing the fi'ed Cuantity of po6der from
the funnel fi'ed at constant height till the top of the pile made by po6der touches the
funnel. 3lo6ability of granules 6as determined by calculating angle of repose by fi'ed
height method.
B C $a#
<1
5./)+
6here, J K angle of repose
h K height of the pile
r K a#erage radius of the po6der cone.
Table 5.? : Rela$%o#(.%- be$>ee# a#,le o& )e-o(e 5D+ a#" &lo>ab%l%$/
A#,le o& Re-o(e 5D+ Flo>ab%l%$/
L 2- &'cellent
2-,- ;ood
-,$ Acceptable
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 55
?eight of sample in gm
"ul1 density +gBmL. K
>olume occupied by the sample
?eight of sample in gm
Tapped density +gBmL. K
>olume occupied by the sample

Experimental
M $- >ery poor
5.@. "+ E Co*-)e((%b%l%$/ 5Ca))F( %#"e7+:
%t is also one of the sample methods to e#aluate flo6 property of a po6der by
comparing the bul1 density and tapped density. A useful empirical guide is gi#en by the
CarrIs compressibility.

1--
density Tapped
density "ul1 , density Tapped
ility Compressib F =
Table 5.5: Rela$%o#(.%- be$>ee# E 'o*-)e((%b%l%$/ a#" Flo>ab%l%$/.
E Co*-)e((%b%l%$/ Flo>ab%l%$/
),1) &'cellent
12,1* ;ood
10,21 3airly acceptable
2,) Poor
,0 >ery poor
L$- >ery #ery poor.
5.9+ Po($<'o*-)e((%o# a((e((*e#$ o& O)o<"%(-e)(%ble $able$ :<
Tablets 6ere e#aluated as per pharmacopeial specifications.
a+ !e%,.$ 2a)%a$%o#

:
T6enty tablets 6ere randomly selected from each batch and indi#idually
6eighed. The a#erage 6eight and standard de#iation of 2- tablets 6as calculated. The
batch passes the test for 6eight #ariation test if not more than t6o of the indi#idual
tablet 6eight de#iates from the a#erage 6eight by more than the percentage sho6n in
officials and none de#iate by more than t6ice the percentage sho6n.
Table No. 5.8: ?eight #ariation tolerances for uncoated tablets
A2e)a,e >e%,.$ o& $able$ 5%# *,+
E De2%a$%o#
A( -e) USP<34/NF<25 A( -e) IP<244@
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 5"

Experimental
134 o) le(( 94 o) le(( 14
F)o* 134 $.)o1,. 32? 94 *, G 7 G 254 *, @.5
*o)e $.a# 32? 254 *, o) *o)e 5
b+ Ha)"#e((

:
3or each formulation, the hardness of * tablets 6as determined using Thermoni1
tablet tester +Campbell &lectronics. !odel 5o. 4HT,2)-. Tablet 6as 1ept diagonally
bet6een the t6o plungers and a pressure 6as applied to it until the tablet bro1e do6n
into t6o parts completely and the reading on the scale 6as noted do6n in 1gBcm
2
.
'+ F)%ab%l%$/

:
(oche friabilator +&lectrolab 3riabilator @ <SP,!odel 5o. &3,1?. 6as used to
test the percent friability of the tablets. The tablets should be carefully dedusted prior to
testing. Tablets 6ere placed in drum, 6hich 6as then rotated for 1-- re#olutions. After
that the tablets 6ere remo#ed and re6eighed. The 6eight lost should not e'ceed the
limit 1.-F. The percentage friability 6as measured using the formula,
E F C H1 < 5!/ !
4
+I J 144
?here, F 3 K friability in percentage
?
-
K %nitial 6eight of tablet
? K ?eight of tablets after re#olution.
"+ T.%'0#e((

:
The thic1ness of the tablets 6as determined using a digital caliper +ASAH%,
%ndia.. 3i#e tablets from each batch 6ere used and a#erage #alues and S4s 6ere
calculated.
e. D%(%#$e,)a$%o# T%*e

:
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 5#

Experimental
In vitro disintegration time of tablets from each formulation 6as determined by
using 4igital Tablet 4isintegration Apparatus. In vitro disintegration test 6as carried out
at /N2
o
C in 2-- ml distilled 6ater. * tablets of each formulation 6ere ta1en and placed
in * tubes of disintegration apparatus. The time ta1en for complete disintegration 6as
noted.
&+ !e$$%#, $%*e
A piece of tissue paper folded double 6as placed in a petri dish containing * ml
of 6ater the tablet 6as placed on the paper, and the time for complete 6etting of the
tablet 6as measured in seconds. The method 6as slightly modified by maintaining
6ater at /
-
c.?etting time corresponding to the time ta1en for the tablet to disintegrate
6hen 1ept motionless on the tongue.
5, + !a$e) ab(o)-$%o# )a$%o :
A piece of tissue paper folded t6ice 6as placed in small petri dish +/.)cm.
containing / ml 6ater. A tablet 6as put on the tissue paper E allo6s to 6et completely.
The 6etted tablet 6as then 6eighed.
The 6ater absorption ratio, (, 6as determined using follo6ing eCuation.
RC 144 5!
b
<!
a
+ / !
a
?here, ?
a
is 6eight of tablet before 6ater absorption
?
b
is 6eight of tablet after 6ater absorption

Three trials for each 6ere performed.
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 5$

Experimental
3ig 5o ).2D method for measuring the 6etting time and 6ater absorption ratio
e+ In-vitro D%((ol1$%o# ($1"%e(:
The dissolution test has been carried out for all the formulations .The in #itro drug
released 6as performed using <SP dissolution apparatus @ %% using 2-- ml of pH *.0
Phosphate buffer at paddle rotation )- rpm at /
-
c. 1- ml of sample 6ere 6ithdra6n at
Predetermined time inter#als of ,*,2,12,1),10......and replaced 6ith the fresh medium
of pH *.0 phosphate buffer ..The samples 6ere filtered through -.$) mm membrane
filter . Same procedure 6as done for pH 1.2 acidic buffers Solution. And analysed at
2/1nm using double beam <>B>isible spectrophotometer.
5.A + Co*-a)%(o# O& O-$%*%Ke" Fo)*1la$%o# !%$. Ma)0e$e" Table$
%n #itro 4issolution studies for optimiAed formulation and uncoated
con#entional tablet +Contramol 4T, Piramal Pharma LT4., !umbai. 4ose )- mg. 6ere
carried out using <SP apparatus type %% at )- rpm.
[Formulation development and evaluation of oro-dispersible tablet by direct
compression Method] Page 5%