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Int J Pharm Biomed Res 2011, 2(4), 237-243

International Journal of
PHARMACEUTICAL
AND BIOMEDICAL
RESEARCH
ISSN No: 0976-0350

Research article

Formulation and evaluation of diclofenac potassium effervescent tablets

G. Rajalakshmi*, C.H. Vamsi, R. Balachandar, N. Damodharan
Department of Pharmaceutics, SRM College of Pharmacy, SRM University, Kattankulathur, Tamil Nadu, India, 603 203

Received: 18 Oct 2011 / Revised: 28 Oct 2011 / Accepted: 03 Nov 2011 / Online publication: 15 Nov 2011

ABSTRACT
In the present study, the design of an oral effervescent tablet of diclofenac potassium was carried out. Six different
formulations were prepared using different diluents, carbonates by wet granulation and direct compression method. The
prepared tablets were evaluated for various pre compression characteristics (like angle of repose, bulk density, tapped
density, cars index and hausners ratio) and post compression characteristics (like weight variation, hardness friability ,drug
content, disintegration, CO2 content, effervescent time, particle size and in vitro dissolution studies). The dissolution test was
carried out in SIF without enzymes, 0.1N HCl and pH 4.8 acetate buffer. Among all the formulations, its F3 formulations
were better in all the terms of precompression and post compression parameters. In F3 formulations, F3A (by direct
compression) and F3B (by wet granulation method) were there. F3B (composed of active dextrates (Emdex), citricacid,
tartaric acid, effersoda and arginine) had given good pre formulation and post compression studies as F3A. Even the drug
release in the medium SIF pH6.8 without enzymes was 99.2% when compared to F3A (98.7%) and marketed tablet (98%).It
had all the qualities of a good effervescent tablet, based on this F3B formulation was selected as the best formulation, and it
was charged for stability studies. It had given better release profile in all the mediums when compared to marketed
conventional tablet (SUPANAC). A better therapeutic objective can be obtained by formulating effervescent tablet of
diclofenac potassium that may help in obviating the demerits of slow release and slow absorption, gastrointestinal side effects
of normal tablets.
Key words: EMDEX, Effersoda, Wet granulation, Direct compression, Hausners ratio, Effervescent time, SIF.

1. INTRODUCTION
The oral dosage forms are the most popular way of taking
medication despite having some disadvantages like slow
absorption and thus onset of action is prolong. This can be
overcome by administrating the drug in liquid from but,
many APIs have limited level of stability in liquid form. For
achieving a prolonged and predictable drug delivery profile
in the gastrointestinal tract is to control the gastric residence
time using a gastro retentive dosage forms that will provide
as with new and important therapeutic options. The design of
oral controlled drug delivery system primarily is aimed at
achieving more predictable and increase availability of drugs.
However, the development process is precluded by several
physiological difficulties such as inability to restrain and
*Corresponding Author. Tel: 044 27453160, Fax:
Email: rajalakshmig67@gmail.com

2011 PharmSciDirect Publications. All rights reserved.

locates the controlled drug delivery system within the desired

region of gastrointestinal tract due to the variable gastric
emptying and motility [1]. So, effervescent tablets acts as an
alternative dosage form. The tablet is added into a glass of
water just before administration and the drug solution or
dispersion is to be drunk immediately. The tablet is quickly
broken apart by internal liberation of CO2 in water due to
interaction between tartaric acid and citric acid with alkali
metal carbonates or bicarbonates in presence of water.
Due to liberation in CO2 gas, the dissolution of API in
water as well as taste masking effect is enhanced. The
advantages of effervescent tablets compared with other oral
dosage forms includes an opportunity for formulator to
improve taste, a more gentle action on patients stomach and
marketing aspects. To manufacture these tablets, either wet
fusion or heat fusion is adopted. The tablets are compressed
soft enough to produce an effervescent reaction that is
adequately rapid. Water soluble lubricants are used to prevent
an insoluble scum formation on water surface. To add

G. Rajalakshmi et al., Int J Pharm Biomed Res 2011, 2(4), 237-243

sweetness to the formulation, saccharin is added since

sucrose is hygroscopic and add too much of bulk to the tablet.
The manufacturing shall be done under controlled climatic
condition to avoid effervescent reaction. The packaging is
done under 25% RH at 25C. Hands of the consumers and
atmospheric moisture after opening the container can also
result in loss of product quality. The most commonly used
effervescent tablet today is aspirin tablet [2].
In the present study, the design of an oral effervescent
tablet of Diclofenac potassium was carried out. Diclofenac
Potassium is a nonsteroidal anti-inflammatory drug (NSAID)
that exhibits anti-inflammatory, analgesic, and antipyretic
activities. It is used for treatment of primary dysmenorrhea,
for relief of mild to moderate pain, for relief of the signs and
symptoms of osteoarthritis and rheumatoid arthritis.[Mylan
drugs.com] The main objective of this work was to formulate
and evaluate Diclofenac potassium effervescent tablets by
using different ratios of carbonates and acids by wet
granulation and direct compression method that helps in
obviating the demerits of slow release and slow absorption,
gastrointestinal side effects of normal tablets of Diclofenac
potassium and to increase the release and immediate effect.
Richard B Lipton [3] had worked on diclofenac potassium
oral solution seen that this diclofenac potassium has given
good therapeutic effect in the solution form, Wildgrubehj and
Terhaag B[4] had also worked on the effect of effervescent
tablets of Diclofenac sodium and shown that the gastro
intestinal side effects are reduced when compared to the
normal tablets of diclofenac . Different carbonates ,acids and
buffers were used to attain good effervescence in short time
and to obtain a clear solution , and to give maximum
therapeutic effect in short span of time when taken orally,
Diclofenac potassium is a weak acidic it gets ionized in the
stomach due to the neutralization capacity of the effervescent
solution stomach pH increases and it is in the ionized form
and gets absorbed. As the stomach pH starts to decrease it
gets absorbed through the permeation from the stomach walls
in the unionized form, CO2 released also helps in the
permeation of the drug .In case of normal tablets they remain
unionized in the stomach and absorb only through permeation
not through solubility as they are in the unionized form. In
case of effervescent tablets due to the initial raise of pH in the
stomach that help in the solubility of the drug and converts
the drug to ionized form, as the pH decreases again due to the
acids in the stomach the drug gets converted to unionized
form and get absorbed through the permeation and CO2
released helps in better permeation. These dosage form
process helps the drug to show better therapeutic effect
compared to the normal tablets.
An attempt was made to formulate effervescent tablet of
diclofenac potassium using different carbonates and acids by
wet granulation and direct compression method. The
prepared tablets were subjected to dissolution in various
media and the best formulation was selected for further
studies.

238

2. MATERIALS AND METHODS

2.1 Materials
Diclofenac potassium (Aptuit laurus Pvt Ltd) and all
excipients used were of analytical grade from S.D fine
chemicals and few as gift sample from Aptuit laurus Pvt Ltd
.All the instruments used for Preformulation study were from
Electrolab. All the glass wares used were of borosilicate,
Tablet compression machine was of Cadmach, Dissolution
apparatus USP type 2 was of Electrolab, UV
spectrophotometer
was
of
PerkinElmer
.Entire
Preformulation and post compression was performed in
40%RH to prevent moisture uptake from the atmosphere.
2.2 Wet granulation and direct compression method
Accurately measured quantities of drug and excipients
were taken as shown in Table 1. IPA was used as granulating
agent in case of wet granulation process. Mixture of drug and
excipients were taken for granulation. IPA was added until
wet mass was formed and passed through 20# to get the
required granules, Granules formed through wet granulation
were dried in oven till the moisture content was below
1%.Then the above dried granules were taken in to v cone
blender and flavor was added to it and blend for 15 min. The
formulation, F3B alone was done by direct compression
method. No granules were prepared in this case. Mixture of
drug and excipients were passed through 40# and were taken
in to v cone blender and flavor was added to it and blend
for 15 min and taken for compression. The tablets were
punched using Rotary compression machine (jaugur) of 25
mm punch. These compressed tablets were transferred in to
packing area and these tablets were packed in paperAluminum packing with LDP coating.
2.3 Preformulation studies
2.3.1 Angle of repose [5]
The flow properties of granules (before compression)
were characterized in terms of angle of repose, Carrs index
and Hausners ratio. For determination of angle of repose (),
the granules were poured through the walls of a funnel,
which was fixed at a position such that its lower tip was at
aheight of exactly 2.0cm above hard surface. The granules
were poured till the time when upper tip of the pile surface
touched the lower tip of the funnel. The tan-1 of the (height
of the pile / radius of its base) gave the angle of repose.
2.3.2 Bulk and tapped density
Granules were poured gently through a glass funnel into a
graduated cylinder cut exactly to 10 mL mark. Excess
granules were removed using a spatula and the weight of the
cylinder with pellets required for filling the cylinder volume

G. Rajalakshmi et al., Int J Pharm Biomed Res 2011, 2(4), 237-243

239

Table 1
Optimized formula for diclofenac potassium effervescent tablets 50mg
Sl No
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18

Ingredients
Diclofenac potassium B.P
Effersoda
Citric acid
Tartaric acid
Sodium citrate
Glycine
Arginine
EMDEX
Sugar
Dextrose
Mannitol
Povidone K 30
sun set yellow
lemon flavor
org flavor
Acesulfame K
Aspartame
Sucralose
Total

F1A
0.05
2.01
0.42
0.25
0.38
-----0.831
-0.001
-0.008
-0.05
-4

F1 B
0.05
1.98
0.25
0.44
0.58
-----0.641
-0.001
-0.008
-0.05
-4

was calculated. The cylinder was then tapped from a height

of 2 cm until the time when there was no more decrease in
the volume. Bulk density and tapped density were calculated.
Hausners ratio and Carrs index were calculated.

F2 A
0.05
1.98
0.35
0.45
-0.3
--0.815
---0.005
-0.04
--0.01
4

% loss =

F2 B
0.05
1.98
0.41
0.39
-0.5
--0.641
--0.005
-0.004
--0.02
4

F3 A
0.05
1.98
0.3
0.48
--0.18
0.948
----0.004
-0.008
--0.05
4

F3 B
0.05
1.98
0.3
0.45
--0.4
0.765
----0.005
0.005
0.005
0.02
-0.02
4

Initial wt. of tablets - Final wt. of tablets

x100
Initial wt of tablets

2.4.4 Weight variation [7]

The prepared diclofenac potassium effervescent tablets

were evaluated for uniformity of weight using 20 tablets,
hardness and friability using 10 tablets, drug content,
disintegration, CO2 content, particle size and in vitro
dissolution studies.

Twenty tablets were weighed individually and the average

weight was determined. Then percentage deviation from the
average weight was calculated. According to IP standards,
not more than two of the individual weight deviates from the
average weight by more than the percentage shown in the
(Table 3) and none deviates by more than twice that
percentage.

2.4.1 Tablet hardness

2.4.5 CO2 content [8]

The resistance of tablet for shipping or breakage, under

conditions of storage, transportation and Handling, before
usage, depends on its hardness. The hardness of tablet of each
formulation was measured by using Pfizer hardness tester.

Thickness of tablets was important for uniformity of

tablet size. Thickness was measured by using screw gauze on
3 randomly selected samples.

Tablet was placed in 100 mL of 10%sulphuric acid

solution, difference in weight after and before was calculated
the resulted weight was the amount of CO2 released. The
drug content in each formulation was determined by 20
tablets and powder equivalent to average weight was added
in 100 mL of methanol, followed by stirring for 30 min. The
solution was filtered through a 0.45 membrane filter, diluted
suitably and the absorbance of resultant solution was
measured spectrophotometrically at 276 nm using methanol
as blank.

2.4.3 Friability

2.4.6 Moisture content

Friability is the measure of tablet strength. Roche

Friabilator was used for testing the friability using the
following procedure. Twenty tablets were weighed accurately
and placed in the plastic chamber that revolves at 25 rpm for
4 minutes dropping the tablets through a distance of six
inches with each revolution. After 100 revolutions the tablets
were reweighed and the percentage loss in tablet weight was
determined.

Take around 50 mL of methanol in titration vessel of Karl

Fischer titrator and titrate with Karl Fischer reagent to end
point. In a dry mortar grind the pellets to fine powder .Weigh
accurately about 0.5 g of the sample, transfer quickly to the
titration vessel, stir to dissolve and titrate with Karl Fischer
reagent to end point.

2.4 Evaluation of effervescent tablets [6]

2.4.2 Tablet thickness

Moisture content =

V X F X 100
Weight of sample in mg

G. Rajalakshmi et al., Int J Pharm Biomed Res 2011, 2(4), 237-243

240

where, F= factor of Karl Fischer reagent, V=volume in mL of

Karl Fischer reagent consumed for sample titration.

release was calculated using an equation obtained from a

standard curve.

2.4.7 Drug content

2.5 Stability studies[11]

Tablet was placed in 100 mL of 10%sulphuric acid

solution, difference in weight after and before was calculated
the resulted weight was the amount of CO2 released. The
drug content in each formulation was determined by 20
tablets and powder equivalent to average weight was added
in 100 mL of methanol, followed by stirring for 30 min. The
solution was filtered through a 0.45 membrane filter, diluted
suitably and the absorbance of resultant solution was
measured spectrophotometrically at 276nm using methanol as
blank.

The promising formulation was tested for a period of

three months at 25C/60%RH and 40C/75%RH, for their
drug content and other parameters.

2.4.8 Content uniformity

In this test, 30 tablets were randomly selected contained
for sample, and 10 tablets should contain not less than 85.0 %
and not more than 115.0 % of the label claim. If one unit
outside the range of 85 to 115% of the label claim and no
units is outside 75 to 125% or if RSD>6% or if both
conditions prevail, test 20 additional units.
2.4.9 Disintegration test
It was performed in disintegration apparatus at 300C
temperature and time was noted. Place one tablet into each
tube and suspend the assembly in to the 1000 mL beaker
containing water maintained at 372C, 252C and operate
the apparatus. Remove the assembly form the liquid. Observe
the tablets, if one or two tablets fail to disintegrate
completely; repeat the test on 12 additional tablets. The
requirement is met if not less than 16 of the total of 18 tablets
tested are disintegrated [9,10].
2.4.10 Invitro release studies
The dissolution test was carried out in SIF without
enzymes, 0.1N HCl, and 4.8 pH acetate buffer. Samples were
taken at predetermined time intervals and after suitable
dilutions absorbance were measured with the help of UV
spectrophotometer at 276 nm and the percentage drug
released at various time intervals were calculated. The release
rate of diclofenac potassium from tablets was determined
using United States Pharmacopeia (USP) Dissolution Testing
Apparatus 2. The dissolution test was performed using 900
mL of 0.1N HCl, 4.5 acetate buffer, 6.8 SIF at 370.5C and
50 rpm. A sample (10 mL) of the solution was withdrawn
from the dissolution apparatus hourly and the samples were
placed with fresh dissolution medium. The samples were
filtered through a 0.45 membrane filter and diluted to a
suitable concentration. Absorbance of these solutions was
measured at 265 nm using spectrophotometrically at 276nm
using respective buffer as blank. Cumulative percentage drug

3. RESULTS AND DISCUSSION

3.1 Preformulation studies
The results of micrometric properties are presented in
Table 2. The flow property was found to be good in all the
formulation. In particular, F2A, F2B showed excellent flow
property. [12]. In case of bulk density and tapped density all
the formulation were within the range of 0.5-0.8g/dl.
Compressibility Index was found to be good in case of F1B,
F2A F3A and fair in case of F1A, F2B and F3B. In case of
Hausners ratio, F1B, F2A and F3A had shown good and
F1A, F2B and F3B were fair compared to others.
3.2 Physical evaluation of tablets
The formulated floating tablets met the pharmacopoeial
requirement of uniformity of weight. All the tablet confirmed
to the requirement of assay as per I.P. Hardness, % Friability,
Thickness, Weight Variation and content uniformity were
within acceptable limit. Results are shown in the Table 3. It
was clear that weight variation holds good for all the
formulations. The drug content was in the range of 99.42100.54 for all the six formulations. In case of Friability,
formulation F1A had very high % of friability than other
formulations. The moisture content was 1.20% and 1.30% in
case of F2A and F2B which is a problem in effervescent
dosage form .The reason for these variations is due to sugar
and dextrose used in the respective formulations. Drying time
for all the formulations is around 2h at 50C , in case of F2
A and F2B, it required more than 2h for the moisture content
to become less than 1% extending drying time lead to color
change .In case of F1A and F1B the moisture content was
0.5%,and in case of F3Aand F3B it was 0.7%. In case of
hardness it was around 10-16Kp. F2A and F3A had
maximum hardness of 16KP and F1A had least hardness of
10Kp due to lack of binder. F3B had given good hardness of
14Kp after which Friability and moisture content were also in
the limit. The comparative study of hardness, moisture
content and friability for all the formulation are showed in
Fig.1.
The thickness of the tablet was between 5.6 and 6mm. All
the formulated tablets had 25mm diameter .The formulations
had pH of 6.8. The effervescent test was carried out in 200ml
water and all the formulations showed effervescence within
50 to 64 sec. The formulation F1B took maximum time of 64
sec to effervescence whereas the formulation F3B the least

G. Rajalakshmi et al., Int J Pharm Biomed Res 2011, 2(4), 237-243

241

Table 2
Pre compression parameters of diclofenac potassium effervescent tablet blend
Sl. No
1
2
3
4
5

Pre compression and post compression studies

Angle of repose()
Bulk density in g/mL
Tap density ing/mL
Compressibility index in %
Hausners ratio

F1A
31.96
0.5
0.61
17.94
1.21

F1B
32.15
0.53
0.62
14.28
1.167

F2A
29.62
0.7
0.66
14.94
1.16

F2B
29.62
0.8
0.6
18.91
1.233

F3A
31.51
0.53
0.62
13.11
1.15

F3B
31.08
0.5
0.5
16.36
1.19

Table 3
Post compression study of diclofenac potassium effervescent tablets
Sl No
1
2
3
4
5
6
7
8
9
10
11

Pre compression and post compression studies

Weight variation in %
Content uniformity in %
Friability in %
Hardness in KP
Thickness of tablet in mm
Diameter of tablet in mm
CO2 content in mg
Moisture content in %
pH
Disintegration time (900 mL water) in sec at 37C
Effervescent time (200 mL water)in sec

F 1A
2.24
99.70
1.16
10
5.6
25
262
0.50
6.8
43
52

F1 B
2.83
100.25
0.24
12
5.9
25
261
0.5
6.8
54
64

F2 A
1.73
99.42
0.12
16
5.9
25
262
1.2
6.8
45
51

F2 B
1.76
100.5
0.2
15
6
25
260
1.3
6.8
48
51

F3 A
2.87
99.85
0.1
16
5.9
25
260
0.7
6.8
48
52

F3 B
2.8
100.5
0.2
14
5.96
25
261
0.7
6.8
48
50

Table 4
Stability data for F3B formulation
Sl No

Post compression studies

of stability sample F3B

1
2
3
4
5
6
7
8

Content uniformity
Friability
Hardness in Kp
CO2 content in mg
Moisture content in %
pH
Disintegration time in sec
Effervescent time in sec

1 Month
25C/60%RH
99.50%
0.2
14
260
0.7
6.8
48
50

40C /75%RH
100%
0.23
14
260
0.75
6.8
48
50

2 Month
25C/60%RH
100.50%
0.2
14
260
0.7
6.8
48
50

40C /75%RH
99.70%
0.25
13
256
0.8
6.8
50
52

3 Month
25C/60%RH
99.10%
0.2
14
2.58
0.7
6.8
48
51

40C /75%RH
99.60%
0.3
13
253
0.8
6.8
50
52

3 month
%CDR
25C/60%RH
0
100.1
100.3
100.1
99.6

%CDR
40C /75%RH
0
99.6
100.3
100
99.3

Table 5
Dissolution profile for stability sample (F3B)
Sl No.

1
2
3
4
5

Time

0
5
10
15
30

1 month
%CDR
25C/60%RH
0
100.2
100.5
100
99.8

%CDR
40C /75%RH
0
99.7
100.1
99.5
99.3

50 sec. This may be due to absence of either Glycine

Arginine or EMIDEX in F1A, F1B. The disintegration test
was performed in 900 mL of water at 37C in these F3B had
taken less time to disintegrate, The formulation F1B had
taken maximum time to disintegrate it took 54 sec at 37C
and 62 sec at 25C whereas F1A and F2B took 52 sec and
F3A took 51 sec. In case of CO2 content F1A, F2A has
released maximum of 262mg. In F1B and F3B 261mg of CO2
was released. The effervescent time, CO2 content,
disintegration time of all formulations is shown in Fig.2.

2 month
%CDR
25C/60%RH
0
100
100.5
100
99.5

%CDR
40C /75%RH
0
100.2
100.3
99.6
99.2

3.3 Invitro dissolution studies

The dissolution test was carried out in SIF without
enzymes, 0.1N HCl and pH4.8 acetate buffer. These revealed
the amount of drug absorbed from the released drug at
different pH conditions in the body. All the formulation had
given good release as shown in the figures. As all the
formulation had disintegration time less than 1 min
immediate release of drug was seen .The results were
compared with the marketed tablet SUPANAC (immediate

G. Raj
ajalakshmi et al., Int
I J Pharm Biom
med Res 2011, 2(44), 237-243

F
Fig.1.
Comparativve study of hardnness, moisture conntent and friabilitty of all
the foormulations

F
Fig.2.
Comparativve study of effervvescent time, CO2 content, disintegration
time of all the formulationss

Fiig.3. Dissolution profile

p
in 0.1NHC
Cl pH1.2

Fig.44. Dissolution proofile in pH 4.5 acetate buffer

242

Fig.5. Disssolution profile iin pH 6.8 SIF witthout enzymes

rellease diclofennac potassium

m). In case of 0.1N
0
HCl (pH
H 1.2)
alll the formulation showed oonly 10-12 % drug release at
a this
condition. The reason
r
for pooor drug release is due to thee poor
solubility of thee drug in this medium. But when compaared to
thee Market tablet the releasee was more du
ue to neutralizzation
off pH1.2 in thhe effervescennt formulation. The dissoolution
pro
ofile 0.1 N HC
Cl is shown inn Fig.3.
In case of acetate buffeer pH 4.5 alll the formulations
showed 40-50%
% of drug releease. But wheen compared to the
Market tablet thhe release waas more due to
t neutralizatiion of
pH
H 4.5 acetate buffer in thee effervescen
nt formulationn. The
disssolution proffile in pH 4.5 aacetate buffer is shown in Fig.4.
F
When the dissolution
d
is carried in pH
H 6.8 SIF without
w
en
nzymes, all thhe formulatioon had given good release. As
shown in Fig.5,, all the form
mulations releaased 98-100%
% drug
rellease at this pH
p condition due to the sollubility of thee drug
in this medium.. As SIF had given 100% drug release it
i was
sellected as thee dissolution medium. Maarketed Immediate
rellease diclofennac potassium
m 50mg tablett (SUPANAC
C) was
compared withh all the foormulation, in
n which preepared
h
shown raapid release compared too the
forrmulations had
maarketed tableets in all thhe mediums.. Among alll the
forrmulations, itss F3 formulattions were bettter in all the terms
off precompression and post compression parameters. In F3
forrmulations theere were F3A
A and F3B out of which F3A
A was
preepared by weet granulationn method whicch had given good
flo
ow properties and post compression
n studies alll the
paarameters likee hardness, ffriability, moiisture contennt and
efffervescent tim
me were good.
F3B (compoosed of active dextrates (E
Emdex), citricacid,
tarrtaric acid, eff
ffersoda and aarginine) whicch was preparred by
dirrect compresssion method hhad given goo
od pre formuulation
an
nd post comprression studiess as F3A. Eveen the drug reelease
in the medium SIF
S pH6.8 wiithout enzymees was 99.2% when
compared to F33A (98.7%) annd marketed tablet (98%). It
I was
preepared by dirrect compresssion method, which reducees the
steep of granulaation preventt the drying time, spray dried
(E
EMDEX) usedd had given good flow properties alll the
paarameters suchh as hardneess ,friability ,moisture coontent,
efffervescence tiime and disinntegration tim
me were withiin the
sellected range. It had all the qualities of a good efferveescent

G. Rajalakshmi et al., Int J Pharm Biomed Res 2011, 2(4), 237-243

tablet, based on this F3B formulation was selected as the best

formulation, and it was charged for stability studies.
3.4 Stability studies
F3B formulation was charged for stability studies at
25C/60%RH and 40C /75%RH. The results are presented
in Table 4 and 5. There were no significant changes in the
stability results of F3B formulation, content uniformity was
within the limits .In case of hardness and friability there was
no change in 25C/60%RH conditions. In case of 40C
/75%RH stability condition there was slight increase in the
friability and decrease in hardness due to the increase in
moisture content, but the changes were within the limits. No
major changes were seen in case of disintegration and
effervescent time. Release profile was similar as the initial
data in both 25C/60%RH, 40C /75%RH condition.
4. CONCLUSIONS
The diclofenac potassium effervescent tablets had been
prepared by wet granulation and direct compression method
with an objective to prevent the side effects like gastric ulcer
of normal conventional tablets of Diclofenac potassium. The
prepared effervescent formulation was thought to be patient
friendly in case of swallow ability and show better
therapeutic effect due to fast release compared to the
marketed tablets of diclofenac potassium.
After performing the precompatibility studies, acids like
(citric acid, tartaric acid), bases like (effersoda), buffers like
(sodium citrate, glycine, arginine), diluents like (mannitol,
sugar, dextrose and dextrates) were selected due to their
better drug - excipient compatability. With the aid of above
information many formulations had been prepared in these
F1A had failed in case of hardness, F1B had failed in case of
effervescent time, F2A and F2B had failed in case of
moisture content, F3 formulation had shown good results in
preformulation and post compression studies all the results.
Among all the formulations, F3 formulations were better in
all the terms of precompression and post compression
parameters. In F3 formulation there were F3A and F3B out of
which F3Awas prepared by wet granulation method which

243

had given good flow properties and post compression studies

all the parameters like hardness, friability, moisture content
and effervescent time were good.
F3B (composed of active dextrates (Emdex), citric acid
,tartaric acid, effersoda and arginine) which was prepared by
direct compression method had given good pre formulation
and post compression studies than F3A and it was charged
for stability studies and had given good stability data with
respect to all the evaluation parameters.
In conclusion F3B can be easily prepared on the
commercial scale. It had given better release profile
compared to the marketed immediate release tablets of
diclofenac potassium (Supanac 50 mg).
5. ACKNOWLEDGEMENT
Authors are thankful to Aptuit laurus Pvt Ltd and Senior
General Manager Sandeep Kachwaha for providing the
facilities (punching), drug and excipients for this research
project.
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