Abstract: The purpose of present research work was to optimize the formulation of fast dissolving tablet of carbamazepine. Carbamazepine is one the most prescribed antiepileptic drug. Fast dissolving tablets of carbamazepine were prepared by using different types of superdisintegrants like croscarmellose sodium and sodium starch glycolate. Fast dissolving tablet is prepared by direct compression method. The formulations were evaluated for wetting time, hardness, friability, content uniformity, invitro disintegration time, release profile. The result revealed that the formulation F5 which containing the 5% croscarmellose sodium as a superdisintegrant have good dissolution profile with shortest Disintegration time. It can be concluded that the tablet of carbamazepine with better pharmaceutical properties than conventional tablets could be obtained using formulation F5.

1. ISSN: 2348 –0882
==========================================================================
Int. J. Pharm. Res. Sci., 2014, 02(1), 47-59.
www.ijprsonline.com
Formulation and Evaluation of Fast Dissolving Tablets of Carbamazepine
Using Solid Dispersion.
Metkari VB1,*, Kulkarni LV1, Patil PS1, Jadhav PA1, Jadhav PH1, Yadav PS1.
1
College of pharmacy Medha Satara, Maharashtra, India.
Corresponding author email: vmetkari@yahoo.com
---------------------------------------------------------------------------------------------------------------------------------Abstract:
The purpose of present research work was to
optimize the formulation of fast dissolving tablet
of carbamazepine. Carbamazepine is one the most
prescribed antiepileptic drug. Fast dissolving
tablets of carbamazepine were prepared by using
different types of superdisintegrants like
croscarmellose sodium and sodium starch
glycolate. Fast dissolving tablet is prepared by
direct compression method. The formulations
were evaluated for wetting time, hardness,
friability,
content
uniformity,
invitro
disintegration time, release profile. The result
revealed that the formulation F5 which containing
the
5%
croscarmellose
sodium
as
a
superdisintegrant have good dissolution profile
with shortest Disintegration time. It can be
concluded that the tablet of carbamazepine with
better pharmaceutical properties than conventional
tablets could be obtained using formulation F5.
Keywords: Fast dissolving tablet, Croscarmellose
sodium, sodium starch glycolate, Direct
compression.
Introduction:
Oral route has been one of the most of popular
routes of drug delivery due to its ease of
administration, patient compliance, least sterility
constraints and flexible design of dosage forms
(Brahmankar et al., 2005).Many patient of
different age group like geriatric and pediatric
complaint of some solid dosage form because of
difficulty in swallowing. So to solve this problem
and increase patient compliance fast dissolving
tablet is prepared. Fast dissolving tablets are those
when put on tongue disintegrating instantaneously
releasing the drug which dissolves or disperses in
the saliva. Fast dissolving tablets are also called as
mouth dissolving tablets, orodispersible tablets,
rapi melts, porous tablets, quick dissolving etc.
The faster the drug into solution, quicker the
absorption and onset of clinical effects. Some
drugs are absorbed from mouth, pharynx and
esophagus as the saliva passes down into the
stomach. In such cases bioavailability of drug is
significantly greater than those observed from
conventional tablets dosage form. According to
European pharmacopoeia, the ODT should
disintegrate in less than three minutes. The basic
approach in development of fast dissolving tablets
is the use of the superdisintegrants like
crosscarmellose sodium and sodium starch
glycolate.
Which
provide
instaneous
disintegration of the tablets after putting on
tounge, their by release the drug in saliva. The
bioavailability of some drug may be increased due
to absorption of drug in oral cavity and also due to
pregastric absorption of saliva containing
dispersed drugs that pass down into stomach
(
Abed et al., 2010). Fast dissolving tablets are
those when put on tongue disintegrating
instantaneously releasing the drug which dissolves
or disperses in the saliva. Fast dissolving tablets
are also called as mouth dissolving tablets,
orodispersible tablets, rapi melts, porous tablets,
quick dissolving etc.The faster the drug into
solution, quicker the absorption and onset of
clinical effects. Some drugs are absorbed from
mouth, pharynx and esophagus as the saliva
47

2. ISSN: 2348 –0882
==========================================================================
Int. J. Pharm. Res. Sci., 2014, 02(1), 47-59.
passes down into the stomach. In such cases
bioavailability of drug is significantly greater than
those observed from conventional tablets dosage
form. According to European pharmacopoeia, the
ODT should disintegrate in less than three
minutes. The basic approach in development of
fast dissolving tablets is the use of the
superdisintegrants like crosscarmellose sodium
and sodium starch glycolate. Which provide
instaneous disintegration of the tablets after
putting on tounge, their by release the drug in
saliva.The bioavailability of some drug may be
increased due to absorption of drug in oral cavity
and also due to pregastric absorption of saliva
containing dispersed drugs that pass down into
stomach (Madhusudan et al.,).
2. MATERIAL AND METHODS:
2.1 Material:
Carbamazepine is obtained as a gift sample from
Abbott pvt ltd, Mumbai. Croscarmellose sodium
is obtained from Fine chem industry Mumbai.
Sodium starch glycolate is obtained from
Chemika Biochemika Reagents. All other
chemicals used were of analytical grade.
2.2 Methods:
2.2.1 Preparation of solid dispersion of
Carbamazepine
Carbamazepine solid dispersions were prepared
by solvent evaporation, melting and kneading
methods using drug: polyethylene oxide N10 in
proportion, viz. 1:1, 1:1.25, 1:1.5, 1:2. (Drug:
Carrier). Methanol and isopropyl alcohol were
selected as common solvents for solid dispersion.
2.2.1.1 Solvent evaporation method:
The 100 mg of carbamazepine was dissolved in 20
ml of methanol in beaker and weighed amount of
polyethylene oxide N 10 was added and stirred to
dissolve both drug and carrier to get clear
solution. Solution was poured on Petri plate and
allowed to evaporate the solvent. The process of
evaporation was operated until all methanols get
evaporated. Solid dispersion prepared was then
dried at room temperature and stored in
desiccators for further study (Lewis et al., 2009).
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2.2.1.2 Kneading method
Accurate weighed amount of Carbamazepine and
polyethylene oxide N 10 were taken into glass
mortar and then methanol was added in small
quantity to make paste. The paste was allowed to
stand for 45 mins and then dried in oven at 400c.
The product obtained was pulverized and passed
through mesh (#) 80 and stored in desiccator for
further study (Madhavi et al., 2011).
2.2.1.3 Physical mixture:
Accurate weighed amount of Carbamazepine and
polyethylene oxide N 10 were taken into glass
mortar and then mixed for 10 minutes to get good
mixture of drug and polymer. Then product was
stored in the desiccator for further study
(Kahkeshan et al., 2012).
2.2.1 Formulation of fast dissolving tablets:
Fast dissolving tablets containing optimized
solid dispersion were prepared by direct
compression method using single punch tablet
machine to produce convex faced tablets
weighing 500 mg each with a diameter of 12
mm. A minimum of 40 tablets were prepared
for each batch (Solanki et al.,2011).
2.2.2 By direct compression technique
The direct compression technique was selected for
developing novel fast dissolving tablets. In direct
compression technique all materials accurately
weighed like solid dispersion complex,
microcrystalline cellulose, sodium saccharine,
talc, magnesium state, and mannitol passed
through a 40 mesh prior to mixing. The solid
dispersion complex was properly mixed with
superdisintegrant, and then with diluents MCC.
The mixture was mixed with talc, sodium
saccharine, magnesium state and mannitol. Then
mixture was subjected to compression using
single punch tablet machine (Solanki et al.,2011).
48

3. Table 1. Formulation of fast dissolving tablets using croscarmellose sodium
Ingredients in (mg)
SD complex
Croscarmellose sodium
Microcrystalline cellulose
Mannitol
Magnesium state
Sodium saccharine
talc
Total weight
F1
250
10
145
75
5
10
5
500
F2
250
20
135
75
5
10
5
500
F3
250
30
125
75
5
10
5
500
F4
250
40
115
75
5
10
5
500
F5
250
50
105
75
5
10
5
500
F6
250
75
80
75
5
10
5
500
Table 2. Formulation of fast dissolving tablets using sodium starch glycolate
Ingredients in (mg)
F1 F2 F3
SD complex
250 250 250
Sodium starch glycolate
10 20 30
Microcrystalline cellulose 145 135 125
Mannitol
75 75 75
Magnesium state
5
5
5
Sodium saccharine
10 10 10
talc
5
5
5
Total weight
500 500 500
resistant to powder flow. However, a high bulk
2.2.3 Characterization of blends:
The quality of tablet, once formulated by rule,
density does not necessarily imply a close-packed
is generally dictated by the quality of
low-porosity bed, as bulk density is directly
physicochemical properties of blends. There are
proportional to true density. Bulk density can be
many formulations and process variables
defined as the mass of powder divided by the bulk
involved in mixing step and all these can affect
volume. Bulk density of powder blends was
the characteristics of blend produced. The
determined using 25ml calibrated plastic
characterization of mixed blend done for the
measuring cylinder, in which powder blends were
flow property of powder that are bulk density,
simply poured and bulk density was measured in
tapped density, Hausner’s ratio, Compressibility
unit gm/ml. Bulk density is also known as fluff or
index, angle
of
repose.
The
various
poured bulk density. It can be calculated by
characteristics of blends tested are given below
following equation,
and results were shown in Table below (Kakde et
Bulk Density = Mass/volume
al.,2010).
ρb = M/Vb
Bulk density
Tapped density
Bulk density of powder blend is always less than
As stated above that due to interparticulate voids
the true density of its component particles because
bulk density of a powder is always less than true
the powder contains interparticulate pores or
density. This statement reveals that whereas as a
voids. The bulk density of powder is dependent on
powder can only possess a single true density, it
particle packing and changes as powder
can have many different bulk densities, depending
consolidates. A consolidated powder is likely to
on the way in which the particles are packed and
have a greater arch strength than a less
the bed porosity. For powders having comparable
consolidated one and may therefore be more
true densities, an increase in bulk density causes
49

4. decrease in porosity. This increases the number of
interparticulate contacts and contacts areas and
causes an increase in cohesion. In very coarse
particles this may still be insufficient to overcome
the gravitational influence on particles. Tapped
density is defined as the mass of a powder divided
by the tapped volume. Tapped density of powder
blends was performed for 100 taps by using
digital bulk density equipment and was measured
in unit of gm/ml. True density is also known as
equilibrium, tapped or consolidated bulk density.
It can be calculated by following equation,
Tapped Density = Mass/ Tapped
volume
ρt = M/Vt
’
Carr s Compressibility index
The simplex way of measurement of the free flow
of powder is compressibility, an indication of ease
with which a material can be induced to flow is
given by compressibility index of the granules
was determined by Carr’s compressibility index (I)
which is calculated by using the formula
(Rockville et al.,2000).
Compressibility index = Bulk volume – Tapped
volume/Bulk
volume
×
100
Table 3. Compressibility Index as an Indication of Powder Flow Properties
Carr̀,s Index (%)
>12
12-16
18-21
23-35
33-38
>40
Type of Flow
Excellent
Good
Fair to passable
Poor
Very poor
Extremely poor
funnel that can be raised vertically until a
maximum cone height (h) was obtained. Radius of
heap (r) was measured and angle of repose was
calculated using formula
-1
Ө = tan h/r
Where, Ө is angle of repose, h is height of
pile and r is radius of base pile.
Hausner ratio
Hausner ratio is an indirect index of ease of
powder flow. It is calculated by the following
formul
Hausner ratio = tapped density/ bulk density
Hausner ratio =
ρt/ ρb
Angle of repose
Angle of repose was determined using fixed
funnel method. The blend was poured through a
Table 4. Angle of Repose as an Indication of Powder Flow Properties
Angle of repose (o)
<25
25-30
30-40
>40
2.2.2.4 Characterization of fast dissolving
tablets:
After compression of powder, the tablets were
evaluated for diameter, thickness and physical
characteristics like
hardness,
friability,
Type of flow
Excellent
Good
Passable
Very poor
disintegration time, wetting time, dispersion
time and dissolution studies. The results were
shown in Table below.
Tablet Thickness
50

5. Ten tablets from each batch formulation were
from each formulation and weighed collectively
selected randomly and their thickness was
and average weight was calculated using digital
measured with a screw gauge for calculating
balance. The individual weights were compared
thickness variation (Shirsand et al.,2010).
with the average weight for obtaining weight
variation.
Uniformity of weight
As per IP twenty tablets were taken randomly
Table 5. Weight Variation Limits for Tablets as per IP.
Average of Tablets (mg) Maximum% difference allowed
130 or less
10
130-324
7.5
More than 324
5
The In vitro dispersion time of fast dissolving
Hardness
Hardness of the tablet was measured using the
tablets of carbamazepine was determined by
Monsanto hardness tester (soumya et al.,2013).
placing one tablet in a beaker containing 100 ml
of phosphate buffer and time required for
Friability
Friability of the tablets was determined using
complete dispersion was determined.
Roche friabilator. This device subjects the
Wetting time
tablets to the combined effect of abrasions and
Wetting time of fast dissolving tablets of
shock in a plastic chamber revolving at 25 rpm
carbamazepine was determined by carefully
and dropping the tablets at a height of 6 inch in
placing tablets on to a twice folded circular tissue
each revolution. Pre-weighed sample of tablets
paper placed in a Petri-dish having the internal
was placed in the friabilator and were subjected
diameter of 5 cm containing 6 ml of water. The
to 100 revolutions. Tablets were dusted using a
time required for water to reach the upper surface
soft muslin cloth and reweighed. The friability
of the tablet and to completely weight the tablet
(F %) is determined by the formula (Rangole et
was noted as wetting time(Rangole et al.,2008).
al., 2008).
Water absorption ratio
% friability = loss in weight/initial
The weight of the tablets prior to placing in Petri
weight×100
dish was noted (wb) using the digital balance. The
weighted tablet was removed and reweighed (wa).
Water absorption ratio(R) was then determined
Drug content uniformity
Drug content of fast dissolving tablets of
according to the following equation.
carbamazepine was calculated by weighing ten
R = 100× (wa-wb)
tablets of each formulation, pulverizing to a fine
Where, wb and wa were tablet weights before and
powder. A quantity of powder equivalent to 10 mg
after water absorption respectively.
of carbamazepine dissolved in methanol and
In-vitro dissolution study
solution was filtered through a 0.45 μm whatmann
In-vitro dissolution study of fast dissolving tablets
filter paper. Carbamazepine content was
of carbamazepine was performed according to
determined by measuring the absorbance at 285
USP type-II dissolution apparatus employing a
nm at UV visible spectrophotometer after
paddle stirrer at 50 rpm using 900 ml of phosphate
appropriate dilution with methanol. The drug
buffer of pH 6.8 at 37±0.5 as dissolution medium.
content was determined using calibration curve.
One tablet was used in each test. Aliquots of the
The mean percent drug content was calculated as
dissolution medium 5 ml were withdrawn at
an average of three dimensions(Masareddy et
specific time interval 5, 10, 15,20,25,30 minutes
al.,2008).
and replaced with the equal volume of fresh
medium. The samples were filtered through 0.45
μm whatman analyzed by measuring the
In Vitro dispersion time
51

6. absorbance at 285 nm. Drug concentration was
IR Spectrum of Carbamazepine
calculated from the standard calibration curve and
IR spectrophotometer was used for infrared
expressed as cumulative percent drug dissolved.
spectroscopy analysis of carbamazepine. The
The release studies were performed in triplicate
samples were prepared in KBr disk by means of a
(Arora et al.,2010).
hydrostatic press. The scanning range was 4004000 cm-1 (Wan et al., 2012).
In-vitro Disintegration time
Disintegration of FDT was generally occurring
DSC of Carbamazepine
due to water uptake by superdisintegrant via
Differential
scanning
calorimetry
(DSC)
capillary action, which results in swelling of
measurements were performed on SDT Q600
superdisintegrants and tablet get disintegrated. It
Differential scanning calorimeter. The accurately
was also reported that increased compaction force
weighed sample was placed in an aluminium pan
may increase or decrease disintegration time. In
and an empty aluminium pan was used as a
the present study disintegration test was carried
reference (Wan et al.,2012).
out on six tablets using the apparatus specified in
XRD of carbamazepine
USP (Electrolab disintegration apparatus USP).
XRD of carbamazepine was carried out by using
0
0
The distilled water at 37 C ± 2 C was used as a
the Philips PW 1729 X-ray generator (Wan et
disintegration media and time in second taken for
al.,2012).
complete disintegration of the tablet with no
3. RESULT AND DISSCUSION:
palpable mass remaining in the apparatus was
measured in seconds (Pandit et al., 2012).
Table.6. Solubility of PM and SD in water:
Drug: Polymer ratio Solubility (mg/ml)
PM
SE KM
1:1
0.13 0.16 0.27
1:1.25
0.14 0.18 0.29
1:1.5
0.15 0.19 0.35
1:2
0.14 0.17 0.26
From table 6 it is know that Solubility of
evaporation and kneading method. Kneading
carbamazepine is increased by different methods
method is only method which gives the high
of solid dispersion like physical mixture, solvent
solubility than other method i.e. 0.35 mg/ml.
Table.7.Solubility data of SD prepared by KM in water:
Drug: Polymer ratio Solubility (mg/ml)
1:1
0.27
1:1.25
0.29
1:1.5
0.35
1:1.75
0.29
1:2
0.26
1:3
0.23
1:4
0.23
From table 7 it is clear that proportion of drug to
polymer ratio 1:1.5 give the high solubility i.e.
0.35 mg/ml that’s why 1:1.5 proportion is used for
preparing fast dissolving tablets which gives high
drug release with in 30 mins i.e. 87.5±1.5.
3.1Drug polymer interaction studies:
Drug and polymer interaction study was
carried out by doing the different analysis of pure
52

7. carbamazepine, physical mixture, solid dispersion,
Fourier Transform Infrared Spectroscopy
polymer and the formulation.
Figure 1. IR spectra of A) Pure carbamazepine, B) polyox N 10 C) Physical Mixture D) Solid
almost the same wave number with same intensity
Dispersion E) Formulation F.
IR spectrum of pure carbamazepine,
in the spectra of physical mixture solid dispersion
polyox N 10, Physical Mixture and Solid
which indicate that the absence of any potential
dispersion are shown in figure 1. The IR spectra
physical or chemical interaction between drug and
of pure carbamazepine showed peak at 3458.37,
polymer and other additives, Hence drug nad
3153.61, 3032.10, 1666.50, 1595.13, 1477.47,
polymer were found to be compatible with the
-1
1377.17 cm indicating stretching of N-H, C-H,
drug.
C-H aromatic, amide, C-N , N-H deformation
respectively. These peaks seemed to be retained at
Differential Scanning Colorimetry Analysis
53

8. Figure 2. DSC thermogram of A) Pure carbamazepine, B) polyox N 10 C) Physical Mixture D) Solid
Dispersion E) Formulation F5
One of the most classic application of DSC
physical mixture, solid dispersion and formulation
analysis is the determination of the possible
F5.Endothermic peak of caarbamazepine was not
interaction between the drug and excipients in the
observed in Physical mixture, solid dispersion and
formulation supporting evidence for compatible
formulation F 5 because carbamazepine is
between drug and excipients was obtained from
dispersed in the polyox N10 at molecular level.
DSC analysis studies. As shown in the figure 2 the
This indicate the absence of any
DSC thermogram of carbamazepine showed sharp
interaction between drug and excipients, Hence
0
endothermic peak at 193.93 c which is near to
from above DSC thermogram, it was found that
melting point of carbamazepine.DSC thermogram
there was compatibility between drug and
0
of polyox N 10 showed sharp melting at 73.44 c
excipients.
which also observed in DSC thermogram of
X- Ray Diffraction (XRD)
XRD pattern were recorded using Philips 1729 X-ray generator. Powder X-ray diffraction patterns
were recorded for drug, physical Mixture, solid dispersion and polymer.
Figure 3 . XRD pattern of A) Pure carbamazepine, B) polyox N 10 C) Physical Mixture D) Solid
Dispersion
Figure 3 shows the diffraction pattern of
peaks were observed at 2θ values of 10.32, 13.32,
pure carbamazepine which shows its crystalline
16.16, 19.76, 25.14, 27.88, and 32.33 in
nature that was demonstrated by numerous sharp,
fingerprint regions referring to its crystallinity.
highly intense and less diffused peaks. These
54

9. Peak height of pure carbamazepine was
selected to calculate the RDC of CBZ, best
physical mixture and solid dispersion. When pure
CBZ was considered as a reference sample, a
significant decrement in crystallinity of the
characterized solid dispersion was observed (˂
0.1).RDC values were 1, 0.9 and 0.6. For pure
drug, physical mixture and solid dispersion
respectively indicating the amorphousness of
drug, polymer.
3.2 Characterization of blend for fast
dissolving tablets:
The data for evaluation of powder blends of
rapidly disintegrating tablets of carbamazepine is
as shown below.
Table 7. Characterization of blends:
Formulation code Bulk density Tapped density Hausner’s̀́ ratio Carr’s index Angle of repose
(gm/cm3)
(gm/cm3)
(%)
(Ө)
0.33±0.007
0.37±0.01
1.14±0.008
12.68±0.01
29.7±0.43
F1
0.33±0.01
0.40±0.012
1.20±0.005
16.62±0.69
29.57±0.33
F2
0.31±0.01
0.36±0.010
1.12±0.005
12.93±0.34
26.33±0.39
F3
0.31±0.01
0.39±0.013
1.17±0.008
17.30±0.21
25.38±0.25
F4
0.32±0.01
0.37±0.016
1.12±0.008
11.62±0.25
24.29±0.05
F5
0.33±0.01
0.40±0.007
1.16±0.005
13.27±0.38
28.38±0.21
F6
0.34±0.01
0.40±0.008
1.17±0.008
14.22±0.34
27.46±0.57
F7
0.30±0.01
0.34±0.008
1±0.007
12.39±0.26
25.19±0.10
F8
0.29±0.01
0.35±0.01
1.18±0.03
17.57±0.27
27.45±0.17
F9
Bulk density of powder blends of different
formulation was found to be in the range of 0.29
to 0.34 gm/cm3 whereas the tapped density was
found to be in the range of 0.35 to 0.40 gm/cm3.
Angle of repose was found to be less than 300
which indicate good flow characteristics of the
powder blends. Carr’s index was found to be in
the range of 11.62 to 17.57 whereas the Hausner
ratio was found to be less than 1.25. Both this
values indicate good flow property and good
compression characteristics.
3.3 Evaluation of fast dissolving tablets
3.3.1 Evaluation of physical parameter of
tablets
The data for evaluation of physical parameters of
fast dissolving tablets of carbamazepine is as
shown below.
55

10. Table 8. Evaluation of fast dissolving tablets.
Formulation code Weight variation
(mg)
Passes
F1
Passes
F2
Passes
F3
Passes
F4
Passes
F5
Passes
F6
Passes
F7
Passes
F8
Passes
F9
Diameter
(mm)
12.00±0.007
12.02±0.007
12.024±0.005
12.024±0.005
12.036±0.011
12.054±0.018
12.054±0.015
12.042±0.017
12.064±0.023
Thickness
Hardness Friability
(mm)
(Kg/cm2)
(%)
4.326±0.019 3.14±0.054 0.65±0.11
4.4±0.035
3.22±0.10 0.63±0.11
4.368±0.024 3.04±0.11 0.54±0.14
4.472±0.035 3.02±0.10 0.59±0.07
4.362±0.019
3.1±0.1
0.63±0.06
4.338±0.039 3.24±0.26 0.74±0.07
4.342±0.04 3.04±0.11 0.62±0.08
4.342±0.052 2.94±0.15 0.72±0.10
4.332±0.016 3.12±0.17 0.59±0.09
During weight variation test none of the tablet was
while thickness was found to be in the range of
found to be deviate by permissible percentage as
4.32 to 4.4 mm. Percentage friability was found to
per Indian pharmacopoeia 5% from the mean
be in the range of 0.49 to 0.74 which is within
value of 20 tablets. Thus it was found that all the
limit <1%.
formulations complied with weight variation test.
Hardness of the tablet was found to be in the
3.3.2 Wetting time and water absorption ratio
range of 2.94 to 3.24, which was found to well
The data for wetting time and water
within the required hardness for the fast dissolving
absorption ratio of fast dissolving tablets of
2
tablets (3 to 4 kg/cm ). Diameter of the tablets
carbamazepine is as shown below.
was found to be in the range of 12 to 12.064 mm
Table 9. Data for wetting time and water absorption ratio.
Formulation code Wetting time Water absorption ratio
(sec)
(%)
F1
130.2±0.44
71.14±0.53
F2
116.4±0.89
72.50±0.47
F3
105.2±0.83
77.14±0.03
F4
106.2±0.83
83.35±0.68
F5
97±0.70
97.03±0.01
F6
101±0.70
87.34±0.38
F7
110.6±0.89
82.38±0.66
F8
102.8±0.44
86.26±0.39
F9
113.4±0.89
75.73±0.10
Wetting time was found to be in the range of 97.00 to 130.2. Water absorption ratio was found to be
in the range of 71.14 to 97.03. It may be due to the hydrophilic nature of carriers used. This thing might
result into increased capillary action which has resulted into decreasing the wetting time and increasing the
water absorption ratio.
3.3.3 Disintegration time, uniformity of content and Disintegration time:
The data for disintegration time, uniformity of content and Disintegration time of fast dissolving tablets of
carbamazepine is as shown below.
56

11. Table 10. Data for disintegration time, drug content and Disintegration time of fast dissolving tablets
of carbamazepine.
Formulation code Disintegration time Drug content Dispersion
(sec)
(%)
time (Sec)
F1
85.33±1.52
95.43±0.91
91.10±0.7
F2
80±1.0
98.23±0.96 83.20±1.20
F3
76±1.0
101.84±1.11 81.46±0.5
F4
65±2.0
99.88±0.511
71±1.5
F5
57±1.0
98.85±1.04
62.20±0.6
F6
61.66±1.52
98.39±1.20
67.16±1.2
F7
71.66±1.52
96.22±0.80
75.87±1.4
F8
61±1.0
98.46±0.61
65.57±0.4
F9
63±1.0
102.08±1.09
64±0.5
3.3.4 Disintegration time:
In vitro disintegration times of all
formulations were found to be in the range of 57
to 85.33 Sec, this was found to be well within the
acceptable limit for fast dissolving tablet (≤ 3
min). In vitro disintegration time of all the
formulations was found to decrease with
correspondent increase in the concentration of
both croscarmellose sodium and sodium starch
glycolate. It may be due to the hydrophilic nature
of sodium starch glycolate and croscarmellose
sodium which attracts water and may increase the
capillary action of the tablet matrices which result
into decreasing the disintegration time.
3.3.5 Uniformity of content:
All the formulations upon spectroscopic analysis
were found to contain carbamazepine in the range
of 95.43 to 102.08 which complies with the
standard for uniformity of content laid down for
carbamazepine in official compendia.
3.3.6 In vitro Dispersion time:
In vitro dispersion time of all formulation
was found to be in range of 62.20 to 91.10 sec,
this was found to be well within acceptable range.
3.3.7 In vitro Dissolution study:
During in vitro dissolution study, it is found that
within 30 minutes drug release was found to be
62% to 83% from F1 to F9 formulation. The F5
formulation which contain 10% of the
croscarmellose sodium which shows 83.6% of
drug release. It was also observed that as the
concentration of the croscarmellose increases drug
release increases upto 10% and then get
decreased. In case of the sodium starch glycolate
concentration used were 2, 4 and 6%. From that
4% concentration of SSG shows 80.2% and other
shows less.
This may also attribute to croscarmellose
sodium and sodium starch glycolate. With
increase in concentration of this polymer capillary
action might have increased which in turn resulted
in reducing the time required for wetting and
disintegration of tablets and finally the dissolution
of drug.
57

12. Table 11. In vitro dissolution profile of formulationF1- F9.
Time
(min)
Cumulative drug release (%)
F1
F2
F3
F4
F5
F6
F7
F8
F9
0
0
0
0
0
0
0
0
0
0
5
10
15
20
25
30
20.3±1.5
24.7±2.5
32.5±2.1
40.1±1.2
51.2±1.2
62.7±2.0
24.0±1.5
29.5±0.7
35.7±1.0
47.5±1.8
59.4±2.8
66.5±2.5
27.2±2.4
33.5±1.4
39.3±2.4
49.2±2.4
62.4±0.7
70.2±1.4
38.0±1.2
41.1±3.2
46.5±2.2
57.1±1.6
65.6±2.3
78.5±2.7
40.2±2.3
47.3±2.2
52.0±1.5
59.7±0.4
69.4±1.4
83.6±2.3
29.2±1.1
34.9±0.9
41.5±1.4
50.8±1.8
65.9±1.4
71.2±2.0
29.2±1.1
34.9±0.9
40.3±0.7
51.3±1.2
61.3±2.0
70.2±1.1
39.5±1.8
40.0±2.5
48.8±1.2
57.8±0.4
67.8±2.0
80.2±0.6
25.4±1.6
31.4±0.8
38.4±1.4
54.9±1.3
59.3±3.3
70.7±1.3
90
Cumulative % drug release
80
70
F1
60
F2
F3
50
F4
40
F5
30
F6
20
F7
10
F8
0
0
5
10
15
20
25
30
35
F9
Time (min)
Figure 4. In vitro dissolution profile of formulationF1- F9.
Conclusion:
The oral fast dissolving tablet of carbamazepine
were formulated and evaluated for various
parameters from the compatibility studies by
DSC, FTIR and XRD of drug it was found to be
compatible with other formulation excipients. All
evaluation parameter were within specification.
The release of drug from the tablet was increased
as the concentration of superdisintegrants was
increased. The croscarmellose sodium shown
faster drug release than sodium starch glycolate.
Formulation F5 release maximum drug within the
30 mins.i.e.83.6% and shown minimum
disintegration time i.e. 57 sec than other
formulation and hence considered best
formulation.
It is concluded that fast dissolving tablets of
carbamazepine could be prepared by using
croscarmellose sodium and sodium starch
glycolate. In which croscarmellose sodium shows
good result as compared to the sodium starch
glycolate.
Acknowledgement:
We wish to thank Abbott healthcare Pvt.Ltd for
providing carbamazepine as a gift sample.
We also wish to thank Yashoda technical campus
Satara for providing instruments and facilities
required for research work.
58

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