S.K. Singh, et.al.

: Formulation and Evaluation of Mucoadhesive Tablet: Influence of Some Hydrophilic Polymers 1111
International Journal of Pharmaceutical Sciences and Nanotechnology
Volume 3 Issue 3 October - December 2010

Research Paper
Formulation and Evaluation of Mucoadhesive Tablet: Influence of Some
Hydrophilic Polymers on the Release Rate and In Vitro Evaluation
S.K. Singh.1*, S.B. Bothara2, S. Singh3, R. Patel4 and R. Dodia5
1

Shree H.N.Shukla Inst. of Pharmaceutical Education and Research, Rajkot, India.

Shri GM BILAKHIA College of Pharmacy ROFEL, Vapi, India.

C.P.S. Mahuda college of Pharmaceiutical sciences, Bhermpur, India

Shree Leuva Patel Trust Pharmacy Mahila College, Amreli, India

Shree Laxminarayandev College of pharmacy, Bharuch, India

ABSTRACT: Extending the residence time of a dosage form at a particular site and controlling the release of drug from
the dosage form are useful especially for achieving controlled plasma level of the drug as well as improving bioavailability.
The objective of this study was to extend the GI residence time of the dosage form and control the release of Tramadol HCl
using mucoadhesive tablet to achieve controlled plasma level of the drug which is especially useful for 12 hrs. Matrix tablets
of Tramadol HCl were formulated using different mucoadhesive polymers namely guar gum, xanthan gum and Methocel
(HPMC K15M and HPMC K100M). Formulations were evaluated for preformulation parameters, in vitro drug release profile
and release kinetics. The formulations were found to have good preformulation characteristics. FTIR spectroscopy indicated
the absence of any significant chemical interaction within dug and excipients. The release mechanism of Tramadol HCl from
matrix tablets indicated anomalous (non-Fickian) transport mechanism and followed zero order kinetics. The retention time
of the mucoadhesive tablet on the mucous membrane were investigated to develop a bioadhesive polymer-based controlled
release delivery system and to evaluate the performance of such a delivery devices. The combination of HPMC K15: HPMC
K100: Xanthan gum (1:2:1) and HPMC K 100: Xanthan gum (2:2) showed a greater bioadhesive strength as compared to
single gum and other hydrophilic polymer combination tablet. The stability studies were performed on optimized formulation
as per ICH guideline, result showed that there was no significant change in physical characteristic, adhesive strength and In
vitro release.

KEY WORDS: Xanthan gum; Methocel; Tramadol HCl; bioadhesive force

Introduction
Oral administration is the most convenient, widely utilized,
and preferred route of drug delivery for systemic action.
However, when administered orally, many therapeutic
agents are subjected to extensive presystemic elimination
by gastrointestinal degradation or first pass hepatic
metabolism (Gupta et al., 1990, Madsen et al., 1998), as a
result of which low systemic bioavailability and shorter
duration of therapeutic activity or formation of inactive or
toxic metabolites have been reported (Jay et al., 2002,
Jimenez et al., 1993). Further, the quick passage of dosage
* For correspondence: S.K. Singh,
Tel: 02792232323; Mob: 09974756126
E-mail: roshan.cg@gmail.com

1111

forms through the absorptive segment of GIT often leads to

unutilized drug, particularly in case of extended delivery of
narrow absorption window drugs (Akiyama et al., 1999).
Much attention has been focused, recently on targeting a
drug delivery system to a particular region of the body for
extended period of drug release, not only for local
targeting of drugs but also for the better control of
systemic delivery. The concept of mucoadhesion was
introduced into controlled drug delivery in the early 1980s.
Mucoadhesives are synthetic or natural polymers, which
interact with the mucus layer covering the mucosal
epithelial surface and mucin constituting a major part of
the mucus. Drug delivery using mucoadhesive dosage form
via transmucosal route, bypasses hepato-gastrointestinal

1112 International Journal of Pharmaceutical Sciences and Nanotechnology

first pass elimination associated with oral administration,

thereby increases the bioavailability and produces longer
therapeutic effect (Harris et al., 1989, Smart et al.,
1984).Tramadol HCl and its O-desmethyl metabolite (M1)
are selective, weak OP3-receptor agonists. The analgesic
properties of Tramadol HCl can be attributed to
norepinephrine and serotonin reuptake blockade in the
CNS, which inhibits pain transmission in the spinal cord.
Due to its short biological half the recommended oral
dosage is 50-100 mg every four to six hours with a
maximum dosage of 400 mg/day (Sean C, 2002, Louis S,
1996). Due to twice to thrice days dose the aim of the
present cram was to develop, characterize and evaluate
mucoadhesive tablet of Tramadol HCl using some
synthetic and natural hydrophilic excipient for prolonged
gastrointestinal absorption.

Experimental Methods
Materials
Tramadol Hydrochloride were procured from Intas
Pharmaceutical Ltd., Ahmedabad, Hydroxy Propyl Methyl
cellulose K100M, Hydroxy Propyl Methyl cellulose K15M
were procured from Colorcon Asia Pvt. Ltd., Lactose,
Microcrystalline cellulose (Avicel pH 102) and Guar gum
were procured from Signet Chemical Corp, PVP K 30
were procured from Nice Chemicals Laboratory,
Magnesium Stearate and Talc from Loba Chemical. All the
chemicals and other reagents used in the study were of AR
grade.
Formulation and Optimization of Excipient
Sustained release mucoadhesive oral matrix tablets
containing Tramadol HCl were prepared by wet
granulation technique using variable concentrations of
HPMC K15M, HPMC K100M, Xanthan gum, Guar gum.
In all case, the amount of the active ingredient is 100mg.
All the ingredients except Avicel pH 102, magnesium
stearate and talc were blended in blender uniformly.
Granulation was done with sufficient binding solution of
PVP K30 and isopropyl alcohol. The lubricated granules
were compressed into tablet using 9 mm standard concave
punch with 10 station single rotary Clit (Jemkay) machine
and keeping average weight 240 mg. All Tramadol HCl
loaded matrix tablet were stored in airtight container at
room temperature for further study. Tablet of batch F1F3,
F4F6, F7F9 and F10F12 contain only single

Volume 3 Issue 3 October-December 2010

mucoadhesive polymer in different concentration, Batch

F13F15 contain combination of two mucoadhesive
polymer having drug:gum ratio (4:2:2) and Batch F16
contain combination of various mucoadhesive polymer
having drug:gum ratio (4:1:2:1). Compositions of various
formulations are shown in (Table 1).
Interference Study
This study has been done to check whether there is any
compatibility related problems are associated with drug
and excipients used for the formulation of tablet. The drug
and excipients must be compatible with one another to
produce a product that is stable, efficacious, attractive and
easy to administer and safe. If the excipients are new and
not been used in formulations containing the active
substance, the compatibility studies are of paramount
importance. The IR spectral analysis of a drug and other
excipients were taken using Press pellet technique (using
KBr). The IR spectras were determined by using Jasco
FTIR-410 (Willard et al., 1988, Sharma 2009, Beckett et
al., 2004, Tayed 2005).
Evaluation of the mucoadhesive tablet
All the mucoadhesive tablets prepared were evaluated for
the following official parameters: Hardness, Friability
(Gilbert S et al., 1990), Weight variation, Thickness and
drug content (USP 2008) as per official procedures. The
values of all the evaluation parameters are shown in
(Table 2).
Swelling Index
Swelling index were determined for each formulation
batch, one tablet was weighed and placed in a beaker
containing 200 ml of buffer media. After each interval the
tablet was removed from beaker and weighed again up to 8
hours. The swelling index was calculated using following
formula (Noha Adel naffee et. al., 2004, Lalla JK et. Al.,
2002, Juan Manuel Llabot et. al., 2002, Baumgartner S
et.al., 2000). Results are summarized in (Table 3)
(Figs. 1 and 2).
Swelling Index (S.I.) = (Wt Wo)/Wo
Where, S.I. = Swelling index
Wt = Weight of tablet at time t
Wo = Weight of tablet before placing in the beaker

1113
3
3

Talc

Mg. stearate
240

60

Avicel PH 102

Total Weight in mg

24

--

Xanthan gum
q.s

--

HPMC K100M

IPA

--

HPMC K15M

PVP K-30

50

Guar gum

F1
100

Ingredient*

Tramadol HCl

240

45

q.s

24

--

--

--

75

100

F2

240

10

q.s

24

--

--

--

100

100

F3

240

60

q.s

24

--

--

50

--

100

F4

240

45

q.s

24

--

--

75

--

100

F5

F7

240

60

q.s

24

--

50

--

--

100

F8

240

45

q.s

24

--

75

--

--

100

*All the quantities are in mg

240

10

q.s

24

--

--

100

--

100

F6

240

10

q.s

24

--

100

--

--

100

F9

240

60

q.s

24

50

--

--

--

100

F10

240

45

q.s

24

75

--

--

--

100

F11

240

10

q.s

24

100

--

--

--

100

F12

Table 1 Composition of Mucoadhesive Tablets of Tramadol Hydrochloride.

S.K. Singh, et.al. : Formulation and Evaluation of Mucoadhesive Tablet: Influence of Some Hydrophilic Polymers 1113

240

10

q.s

24

--

50

50

--

100

F13

240

10

q.s

24

50

--

50

--

100

F14

240

10

q.s

24

50

50

--

--

100

F15

240

10

q.s

24

25

50

25

--

100

F16

Volume 3 Issue 3 October-December 2010

1114 International Journal of Pharmaceutical Sciences and Nanotechnology

Table 2 Physical Properties of Tablets of Batch F1 to F16.

Batch
no.

Weight
Variation (mg)

Hardness
2
(kg/cm )

Thickness
(mm)

Friability
(%)

Drug content
uniformity (mg)

F1

240.75.02

6.70.252

3.030.11

0.55

98.94

F2

240.54.00

6.60.289

2.800.05

0.58

99.10

F3

239.63.99

6.40.462

2.760.05

0.53

98.92

F4

239.43.77

7.10.361

2.700.15

0.39

98.72

F5

240.33.01

6.60.173

2.660.05

0.41

98.19

F6

240.32.72

7.40.551

2.930.15

0.48

98.92

F7

240.12.17

6.40.436

2.550.08

0.61

97.10

F8

240.22.29

6.90.306

2.620.05

0.72

99.28

F9

239.82.05

7.10.458

2.530.052

0.67

98.30

F10

240.12.47

6.60.173

2.810.076

0.48

97.46

F11

240.02.11

6.60.208

2.760.115

0.39

98.19

F12

241.02.55

6.70.208

2.830..064

0.47

98.82

F13

240.12.13

6.70.666

2.530.052

0.54

97.30

F14

241.12.57

6.40.603

2.810.076

0.56

97.46

F15

240.52.23

7.10.208

2.760.115

0.44

99.19

F16

240.32.25

7.00.200

2.830..064

0.38

99.82

Each reading is an average of three determinations (Avg. S.D)

Table 3 Swelling Index of Tablets of Batch F1 to F16

Time (hrs)

Batch
no.

F1

0.624

0.852

1.041

1.166

1.248

1.250

--

--

F2

0.558

0.862

1.045

1.186

1.065

1.024

--

--

F3

0.672

0.918

1.122

1.245

1.327

1.347

1.306

--

F4

0.616

0.950

1.116

1.241

1.324

1.344

1.386

--

F5

0.120

0.399

0.605

0.852

0.934

1.140

1.181

1.201

F6

0.126

0.224

0.477

0.646

0.857

0.983

1.025

1.152

F7

0.204

0.532

0.660

0.830

0.915

1.000

1.043

1.085

F8

0.259

0.570

0.674

0.736

0.860

0.901

0.942

0.983

F9

0.561

0.880

1.160

1.380

1.460

1.480

1.520

1.540

F10

0.688

0.934

1.016

1.119

1.140

1.222

1.305

1.322

F11

0.599

0.803

0.926

1.008

1.131

1.172

1.254

1.295

F12

0.674

0.922

1.150

1.138

1.145

1.276

1.321

1.333

F13

0.526

0.822

1.045

1.142

1.198

1.224

1.236

1.242

F14

0.656

0.942

1.124

1.145

1.185

1.215

1.266

1.275

F15

0.554

0.852

0.999

1.256

1.456

1.654

1.789

1.952

F16

0.599

0.769

0.921

1.164

1.289

1.546

1.654

1.899

S.K. Singh, et.al. : Formulation and Evaluation of Mucoadhesive Tablet: Influence of Some Hydrophilic Polymers 1115

ADHESIVE STRENGTH

Adhesive strength

35
30
25
20
15
10
5
0
F1

F2

F3

F4

F5

F6

F7

F8

F9 F10 F11 F12 F13 F14 F15 F16

Batch No.

Swelling Index

Fig. 1 Adhesive strength of formulation F1 F16.

Swelling Index

2
1.9
1.8
1.7
1.6
1.5
1.4
1.3
1.2
1.1
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0

F1
F2
F3
F4
F5
F6
F7
F8
F9
F10
F11
F12
F13
F14
F15
F16
0

4
5
Tim e (hrs)

Fig. 2 Swelling index of formulation F1 F16.

In vitro mucoadhesive Strength
Mucoadhesive strength of the tablet was measured on the
modified physical balance. The design used for measuring
the bioadhesive strength was shown in (Figure 3). The
apparatus consist of a modified double beam physical
balance in which the right pan has been replaced by a glass

slide with copper wire and additional weight, to make the

right side weight equal with left side pan. A taflone block
of 3.8 cm diameter and 2 cm height was fabricated with an
upward portion of 2 cm height and 1.5 cm diameter on one
side. This was kept in beaker filled with buffer media 0.1N
HCl pH 1.2, which was then placed below right side of the

1116 International Journal of Pharmaceutical Sciences and Nanotechnology

balance (Mahesh D. Chavanpatil et. al., 2006, Bhupinder

Singh et. al., 2002, Kashappa Goud H. et. al., 2004, Owens
TS, et. al., 2005, Bhupinder Singh et. al., 2006)

G
E
A

I
F

Volume 3 Issue 3 October-December 2010

hand set up of the balances. The tablet was struck on to the

lower side of the left hand side pan. The 5 g weight from
the right pan was then removed. This lowered the left pan
along with the tablet over the membrane with a weight of 5
g. this was kept undisturbed for 3 minutes. Then, the
weight on the right hand side was slowly added in an
increment of 0.5 g till the tablet just separated from the
membrane surface. The excess weight on right pan i.e.,
total weight minus 5 g was taken as a measure of the
mucoadhesive strength. From the mucoadhesive strength,
the force of adhesion was calculated using the following
formula:
Force of adhesion (N) =

Bioadhesive strength
9.81
100

Bond strength (N/m2) =

Force adhesion (N)

Surface area of tablet (m 2 )

Results are summarized in (Table 3).

Fig. 3 In vitro Mucoadhesive Strength Measurement
Apparatus (A) Right pan, (B) Left pan, (C) Teflon
block, (D) Stomach membrane, (E) Teflon-coated
glass slide (F) Beaker containing 1.2 pH buffer, (G)
Threads, (H) Pointer and (I) Scale
The procine gastric mucus membrane was used as
model membrane and a pH 1.2 solution was used as the
moistening fluid. The procine stomach mucosa (Ranga Rao
et. al., 1989, Achar L et. al., 1994) was kept in Tyrode
solution at 37C for 2 hours. The underlying mucus
membrane was separated and washed thoroughly with a
pH 1.2 solution. It was then tied to Teflon-coated glass
slide and this slide was fixed over the protrusion in Teflon
block using a thread. The block was then kept in beaker
containing pH 1.2 buffer solution at the level that just
touches the membrane. By keeping a 5g weight on the
right pan, the two sides of the balance were made equal.
The beaker with the Teflon block was kept below the left

In-Vitro Dissolution Study

The in vitro drug release studies of the matrix tablets were
conducted in USP type II dissolution apparatus
equilibrated (TDT08L, USP ETC-11LFC12 Electro lab)
at temperature 370.5oC and 50 rpm speed. The dissolution
studies were carried out in triplicate for 12 hours in 900ml
of gastric fluid (pH 1.2). The dissolution samples were
collected at every 1 hours interval and replaced with an
equal volume of gastric fluid to maintain the volume
constant. The sample solution was diluted sufficiently and
analyzed at 271 nm as mentioned in IP by a UV
spectrophotometer (shimadzu, Kyoto, Japan). The amount
of drug present in the sample was calculated with the help
of appropriate calibration curves constructed from
reference standard of the respective drug. Drug dissolved
at specified period was plotted as a percent release versus
time (hours) curve, depicted in (Figure 4).

Table 3 Swelling Index of Tablets of Batch F1 to F16.

Batch no.
F1
F2
F3
F4
F5
F6
F7
F8

0
0
0
0
0
0
0
0
0

1
0.624
0.558
0.672
0.616
0.120
0.126
0.204
0.259

2
0.852
0.862
0.918
0.950
0.399
0.224
0.532
0.570

3
1.041
1.045
1.122
1.116
0.605
0.477
0.660
0.674

Time (hrs)
4
5
1.166 1.248
1.186 1.065
1.245 1.327
1.241 1.324
0.852 0.934
0.646 0.857
0.830 0.915
0.736 0.860

6
1.250
1.024
1.347
1.344
1.140
0.983
1.000
0.901

7
--1.306
1.386
1.181
1.025
1.043
0.942

8
----1.201
1.152
1.085
0.983

Table 3 Contd

S.K. Singh, et.al. : Formulation and Evaluation of Mucoadhesive Tablet: Influence of Some Hydrophilic Polymers 1117

Batch no.

0
0
0
0
0
0
0
0

F10
F11
F12
F13
F14
F15
F16

1
0.688
0.599
0.674
0.526
0.656
0.554
0.599

2
0.934
0.803
0.922
0.822
0.942
0.852
0.769

3
1.016
0.926
1.150
1.045
1.124
0.999
0.921

Time (hrs)
4
5
1.119 1.140
1.008 1.131
1.138 1.145
1.142 1.198
1.145 1.185
1.256 1.456
1.164 1.289

6
1.222
1.172
1.276
1.224
1.215
1.654
1.546

7
1.305
1.254
1.321
1.236
1.266
1.789
1.654

8
1.322
1.295
1.333
1.242
1.275
1.952
1.899

F1
F2
F3
F4
F5
F6
F7
F8

Cum % drug release v/s Time (hr)

c u m . % d ru g re le a s e

100
90
80
70
60
50
40
30
20
10
0
0

6
7
Time (hrs)

10

11

12

F9
F10
F11
F12
F13
F14
F15
F16

Fig. 4 Percentage cumulative drug release of formulation F1 F16.

Analytical method validation
The method was validated according to the international
conference of Harmonization guideline for validation of
analytical procedure (ICH 2005). The validated parameters
were accuracy and precision. The accuracy and precision
were investigated at three concentration levels of tramadol
HCl with six independent replicates on the same day and
on the six consecutive days. The intraday and interday bias
values were found to be less than 1.65% and 1.12% and
intraday and interday relative standard deviation values
were less than 2.16% and 1.84%, respectively.
Data Analysis
The release data obtained from various batches was studied
with respect to effect of drug: polymer ratio and diluents
ratio. To analyze the mechanism of drug release from the
formulation, the dissolution profile of all the batches was
fitted to zero order, first-order, Higuchi, Hixon-Crowell,
Korsemeyer and Peppas, and Weibull models to ascertain

the kinetic modeling of drug release (Sanford Bolton,

1997)
Results are summarized in (Table 5).
Stability Studies
The success of an effective formulation can be evaluated
only through stability studies. The purpose of stability
testing is to obtain a stable product which assures its safety
and efficacy up to the end of shelf life at defined storage
conditions and peak profile. Stability studies of optimized
formulation (F15 and F16) of Tramadol HCl were placed
on plastic tubes containing desiccant and stored at
conditions, such as at room temperature, oven temperature
(402oC and 75 5%) and refrigerator (2-8oC) for a period
of 6 month. The tablets were evaluated for mucoadhesive
properties and in vitro drug release after 2, 4 and 6 months
(Kulkarni G T et. al., 2004, Elizabeth B Vadas et. al.,
2000, ICH 2005).

1118 International Journal of Pharmaceutical Sciences and Nanotechnology

Results obtained were compared with data obtained for

zero time at room temperature, oven (402oC and humidity
75 5%) and refrigerator condition.

Volume 3 Issue 3 October-December 2010

The result of the mucoadhesive strength of optimized

formulation (F15 and F16) after stability study shown in
(Table 6).

Table 5 Kinetic values obtained from in vitro released data of different

Tramadol HCl Mucoadhesive tablets formulations

Zero order plot

Formulation

Correlation

Higuch

First Order plot

coefficient

Peppas Model

Model

Hixsoncrowell

Correlation

Correlation

Slope

Correlation

Correlation

coefficient

coefficient

(n)

coefficient

coefficient

F1

-13.600

0.9820

0.6911

0.8608

0.9928

0.5377

0.9934

0.9434

F2

-11.413

0.9784

0.5142

0.9415

0.9980

0.5178

0.9986

0.9881

F3

-9.6875

0.9621

0.4396

0.9547

0.9260

0.4958

0.9949

0.9062

F4

-10.800

0.9735

0.3661

0.9268

0.9540

0.7006

0.9438

0.9631

F5

-9.5172

0.9891

0.1805

0.5091

0.9912

0.7111

0.9954

0.9780

F6

-8.3734

0.9903

0.3228

0.8009

0.9906

0.6830

0.9946

0.9290

F7

-9.6523

0.9906

0.3447

0.9118

0.9879

0.7200

0.9931

0.9733

F8

-8.8515

0.9931

0.3120

0.8947

0.9821

0.7325

0.9924

0.9609

F9

-8.5790

0.9895

0.3244

0.8802

0.9767

0.7994

0.9939

0.9540

F10

-10.443

0.9855

0.1356

0.1968

0.9961

0.5778

0.9982

0.9879

F11

-8.7675

0.9611

0.2897

0.9888

0.9939

0.5626

0.9938

0.9979

F12

-8.3800

0.9819

0.3111

0.9489

0.9849

0.5526

0.9913

0.9879

F13

-6.8411

0.9821

0.1842

0.9575

0.9972

0.7815

0.9942

0.9884

F14

-6.8554

0.9413

0.2565

0.9154

0.9841

0.6266

0.9670

0.9699

F15

-7.1766

0.9989

0.1084

0.5241

0.9702

0.7836

0.9891

0.9460

F16

-7.3398

0.9966

0.2385

0.7941

0.9641

0.7639

0.9885

0.9040

Table 6 Stability studies of formulation as per ICH after 6 month.

F15

F16

Stability studies of formulation stored at 2-80C

Mucoadhesive
strength (g)

Mucoadhesion
force (N)

Mucoadhesive
strength (g)

Mucoadhesion
force (N)

29.580.042

0.29010.0004

31.690.071

0.31080.0006

Stability studies of formulation stored at Room temperature

29.480.042

0.28920.0004

31.4650.035

0.30870.0003

Stability studies of formulation stored at 402oC and 75 5%

29.330.016

0.28770.0001

31.540.035

0.30950.0003

S.K. Singh, et.al. : Formulation and Evaluation of Mucoadhesive Tablet: Influence of Some Hydrophilic Polymers 1119

Results and Discussion

Mucoadhesive drug delivery of tramadol HCl were
formulated, by using various synthetic and natural
polymers. Tramadol HCl mucoadhesive matrix tablet were
prepared by wet granulation techniques. Tramadol HCl
meets all the ideal characteristics to formulate in the form
of oral drug delivery system.

The FTIR spectral analysis showed that there was no

appearance or disappearance of any characteristic peaks of
pure drug Tramadol HCl in the optimized formulation of
drug and polymer (Figure 5, 6 and 7), which confirms the
absence of chemical interaction between drug and
polymers.

Fig. 5 IR spectra of pure drug Tramadol Hydrochloride.

Fig. 6 IR spectra of optimized formulation- F15.

1120 International Journal of Pharmaceutical Sciences and Nanotechnology

Volume 3 Issue 3 October-December 2010

Fig. 7 IR spectra of Optimized formulation- F16.

All the batches were evaluated for the physical
properties and hardness of the tablet in the range of 6.4 to
7.5 (kg/cm2). Percentage weight loss in the friability test
was less than 1% in all batches and all the batches
contained Tramadol HCl within 100 5% of labeled
content. Overall, the prepared tablet batches were of good
quality with regards to hardness, friability and drug
content.
The in vitro mucoadhesive strength study was
performed on the modified physical balance to measure the
force (N) required for detaching the tablet. The
bioadhesion characteristics were affected by the
concentration of the mucoadhesive polymer. Viscosity of
the polymer also affects the mucoadhesive strength of the
tablet.
From the overall dissolution profile, it was concluded
that the drug release rate decreased as concentration of the
polymer increased, which was also affected by the type of
polymer used. This can probably attributed to different
diffusion and swelling behavior of the polymer.
The stability study showed that there was no change in
the appearance and on drug release pattern of the tablet.
From the result of the dissolution data, the korsmeyer
and peppas model found to be best fitted in all dissolution
profile having a higher correlation coefficient. Thus, it was
concluded that the drug release occurred via a diffusion
mechanism and due to affinity of hydrophilic polymers
towards water.

Conclusion
The cram was undertaken with an endeavor to formulate
and evaluate effect of hydrophilic polymer on release rate
of mucoadhesive tablet. mucoadhesive tablet were
formulated using, various hydrophilic polymers and their
combinations in varying concentrations. Tablet were
subjected to various evaluation parameters such as
hardness, friability, drug content, mucoadhesive strength
study and In vitro drug release study. It was revealed that
all batches had acceptable physical parameters. The
optimized formulation (F15 and F16) have good
mucoadhesion along with in vitro drug release. It was
observed that all batches followed the equation of zero
order, higuchi matrix and peppas drug release profiles.
Stability studies revealed that there was no significant
change in the hardness, friability, drug content and in vitro
dissolution profile of formulation F15 and F16. Thus these
formulations were stable at different condition of
temperature. The present study shows that there is
influence of polymer on release profile of oral
mucoadhesive tablet. The combination of hydrophilic
synthetic (HPMC) and natural gum (Xanthan gum) can be
used for designing oral mucoadhesive drug delivery
system.

Acknowledgement
The authors are grateful to the Principal and Management
of Shree H.N. Shukla Institute of Pharmaceutical

S.K. Singh, et.al. : Formulation and Evaluation of Mucoadhesive Tablet: Influence of Some Hydrophilic Polymers 1121

Education and Research, Rajkot, Gujarat and Shree Leuva

Patel Trust Pharmacy Mahila College, Amreli, Gujarat, for
extending laboratory facilities and other required amenities
to carry out this work.

Juan Manuel Llabot, Ruben Hilario Manzo Daniel Alberto

Allemandi,
Double-Layered
Mucoadhesive
Tablets
Containing Nystatin, AAPS PharmSciTech; 2002; 3 (3) article
22.

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