Nagesh et al. UJP 2013, 02 (02): Page 118-124 www.ujponline.

com

Research Article
Universal Journal of Pharmacy ISSN 2320-303X
Take Research to New Heights

DESIGN AND IN-VITRO EVALUATION OF GASTRORETENTIVE

DRUG DELIVERY SYSTEM OF CARVEDILOL
Nagesh C1*, Attimarad SL1, Kugaji MS2, Shreenal Patel3, Venkatesh JS3
1
Maratha Mandal’s College of Pharmacy, Belgaum, Karnataka, India
2
Maratha Mandal’s NGH Institute of Dental Science and Research Centre, Belgaum, Karnataka, India
3
SCS College of Pharmacy, Harpanahalli, Karnataka, India

Received 14-02-2013; Revised 10-03-2013; Accepted 13-04-2013

ABSTRACT
The purpose of the study was to develop floating tablet of carvedilol using HPMC and various natural gums like guar
gum, xanthan gum and gum ghatti along with incorporation of gas generating agent, sodium bicarbonate. The floating
tablet of carvedilol was prepared by wet granulation technique using solution of PVP K30 in isopropyl alcohol, using
varying concentration of HPMC and natural gums. Postcompressional parameters like hardness, friability, thickness,
weight variation, content uniformity, in vitro buoyancy and in vitro dissolution studies were carried out. The results of
in vitro release of natural gums containing floating tablets has shown maximum drug release upto 97% in 24 hrs and
remain buoyant for 24 hrs. The optimized formulations were subjected to various kinetic release investigations like
zero order, first order, Higuchi and Korsmeyer-Peppas plot. The results indicated that the formulations followed
peppas model with n value more than 0.5, confirms that drug release followed non-fickian diffusion mechanism. All the
formulations followed Higuchi matrix with first order release kinetics. Stability studies were performed on the
promising formulations at 40±20C with 75±2 RH for 30 days.
Keywords: Carvedilol, Guar Gum, Xanthan Gum, Gum Ghatti, Buoyancy Studies.

INTRODUCTION soluble at high pH environment (e.g. weakly basic drugs

Oral route is considered most natural, uncomplicated,
convenient and safe due to its ease of administration,
patient acceptance and cost-effective manufacturing
process1. However, this route has several physiological
problems, including an unpredictable gastric emptying
rate that varies from person to person, a brief
gastrointestinal transit time (8–12 h), and the existence
of an absorption window in the upper small intestine
for several drugs 2,3. These difficulties have prompted
researchers to design gastro retentive drug delivery
systems (GRDDS)3,4. GRDDS are primarily controlled
release drug delivery systems, which gets retained in
the stomach for longer period of time, thus helping in
absorption of drug for the intended duration of time.
This in turn improves bioavailability, reduces drug
wastage and improves solubility of drugs that are less
*Corresponding Author:
Dr. Nagesh C,
Professor and Head Department of Pharmaceutics,
Maratha Mandal’s College of Pharmacy,
Belgaum-590 016
E-mail: nagesh_73@rediffmail.com
Universal Journal of Pharmacy, 02(02), Mar-Apr 2013
like papaverine, domperidone). It also helps in
achieving local delivery of drug to the stomach and
proximal small intestine. Gastro retentive drug delivery
devices can be useful for the spatial and temporal
delivery of many drugs.
Many drugs categorized as once a day delivery have
demonstrated to have sub optimal absorption due to
dependence on transit time of the dosage form.
Therefore, a system designed for longer gastric
retention will extended the time within which drug
absorption can occur in small intestine. Thus it has
been suggested that compounding the drugs with
narrow absorption window in a unique dosage form
prolongs gastric residence time and would enable an
extended absorption phase of these drugs5. Different
methodologies have been reported in the literature to
increase the gastric retention of drugs, like intra-
gastric floating systems, hydro dynamically balanced
systems, extendable or expandable and super porous
biodegradable hydrogel systems6. The floating drug
delivery systems result in long lasting intra-gastric
buoyancy which may not only provide a sustained site
of specific therapeutic action but also may lead to a
reduction in side effects and better patient
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compliance7. Natural gums are the most popular
hydrophilic polymers because of their cost-
effectiveness and regulatory acceptance.
The present study was aimed to design and evaluate a
novel gastro retentive, floating, swellable, controlled
release tablet by combining three polymers with
different concentrations of xanthan gum, gum gatti and
Guar Gum a gel forming agent. Furthermore sodium
bicarbonate was used as a gas generating agent.
For the present study carvedilol was selected as a
model drug. As carvedilol is extensively used in
patients with hypertension and angina or congestive
cardiac failure. The drug has a low solubility in
gastrointestinal fluids and undergoes extensive first-
pass metabolism in the liver, which leads to the low
absolute oral bioavailability, which is about 20% in
humans with a half life of 7-10 hours8. Carvedilol
contains α-hydroxyl secondary amine, with a pKa of
7.8. It exhibits pH dependent solubility. Its solubility
increases with decreasing pH9. These points make
Carvedilol a suitable candidate for the study. Thus
there is a need to design and formulate a dosage form
for hypertension which attempts to overcome the
disadvantage of variable bioavailability of carvedilol.
MATERIALS AND METHODS
Carvedilol was received as a gift sample from Shodhana
laboratories Ltd, Hyderabad. HPMC K4 M, xanthan gum,
guar gum, gum ghatti and Sodium bicarbonate were
obtained (as gift sample) from SD Fine Chem., Mumbai.
Lactose and Micro crystalline cellulose was obtained
from S.D. Fine chemical Pvt Ltd, Mumbai. All the other
chemicals used were of analytical grade.
Wet granulation method has been employed to prepare
floating system of carvedilol with hydroxypropyl methyl
cellulose (HPMC K4 M) and natural gums like guar gum,
xanthan gum and gum ghatti. All the ingredients were
accurately weighed and passed through sieve no 60.
Accurately weighed quantities of HPMC K4 M and
sodium bicarbonate were taken in mortar and pestle.
Exactly weighed amount of drug was added and mixed
thoroughly. The remaining excipients were added in
geometrical proportions and mixed for 15 min.10%
isopropyl alcoholic solution of PVP K30 was used as
granulating agent. The prepared damp mass was passed
through sieve # 16 and granules were dried in hot air
oven for 15 min. The dried granules were again passed
through sieve #30 to obtain uniform particulates.
Tablets were compressed by using tablet punching
machine (Shakti eng. Pvt. Ltd)

Table 1: formulation of Preliminary Formulation

Ingredients F1 F2 F3 F4
Drug 55 55 55 55
HPMC K4 40 50 60 70
NaHCO3 10 10 10 10
Micro Crystalline Cellulose 40 30 20 10
Magnesium Stearate 3 3 3 3
Talc 2 2 2 2
Total Wt. (mg) 150 150 150 150
*All quantities in mg/tablet.
Screening of polymers and excipients obtained, further experiments were designed using
Preliminary four formulations were designed by HPMC various natural polymers to develop optimized formula.
for screening of floating system. Based on the results

Table 2: Formulations of floating tablets using natural gums

Ingredients GGF1 GG F2 GG F3 GG F4 X F5 X F6 X F7 X F8 GT F9 GT F10 GT F11 GT F12
Drug 55 55 55 55 55 55 55 55 55 55 55 55
Guar gum 10 20 30 40 - - - - - - - -
Xanthan gum - - - - 40 50 60 70 - - - -
Gum ghatti - - - - - - - - 40 50 60 70
Sodium bicarbonate 10 10 10 10 10 10 10 10 10 10 10 10
Microcrystalline cellulose 70 60 50 40 35 25 15 5 35 25 15 5
Magnesium Stearate 3 3 3 3 3 3 3 3 3 3 3 3
Talc 2 2 2 2 2 2 2 2 2 2 2 2
Total weight(mg) 150 150 150 150 150 150 150 150 150 150 150 150
*All quantities in mg/tablet.

Universal Journal of Pharmacy, 02(02), Mar-Apr 2013 119

Nagesh et al. UJP 2013, 02 (02): Page 118-124
Evaluation of tablets
Appearance
The tablets were checked for presence of cracks,
depressions, pinholes etc if any, uniformity of the color
and the polish of the tablets.
Hardness
This test is used to check the hardness of the tablet,
which may undergo chipping or breakage during
storage, transportation, and handling10.For this test
five tablets were selected randomly and the hardness
of each tablet was measured with Monsanto hardness
tester. The hardness is usually measured in terms of
kg/cm2.
Friability test
Friability test was carried out to evaluate the hardness
and stability instantly. The study was conducted using
Roche friabilator11. 10 tablets were weighed (W0)
initially and placed in rotating drum. Then the tablets
were subjected for completion of 4 min or 100 rpm, the
tablets were again weighed. The % loss in weight or
friability (F) was calculated by formula given below.
Weight variation
This test was performed to maintain the uniformity of
weight of each tablet, which should be in the
prescribed range11. This was done by weighing 20
tablets individually and average weight was calculated
and percent deviation was also calculated by
comparing individual weight with average weight of
tablets. The values are then compared with IP limits.
Not more than two of individual weight deviates from
the average weight.
Thickness
Thickness of tablet is important for uniformity of the
tablet size11. Thickness was measured using digital
screw gauze (Mitu Toyo).
Uniformity of drug content
The content uniformity is mandatory for tablets. This
test was performed by selecting 10 tablets were
randomly, weighed and powdered. A tablet triturate
equivalent to 55mg of drug weighed accurately,
dissolved in 0.1N HCl and diluted to 100ml with the
same. Further dilutions were done suitably and
absorbance was measured at 240nm using UV
spectrophotometer11.
In vitro buoyancy determination
The in vitro buoyancy was determined by floating lag
time11,12. The tablets were placed in a 100-ml beaker
containing 0.1N HCl. The time required for the tablet
to rise to the surface and float was determined as
floating lag time and total duration of time by which
dosage form remain buoyant is called Total Floating
Time (TFT).
In vitro dissolution studies
The in vitro dissolution of carvedilol from floating
tablets was determined by using USP XXIII dissolution
Universal Journal of Pharmacy, 02(02), Mar-Apr 2013
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apparatus by rotating paddle method14. The dissolution
test was performed in 900ml 0.1N HCl solution at 37°C
± 0.5oC with a 50 rpm. At every 1 hour interval, 5ml of
sample was withdrawn from the dissolution medium
and the same amount of fresh solution was replaced to
maintain the constant volume. The samples were
filtered and diluted to a suitable concentration with
0.1 N HCl solution. The absorbance of the solution was
measured at 240nm using UV-Visible spectrophotometer
(Shimadzu 1700). Studies were done in triplicates and
the mean values were taken.
Kinetics of Drug Release
In order to investigate the model of drug release from
tablets, the drug release data of the formulation was
analyzed with the following models, Qt = Qo – Ko t (
Zero Order kinetics), Log C = Log C0 - kt / 2.303 ( first
order kinetics ) , Q0 1/3 – Qt1/3 = KHC t ( Hixon
crowell model), Qt = kH (t)0.5 (Higuchi Model ) and
Koresmeyer-peppas equation Log ( Mt/ M∞ ) = log K +
nlog t. where Mt is the amount of the drug release at
time t, M∞ is the amount of drug release after infinite
time, K is a release rate constant and n is the diffusion
exponent of the drug release mechanism15,16,17.
Stability studies
The stability studies were carried out for 30 days for
selected formulations. The formulations were analysed
for the physical appearance, drug content, floating
ability and invitro release studies18.
RESULTS AND DISCUSSION
Evaluation results of floating tablets
Four formulations of carvedilol with HPMC in different
concentration were prepared. All formulation batches
were prepared by wet granulation technique. Twelve
formulations of carvedilol with three natural gums like
guar gum, xanthan gum and gum ghatti in different
conc. were prepared. All the floating tablets were
prepared by wet granulation technique. The prepared
tablets were evaluated for hardness, friability,
uniformity of weight, uniformity of drug content,
thickness, floating lag time, in vitro floating time, in
vitro dissolution.
The hardness of different formulations was found to be
between 4.26 to 4.93 kg/cm2, indicating satisfactory
mechanical strength. The friability was below 1% for all
formulations, which is an indication of good resistance
mechanical shock. All the tablets passed weight
variation test as the % weight variation was within the
Pharmacopoeial limits of ± 7.5% of the weight. The drug
content varied between 94.27-94.81%, with low
standard deviation uniformity and distribution of drug
throughout batches. Tablet thickness was found to be
2.720-2.774mm. All post compressional parameters for
preliminary and gum formulations are tabulated in
(Table 3 and 4).
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Table 3: Postcompressional parameters of preliminary formulations

Parameters
Formulation
Hardness Friability Weight Variation Thickness Buoyancy Drug Content
code
(kg/cm2 ) (%) (mg) (mm) Time(hr) (%)
More than
PF1 4.67±0.152 0.93 151.05±0.693 2.760±0.012 97.81±0.001
12hrs
More than
PF2 4.9±0.1 0.279 150.77±0.7663 2.720±0.006 95.11±0.003
12hrs
More than
PF3 4.93±0.15 0.333 151.19±1.26 2.758±0.009 95.11±0.003
12hrs
More than
PF4 4.93±0.115 0.606 150.96±1.293 2.771±0.003 94.94±0.003
12hrs

Table 4: Postcompressional parameters of gum formulations

Parameters
Formulation
code Hardness Friability Weight Variation Thickness Buoyancy Time Drug
(kg/cm2 ) (%) (mg) (mm) (hr) Content(%)
GGF1 4.5±0.1 0.25 151.9±1.031 2.763±0.004 More than 24hrs 95.95±0.002

GGF2 4.73±0.115 0.27 151.48±1.073 2.774±0.008 More than 24hrs 95.78±0.001

GGF3 4.66±0.152 0.38 151.46±1.342 2.761±0.009 More than 24hrs 95.11±0.004
GGF4 4.33±0.115 0.29 151.55±1.181 2.773±0.006 More than 24hrs 94.61±0.003
XF1 4.26±0.115 0.293 151.72±0.9426 2.745±0.005 More than 24hrs 94.61±0.002
XF2 4.66±0.152 0.320 152.2±1.156 2.729±0.006 More than 24hrs 94.78±0.005
XF3 4.7±0.1 0.240 151.24±1.034 2.728±0.004 More than 24hrs 95.45±0.003
XF4 4.6±0.000 0.307 151.6±1.217 2.729±0.004 More than 24hrs 95.11±0.003
GTF1 4.3±0.1 0.372 151.33±1.159 2.742±0.005 More than 24hrs 94.27±0.006
GTF2 4.63±0.208 0.213 151.57±1.156 2.760±0.016 More than 24hrs 94.44±0.002
GTF3 4.6±0.173 0.267 151.99±1.789 2.752±0.006 More than 24hrs 94.27±0.001
GTF4 4.66±0.321 0.186 150.93±1.259 2.758±0.006 More than 24hrs 94.94±0.002
All values are reported as mean ± SD with three times

For the determination of Buoyancy lag time the floating
strategy was taken into consideration in the design of
drug delivery system. For all formulations, lag time is
in the range of 15 sec to 180 sec, values were given in
(table no 5). All the formulations are made with same
concentration of gas generating agent but the results
showed that the concentration of HPMC and natural
gums affects the buoyancy lag time. From this study, it
was concluded that as the gum or HPMC concentration
increases, the buoyancy lag time also increases. So the
concentration of the gum is directly proportional to the
buoyancy lag time. The results of buoyancy showed PF4
was floated within lag time 60 sec. but as natural gums
containing floating tablets taken more lag time i.e.
more than 120 sec as compared with PF4. This may be
due to more density of natural gums.
Universal Journal of Pharmacy, 02(02), Mar-Apr 2013
In vitro floating studies were conducted to know how
much time a tablet will take to float. The in vitro
performed by placing tablets in USP XXIII dissolution
apparatus-II containing 900 ml of 0.1N HCl maintained
at a temperature of 37±0.5ºC. The time duration of
tablet floatation was observed and noted visually. All
the designed formulations have floated more than 24
hrs.
In vitro drug release study was performed using USP
XXIII dissolution test apparatus-II at 50rpm using 900 ml
of 0.1N HCl buffer maintained at 37±0.5ºC as the
dissolution medium.
In preliminary formulations, PF1 and PF2 showed 89.53
%( in 10 hrs) and 86.25% (in 12 hrs) drug release
respectively. PF3 and PF4 formulation had shown drug
release up to 88.16% and 93.42% in 24 hrs respectively.
In vitro drug release of four formulations was shown in
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the figure 1. Perusal to figure 1 formulation PF1 shown Peppas models to ascertain the mechanism of drug
drug release up to 10 hrs due to insufficient release.
concentration of HPMC K4M. Therefore in PF2
formulation, the concentration of HPMC was increased
but here the drug release up to 12 hrs. From the data it
was confirmed that still concentration of HPMC K4M
was insufficient to get desired drug release. Therefore
in PF3 and PF4 formulations are made with higher
concentration of HPMC K4 and we found the drug
release up to 24 hrs as shown in the figure 1.

Table 5: floating lag time of all the formulations

Sr. Formulation Floating lag time
No. code (sec) Fig 1: In vitro dissolution study of preliminary formulations
1 PF1 15 sec
2 PF2 20 sec
3 PF3 30 sec
4 PF4 60 sec
5 GGF1 45 sec
6 GGF2 55 sec
7 GGF3 75 sec
8 GGF4 120 sec
9 XF1 90 sec
10 XF2 120 sec
Fig 2: In vitro dissolution study of guar gum formulations
11 XF3 120 sec
12 XF4 180 sec
13 GTF1 120 sec
14 GTF2 120 sec
15 GTF3 180 sec
16 GTF4 180 sec

Based on the above experiments, it was concluded that

PF3 and PF4 formulations were suitable to get desired
drug release. Thatswhy in the further batch, instead of Fig 3: In vitro dissolution study of xanthan gum formulations
HPMC K4M, various natural gums such as guar gum,
xanthan gum and gum ghatti were choosen.
In preliminary formulations, in vitro dissolution study
had shown the effect of HPMC concentration on drug
release of carvedilol. Similarly, comparative in vitro
drug release of floating tablets containing natural gums
in different concentration has showen in the figure 2 to
4. The results indicated that as the concentration of
the natural gums were increased, initial drug release as
well as drug release in later hours was decreased as
compared to the HPMC floating tablets. Fig 4: In vitro dissolution study of gum ghatti formulations
Perusal to figure 2 to 4 showed drug release maintained
24 hrs in all gum formulations. So it was concluded that
all three natural gums are suitable to get better drug The regression co-efficients values which give an idea
release profile as compared to HPMC formulations. on the release rate profile for different drug release
In vitro drug release data of all the FDDS formulations kinetics models for different formulations were shown
was subjected to goodness of fit test by linear in table no 6. Models with highest regression co-
regression analysis according to zero order and first efficients were judged to be the most appropriate
order kinetic equations, Higuchi’s and Korsmeyer– model for the dissolution rate.

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The data of various models reviewed that formulations diffusion. All the formulations followed higuchi matrix
followed peppas model with n value more than 0.5 and with first order release kinetic.
thus release can be concluded as non Fickanian

Table 6: Release kinetics data of all the formulations

Zero order First order Higuchi Korsmeyer peppas

Formulation code % CDR
R2 R2 R2 n R2
PF1 89.53 0.979 0.888 0.879 0.809 0.937
PF2 86.25 0.926 0.838 0.794 0.755 0.908
PF3 88.16 0.888 0.930 0.869 0.709 0.939
PF4 93.42 0.896 0.947 0.891 0.717 0.952
GGF1 72.47 0.866 0.901 0.866 0.748 0.915
GGF2 78.79 0.851 0.897 0.881 0.718 0.937
GGF3 89.60 0.833 0.890 0.877 0.736 0.940
GGF4 94.96 0.814 0.914 0.894 0.696 0.950
XF1 84.07 0.849 0.896 0.849 0.770 0.910
XF2 89.14 0.841 0.898 0.869 0.780 0.921
XF3 95.62 0.829 0.925 0.908 0.847 0.930
XF4 74.05 0.857 0.903 0.862 0.807 0.888
GTF1 95.38 0.843 0.935 0.927 0.747 0.964
GTF2 90.27 0.876 0.937 0.911 0.735 0.958
GTF3 80.22 0.877 0.941 0.917 0.740 0.948
GTF4 67.85 0.851 0.866 0.864 0.787 0.903

Stability study for optimized formulations was
conducted to see the effect of temperature and
humidity on tablets. By placing the tablets at elevated
temperature (40oC) and humidity (75% RH) conditions
for a period of one month, at an intervals of every one
week, the tablets were visually examined for any
physical changes, changes in drug content, floating lag
time, total floating time and in vitro drug release
study. The results indicated that there was no
significant change in the tablet properties. Hence it
can be concluded that the formulated floating matrix
tablets are stable under appropriate storage
conditions.
CONCLUSION
This study discusses the preparation of floating
controlled release tablets of carvedilol. The gastro
retentive floating drug delivery is a promising approach
to achieve in vitro buoyancy and there by longer
gastric retention time by using natural polymers like
xanthan gum, gum gatti guar gum and gas generating
agent sodium bicarbonate. The in vitro evaluation of
drug delivery system indicated that floating tablets
containing natural polymers like both xanthan and guar
gum exhibited more controlled release than xanthan
gum alone and guar gum alone. From the in vitro
dissolution it was confirmed that the drug release
mechanism during its stability studies was non fickians
diffusion. The results of stability indicated that there
was no change in the formulation after one month
Universal Journal of Pharmacy, 02(02), Mar-Apr 2013
accelerated stability study. The prepared formulation
of carvedilol tablet was stable.
ACKNOWLEDGEMENT
Authors are thankful to the Management SCS College of
Pharmacy, Harapanahalli for providing us the necessary
facility to conduct our research.
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Floating matrix dosage form for

Source of support: Nil, Conflict of interest: None Declared

Universal Journal of Pharmacy, 02(02), Mar-Apr 2013 124