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51]

Original Article

Formulation and evaluation of modifiedrelease

effervescent floating tablets of ofloxacin
Sarat Chandra Prasad Malisetty, Ravi Teja Allena, Swetha Sandina, HV Gangadharappa
Department of Pharmaceutics, Jagadguru Sri Shivarathreeswara College of Pharmacy, Jagadguru Sri Shivarathreeswara University,
Mysore, Karnataka, India

ABSTRACT
Aims: Ofloxacin is used as antimicrobial agent. Due to its
high solubility in gastric pH, a floating drug delivery system
was selected to improve the bioavailability and therapeutic
efficacy of the drug. Settings and Design: The purpose of
the study was to prepare and evaluate effervescent floating
tablets of ofloxacin to prolong its gastric residence and
increase bioavailability. Materials and Methods: Drug,
semisynthetic and natural polymers, such as HPMC K4M,
Guar gum, Xanthan gum and Chitosan, were used.Sodium
bicarbonate and citric acid were used as gasgenerating
agents and tablet compression was done by direct
compression. The prepared tablets were characterized
and were evaluated for invitro floating behavior, swelling
index, invitro drug release studies and release kinetics.
Results: Formulation F6 containing xanthan gum and
chitosan in a 1:1 ratio attained sustained release for 12h
and drug release observed was about 76.7%. Swelling
index was in the range 62.171.49% to 194.021.05%.
Floating lag time was observed in the range 4.116.26min.
Conclusion: The invitro results showed better drug
release conditions, supported by followup invivo studies,
suggesting that this formulation is advantageous over the
current marketed formulation, through increased gastric
residence and bioavailability.

Key words: Chitosan, effervescent floating drug

delivery system, HPMC K4M, invitro release studies,

invivo studies, ofloxacin

INTRODUCTION
An oral tablet is the most preferred route for drug
administration because it is more natural and less invasive
than other traditional routes. Though it is less invasive, the

real challenge is to increase the dosage in the gastrointestinal

tract by increasing gastric residence time. Normal gastric
residence times usually range between 5min and 2h.
Gastric emptying is unpredictable in the presence of
food and disease conditions, though drugs with a short
halflife are eliminated quickly from the stomach. Various
oral controlled delivery systems have been designed,
which can overcome these problems and release a drug
to maintain its plasma concentration for a longer period
of time in the stomach. This has led to the development
of oral gastroretentive dosage forms. Gastroretention is
essential for drugs that are absorbed from the stomach,
drugs that are poorly soluble or degraded by the higher
pH of the intestine, and drugs with absorption, which can
be modified by changes in the gastric emptying time. This
dosage form improves bioavailability, therapeutic efficacy
and may even also allow a possible reduction in the dose
because of steady therapeutic levels of a drug, for example,
furosemide and ofloxacin.[1]
The main purpose of a floating drug delivery system is
to increase the gastric residence time of the dosage form
by generating gas and followed by swelling of the system,
which retards the drug release by forming a gel layer around
the surface of the system.[2]
Floating drug delivery systems offers advantages, such as drug
with narrow absorption window and required localized action,
over other tablet dosage forms of drugs that are absorbed in
the stomach, for example ferrous salts and antacids.These
floating systems will increases the bioavailability of the
drug by floating the dosage form in the stomach for a longer
period of time; increased patient compliance is seen because
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Address for correspondence: Mr. Sarat Chandra Prasad Malisetty,

Department of Pharmaceutics, Jagadguru Sri Shivarathreeswara
College of Pharmacy, Jagadguru Sri Shivarathreeswara University,
Mysore570015, Karnataka, India.
Email:malisettysarat@yahoo.com

International Journal of Health & Allied Sciences Vol. 2 Issue 2 Apr-Jun 2013

Website:
www.ijhas.in

DOI:
10.4103/2278-344X.115685

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Malisetty, etal.: Formulation and evaluation of modified-release effervescent floating tablets of ofloxacin

of reduced pill burden. Effervescent floating drug delivery

systems can remain in the stomach for long periods and hence
can release the drug over a prolonged period of time. These
systems are suitable for a narrow absorption window.[3,4]
Ofloxacin is a fluoroquinolone with antibacterial activity,
which is effective against both Grampositive and
Gramnegative bacteria. It is used in diseased conditions
such as respiratory tract infections. The dose of ofloxacin
for adults is about 200-400mg for 12h.[5] Ofloxacin exhibits
pHdependent solubility. The solubility of ofloxacin in
water is 60mg/ml at a pH value ranging from 2 to 5, which
falls to 4mg/ml at pH7(near isoelectric pH).[2]
Ofloxacin floating tablets were prepared by previous
researchers using the wet granulation technique by
incorporating natural polymers such as Guar gum, locust
bean gum and hydroxypropyl methylcellulose(HPMC)
K100M as swelling polymers with sodium bicarbonate
as a gasgenerating agent.[6] HPMC K4M was used as a
floating polymer.[7]
In the present study, different formulations were formulated
in different polymer ratios and evaluated for invitro buoyancy
and gelling studies. In addition, various characterization
studies were performed to check the compatibility of the
prepared formulation; based on data from invitro drug
release studies, the best formulation was selected for invivo
studies. In vivo studies were carried out in rabbits as an
animal model(SpragueDawley) and drug concentration
in blood was measured by the highperformance liquid
chromatography, and pharmacokinetic parameters were
calculated.

MATERIALS AND METHODS

Pharmaceuticals(Pondicherry, India). Chitosan, Xanthan

gum and Eudragit E100 were purchased from Sigma
Aldrich(Bangalore, India. HPMC K4M was purchased
from Shreeji Chemicals(Mumbai, India). All other
chemicals and reagents used were of analytical grade.

Preparation of effervescent floating tablets

The direct compression technique was adopted for
preparation of effervescenttype floating tablets by
employing polymer types such as HPMC K100M, K4M,
Chitosan, Xanthan gum, Guar gum and Eudragit E100.
The formulation table of the tablets is shown in Table1.
The components were blended for 15 to 20min according
to ascending order of weight and finally with magnesium
stearate as a lubricant. Direct compression was done by
using Rimek Minipress1(model1674; Mumbai, India)
machine with flat face punches and dies(12mm in
diameter).[8]

Compatibility study
The integrity and compatibility of ofloxacin and the
polymers used in the tablets were studied by Fourier
transforminfrared(FTIR8400; Shimadzu Co., Tokyo
Japan) spectroscopy. Pelletization was done by using a KBr
press. The FTIR spectra were recorded in the wavelength
region between 4000 and 400 cm1.

Differential scanning calorimetry

About 5mg of the sample was weighed and crimped into an
aluminum pan, and analyzed at the scan range 0C300C
at a heating rate of 5C/min under a nitrogen flow rate
of 25ml/min. It was measured by differential scanning
calorimetry(DSC) using Q200 V24.4 Build 116(Universal
V4.7A TA Instruments, New Castle, USA).

Scanning electron microscopy

Materials
Ofloxacin was a kind gift sample from Pondchy

Morphological details of the tablets before and after

dissolution in buffer were determined by scanning electron

Table1: Formulation of SR ofloxacin tablets F1-F10

Ingredient(mg)
Ofloxacin
HPMC K4M
Guar gum
Chitosan
Xanthan gum
Eudragit E 100
Sodium bicarbonate
Citric acid(anhydrous)
Magnesium stearate (%)
Total weight**

F1
200
30
200

50
20
1
500

F2
200
30

200

50
20
1
500

F3
200
30

200

50
20
1
500

F4
200
30

200
50
20
1
500

Formulation
F5
F6
200
200
30
30
100

100
100

100

50
50
20
20
1
1
500
500

F7
200
30

100
100
50
20
1
500

F8
200
30
100

100

50
20
1
500

F9
200
30

100

100
50
20
1
500

F10
200
30
100

100
50
20
1
500

HPMC: Hydroxypropyl methylcellulose, SR: Sustainedrelease, **Excluding magnesium stearate

100

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Malisetty, etal.: Formulation and evaluation of modified-release effervescent floating tablets of ofloxacin

microscopy(SEM). It was measured using the Joel SEM

analysis Instrument(model JSM 840A., Korea, Japan).

Bulk density
A 5g weight of ofloxacin powder was weighed and gently
poured through a shortstemmed glass funnel into a 100ml
graduated glass cylinder.[9] The volume occupied by granules
was read and the bulk density of the powder was determined
and measured in terms of g/cm3.

Tapped density
Tapped density was determined by USP method II. The
tablet blend was filled into the 100ml graduated cylinder of
the tap density tester ETD1020, which was operated for a
fixed number of taps until the powder bed volume reached
a minimum. It was measured in terms of g/cm3.

Compressibility index and Hausners ratio

This was measured to assess the property of a powder
to be compressed; as such they are measured for relative
importance of interparticulate interactions. Compressibility
index was calculated.[10]

Angle of repose
The circumference of a pile of powder was drawn with a
pencil and the height of the pile was measured without
disturbing the pile. The radius of the pile was noted down
as r cm and calculated.

Weight variation
Twenty tablets were selected randomly in every batch
and average weight was calculated.(As per Indian
pharmacopoeia, limit5% for 500mg tablets.) Then the
deviation of individual weight values from average weight
and standard deviation were calculated.

Hardness
Crushing strength was determined using an Erweka IHT
100(Ahmedabad, India). Ten tablets were randomly
selected from each batch. In the tablets the crushing strength
was additionally transformed to tensile strength. It was
measured in terms of Kg.[11]

Friability
Twenty tablets are weighed and placed in a plastic chamber,
which was revolved at 25 r.p.m. for 4min. The tablets are
then reweighed to % loss in weight. The friability of the
tablets was determined by average hardness and standard
deviation was calculated.

Determination of thickness
Thicknesses of five randomly selected tablets from each
batch were measured with a digital Vernier caliper. Then

average thickness and standard deviation were calculated.

Tablet thickness should be controlled within 5% variation
from a standard value.

In vitro buoyancy
In vitro buoyancy was determined by visually observing
floating lag time; tablets were placed in a 100ml beaker
containing 0.1 N HCl. The time required for the tablets to
rise to the surface and float was considered as the floating lag
time. The time between tablet placement in the beaker and
their buoyancy and total floating duration was recorded.[12]

Swelling studies
The swelling behavior of the tablets was determined in
triplicate. Tablets were weighed and placed in a glass beaker,
containing 200ml of 0.1 N HCl, maintained in a water
bath at 370.5C for 10h. The tablets were removed after
every 2h interval up to 10h and the excess surface liquid
was carefully removed with a filter paper and weighed.[13,14]

Drug content
Five tablets were selected randomly from a batch, weighed
and powdered in a mortar. An accurately weighed quantity
of powdered tablets equivalent to 100mg was transferred
to a standard flask and the volume was made up to the
mark with 0.1 N HCl; the solution was filtered through
a 0.45m membrane paper. Analysis was done using a
spectrophotometric method at 293nm.[15]

In vitro release studies

Dissolution test was carried out using the USP apparatus
IIElectrolab EDT 08L(Mumbai, India). A900ml volume
of 0.1 N hcl was used as the dissolution medium and the
paddle was rotated at 50 r.p.m. for 12h. A5ml volume of
the sample was withdrawn at predetermined time intervals
and 5ml of fresh medium was replaced to maintain the sink
condition. the collected samples were analyzed at 293nm
by UV spectrophotometry.[16]

In vivo floating studies

The gastric retention property of the effervescent floating
formulation F6(placebo) was studied in male albino
rabbits. Barium sulfate was used as a radio opaque marker
in the tablet formulation. The formulation was administered
orally to rabbits with 5ml of water. Xray pictures were
taken at different time intervals, 2nd, 6thand 12thhours.

Bioequivalence studies
In vivo experimental studies were performed after approval
from the institutional animal ethical committee. The tablets
were given in oral administration. The prepared ofloxacin
effervescent formulation was compared with commercially

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available tablets as a reference(Oflox200mg tablet). Using

the selected formulation F6 and a reference formulation,
invivo studies were carried out by using rabbits as an animal
model(SpragueDawley). Rabbits were fasted overnight
before administration of dose. The animals were weighed
and numbered, and they were divided into four groups each
containing six rabbits. The reference drug was administered
to the first group. A200mg dose of the tablet effervescent
formulation F6 was administered to the second, third and
fourth groups. Blood was collected from the ear portal vein
at time intervals of 0.5, 1, 2, 3, 4, 6, 8, 10 and 12h.
The plasma concentration of the drug was estimated using
highperformance liquid chromatography validated for
efficiency, linearity, accuracy and precision. The estimation
was carried out using an ODS, C18(2504.6mm, 5 m;
Phenomonex, Hyderabad, India) column and absorbance
was recorded at 293nm by using a UV detector. The
mobile phase was prepared using a methanol:acetonitrile:
water solution containing 1.5g phosphoric acid per
liter(5:5:80, v/v/v) and absorbance was recorded at
293nm with a UV detector by highperformance liquid
chromatography. Flow rate was maintained at 0.9ml/
min. Blood containing EDTA(anticoagulant) was
centrifuged at 3500 r.p.m. for 15min. The supernatant
was collected and acetonitrile(1mg/ml) was added to
precipitate the proteins. The precipitated proteins were
settled by centrifugation at 8000 r.p.m. for 8min and the
supernatant was collected. A1ml volume of the collected

supernatant was filtered through a 0.45m membrane

filter and this solution was stored at20C until
highperformance liquid chromatography analysis. [17]
Plasma concentrationtime profiles were evaluated by
extravascular method of residuals. The following
pharmacokinetic parameters were determined using the
Kinetica 5.0 software: Cmax and Tmax.

Kinetics and mechanism of drug release

In vitro release was analyzed using kinetic models, and release
kinetics were described by employing different equations,
such as zeroorder,[18] firstorder,[19] Higuchi,[20] Hixson and
Crowell equation,[21] and Korsmeyer Peppas equation.[2224]

Stability studies
Stability studies were carried out for optimized patch at
45C/75% relative humidity in a humidified chamber for
90days. After 90days the samples were analyzed for drug
content and drug release.

RESULTS
Compatibility studies by FTIR
The FTIR spectra result[Figure1] indicated that there
was no drugpolymer interaction. The IR spectra recorded
for ofloxacin and the physical mixture pure ofloxacin
showed characteristic peaks at 3423 cm1(OH stretching),
3041 cm1(CH stretching, aliphatic), 2929 cm1(CH,
aromatic), 1718 cm1(C=O stretching) and 707 cm1(OH

Figure 1: (a) FT-IR spectrum of pure drug ofloxacin. (b) FT-IR spectrum of the physical mixture
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Malisetty, etal.: Formulation and evaluation of modified-release effervescent floating tablets of ofloxacin

deflection). In the formulation, peaks were observed at

3041, 2929, 1724 and 700 cm1.

Differential scanning calorimetry

The comparative DSC thermograms of pure ofloxacin and
physical mixture are represented in Figure2. The DSC
thermogram of ofloxacin displayed a characteristic peak
at 271.5C corresponding to its melting point. The drug
peak appeared in the thermogram at 269.8C, confirming
the chemical integrity of the drug.

Scanning electron microscopy

The surface morphology of the tablets before dissolution
shows that there were no cracks in the tablets. After
dissolution the tablets showed cracks, which indicated that
drug release might have been by swelling and erosion of
the polymer. An SEM photograph is shown in Figure3.

Preformulation studies
the preformulation studies of ofloxacin were evaluated
for various physical properties and the results are shown
in the Table2. The bulk density of powder indicated

good packaging character of the tablets. Carrs index

was found to be below 15% for all formulations, which
indicated acceptable flow properties. Hausners ratio for
all formulations was less than 2%, which also indicated
the good flow property and packaging characters of the
powders. angle of repose showed that the flow property of
the power was excellent and it was within acceptable limits.

Physical evaluation of ofloxacin tablets

Physical evaluation of tablets was studied. The average weight
of tablets was found to contain 0.5010.02 to 0.5240.03mg.
Hardness was found to be 4.30.3 to 4.90.3kg and friability
was found to be 0.260.19 to 0.820.13%. The thickness
of the tablets was found to be 4.260.02 to 4.990.03mm.
The evaluation results show that all the parameters were within
acceptable limits.Individual readings of all formulations were
tabulated in Table 3.

In vitro buoyancy
(a) Indicated that gasgenerating agents help to overcome
gravitational force when the tablet is quickly immersed
in 2 s.
(b) Indicated that after 4min the system floats by gas
entrapment in the core, which helps to float the tablet.
(c) Image(c) showed that after the 12thhour, tablets tend to
float at the top portion, indicating it can float in gastric
pH for more than 12h.

Figure 2: Comparative DSC thermogram of pure drug and

formulations

Figure 3: SEM photographs of tablets (a) before and (b)

after dissolution

Table2: Physical evaluation of tablets

Formulation
F1
F2
F3
F4
F5
F6
F7
F8
F9
F10

Bulk density(g/cm3)
0.3930.090
0.4120.012
0.4110.018
0.3970.013
0.3600.070
0.4170.030
0.4290.021
0.3970.020
0.4130.080
0.4090.060

Tapped density(g/cm3)
0.4910.12
0.5240.11
0.5060.07
0.4970.09
0.4370.08
0.5250.02
0.5420.04
0.4680.09
0.5420.07
0.5520.07

Carrs index
19.920.05
21.400.06
18.800.08
20.040.07
17.760.05
20.600.09
20.970.04
15.100.06
23.790.17
25.840.07

Hausners ratio
1.240.01
1.270.15
1.230.02
1.250.09
1.210.05
1.250.06
1.260.04
1.170.08
1.310.07
1.340.07

Angle of repose
28 65
29 39
27 34
29 37
28 64
29 55
27 78
28 91
27 78
29 44

*MeanSD(n=3)

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Formulations F1, F2, F3, F5, F6 and F8 showed floating

time greater than 12h and formulations F4, F7, F9 and
F10 showed less floating time when compared with the
other formulations because of Eudragit, which was more
soluble in pH less than 5, so it was partially disintegrated
after 8-10h; although it disintegrated, it showed good release
and its the floating time decreased when compared with the
other formulations. Results are shown in Figure4.

Swelling studies
Swelling studies revealed that the F2 formulation showed
more swelling in 0.1 N HCl because of its hydrophobic
nature and more gelling properties of Chitosan, and percent
swelling observed was 194.021.05%, followed by the F3
formulation, which contained Xanthan gum as a polymer
and whose percent swelling was 176.741.64%, which was
due to the high viscosity of the polymer. Formulation F4
showed 141.852.09% swelling because of Eudragit, which
was hydrophilic and disintegrated without much swelling.
When Xanthan gum was in combination with Chitosan
it showed a percent swelling of about 127.681.67%,
which was due to hydrophobic Chitosan. Least swelling
was observed with formulation F10, 62.171.49%, due
to the less viscous Guar gum and hydrophilic Eudragit

E100, which helped majorly in disintegration of the dosage

form rather than percent swelling. Results are shown in
Figures5 and 6.

In vitro release studies

In vitro release studies showed that formulation F4 showed
91.4% drug release at the end of the 12thhour due to the
presence of Eudragit, which was soluble in gastric pH, so
it showed more release at the 10thhour itself. F6 attained
a sustained release pattern and its percentage drug release
was about 76.7%. Chitosan is a hydrophobic polymer,
which showed better gelling properties and helped in the
retardation of drug release. In every batch, HPMC K4M
was used to reduce the density of the formulation and also
it was used as the releaseretarding polymer. Acomparative
graph for formulations F1F10 is shown in Figure7.

In vivo floating studies

An Xray image of rabbits was taken on empty stomach
prior to administration of tablet formulation, which is
shown in Figure8. Xray images taken at the 2nd, 6thand
12thhour showed the presence of tablets in the stomach
region, which indicated its retention in the stomach. The
tablets were strong enough for withstanding repetitive

Figure 4: In vitro floating behavior of effervescent floating tablets

Figure 5: (a) Swelling of tablets at the 1 hour (b), at the 8 hour and (c) at the 12th hour
st

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th

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gastric contraction. This showed that effervescent floating

tablets with improved mechanical strength could prolong
gastric retention and results are shown in Figure8.

Pharmacokinetic studies were carried out for F6 and

marketed(Oflox200mg tablet) in rabbits. The plasma
concentration of drug in Oflox and in the prepared
effervescent formulation is shown in Figure9. The T1/2

Figure 7: Comparative in vitro drug release profile of

effervescent tablets

Figure 6: Swelling studies of all formulations

Bioequivalence studies

Figure 8: X-ray images showing gastric retention of the floating matrix tablet formulation G-VI in a rabbit model at different
time intervals
Table3: Physical evaluation of tablets
Formulation
F1
F2
F3
F4
F5
F6
F7
F8
F9
F10

Weight variation(%)
0.5140.02
0.5060.03
0.5130.02
0.5240.03
0.5010.02
0.5110.02
0.5070.02
0.5120.03
0.5020.02
0.5030.02

Hardness(kg)
4.60.1
4.50.2
4.80.3
4.30.5
4.60.1
4.50.3
5.00.3
4.80.5
4.30.3
4.50.2

Parameters
Friability(%)
0.260.19
0.560.15
0.820.13
0.450.02
0.790.15
0.560.36
0.540.18
0.420.08
0.380.04
0.410.02

Thickness(mm)
4.890.02
4.560.02
4.260.02
4.360.02
4.540.02
4.660.02
4.390.02
4.560.02
4.990.03
4.360.03

Drug content(%)
99.922.72
98.892.43
99.542.23
100.022.54
98.022.36
99.052.32
98.252.38
99.262.55
97.252.12
98.882.19

*MeanSD(n=3)

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Malisetty, etal.: Formulation and evaluation of modified-release effervescent floating tablets of ofloxacin

value for Oflox was found to be 9h, whereas the T1/2

value for the prepared formulation was found to be 10h.
The Tmax value for both Oflox and the F6 formulation was
found to be 6h. The Cmax value for Oflox was found to be
20.150.612g/ml, whereas Cmax for F6 was found to be
18.140.356g/ml as shown in Figure9. The area under
the curve values for Oflox and F6 were 18.378.15 and
18.067.26g/h ml, respectively. The mean residence time
values for Oflox and F6 were found to be 14.9 and 17.4h.

Stability studies
Stability studies were conducted for the final formulation
and physicochemical changes such as color, appearance
and drug content were observed. Tablets were analyzed at
intervals of 15, 30, 45, 60 and 90days. Drug content was
in the range 92.020.02 to 96.121.45%. The results
indicate that all formulations were stable. Results are shown
in Figure10.

Mechanism of drug release

From release kinetics it was revealed that the bestfit model
for formulation F6 was Higuchi, with a release exponent
value(n) of 0.538, which showed that the mechanism
pattern of the tablets was Fickian diffusion.

DISCUSSION
FTIR[Figure1] shows that there is no interaction in the
prepared formulations and FTIR characteristic peaks of
the drugs appeared at the same wave number, indicating
no modification or interaction between the drug and the
polymers used. This showed that there was no potential
incompatibility of the drug with the polymers used in the
formulations.
The DSC[Figure2] thermogram of ofloxacin showed the
characteristic peak at 271.5C corresponding to its melting
point. The drug peak for the prepared tablet formulation
appeared at 269.8C. This indicates that the drug did not
undergo any changes in the formulations.
From the preformulation studies it is clear that the tablet
has acceptable flow properties and packaging ability, and
they are in the range of pharmaceutical limits. Physical
evaluation showed that the tablet does not float when
hardness is greater than 5 and it is observed that increase
in hardness leads the tablet to break in 0.1 N HCl.
In vitro buoyancy studies were identical with invivo floating
studies in rabbits. Hence gastric floating drug delivery was
achieved for more than 12h in all formulations except F4,
F7, F9 and F10.

Figure9: Plasma concentration(meanSD) of Oflox(n=3)

and F6

Swelling studies showed good swelling property and invitro

release of the drug from the floating tablets by the swelling
mechanism, which can be clearly observed in the SEM
photographs[Figure3].
When comparing the finalized best formulation F6 with the
marketed product, the study reveals that there is a change
in T1/2 value between Oflox and the prepared formulation.
Cmax decreased for the prepared formulation F6 and Tmax
for both formulations remained same, suggesting that the
bioavailability of ofloxacin is same. In comparison with the
marketed formulation, a conventional tablet, the prepared
tablet is more advantageous.

Figure 10: Shelf life analysis for formulation F-6

106

This investigation offers an added advantage for drugs, which

show better availability in gastric pH and also increased
gastric residence time of the dosage form; ofloxacin is a
model drug to depict the investigation. While conventional

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Malisetty, etal.: Formulation and evaluation of modified-release effervescent floating tablets of ofloxacin

dosage forms fail to maintain gastric residence time, they will

undergo rapid disintegration in the stomach. The prepared
dosage forms are able to withstand 12h in the stomach.

8.

9.

CONCLUSION
The prepared floating matrix tablets were subjected to various
pharmaceutical parameters such as bulk density, tapped
density, angle of repose, weight variation, thickness, hardness
and friability. The results indicated that the parameters drug
content, swelling behavior, invitro drug release data, invitro
buoyancy and stability data are within pharmacopoeial
limits. FTIR and DSC studies confirmed that there was no
interaction between ofloxacin and other ingredients used in
the tablet formulations. F6 showed sustained invitro drug
release, and also showed better swelling and floating lag time.
The release kinetics of the drug from the tablets followed the
Higuchi model and the mechanism was found to be Fickian
diffusion. The stability studies were performed according
to ICH guidelines and results confirmed that the selected
formulation was stable. In conclusion, we recommend
oncedaily ofloxacin tablets prepared by combination of
Chitosan and Xanthan gum in an effervescent floating matrix
for use in treatment of bacterial infections.

ACKNOWLEDGEMENT

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The authors wish to thank the principal(JSS College of Pharmacy,

JSS University, Mysore) for the support to carry out the research
work.

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How to cite this article: Malisetty SP, Allena RT, Sandina S,

Gangadharappa HV. Formulation and evaluation of modified-release
effervescent floating tablets of ofloxacin. Int J Health Allied Sci
2013;2:99-107.
Source of Support: Nil, Conflict of Interest: None declared

International Journal of Health & Allied Sciences Vol. 2 Issue 2 Apr-Jun 2013

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