Singh Lokendra Pal et al.

/ JPBMS, 2011, 5 (11)

Available online at www.jpbms.info

ISSN NO- 2230 - 7885

Review Article
JPBMS
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES

Floating Effervescent Tablet : A Review

*Lokendra Pal Singh1, Dr. Rajesh K.S1, Deepak.G.Umalkar1, VijayKumar Chauhan1, Viralkumar Rana1 , Kamini S. Vasava1.
1Department of Pharmaceutics, Parul institute of Pharmacy, Limda, Vadodara, Gujarat-391760, India.

Abstract:
In recent years scientific and technological advancements have been made in the research and development of oral drug
delivery system. The reasons that the oral route achieved such popularity may be in part attributed to its ease of
administration. Oral sustained drug delivery system is complicated by limited gastric residence times (GRTs). To overcome
these limitations, various approaches have been proposed to increase gastric residence of drug delivery systems in the
upper part of the gastrointestinal tract which includes floating drug dosage systems (FDDS) , effervescent and non
effervescent system, swelling or expanding systems, mucoadhesive systems magnetic systems, modified-shape systems,
high density system and other delayed gastric emptying devices. Among these systems, FDDS have been most commonly
used. Effervescent FDDS are the most advantageous approach to gastric retention effervescent agent produce CO2 When
come to contact with G.I fluid and support to float dosage form.

Keywords: Gastro retentive systems; Floating systems; buoyant delivery Systems; Swelling system.

Introduction:
Oral drug delivery has been known for decades as the
most widely utilized route of administered among all the
routes that have been employed for the systemic delivery
of drug via various pharmaceutical products of different
dosage forms. The reasons that the oral route achieved
such popularity may be in part attributed to its ease of
administration.[1] Oral sustained drug delivery system is
complicated by limited gastric residence times
(GRTs).Rapid GI transit can prevent complete drug release
in the absorption zone and reduce the efficacy of the
administered dose since the majority of drugs are

absorbed in stomach or the upper part of small intestine[2,

3]. To overcome
these limitations, various approaches
have been proposed to increase gastric residence of drug
delivery systems in the upper part of the gastrointestinal
tract includes floating drug dosage systems (FDDS) [4-8]
swelling or expanding systems [9], mucoadhesive systems
[10,11], modified-shape systems [12], high-density system [13],
and other delayed gastric emptying devices. Among these
systems, FDDS have been most commonly used. Floating
drug delivery system (FDDS) has less density (<1.004
gm/cm3) than gastric fluid so they buoyant in fluid and
show sustained release.

Figure 1: Floating dosage form

Advantages of Floating Drug Delivery [24-27]

Enhanced bioavailability
Enhanced first-pass biotransformation

*Corresponding Author
Mr.Lokendra Pal Singh,M.Pharm,
Department of Pharmaceutics,
Parul Institute of Pharmacy
Limda,Vadodara,Gujarat ,India.

Sustained drug delivery/reduced frequency of dosing

Targeted therapy for local ailments in the upper GIT
Reduced fluctuations of drug concentration
Improved receptor activation selectivity
Reduced counter-activity of the body
Extended time over critical (effective) concentration
Minimized adverse activity at the colon
Site specific drug delivery

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Limitations [13, 28]:

These systems require a high level of fluid in the

stomach for drug delivery to float and work efficiently.
Not suitable for drugs that have solubility or stability
problem in GIT.
Drugs such as nifedipine which is well absorbed along
the entire GIT and which undergoes first pass
metabolism, may not be desirable.
Drugs which are irritant to gastric mucosa are also not
suitable.
The drug substances that are unstable in the acidic
environment of the stomach are notsuitable
candidates to be incorporated in the systems.
The dosage form should be administered with a full
glass of water (200-250 ml).
These systems are not advantageous over the
conventional dosage forms for those drugs, which are
absorbed throughout the gastrointestinal tract.

2 complications, that of short gastric residence time and

unpredictable gastric emptying rate.

Mechanism of Floating of Floating Effervescent

Tablet: [30]
When the dosage form administered it contact with gastric
fluid and produce effervescent and evolved CO2 gas. This
support to penetrate the fluid in tablet and float, the low
density polymer HPMC various grade provide low density
system so it buy out efficiently in gastric fluid. The system
is as design to float and shows sustains release for better
patient compliance and reduces dose frequency and
adverse effect of drug.
Figure 2: Mechanism of Floating

Mode of Action of FDDS:

Basic Gastrointestinal Tract Physiology:
Anatomically the stomach is divided into 3 regions:
Fundus , body, and antrum (pylorus). The proximal part
made of fundus and body acts as a reservoir for
undigested material,
Whereas the antrum is the main site for mixing motions
and act as a pump for gastric emptying by propelling
actions.13Gastric emptying occurs during fasting as well
as fed states.
The pattern of motility is however distinct in the 2 states
.During the fasting state an inter digestive series of
electrical events take place, which cycle both through
stomach and intestine every 2 to 3 hours.14 This is called
the inter digestive myloelectric cycle or migrating
myloelectric cycle (MMC),
This is further divided into following 4 phases as
described by Wilson and Washington. [15]
1. Phase I (basal phase) lasts from 40 to 60 minutes with
rare contractions.
2. Phase II (pre burst phase) lasts for 40 to 60 minutes
with intermittent action potential and contractions. As the
phase progresses the intensity and frequency also
increases gradually.
3. Phase III (burst phase) lasts for 4 to 6 minutes. It
includes sin tense and regular contractions for short
period .It is due to this wave that all the undigested
material is swept out of the stomach down to the small
intestine. It is also known as the housekeeper wave.
4. Phase IV lasts for 0 to 5 minutes and occurs between
phases III and I of 2 consecutive cycles.
After the ingestion of a mixed meal, the pattern of
contractions changes from fasted to that of fed state. This
is also known as digestive motility pattern and comprises
continuous contractions as in phase II of fasted state.
These contractions result in reducing the size of food
particles (to less than 1 mm), which are propelled toward
the pylorus in a suspension form. During the fed state
onset of MMC is delayed resulting in slowdown of gastric
emptying rate.16Scintigraphic studies determining gastric
emptying rates revealed that orally administered
controlled release dosage forms are subjected to basically

Factors Affecting Gastric Retention:

Gastric residence time of an oral dosage form is affected by
several factors.
o To pass through the pyloric valve into the small
intestine the particle size should be in the range of 1to
2 mm.15
o The pH of the stomach in fasting state is ~1.5 to2.0
and in fed state is 2.0 to 6.0. A large volume of water
administered with an oral dosage form raises the pH
of stomach contents to 6.0 to 9.0. Stomach doesnt get
time to produce sufficient acid when the liquid
empties the stomach; hence generally basic drugs
have a better chance of dissolving in fed state than in a
fasting state.
o The rate of gastric emptying depends mainly on
viscosity, volume, and caloric content of meals.
Nutritive density of meals helps determine gastric
emptying time. It does not make any difference
whether the meal has high protein, fat, or
carbohydrate content as long as the caloric content is
the same. However, increase in acidity and caloric
value slows down gastric emptying time.
o Biological factors such as age ,body mass index (BMI),
gender, posture, and diseased states(diabetes,
Chrons disease) influence gastric emptying. In the
case of elderly persons, gastric emptying is slowed
down. Generally females have slower gastric emptying
rates than males. Stress increases gastric emptying
rates while depress ion slows it down. [17]The resting
volume of the stomach is 25 to 50 mL.
o Volume of liquids administered affects the gastric
emptying time. When volume is large, the emptying is

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Singh Lokendra Pal et al. / JPBMS, 2011, 5 (11)

faster. Fluids taken at body temperature leave the

stomach faster than colder or warmer fluids. Studies
have revealed that gastric emptying of a dosage form
in the fed state can also be influenced by its size.
Small-size tablets leave the stomach during the
digestive phase while the large-size tablets are
emptied during the housekeeping waves

Various Approaches of FDDS:

Floating Drug Delivery Systems (FDDS):

Floating systems was first described by Davis in

1968.FDDS is an effective technology to prolong the
gastric residence time in order to improve the
bioavailability of the drug. FDDS are low-density
systems that have sufficient buoyancy to float over the
gastric contents and remain in the stomach for a
prolonged period [18, 19]. While the system floats over
the gastric contentsthe drug is released slowly at the
desired rate [20, 21], which results in increased GRT and
reduces fluctuation inplasma drug concentration [22].

Classification of Floating Drug Delivery Systems

(FDDS):
Floating drug delivery systems are classified depending
onthe use of two formulation variables:
1. Effervescent system
2. Non Effervescent system

Effervescent Systems:
These buoyant delivery systems utilize matrices prepared
with swellable polymers such as Methocel or poly
saccharides, e.g., chitosan, and effervescent components,
e.g., sodium bicarbonate and citric or tartaric acid [23] or
matrices containing chambers of liquid that gasify at body
temperature[24-26]. Flotation of a drug delivery system in
the stomach can be achieved by incorporating a floating
chamber filled with vacuum, air or an inert gas [27].Gas can
be introduced into the floating chamber by the
volatilization of an organic solvent (e.g.,ether or
cyclopentane) or by the CO2 produced as a result of an
effervescent reaction between organic acids and
carbonatebicarbonate salts[28]. The matrices are
fabricated so that upon arrival in the stomach, carbon
dioxide is liberated by the acidity of the gastric contents
and is entrapped in the gellified hydrocolloid. This
produces an upward motion of the dosage form and
maintains its buoyancy. A decrease in specific gravity
causes the dosage form to float on the chyme [23].
Recently a multiple-unit type of floating pill, which
generates carbon dioxide gas, has been developed [19]. The
system consisted of sustained- release pills as seeds
surrounded by double layers. The inner layer was an
effervescent layer containing both sodium bicarbonate
and tartaric acid. The outer layer was a swellable
membrane layer containing mainly polyvinyl acetate and
purified shellac. Moreover, the effervescent layer was
divided into two sub layers to avoid direct contact
between sodium bicarbonate and tartaric acid. Sodium
bicarbonate was contained in the inner sublayer and
tartaric acid was in the outer layer. When the system was
immersed in a buffer solution at 37C, it sank at once in
the solution and formed swollen pills, like balloons, with a

density much lower than 1 g/ ml. The reaction was due to

carbon dioxide generated by neutralization in the inner
effervescent layers with the diffusion of water through the
outer swellable membrane layers. The system was found
to float completely within 10 min and approximately
80%remained floating over a period of 5 hr irrespective of
pH and viscosity of the test medium. While the system was
floating, a drug (p-amino benzoic acid) was released. A
variant of this approach utilizing citric acid (anhydrous)
and sodium bicarbonate as effervescing agents and HPC-H
grade as a release controlling agent has also been
reported. In vitro results indicated a linear decrease in the
FT of the tablets with an increase in the amount of
effervescing agents in the range of 1020%. Attempts have
also been made to develop SR floating tablets using a
mixture of sodium bicarbonate, citric acid and chitosan.

Method of Preparation of Floating Effervescent

Tablet [36]:
By direct compression
By wet granulation
Hot melt extruction method

Non Effervescent Systems:

Non effervescent systems incorporate a high level (20
75% w/w) of one or more gel-forming, highly swellable
,cellulosic hydrocolloids (e.g., hydroxyethyl cellulose
,hydroxypropyl cellulose, hydroxypropyl methylcellulose
[HPMC], and sodium carboxymethyl cellulose), poly
saccharides, or matrix-forming polymers (e.g. polycar
bophil, polyacrylates, and polystyrene) into tablets or
capsules[30]. Upon coming into contact with gastric fluid,
these gel formers, polysaccharides, and polymers hydrate.

Evaluation of Floating Drug Delivery Systems:

Various parameters that need to be evaluated in gastro
retentive formulations floating effervescent tablet include
pre compression evaluation like flow properties , bulk
density, tapped density, hausner ratio, and carrs index.
Post compression evaluation floating lag time, floating
duration, swelling index and dissolution profiles,
generally performed in simulated gastric fluids at 370C.

Measurement of Buoyancy Capabilities of the

FDDS:
The floating behaviour was evaluated with resultant
weight measurements. The experiment was carried out in
two different media, deionised water and simulated meal,
in order to monitor possible difference. The apparatus and
its mechanism are explained earlier in this article. The
results showed that higher molecular weight polymers
with slower rate of hydration had enhanced floating
behaviour and it was observed more in simulated meal
medium compared to deionised water.

Floating Lag Time :The test for floating time measurement is usually
performed in stimulated gastric fluid or 0.1 mole.lit-1HCl
maintained at 370C. It is determined by using USP
dissolution apparatus containing 900 ml of 0.1mole.lit-1
HCl as the dissolution medium at 370C. The time taken by
the dosage form to float is termed as floating lag time and

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the time for which the dosage form floats is termed as the
floating or flotation time Recently Gohel et al [54]

In-vitro Dissolution:The proposed relevant in vitro dissolution method to

evaluate a floating drug delivery system (for tablet dosage
form). A 100-mLglass beaker was modified by adding a
side arm at the bottom of the beaker so that the beaker
can hold 70 ml of 0.1 mole.lit-1 HCl dissolution medium
and allow collection of samples. A burette was mounted
above the beaker to deliver the dissolution medium at a
flow rate of 2 ml/min to mimic gastric acid secretion rate.
The performance of the modified dissolution apparatus
was compared with USP dissolution Apparatus 2 (Paddle).
The problem of adherence of the tablet to the shaft of the
paddle was observed with the USP dissolution apparatus.
The tablet did not stick to the agitating device in the
proposed dissolution [46].

Method:
The drug release followed zero-order kinetics in the
proposed method. Similarity of dissolution curves was
observed between the USP method and the proposed
method at 10% difference level (f2=57). The proposed test
may show good in vitro-in vivo correlation since an
attempt is made to mimic the in vivo conditions such as
gastric volume, gastric emptying, and gastric acid
secretion rate. [47]

Drug Release:
Dissolution tests are performed using the dissolution
apparatus. Samples are withdrawn periodically from the
dissolution medium with replacement and then analyzed
for their drug content after an appropriate dilution. [48]

Determination of Swelling Index:

The swelling behavior of the dosage unit was measured by

studying its weight gain. The swelling index of tablets was
determined by placing the tablets in the basket of
dissolution apparatus using dissolution apparatus using
dissolution medium distilled water at 37 0.5C. After
0.5,1, 2, 3, 4, 5 and 6 hours each dissolution basket
containing tablets was withdrawn and blotted with tissue
paper to remove the excess of water and weighed on the
analytical balance. The swelling index was calculated by
using the following formula. [49]
Swelling Index= Wet weight-Dry weight* 100
Dry weight

Content Uniformity,
(Tablets):

Hardness,

Friability

Drugs Used In the FDDS [14-22]

Floating Microspheres- Aspirin, Griseofulvin, Pnitroaniline, Indomethasone, Ibuprofen, Ketoprofen,
Piroxicam, Verapamil, Cholestyramine, Theophylline,
Nifedipine, Nicardipine Dipyridamol , Tranilast and
Terfinadine
Floating granules- Diclofenac sodium, Indomethacin
and Prednisolone
Films Cinnarizine, Albendazole
Floating tablets and pills- Acetaminophen,
Acetylsalicylic acid, Ampicillin, Amoxycillin trihydrate ,
Atenolol , Cephalexin, Cefuroxime, Fluorouracil, Isosorbide
mononitrate, Isoniazide, Para-amino benzoic acid,
Piretanide, Theophylline, Verapamil hydrochloride,
Chlorpheniraminemaleate, Aspirin, Calcium Carbonate,
Fluorouracil, Prednisolone, Sotalol, Pentoxyfilline and
Diltiazem hydrochloride.
Floating capsules- Chlordiazepoxide hydrogen
chloride, Diazepam, Furosemide, Misoprostol, L-Dopa,
Benserazide, Ursodeoxycholic acid, Pepstatin and
Propranolol.

Table no.1: Marketed Preparations of Floating Drug Delivery Systems[50-55]

Sr. No

Drug
Diazepam floating capsule

1.
2.
3.

Antacid preparation
Aluminium Magnesium antacid

Almagate
Topalkan

4.
5.

Benserazide and L-Dopa

Ciprofloxacin floating tablets

Madopar
Cifran OD

6.

Effervescent floating
liquidalginatepreparationLiquid
Ferrous Sulphate colloidal
Gel formingFDD
Misoprostol
Bilayer floating capsule

Gaviscon

7.
8.

Applications
Systems:

of

Floating

Drug

Delivery

Floating drug delivery offers several applications for drug

shaving poor bioavailability because of the narrow
absorption window in the upper part of the
gastrointestinal tract. It retains the dosage form at the site

Brand name
Valrelease

Manufacturer
Roche, USA
Flot-Coat
Pierre
Fabre
Drug, France
Roche Products, USA
OD
Ranbaxy, India
Glaxo Smithkline,India

Conviron
Cytotec

Ranbaxy, India
Pharmacia, USA

of absorption and thus enhances the bioavailability. These

are summarized as follows. [65]

Sustained Drug Delivery:

HBS systems can remain in the stomach for long periods
and hence can release the drug over a prolonged period of

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Singh Lokendra Pal et al. / JPBMS, 2011, 5 (11)

time. The problem of short gastric residence time

encountered with an oral CR formulation hence can be
overcome with these systems. These systems have a bulk
density of G1 as a result of which they can float on the
gastric contents .These systems are relatively large in size
and passing from the pyloric opening is prohibited.
Recently sustained release floating capsules of nicardipine
hydrochloride were developed and were evaluated in
vivo. The formulation compared with commercially
available MICARD capsules using rabbits. Plasma
concentration time curves showed a longer duration for
administration (16 hours) in the sustained release floating
capsules as compared with conventional MICARD capsules
(8 hours). [41]Similarly a comparative study [63] between
the Madopar HBS and Madopar standard formulation was
done and it was shown that the drug was released up to 8
hours in vitro in the former case and the release was
essentially complete in less than 30 minutes in the latter
case.66

Site-Specific Drug Delivery:

These systems are particularly advantageous for drugs
that are specifically absorbed from stomach or the
proximal part of the small intestine, e.g., riboflavin and
furosemide . Furosemide is primarily absorbed from the
stomach followed by the duodenum. It has been reported
that a monolithic floating dosage form with prolonged
gastric residence time was developed and the
bioavailability was increased.AUC obtained with the
floating tablets was approximately1.8 times those of
conventional furosemide tablets. [58] A bilayer-floating
capsule was developed for local delivery of misoprostol,
which is a synthetic analog of prostaglandinE1 used as a
protectant of gastric ulcers caused by administration of
NSAIDs. By targeting slow delivery of misoprostol to the
stomach, desired therapeutic levels could be achieved and
drug waste could be reduced. [67]

Absorption Enhancement Drugs:

Those have poor bioavailability because of site specific
absorption from the upper part of the gastrointestinal
tract are potential candidates to be formulated as floating
drug delivery systems, thereby maximizing their
absorption .A significant increase in the bioavailability of
floating dosage forms (42.9%) could be achieved as
compared with commercially available LASIX tablets
(33.4%) and enteric coated LASIX-long product (29.5%).
[68]

Conclusion:
Drug absorption in the gastrointestinal tract is a highly
variable procedure and prolonging gastric retention of the
dosage form extends the time for drug absorption. FDDS
promises to be a potential approach for gastric retention.
Although there are number of difficulties to be worked out
to achieve prolonged gastric retention, a large number of
companies are focusing toward commercializing this
technique.

Future Perspectives:

Floating dosage form offers a great future potential as

evident from several recent updated research and
publications. Among the recently used clinical drugs
several narrow absorption window drugs may benefit
from compounding into a FDDS. Replacing parentral
administration of drugs to oral pharmacotherapy would
substantially improve treatment and patient compliances
too. Drugs that have poor bioavailability because of their
limited absorption to the upper gastrointestinal tract can
be delivered efficiently by FDDS. Thereby maximizing
their absorption and improving their absolute
bioavailability. The floating concept can also be utilized in
the development of various anti-reflux formulations.
Developing a controlled release system for the drugs,
which have potential to treat the Parkinsons disease, is
also an important area of consideration. Combination
therapy for FDDS needs to be developed to treat H. Pylori
infection. The study of the effect of various geometric
shapes must be carried out for future aspect of FDDS. A
design of novel polymers can be investigated according to
clinical and pharmaceutical need of a FDDS.

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Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 05, Issue 05