Journal of Drug Discovery and Development

Volume 2, Issue 1 - 2018, Pg. No. 11-17

Peer Reviewed & Open Access Journal
Research Article

Gastroretentive Drug Delivery System

Wasim Fayaz1, Pankaj Chasta2, Tawseef Hassan Sheikh3, Muddasir
Ahmad Rather4, Aqib Hussain Kumar5, Aadil Mustafa6
Associate Researcher, 2Assistant Professor, 3,4,5,6,7Faculty of Pharmaceutical Sciences, Mewar University, Chittorgarh,
1

Rajasthan, India-312901.

Abstract
Gastroretentive dosage form (GRDF) has played an important role in the past few periods in improving
the limitation of most predictable and oral controlled release drug delivery system related to fast gastric-
emptying time. GRDF system can be defined as a system which remains in the stomach for an adequate
time interval against all the physiological barriers, and releases active moiety in a well-ordered manner. This
paper gives an overview of the parameters affecting gastric emptying as well as on the main thoughts used
to design pharmaceutical dosage forms with prolonged gastric residence times. In particular, bioadhesive,
size-increasing, and floating drug delivery systems are presented, and their major advantages and limitations
are discussed. Both single and multiple-unit dosage forms with dual working arrangements are reviewed.
Dual-working classifications are more efficient than the traditional systems.

Introduction which have a narrow absorption window (NAW) in the

From the past many years, oral drug administration has
been the main route for drug delivery. During the past
two decades, many oral delivery systems have been
developed to act as drug reservoirs from which the
active substance can be released over a defined period
of time at a prearranged and controlled rate. However,
this route has some physiological problems, including an
unpredictable gastric emptying rate that varies from person
to person, a brief gastrointestinal transit time (8–12 h),
and the presence of an absorption window in the upper
small intestine for several drugs.1 To express a specific site
orally administered controlled release dosage form, it is
desirable to succeed a prolonged gastric residence time
by the drug delivery. Prolonged gastric retention develops
bioavailability, increases the duration of drug release,
reduces drug unwanted, and improves the drug solubility
that are less soluble in a high pH environment.2 Drugs that
are simply absorbed from the gastrointestinal tract (GIT)
and have short half-lives are removed fast from the systemic
circulation. Frequent dosing of these drugs is mandatory
to achieve suitable therapeutic activity. Also, the drugs
upper part of GIT are not proper for oral sustained release
drug delivery system due to the brief gastric emptying
time as tablets have 2.7±1.5 hours (h) stomach transit and
3.1±0.4 h intestinal transit time.3 Thus the bioavailability
of such drugs having absorption window in stomach is
generally restricted. Gastroretentive drug delivery is one of
those methods to prolong gastric residence time, thereby
targeting site-specific drug release in the stomach for local
or systemic effects. These dosage forms can endure in
the gastric region for long periods and hence significantly
prolong the gastric preservation time of the drugs. It will
release the drug in stomach in a well-ordered manner, so
that the drug could be provided continuously to absorption
site in GIT, i.e. stomach.4 Gastroretentive drug delivery is
prepared with the purpose to retain drug in the gastric
region for prolonged time and release incorporated drug
candidates and thereby allow sustained and prolonged
input of the drug to the upper part of the GIT, thus leading
to its optimum bioavailability. Gastroretentive drug delivery
got popularity from last two periods leading to its potential
application to recover oral delivery of some important
drugs, for which prolonged gastroretention can importantly

Corresponding Author: Wasim Fayaz, Faculty of Pharmaceutical Sciences, Mewar University, Chittorgarh, Rajasthan, India-312901.
E-mail Id: wasimfayaz25@gmail.com
Orcid Id: https://orcid.org/0000-0002-8063-4083
How to cite this article: Fayaz W, Chasta P, Sheikh TH et al. Gastroretentive Drug Delivery System. J Durg Dis Dev 2018; 2(1): 11-17.

Copyright (c) 2018 Journal of Drug Discovery and Development

Fayaz W et al.
J. Durg. Dis. Dev. 2018; 2(1)
improve their oral bioavailability. GRDDs not only prolong
the dosing breaks, but also increase the patient compliance
beyond the equal of existing controlled release dosage
form.5
Physiology of the Stomach
Physically, the stomach is divided into three regions: fundus,
body and antrum (pylorus). The proximal part made one
novel approach in this part is GRDDS (gastro retentive
drug delivery system). Dosage forms that can be engaged
in the stomach are called GRDDs. GRDDs can develop the
controlled delivery of drugs that have an absorption window
by continuously releasing the drug for a elongated period
of time before it reaches its absorption site.6 Prolonging
the gastric retention of the drugs is sometimes desired for
succeeding therapeutic benefits of drugs that are absorbed
from the proximal part of the GIT (gastro intestinal tract)
or those are less soluble in or are degraded by alkaline pH
or they happenstance at the lower part of the GIT. GRDDs
are useful for such drugs by educating their:7
• Bioavailability
Figure 1.Physiology of Stomach
Figure 2.Phase of Gastric Cycle
12
• Therapeutics efficiency and possible reduction of the
dose
• Maintenance of constant therapeutic levels over a
prolonged period and thus reduction in fluctuation
in the therapeutic levels
• Reduce drug wastage
• Improve solubility of drugs that are less soluble at
high pH environment (e.g. weakly basic drug like
domperidone, papaverine)
Of fundus and body acts as a reservoir for undigested
materials, while the antrum is the main site for mixing
motions and acts as a pump for gastric emptying by
propellingactions.8,9.Gastric emptying occurs in both
the fasting and fed states. During the fasting state, an
interdigestive chain of electrical events takes place which
cycle both through stomach and intestine every 2–3 h,
which is called as interdigestive myloelectric cycle or
migrating myoelectric cycle (MMC), which is further divided
into four phases. After the ingestion of a mixed meal, the
arrangement of contractions changes from fasted to that
of fed state which is also termed as digestive motility
configuration.10.

13
• Phase 1: (Basic phase) lasts from 30–60 minutes with
rare contractions.
• Phase 2: (Preburst phase) lasts for 20–40 minutes
with intermittent action potential and contractions.
• Phase 3: (Burst phase) lasts for 10–20 minutes which
includes intense and regular contractions for a short
period.
• Phase 4: lasts for 0–5 minutes and occurs between
phase 2 and 1 of two consecutive cycles.
Need for GRDDs
• Conventional oral delivery is commonly used in
pharmaceutical field to treat diseases. However,
conventional delivery had many problems and the
major drawback is non-site specificity.
• Some drugs are absorbed at specific site. They need
release at specific site or a release such that extreme
amount of drug reaches the specific site.
• Pharmaceutical field is now focusing towards such
drugs which require specific site.
• Gastroretentive delivery is a site-specific delivery for
the delivery of drugs either at stomach or at intestine.
It is obtained by retaining dosage form into stomach
and the drug is released in a controlled manner to the
specific site either in stomach, duodenum or intestine.11
Merits
• Delivery of drugs with fine absorption window in the
small intestine region.
• Longer residence time in the stomach could be
advantageous for local action in the upper portion of
the small intestine, for example, treatment of peptic
ulcer disease.
• Better bio-availability is expected for drugs that are
absorbed readily upon release in the GI tract such as
cyclosporine, ciprofloxacin, amoxycillin, captopril, etc.
• Patient compliance by making once-a-day therapy.
• Therapeutic efficacy improved.
• Moderates frequency of dosing.
• Directed therapy for local ailments in the upper GI tract.
• Prolongs the residence period of the dosage form at
the site of absorption.
• Avoids the first pass metabolism.
• Outstanding accessibility.
• Fast absorption because of enormous blood supply
and good blood flow rates.
• Drug bioavailability increases due to first pass
metabolism.
• Specific site for drug delivery.
• Decreasing mucosal irritation by drugs, by drug
releasing slowly at a controlled rate.
• Reducing mucosal irritation by drugs, by drug releasing
slowly at a controlled rate.12
Fayaz W et al.
J. Durg. Dis. Dev. 2018; 2(1)
Demerits
• Floating systems have the limitation that they need high
level of fluids in the stomach for floating and working
efficiently. So more water drinking is prescribed with
such dosage forms.
• In supine posture (like sleeping), floating dosage form
may get cleared away (if not of larger size) by contractile
waves. So patient must not take floating dosage form
just before going to bed.
• Drugs having stability problem in high-acidic
environment, having very small solubility in acidic
environment, and drugs causing irritation to gastric
mucosa cannot be incorporated into GRDDs.
• Swellable dosage form must be clever to swell fast
before its exit from stomach and achieve size larger
than pylorus aperture. It need be capable to resist the
housekeeper waves of Phase III of MMC.
• Gastric retention is influenced by several factors such
as gastric motility, pH and presence of food. These
factors are never endless and hence the buoyancy
cannot be predicted.
• The major trial for a bioadhesive system is the high
turnover rate of gastric mucus.
• There is also probability of esophageal binding with
bioadhesive drug delivery systems.
• Drugs which have stability and solubility problems in
GIT are not appropriate candidates for these types
of systems.12
Approaches of Various Gastroretentive Drug
Delivery Systems
Swelling and Expanding Systems
This method is based on the swelling properties of the
polymers. As the size of the system is prolonged (due to
swelling), the system is confined to the stomach, as (due to
increased size) it cannot pass over the pyloric sphincters.
So this method is also called as “Plug-type system”. In the
system, polymers are used with a suitable molecular mass
and swelling properties, which (in addition to imparting
floatation) also result in controlled and sustained drug
release. This system makes contact with gastric media;
the polymer absorbs water and swells, developed swelling
systems of Losartan tablets using sodium bicarbonate,
sodium carboxy methyl cellulose (Na CMC), and hydroxyl
ethyl cellulose (HEC). The improved formulation showed
swelling to 2 cm in diameter within 3 h and floating time
more than fabricated swelling systems of levofloxacin
hemihydrates, using gel-forming polymers including:
sodium alginate, gellan gum, pectin and xanthan gum.
Effect of cross-linkers like aluminum and calcium chloride
on the drug release was also studied.13
Fayaz W et al.
J. Durg. Dis. Dev. 2018; 2(1)
Figure 3.Swellable Tablets in Stomach14
Bioadhesive Systems
These methods usually contain a synthetic and natural
polymer that are accomplished to tie on the mucus lining,
gastric epithelial cell surface, and enlarge the GRT. These
systems use the natural and synthetic polymers, i.e.,
hydrophilic gelling constituents by forming hydrogen bond
with various groups, such as sulfate, hydroxyl, carboxyl
and amide groups (e.g., cross-linked carrageenan, sodium
alginate, Na CMC and polyacrylic acids) that can stick on
the epithelial surface of the GIT, fabricated bioadhesive
methods of Ofloxacin tablets using hydroxypropyl methyl
cellulose (HPMC K100M), crospovidone and psyllium husk
polymers. Optimized formulations showed the drug release
for 24 h.15 Fabricated floating mucoadhesive systems of
Dipyridamole tablets using HPMC K4M and carbopol 934P.
The improved formulations showed 99.92% drug released
at 12 h.16
Floating Drug Delivery Systems
In 1968, Davis first described the FDDS. These methods are
low-density systems. Due to low-density, it offers enough
buoyancy to float the drug in gastric media in the stomach
for a long time. The system floats in the gastric media and
the drug is slowly delivered at the required rate that results
in enlarged GRT along with reduced fluctuations in plasma
drug concentration. It has three types, i.e., raft-forming
systems, effervescent systems and non-effervescent
systems.17 FDDS of Cefuroxime Axetil tablets using several
grades of HPMC. In vivo radiographic studies of the improved
formulations were also conducted in five healthy human
volunteers, which showed 6 h gastroretention.18 Fabricated
gastroretentive floating method of Ofloxacin tablets using
HPMC K100M and sodium bicarbonate polymers utilizing
Box Behnken designs. In vitro studies of the improved
formulations showed the drug release above 12 h and
excellent buoyancy properties: floating lag time less than 1
min, floating time more than16 h.19 The prepared floating
14
pellets of Theophylline by hot melt extrusion techniques
using the ammonio-methacrylate (Eudragit RSPO) co-
polymer. Improved formulation was showing the increased
floating potency after 30 min due to matrix swelling20 in
prepared floating bioadhesive systems of Ondansetron
Hydrochloride tablets. These tablets were prepared using
different concentrations of extending rate releasing polymer
Na CMC and HPMC for the drug release in upper part of GIT.
Optimized formulation showed well results for buoyancy
and content uniformity.21
Effervescent Systems
These systems are prepared with swellable polymers, for
instance, polysaccharides (e.g., chitosan) or methocel
and effervescent agents, e.g., citric acid or tartaric acid
and sodium bicarbonate or matrices containing reservoirs
of liquid which evaporate at the body temperature. The
matrices are made so that upon connection with gastric
fluid, carbon dioxide is released by the acidity of gastric
content and entrapped in the gel hydrocolloid. This
makes the upward motion and maintains the buoyancy22
prepared effervescent matrix tablets of water soluble
drug Tapentadol Hydrochloride using xanthan gum and
chitosan polymers utilizing the 32 packed factorial designs.
Improved formulations showed sustained drug release
pattern. X-ray studies of the improved formulations showed
gastroretention for 6 h.23
Non-effervescent Systems
These systems are made by using gel‐forming or highly
swellable cellulose-type hydrocolloids, polysaccharides
and matrix-making polymers such as polystyrene,
polymethacrylate, polyacrylate and polycarbonate. In the
method, the dosage form swells when it comes in contact
with gastric fluids and attains a bulk density of less than 1
g/mL. The air trapped within the swollen matrix imparts
buoyancy to the dosage form.24 Developed non-effervescent

15
low density floating systems of Cefpodoxime Proxetil tablets
by direct compression technique using Accurel® MP1000,
gum dammar and HPMC K15M polymers. In vivo studies
of the improved preparations in rabbit were carried out
by using barium sulfate radio opaque marker.25
Raft-Forming Systems
These systems contain a gel-forming solution (e.g., sodium
alginate solution containing bicarbonates or carbonates)
which swell and form a sticky cohesive gel containing
trapped CO2 bubbles in contact with gastric fluid. These
methods are used in the antacid formulation because
a cover produce sat the top of gastric fluids in the raft
forming systems. Therefore, such systems are useful in
for gastroesophageal reflux treatment. In vitro studies of
the improved formulation exhibited the drug release of
98.86% in 12 h and showed the maximum raft strength.26
High-density Systems
This system is made by covering the drug or mixed with
heavy inert material such as titanium dioxide, barium
sulfate, iron and zinc oxide powder. In the system, the
formulation density exceeds the common stomach content
(1.004 g/mL). The resulting tablets can be coated with a
suitable polymer in order to obtain desired release profile.27
In vitro studies the FDDS offers a capable drug delivery
system for development of bioavailability of Diltiazem
Hydrochloride.28
Figure 4.High-density Systems29
Magnetic Systems
In these systems, a slight internal magnet in the system and
a magnet located on the abdomen above the position of
the stomach, is employed. In this system, an extracorporeal
magnet is used which enlarges the GRT of the dosage
form27 investigated a magnetic system of acetaminophen
tablets. These tablets were prepared by direct compression
process using ultrafine ferrite, microcrystalline cellulose and
hydroxypropyl cellulose-H polymers. The authors studied
the result of gastric residence of acetaminophen magnetic
tablets on drug bioavailability; a stable magnet (neodymium
iron-boron magnet) was applied to the stomach of beagle
dogs for 8 h after administration of the magnetic tablets.30
Fayaz W et al.
J. Durg. Dis. Dev. 2018; 2(1)
Ion-Exchange Resins
Ion-exchange resins are complete with bicarbonate and
bound to a negative charge drug. The resulting beads are
encapsulated in a semipermeable membrane to overcome
the fast loss of carbon dioxide. After arriving in the stomach,
an interchange of bicarbonate and chloride ion takes place.
As a result of this reaction, carbon dioxide is released
and is entrapped in the membrane carrying the beads
towards the gastric media and producing a floating sheet
of resin to distinguish the uncoated beads, which will be
sunk rapidly.22 It produced an ion exchange resin system of
Samarium-152 (III) chloride hexahydrate pill. It was covered
with biocompatible polymer Eudragit TM L100. In vitro
breakdown studies of optimized formulations showed that
all the capsules remained intact in the simulated gastric
fluid for 72 h and started to disintegrate in less than 15
min when in the simulated intestinal fluid.31
Factors Controlling Gastric Retention of Dosage
Forms
Density of Dosage Forms
The density of a dosage form also affects the gastric
emptying rate and controls the location of the system in
the stomach. Dosage forms having a density lower than the
gastric contents can float to the surface, while high-density
systems drop to bottom of the stomach.32 Both locations
may isolate the dosage system from the pylorus. A density
of <1.0 gm/cm3 is necessary to exhibit floating property.33
Shape and Size of the Dosage Form
Size and shape of the dosage forms are important in
designing indigestible single-unit solid-dosage forms.
The mean gastric residence times of non-floating dosage
forms are extremely variable and greatly dependent on
their size, which may be large, medium or small units.
In most cases, the larger the dosage form the better will
be the gastric retention time (GRT) due to the larger size
of the dosage form would not permit this to quickly pass
through the pyloric antrum into the intestine.34 Dosage
forms having a diameter of more than 7.5 mm show an
improved gastric residence time compared with one having
9.9 mm. Ring-shaped devices have a well gastric residence
time as compared with other shapes.35
Food Intake and Its Nature
Food ingestion, viscosity and volume of food, caloric value
and frequency of feeding have a profound effect on the
gastric retention of dosage forms. The presence or absence
of food in the gastrointestinal tract (GIT) effects the gastric
retention time (GRT) of the dosage form. Usually the
Fayaz W et al.
J. Durg. Dis. Dev. 2018; 2(1)
presence of food in the gastrointestinal tract (GIT) increases
the gastric retention time (GRT) of the dosage form and
thus, the drug absorption increases by allowing its stay
at the absorption site for a longer period. Again, increase
in acidity and caloric value slows down gastric emptying
time (GET), which can increase the gastric retention of
dosage forms. [36]
Effect of Gender, Posture and Age
Generally, females have slow gastric emptying rates than
males. The effect of posture does not have any significant
alteration in the mean gastric retention time (GRT) for
individuals in vertical, ambulatory and supine state. In
case of elderly people, gastric emptying is slowed down.37
Conclusion
Based on the literature surveyed, it may be concluded
that gastroretentive drug delivery offers several potential
advantages for drug with poor bioavailability due their
absorption is controlled to the upper gastrointestinal
tract (GIT) and they can be delivered powerfully thereby
maximizing their absorption and enhancing absolute
bioavailability. Another promising area of investigation
for gastroretentive drug delivery system is eradication
of Helicobacter pylori, which is now understood to
be causative bacterium of chronic gastritis and peptic
ulcers. Although, this microorganism is highly sensitive
to many antibiotics, its complete eradication needs high
concentration of antibiotics to be maintained within gastric
mucosa for a prolonged time period. An important feature
to take into reason is the stomach physiology. The time
when the drug is taken (during or apart from the meal)
is the main parameter. All these gastroretentive drug
delivery systems (high-density, floating, expandable or
unfoldable or enlargement, superporous, bioadhesive,
magnetic systems, etc.) are interesting and existing their
own advantages and disadvantages. In the future, it is
predictable that they will become of increasing importance,
ultimately leading to improved efficiencies of several types
of pharmacotherapies.
Conflict of Interest: None
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Date of Submission: 2018-05-07
Date of Acceptance: 2018-06-20