ISSN: 2277- 7695

CODEN Code: PIHNBQ

ZDB-Number: 2663038-2
Received: 19-02-2014 IC Journal No: 7725
Accepted: 21-04-2014
Vol. 3 No. 3. 2014
Online Available at www.thepharmajournal.com

THE PHARMA INNOVATION - JOURNAL

Floating Drug Delivery System: A Novel Approach
Meenakshi Kandwal 1*, Dr. G. Gnanarajan 1, Dr. Preeti Kothiyal 1

1. Shri Guru Ram Rai Institute of Technology and Sciences, Dehradun, Uttarakhand.

Author for correspondence: Meenakshi Kandwal, Email: meenu.kandwal23@gmail.com

Floating drug delivery system are designed to prolong the gastric residence time after oral administration at
particular site and controlling the release of drug for achieving the controlled plasma level as well as improving
bioavailability. They provide local delivery to specific regions like stomach and proximal small intestine and shows
better bioavailability and improved therapeutic activity and substantial benefit to patients. They offer several
advantages over conventional dosage forms. Effervescent and Non-effervescent are two classes of floating drug
delivery system and can formulate either in single unit dosage form or in multiple unit dosage form.
Keyword: Floating drug delivery system, effervescent, non-effervescent.

1. Introduction
Oral delivery of drugs is by far the most administered dosage form [3]. The relatively brief
preferable route of drug delivery due to the ease gastric emptying time in humans, which normally
of administration, low cost of therapy, patient averages 2–3 h through the major absorption zone
compliance and flexibility in formulation etc. (stomach or upper part of the intestine), can result
Oral sustained drug delivery formulations show in incomplete drug release from the drug delivery
some limitations connected with the gastric system leading to diminished efficacy of the
emptying time. Variable and too rapid administered dose [4]. Gastroretentive systems can
gastrointestinal transit could result in incomplete remain in the gastric region for several hours and
drug release from the device into the absorption hence significantly prolong the gastric residence
window leading to diminished efficacy of the time of drugs. Prolonged gastric retention
administered dose [1]. Gastro retentive drug improves bioavailability, reduces drug waste and
delivery systems are the systems which are improves solubility for drugs that are less soluble
retained in the stomach for a longer period of in a high pH environment. It has applications also
time and thereby improve the bioavailability of for local drug delivery to the stomach and
drugs that are preferentially absorbed from upper proximal small intestines. Gastro retention helps
GIT [2]. The drug bioavailability of to provide better availability of new products
pharmaceutical dosage forms is influenced by with new therapeutic possibilities and substantial
various factors. One of the important factors is benefits for patients [5]. The identification of new
the gastric residence time (GRT) of these dosage diseases and the resistance shown towards the
forms. The gastric emptying process from the existing drugs called for the introduction of new
stomach to small intestine generally lasts from a therapeutic molecules. In response, a large
few minutes to 12 h. This variability leads to an number of chemical entities have been
unpredictable bioavailability of an orally introduced, of which some have absorption all

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over the gastrointestinal tract (GIT), some have 1. Phase I (basal phase) lasts from 40 to 60
absorption windows (i.e. absorption sites, minutes with rare contractions.
especially the upper part of the small intestine)
and some drugs have poor solubility in intestinal 2. Phase II (pre burst phase) lasts for 40 to 60
media. The drugs belonging to the second and minutes with intermittent action potential and
third categories and the drugs which are required contractions. As the phase progresses the
for local action in the stomach, require a intensity and frequency also increases
specialized delivery system. All the above gradually.
requirements can be met and effective delivery of
the drugs to the absorption window, for local 3. Phase III (burst phase) lasts for 4 to 6
action and for the treatment of gastric disorders minutes. It includes intense and regular
such as gastro-oesophageal reflux, can be contractions for short period. It is due to this
achieved by floating drug delivery systems wave that all the undigested material is swept
(FDDS) [6]. out of the stomach down to the small
intestine. It is also known as the housekeeper
2. Basic Gastrointestinal Tract Physiology [7, 8] wave.
Basically stomach is divided into 3 regions:
fundus, body, and antrum (pylorus). The 4. Phase IV lasts for 0 to 5 minutes and occurs
proximal part made of fundus and body acts as a between phases III and I of 2 consecutive
reservoir for undigested material, the antrum is cycles.
the main site for mixing motions and act as a
pump for gastric emptying by propelling actions. After the ingestion of a mixed meal, the pattern of
Gastric emptying occurs during fasting as well as contractions changes from fasted to that of fed
fed states. The pattern of motility is however state. This is also known as digestive motility
distinct in the 2 states. During the fasting state an pattern and comprises continuous contractions as
interdigestive series of electrical events take in phase II of fasted state. These contractions
place, which cycle both through stomach and result in reducing the size of food particles (to
intestine every 2 to 3 hours. This is called the less than 1 mm) which are propelled toward the
interdigestive myoelectric cycle or migrating pylorus in a suspension form. During the fed state
myoelectric cycle (MMC) which is further onset of MMC is delayed resulting in slowdown
divided into following 4 phases. of gastric emptying rate

Fig. 1: Motility pattern in GIT

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3. Floating drug delivery system {FDDS} [9] of time. While the system is floating on the
FDDS have a bulk density less than gastric fluids gastric contents (given in the Fig. 2A), the drug is
and so remain buoyant in the stomach without released slowly at the desired rate from the
affecting the gastric emptying rate for a system. After release of drug, the residual system
prolonged period of time. While the system is is eliminated from the stomach. This results in an
floating on the gastric contents, the drug is increased GRT and a better control of the
released slowly at the desired rate from the fluctuations in plasma drug concentration.
system. After release of drug, the residual system However, besides a minimal gastric content
is emptied from the stomach. This results in an needed to allow the proper achievement of the
increased GRT and a better control of buoyancy retention effect, a minimal level of
fluctuations in plasma drug concentration. The floating force (F) is also required to maintain the
floating sustained release dosage forms present buoyancy of the dosage form on the surface of
most of the characteristics of hydrophilic matrices the meal. To measure the floating force kinetics, a
and are known as hydrodynamically balanced novel apparatus for determination of resultant
systems (HBS) since they are able to maintain weight has been reported in the literature. The
their low apparent density while the polymer apparatus operates by measuring continuously the
hydrates and builds a gelled barrier at the outer force equivalent to F (as a function of time) that
surface. The drug is released progressively from is required to maintain a submerged object. The
the swollen matrix, as in the case of conventional object floats better if F is on the higher positive
hydrophilic matrices. These forms are expected to side (Fig. 2B). This apparatus helps in optimizing
remain buoyant on the gastric contents without FDDS with respect to stability and sustainability
affecting the intrinsic rate of emptying because of floating forces produced in order to prevent
their bulk density is lower than that of the gastric any unforeseeable variations in intragastric
contents. Among the different hydrocolloids buoyancy.
recommended for floating formulations, cellulose
ether polymers are most popular, especially F = F buoyancy – F gravity = (Df – Ds) g v
Hydroxypropyl methylcellulose (HPMC). Fatty Where, F = total vertical force
material with a bulk density lower than one may DF = fluid density
be added to the formulation to decrease the water Ds = object density
intake rate and increase buoyancy. v = volume and
g = acceleration due to gravity
4. Mechanism of floating systems [10]
Various attempts have been made to retain the 5. Advantages of floating drug delivery system
[28]
dosage form in the stomach as a way of
increasing the retention time. These attempts 1. The Floating systems are advantageous for
include introducing floating dosage forms (gas- drugs meant for local action in the Stomach e.g.
generating systems and swelling or expanding Antacids.
systems), mucoadhesive systems, high-density
systems, modified shape systems, gastric- 2. Acidic substances like aspirin cause irritation
emptying delaying devices and co-administration on the stomach wall when come in contact with
of gastric emptying delaying drugs. Among these it. Hence FDDS may be useful for the
the floating dosage forms are the most commonly administration of aspirin and other similar drugs.
used. Floating drug delivery systems (FDDS)
have a bulk density less than gastric fluids and so 3. The Floating systems are advantageous for
remain buoyant in the stomach without affecting drugs absorbed through the stomach. e.g. Ferrous
the gastric emptying rate for a prolonged period salts, antacids.

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4. Administration of prolongs release floating 7. Certain types of drugs can benefit from using
dosage forms, tablet or capsules, will result in FDDS. These include:
dissolution of the drug in the gastric fluid. They a) Drugs acting locally in the stomach.
dissolve in the gastric fluid and then will be
available for absorption in the small intestine b) Drugs those are primarily absorbed in the
after emptying of the stomach contents. stomach.
c) Drugs those are poorly soluble at an
5. It is therefore expected that a drug will be fully alkaline pH
absorbed from floating dosage forms if it remains
in the solution form even at the alkaline pH of the d) Drugs with a narrow window of
intestine. absorption.

6. FDDS provides advantages such as the e) Drugs absorbed rapidly from the GI tract.
delivery of drugs with narrow absorption f) Drugs those degrade in the colon
windows in the small intestinal region.

Fig 2: It shows mechanism of floating systems.

6. Disadvantages of floating drug delivery 5. Drug substances that are unstable in the acidic
systems [6] [27] environment of the stomach are not suitable
1. Floating system is not feasible for those drugs candidates to be incorporated in the system.
that have solubility or stability problem in 6. The dosage form should be administered with
GIT. a full glass of water (200-250 ml).
2. These systems require a high level of fluid in 7. These systems do not offer significant
the stomach for drug delivery to float and advantages over the conventional dosage
work efficiently. forms for drugs which get absorbed
3. Drugs such as Nifedipine which is well throughout gastrointestinal tract.
absorbed along the entire GIT and which
undergoes first pass metabolism may not be 7. Suitable drug candidates for gastroretention
[8]
desirable.
4. Drugs which are irritant to gastric mucosa are In general, appropriate candidates for GRDDS
not suitable. are molecules that have poor colonic absorption

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but are characterized by better absorption chlordiazepoxide and cinnarazine

properties at the upper parts of the GIT: 3. Drugs that act locally in the stomach, e.g.,
antacids and misoprostol
1. Narrow absorption window in GI tract e.g., 4. Drugs that degrade in the colon, e.g.,
riboflavin and levodopa. ranitidine HCl and metronidazole
2. Primarily absorbed from stomach and upper 5. Drugs that disturb normal colonic bacteria
part of GI tract, e.g., calcium supplements, e.g., amoxicillin trihydrate.

Marketed products of FDDS [29]

Brand Name
Delivery System Drug Dose Company Name

Val release®
Floating Capsule Diazepam (15 mg) Hoffmann-LaRoche

Topalkan® Floating liquid Pierre Fabre Drug,

Al-Mg Antacid
alginate preparation France
Conviron® Colloidal gel forming
Ferrous sulphate Ranbaxy, India
FDDS
Cytotech® Bilayer floating Misoprostol
Pharmacia, USA
capsule (100µg/200µg)
Cifran OD® Gas generating
Ciprofloxacin(1gm) Ranbaxy, India
floating form
Effervescent floating
Liquid Gaviscon® Al hydroxide (95mg), GlaxoSmithKline,
liquid alginate
Mg Carbonate (358mg) India
preparation
Madopar HBS
Floating CR capsule Levodopa & Benserazide Roche product, USA

8. Drugs unsuitable for gastro retentive drug  Density – GRT is a function of dosage form
delivery [8] buoyancy that is dependent on the density.
1. Drugs that have very limited acid solubility
e.g. phenytoin etc.  Size – Dosage form units with a diameter of
more than 9.5mm are reported to have an
2. Drugs that suffer instability in the gastric increased GRT.
environment e.g. erythromycin etc.
 Shape of dosage form – Tetrahedron and
3. Drugs intended for selective release in the ring-shaped devices with a flexural modulus
colon e.g. 5- amino salicylic acid and of 48 and 22.5 kilopounds per square inch
corticosteroids etc. (KSI) are reported to have better GRT. 90%
to 100% retention at 24 hours compared with
9. Factors affecting gastric retention [8, 24] other shapes.
The gastric retention time (GRT) of dosage form
is controlled by several factors that affect their  Single or multiple unit formulation –
efficacy as a gastroretentive system. Multiple unit formulations show a more

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predictable release profile and insignificant Propantheline, Opiates like Codeine and
impairing of performance due to failure of Prokinetic agents like Metoclopramide and
units, allow coadministration of units with Cisapride.
different release profiles or containing
incompatible substances and permit a larger  Biological factors – Diabetes and Crohn’s
margin of safety against dosage form failure disease.
compared with single unit dosage forms.
10. Approaches to design floating dosage [26]
 Fed or unfed state – Under fasting
conditions, the GI motility is characterized by (a) Single-Unit Dosage Forms
periods of strong motor activity or the  In Low-density approach the globular shells
migrating myoelectric complex (MMC) that apparently having lower density than that of
occurs every 1.5 to 2 hours. The MMC gastric fluid can be used as a carrier for drug
sweeps undigested material from the stomach for its controlled release. A buoyant dosage
and, if the timing of administration of the form can also be obtained by using a fluid-
formulation coincides with that of the MMC, filled system that floats in the stomach. In
the GRT of the unit can be expected to be coated shells 24 popcorn, poprice, and
very short. However, in the fed state, MMC is polystyrol have been used as drug carriers.
delayed and GRT is considerably longer. Sugar polymeric materials such as
methacrylic polymer and cellulose acetate
 Nature of meal – Feeding of indigestible phthalate have been used to undercoat these
polymers or fatty acid salts can change the shells. These are further coated with a drug-
motility pattern of the stomach to a fed state, polymer mixture. The polymer of choice can
thus decreasing the gastric emptying rate and be either ethyl cellulose or hydroxypropyl
prolonging drug release. cellulose depending on the type of release
desired. Finally the product floats on the
 Caloric content – GRT can be increased by gastric fluid while releasing the drug
four to 10 hours with a meal that is high in gradually over a prolonged duration.
proteins and fats.
 Fluid- filled floating chamber type of
 Frequency of feed – The GRT can increase dosage forms includes incorporation of a gas-
by over 400 minutes when successive meals filled floatation chamber into a microporous
are given compared with a single meal due to component that houses a drug reservoir.
the low frequency of MMC. Apertures or openings are present along the
 Gender – Mean ambulatory GRT in males top and bottom walls through which the
(3.4±0.6 hours) is less compared with their gastrointestinal tract fluid enters to dissolve
age and race-matched female counterparts the drug. The other two walls in contact with
(4.6±1.2 hours), regardless of the weight, the fluid are sealed so that the undissolved
height and body surface. drug remains therein. The fluid present could
be air, under partial vacuum or any other
 Age – Elderly people, especially those over suitable gas, liquid, or solid having an
70, have a significantly longer GRT. appropriate specific gravity and an inert
behavior. The device is of swallowable size,
 Posture – GRT can vary between supine and remains afloat within the stomach for a
upright ambulatory states of the patient. prolonged time, and after the complete release
the shell disintegrates passes off to the
 Concomitant drug administration– intestine and is eliminated.
Anticholinergics like Atropine and

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 Hydrodynamically balanced systems (HBS) 11. Classification of Floating Drug Delivery

are designed to prolong the stay of the dosage System [11]
form in the gastro intestinal tract and aid in A. Effervescent system
enhancing the absorption. Such systems are a. Gas generating system
best suited for drugs having a better solubility b. Volatile liquid containing system
in acidic environment and also for the drugs
having specific site of absorption in the upper B. Non-effervescent System
part of the small intestine. To remain in the a. Colloidal gel barrier system.
stomach for a prolonged period of time the b. Alginate beds.
dosage form must have a bulk density of less c. Hollow microspheres / Microballoons.
than 1. It should stay in the stomach, maintain d. Intragastric Floating Drug Delivery
its structural integrity, and release drug Device / Microporous compartment
constantly from the dosage form. system

 3- layer principle A. Effervescent Floating Dosage Forms:

These are matrix types of systems prepared with
(b) Multiple-Unit Dosage Forms the help of swellable polymers (methylcellulose
The purpose of designing multiple-unit dosage and chitosan) and various effervescent
form is to develop a reliable formulation that has compounds (sodium bicarbonate, tartaric acid,
all the advantages of a single-unit form and also and citric acid). They are formulated in such a
is devoid of any of the disadvantages of single- way that when come in contact with acidic gastric
unit formulations. Single unit formulations are contents, CO2 liberate and gas entrapped in
associated with problems such as sticking swollen hydrocolloids which provides buoyancy
together or being obstructed in gastrointestinal to the dosage forms [12, 13]
tract, which may have a potential danger of
producing irritation. Multiple unit systems avoid a. Gas-Generating Systems:
the all-or-none gastric emptying nature of single These buoyant delivery systems utilize
unit systems. It reduces the intersubject effervescent reactions between
variability in absorption and the probability for carbonate/bicarbonate salts and citric/tartaric acid
dose dumping is lower. Microspheres have high to liberate CO2 which gets entrapped in the
loading capacity and many polymers have been gellified hydrocolloid layer of the systems thus
used such as albumin, gelatin, starch, decreasing its specific gravity and making it to
polymethacrylate, polyacrylamine, and float over chyme [14, 15].
polyalkylcyanoacrylate. Spherical polymeric
microsponges, also referred to as microballoons b. Volatile liquid containing systems:
have been prepared. Microspheres have a The GRT of a drug delivery system can be
characteristic internal hollow structure and show sustained by incorporating an inflatable chamber,
an excellent in vitro floatability. In Carbon which contains a liquid (like ether, cyclopentane),
dioxide–generating multiple-unit oral that gasifies at body temperature to cause the
formulations several devices with features that inflation of the chamber in the stomach. The
extend, unfold, or are inflated by carbon dioxide device may also consist of a bio-erodible plug
generated in the devices after administration have made up of PVA, Polyethylene, etc. that
been described in the recent patent literature. gradually dissolves and causing the inflatable
These dosage forms are excluded from the chamber to release gas and collapse after a
passage of the pyloric sphincter if a diameter of predetermined time to permit the spontaneous
~12 to 18 mm in their expanded state is exceeded. ejection of the inflatable systems from the
stomach [16, 17].

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B. Non-effervescent Floating Dosage Forms: prepared by dropping sodium alginate solution

The non-effervescent FDDS works on the into aqueous solution of calcium chloride,
mechanism of polymer swelling, bioadhesion of causing the precipitation of calcium alginate. The
the polymer to mucosal layer of GI tract. The beads are then separated, snap-frozen in liquid
most commonly used excipients for the nitrogen, and freeze-dried at -40 ºC for 24 hours,
preparations of non-effervescent FDDS are gel leading to the formation of a porous system,
forming or swellable cellulose type which can maintain a floating force for over 12
hydrocolloids, polysaccharides and matrix- hours [16, 18].
forming polymers like polycarbonate,
polyacrylate, polymethacrylate, and polystyrene. c. Hollow microspheres / Microballoons:
The formulation method includes simple It is prepared by a novel emulsion solvent
approach of thoroughly mixing of the drug and diffusion method. The ethanol/dichloromethane
the gel-forming hydrocolloid. After oral solution of the drug and an enteric acrylic
administration this dosage form swells in contact polymer was poured into an agitated solution of
with gastric fluids and attains bulk density of less Poly Vinyl Alcohol (PVA) that was thermally
than 1. The air entrapped within the swollen controlled at 40 ºC. The gas phase is generated in
matrix imparts buoyancy to the dosage form, so the dispersed polymer droplet by the evaporation
formed swollen gel-like structure acts as a of dichloromethane formed and internal cavity in
reservoir and allows sustained release of drug the microsphere of the polymer with drug [18, 19].
through the gelatinous mass [12, 16, 18].
d. Intragastric/Microporous compartment
a. Colloidal gel barrier system: system:
A system that contains drug with gel-forming The system composed of a drug reservoir
hydrocolloids meant to remain buoyant on the encapsulated in a microporous compartment
stomach content. This prolongs GRT and having pores on top and bottom surfaces. The
maximizes the amount of drug that reaches its peripheral walls of the reservoir compartment
absorption sites in the solution form for ready were completely sealed to prevent any physical
absorption. This system incorporates a high level contact of the undissolved drug with walls of the
of one or more gel forming highly swellable stomach [19, 20]. Novel levodopa gastro retentive
cellulose type hydrocolloids. e.g. HEC, HPMC, dosage form based on unfolding polymeric
NaCMC, Polysacchacarides and matrix forming membranes which combines extended dimensions
polymer such as polycarbophil, polyacrylates and with high rigidity. It was folded into a large size
polystyrene, incorporated either in tablets or in gelatin capsules. In vitro studies showed that
capsule. On coming in contact with gastric fluid, unfolded form reached within 15 minutes after
the hydrocolloid in the system hydrates and forms administration and it was confirmed in vivo in
a colloidal gel barrier around the gel surface. The beagle dogs. The unfolded form was maintained
air trapped by the swollen polymer maintains a for at least 2 hours. It was concluded that this
density less than unity and confers buoyancy to dosage form could improve therapy of different
this dosage forms [17, 18]. narrow absorption window drugs. However, there
are possibilities of the polymeric films to get
b. Alginate beads: Multi-unit floating dosage stuck in the oesophagus causing extreme
forms have been developed from freeze-dried discomfort to the patient or drug related injuries
calcium alginate. Spherical beads of and repeated administration of rigid dosage form
approximately 2.5 mm in diameter can be may result in gastric obstruction [20, 21].

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Fig 3: It shows intra-gastric floating drug delivery device

12. Applications of floating drug delivery delivery system may also reduce the dosing
systems [22] frequency.
 Enhance bioavailability: The bioavailability  Absorption enhancement: Drugs which are
of CR-GRDF is significantly enhanced in having poor bioavailability because of site
comparison to the administration of non- specific absorption from the upper part of the
GRDF CR polymeric formulations. There are GIT are potential candidates to be formulated
several different processes, related to as floating drug delivery systems, there by
absorption and transit of the drug in the maximizing their absorption.\
gastrointestinal tract, that act concomitantly to
influence the magnitude of drug absorption.  Minimize adverse activity at the colon:
Retention of the drug in the HBS systems at
 Sustained drug delivery: Oral CR the stomach minimizes the amount of drug
formulations are encountered with problems that reaches the colon. Thus, undesirable
such as gastric residence time in the GIT. activities of the drug in colon may be
These problems can be overcome with the prevented. This pharmacodynamic aspect
HBS systems which can remain in the provides the rationale for GRDF formulation
stomach for long periods and have a bulk for beta-lactam antibiotics that are absorbed
density <1 as a result of which they can float only from the small intestine, and whose
on the gastric contents. These systems are presence in the colon leads to the
relatively larger in size and passing from the development of microorganism’s resistance.
pyloric opening is prohibited.
 Reduce fluctuations of drug concentration:
 Site–specific drug delivery systems: These Continuous input of the drug following
systems are particularly advantageous for controlled release gastro-retentive dosage
drugs those are specifically absorbed from the form administration produces blood drug
stomach or the proximal part of the small concentrations within a narrower range
intestine. The controlled, slow delivery of compared to the immediate release dosage
drug to the stomach provides sufficient local forms. Thus, fluctuations in drug effects are
therapeutic levels and limits the systemic minimized and concentration dependent
exposure to the drug. It reduces the side adverse effects that are associated with peak
effects which are caused by the drug in the concentrations can be prevented. This feature
blood circulation. In addition, the prolonged is of special importance for drugs with a
gastric availability from a site directed narrow therapeutic index.

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surface of a pile of powder or granules and the

13. Evaluation Techniques [23] horizontal plane. The granules were allowed to
In vitro evaluation of floating tablets flow through the funnel fixed to a stand at
Evaluation was performed to assess the definite height (h). The angle of repose was then
physicochemical properties and release calculated by measuring the height and radius of
characteristics of the developed formulations. the heap of granules formed.

I. Pre-compression parameters tan Ѳ = h/r

a) Angle of Repose (Ѳ) Ѳ = tan-1 (h/r)
The frictional forces in a loose powder or Where Ѳ = angle of repose
granules can be measured by angle of repose. h = height of the heap
This is the maximum angle possible between the r = radius of the heap

Table 1: It shows relationship between angle of repose and powder flow

Angle of Repose Powder Flow
<25 Excellent
25-30 Good
30-40 Passable
>40 Very Poor

b) Compressibility Index c) Hardness: Hardness indicates the ability of a

The flowability of powder can be evaluated by tablet to withstand mechanical shocks while
comparing the bulk density (ρo) and tapped handling. The
density (ρt) of powder and the rate at which it hardness of the tablets was determined using
packed down. Compressibility index was Monsanto hardness tester. It was expressed in
calculated by – kg/cm2. Three tablets were randomly picked and
hardness of the tablets was determined.
Compressibility index (%) = ρt – ρo x100
pt d) Friability test
The friability of tablets was determined by using
Where ρo = Bulk density g/ml Roche Friabilator. It was expressed in percentage
ρt = Tapped density g/ml. (%). Ten tablets were initially weighed (W initial)
and transferred into friabilator. The friabilator
II. Post-compression parameters was operated at 25 rpm for 4 minutes or run up to
100 revolutions. The tablets were weighed again
a) Shape of Tablets (Wfinal). The % friability was then calculated by –
Compressed tablets were examined under the
magnifying lens for the shape of the tablet. %F = 100 (1-W0/W)
% Friability of tablets less than 1% was
b) Tablet Dimensions considered acceptable.
Thickness and diameter were measured using a
calibrated varnier caliper. Three tablets of each e) Tablet Density
formulation were picked randomly and thickness Tablet density was an important parameter for
was measured individually. floating tablets. The tablet would floats only
when its density was less than that of gastric fluid
(1.004). The density was determined using

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following relationship. f) Weight Variation Test

Ten tablets were selected randomly from each
V = πr2h batch and weighed individually to check for
d = m/v weight variation. A little variation was allowed in
v = volume of tablet (cc) the weight of a tablet by U.S Pharmacopoeia. The
r = radius of tablet (cm) following percentage deviation in weight
h = crown thickness of tablet (g/cc) variation was shown in table 2.
m = mass of tablet

Table 2: It shows percentage deviation in weight variation

Average weight of a tablet Percentage deviation
130 mg or less 10
>130 mg and <324 mg 7.5
324 mg or more 5

g) Buoyancy / Floating Test But sometimes as the vessel is large and paddles
The time between introduction of dosage form are at bottom, there is much lesser paddle force
and its buoyancy on the simulated gastric fluid acts on floating dosage form which generally
and the time during which the dosage form floats on surface. As floating dosage form not
remain buoyant were measured. The time taken rotates may not give proper result and also not
for dosage form to emerge on surface of medium reproducible results. Similar problem occur with
called Floating Lag Time (FLT) or Buoyancy Lag swellable dosage form, as they are hydrogel may
Time (BLT) and total duration of time by which stick to surface of vessel or paddle and gives
dosage form remain buoyant is called Total irreproducible results. In order to prevent such
Floating Time (TFT). problems, various types of modification in
dissolution assembly made are as follows.
h) Swelling Study
The swelling behavior of a dosage form was B. To prevent sticking at vessel or paddle and to
measured by studying its weight gain or water improve movement of dosage form, method
uptake. The dimensional changes could be suggested is to keep paddle at surface and not too
measured in terms of the increase in tablet deep inside dissolution medium.
diameter and/or thickness over time. Water
uptake was measured in terms of percent weight C. Floating unit can be made fully submerged, by
gain, as given by the equation. attaching some small, loose, non- reacting
material, such as few turns of wire helix, around
WU = (W1 – W0) x 100 dosage form. However this method can inhibit
W0 three dimensional swelling of some dosage form
and also affects drug release.
Wt = Weight of dosage form at time t.
W0 = Initial weight of dosage form. D. Other modification is to make floating unit
fully submerged under ring or mesh assembly and
i) In-vitro Dissolution Test [25] paddle is just over ring that gives better force for
movement of unit.
A. In-vitro dissolution test is generally done by
using USP apparatus with paddle and GRDDS is E. Other method suggests placing dosage form
placed normally as for other conventional tablets. between 2 ring/meshes.

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F. In previous methods unit have very small area, Pharmaceutics and Biopharmaceutics 2008;
which can inhibit 3D swelling of swellable units, 69:255–263.
another method suggest the change in dissolution 4. Singh BN, Kim KH. Floating drug delivery
vessel that is indented at some above place from
systems: an approach to oral controlled drug
bottom and mesh is place on indented
protrusions, this gives more area for dosage form. delivery via gastric retention. Journal of
Controlled Release 2000; 63:235–259.
G. Inspite of the various modifications done to 5. Mayavanshi AV, Gajjar SS. Floating drug
get the reproducible results, none of them showed delivery systems to increase gastric retention
co-relation with the in-vivo conditions. So a of drugs: A Review. Research J Pharm and
novel dissolution test apparatus with modification Tech 2008; 1(4).
of Rossett-Rice test apparatus was proposed.
6. Narang N. An Updated Review On: Floating
14. Conclusion Drug Delivery System (FDDS). Int J App
Drug absorption in the gastrointestinal tract is a Pharm 2011; 3(1):17.
highly variable procedure and prolonging gastric 7. Chandel A, Chauhan K, Parashar B, Kumar
retention of the dosage form extend the time for H, Arora S. Floating drug delivery systems: A
drug absorption. They can be delivered better approach. International Current
efficiently thereby capitalizing on their Pharmaceutical Journal 2012; 1(5):110-118
absorption and enhancing absolute
8. Kumar S, Jamil F, Rajput M, Sharma S.
bioavailability. FDDS promises to be a potential
approach for gastric retention. FDDS is Gastro Retentive Drug Delivery System:
advantageous for drugs that are absorbed Features and Facts. International Journal of
primarily in the upper segment of GI tract i.e. Research in Pharmaceutical and Biomedical
stomach, duodenum and jejunum when compared Sciences 2012; 3(1).
to the conventional dosage forms. The increasing 9. Hardenia SS, Jain A, Patel R, Kaushal A.
sophistication of delivery technology will ensure
Floating Drug Delivery Systems. A Review
the development of increase number of
gastroretentive drug delivery to optimize the Asian Journal of Pharmacy and Life Science
delivery of molecules that exhibit absorption 2011; 1(3).
window, low bioavailability and extensive first 10. Makwana A, Sameja K, Parekh H, Pandya Y.
pass metabolism. Advancements in controlled release
gastroretentive drug delivery system: A
15. References review. Journal of Drug Delivery &
1. Dixit N. Floating Drug Delivery System
Therapeutics 2012; 2(3):12-21.
Journal of Current Pharmaceutical Journal of
Current Pharmaceutical Research 2011; 11. Chandel A, Chauhan K, Parashar B, Kumar
7(1):6-20. H, Arora S. Floating drug delivery systems. A
2. Rao GK, Mandapalli PK, Manthri RP, Reddy better approach, International Current
VP. Development and in vivo evaluation of Pharmaceutical Journal 2012; 1(5):110-118.
gastroretentive delivery systems for 12. Arora S, Javed AKKR, Ahuja A. Floating
cefuroxime axetil, Saudi Pharmaceutical drug delivery system: A Review. AAPS
Journal (2013) 21, 53-59. Pharm Sci Tech 2005; 06(03).
3. Sungthongjeen S, Sriamornsak P, 13. Rubinstein A, Friend DR. Specific delivery to
Puttipipatkhachorn S. Design and evaluation the gastrointestinal tract, in: A. J. Domb (Ed.),
of floating multi-layer coated tablets based on Polymeric site- specific Pharmacotherapy,
gas formation, European Journal of Wiley, Chichester, 1994, 282-283.

Vol. 3 No. 3 2014 www.thepharmajournal.com Page | 68

The Pharma Innovation - Journal

14. Chawla G, Gupta P, Koradia V, Bansal AK. of Research in Pharmaceutical and

Gastroretention: A Means to Address Biomedical Sciences 2011; 2(2).
Regional Variability in intestinal drug 24. Mishra J, Kumar DA. Recent advances in
Absorption. Pharmaceutical technology 2003; gastro retentive drug delivery system: A
27(2):50-68. review. Mintage journal of Pharmaceutical &
15. Moursy NM, Afifi NH, Ghorab DM, El- Medical Sciences 2013; 25-27.
Saharty Y. Formulation and evaluation of 25. Patel N, Nagesh C, Chandrashekhar S, Patel
sustained release floating capsules of J, Devdatt J. Floating drug delivery system:
Nicardipine hydrochloride, Pharmazie, 2003; An innovative acceptable approach in Gastro
58:38-43. retentive drug delivery. Asian J Pharm Res
16. Vyas SP, Roop KK. Controlled Drug 2012; 2(1):07-18.
Delivery Concepts and Advances, First 26. Chikhalikar SS, Wakade RB. Floating Drug
Edition, New Delhi, 2002, 196-217. Delivery System – An approach to oral
17. Sangekar S. Evaluation of effect of food and controlled drug delivery. Int J Pharm Tech
specific gravity of the tablets on gastric Res 2012; 4(4).
retention time. Int J Pharm 1987; Vol- 27. Kataria S, Middha A, Bhardwaj S, Sandhu P.
35(3):34-53. Floating drug delivery system – A review.
18. Jain NK. Progress in Controlled and Novel IRJP 2011; 2(9):18-24
Drug Delivery Systems. First Ed. CBSS. 28. Pandey SD, Vaidya PV, Gulhane PN.
Gopalakrishnan et al. Journal of Floating drug delivery system (FDDS): A
Pharmaceutical Science and Technology. new way for oral drug delivery system.
Publishers and Distributors, New Delhi International Journal of Pharmaceutical and
Bangalore 2004; 3(2):84-85 Clinical Science 2013; 3(1):1-13
19. Goyal M, Prajapati R, Purohit KK, Mehta SC. 29. Mahale GS, Derle ND. Floating drug delivery
Floating drug delivery system. Journal of system: A novel approach. JPSI 2012; 1(4):1-
current pharmaceutical research 2011; 5(1):7- 6.
18.
20. Klausner EA, Sara E, Lavy E, Friedman M,
Hoffman A. Novel levodopa gastro-retentive
dosage form: in-vivo evaluation in dogs. J
Control Release 2003; 88:117-126.
21. Kale RD, Tayade PT. A multiple unit floating
drug delivery system of Piroxicam using
Eudragit polymer. Indian J Pharm Scie 2007;
69(1):120-123.
22. Kumar M, Jha S, Singh SK, Mishra AK,
Bhagat S. Floating drug delivery system: A
innovative approach. Journal of Drug
Delivery & Therapeutics 2012; 2(6):117-123.
23. Sharma N, Agarwal D, Gupta MK, Khinchi
M. A Comprehensive Review on Floating
Drug Delivery System. International Journal

Vol. 3 No. 3. 2014 www.thepharmajournal.com Page | 69