Int. J. Pharm. Sci. Rev. Res., 62(1), May - June 2020; Article No.

27, Pages: 160-167 ISSN 0976 – 044X

Review Article

A Review on Osmotic Drug Delivery System

C.M. Dhage*, D.M. Shinkar1, V.T.Pathan2, A.G.Jadhav3

*,1,2Department of Pharmaceutics, Sandip Institute of Pharmaceutical Sciences, Mahiravani, Trimbak Road, Nashik - 422213,
Maharashtra, India.
3Department of Pharmacognosy, Sandip Institute of Pharmaceutical Sciences, Mahiravani, Trimbak Road, Nashik - 422213, Maharashtra,

India.
*Corresponding author’s E-mail: dhagechaitali96@[Link]

Received: 03-02-2020; Revised: 16-04-2020; Accepted: 27-04-2020.

ABSTRACT
Novel drug delivery system is the key of pharmaceutical research & development. Many conventional drug delivery systems have
been designed to modulate or modified the release a drug over an extended period of a time. Osmotic drug delivery system (ODDS)
used the basic principle of osmotic pressure for controlled release of drugs. Because of that to maintain drug concentration within
therapeutic window & minimize side effect. This review highlights the theoretical concept of drug delivery, principle, and types of
osmotic drug delivery system, general consideration, and advantage, disadvantages of this system.
Keywords: Novel drug delivery system, osmosis, osmotic drug delivery system, osmotic pressure, controlled formulation, osmotic
pump.

INTRODUCTION water-soluble component dissolves, and an osmotic

pumping system result. Subsequently, water diffuses into

I n recent year, considerable attention has been focused

on the development of novel drug delivery system
(NDDS) osmotically controlled drug delivery system
(ODDS) are the type of NDDS which utilize osmotic
pressure for controlled delivery of active agent. The
the core through the micro porous membrane, setting up
an osmotic gradient and thereby controlling the release of
drug. Osmosis can be defined as the spontaneous
movement of a solvent from a solution of lower solute
concentration to a solution of higher solute concentration
release of drug from osmotic system is independent of
through an ideal semipermeable membrane, which is
gastric pH &gastric motility. However, drug release from
permeable only to the solvent but impermeable to the
oral controlled release dosage forms may be affected by
solute. The pressure applied to the higher-concentration
pH, GI motility and presence of food in the GI tract3.
side to inhibit solvent flow is called the osmotic pressure.
Osmotically controlled drug delivery systems (OCDDS) is
Recently, osmotic tablets have been developed in which
one of the most promising drug delivery technology that
the delivery orifice is formed by the incorporation of a
use osmotic pressure as a driving force for controlled
leachable component in the coating. When the tablet
delivery of active agents. Drug release from OCDDS is
interacts with the fluid condition, the water-solvent part
independent of pH and hydrodynamic conditions of the
breaks up, and an osmotic siphoning framework result.
body because of the semi permeable nature of the rate-
Subsequently, water diffuses into the core through the
controlling membrane and the design of deliver orifice
micro porous membrane, setting up an osmotic gradient
used in osmotic systems, so a high degree of In vitro/In vivo
and thereby controlling the release of drug. Osmosis can
correlation is achieved. Osmosis refers to process of
be defined as the spontaneous movement of a solvent
movement of solvent from lower concentration of solute
from a solution of lower solute concentration to a solution
towards higher concentration of solute across a
of higher solute concentration through an ideal
semipermeable membrane. Osmotic pressure is minimum
semipermeable membrane, which is permeable only to the
pressure which needs to be applied to a solution to prevent
solvent but impermeable to the solute. The pressure
the inward flow of its pure solvent across a semipermeable
applied to the higher-concentration side to inhibit solvent
membrane. Osmotic Pump Controlled Release Preparation
flow is called the osmotic pressure.1-3
is a novel drug delivery system with internally drug delivery
rate as characteristic and controlled with the osmotic Advantages
pressure difference between inside and outside of the
• Drug release from osmotic pumps is independent of
semipermeable membrane as drug delivery power.
the gastric pH and hydrodynamic Condition of the
Now days, osmotic tablets have been developed in which body.
the delivery orifice is formed by the incorporation of a
• Higher release rates are possible from osmotic
leachable component in the coating. Once the tablet
systems than with conventional diffusion based drug
comes in contact with the aqueous environment, the
delivery systems.

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• Easy formulation and simple operation. Where, n2 represents the molar concentration of sugar in
solution, R depicts the gas constant, and t the absolute
• The delivery rate of drug(s) from these systems is
temperature.7
highly predictable and programmable by modulating
the release control parameters.
• Improved patient compliance with reduced dosing
frequency.
• It is possible to attain better release rates than those
obtained with conventional diffusion
• Drug release from the OCODDSs exhibits significant in
vitro-in vivo correlation [IVIVC] within specific limits.
• Increased safety margin of high potency drugs
• Reduced side effects.
• Drug release from the osmotic systems is minimally
affected by the presence of food. Figure 1: Schematic Illustrating Osmotic Flow and the
Attainment of Osmotic Equilibrium
• Delivery may be delayed or pulsed, if desired.
General Considerations and Material Used
• They are suitable for a wide range of drug.
Osmotic pump basically contains a medication and semi
• Sustained and consistent blood levels within the permeable membrane. In this case, itself may act as an
therapeutic window. osmogen and shows good water aqueous solubility. On the
off chance that the medication doesn't forces any
• They are well characterized and understood.
osmogenic salt and other sugar can be joined in the plan.
• Reduced interpatient variability. 3,4 Osmogens are unreservedly water solvent and fit for
delivering osmotic weight.
Disadvantage:
Single osmogen can be used for the formulations and in
• High cost. some case combination of osmogens have been used.
• If the coating process is not well controlled there is a Apart from these essential components, other materials
risk of film defects, which results in dose dumping. such as hydrophilic and hydrophobic polymers and
hydrogel. Wicking agent, solubilizing agents surfactants
• Hole Size is critical in case of elementary osmotic have been utilized depending on the type of formulations.
system. The semipermeable membrane usually contains a
• Drug release from the osmotic systems is affected to plasticizer and in some cases surfactants, flux regulating
some extent by the presence of food. agent and pore forming agent. Apart from the above
materials, common tableting aid such as lubricants, binder,
• Retrieval of therapy is not possible in the case of diluents, glidants, wetting agent etc.
unexpected adverse event
Basic Components of Osmotic Pump
• Rapid development of tolerance
1) Osmogens: Drug itself may act as an osmogen and
• Integrity and consistency of the coating process is not shows great aqueous solubility (e.g. potassium chloride
well controlled there is dose dumpling. The film beads pump). Osmogenes are fundamental ingredient of the
or particles must be instigated to combine into a film osmotic formulation. They include inorganic salts and
with steady properties. carbohydrates. Generally, combination of osmogen is
• Laser drilling is capital intensive. utilized to achieve optimum osmotic pressure inside the
framework. For the selection of osmogen, the two most
• Hypersensitivity reaction may occur after critical properties to be considered are osmotic movement
implantation.4,5 and aqueous solubility.
Principle of Osmosis Osmotic agents are classified as:-
Abbe nollet first reported osmotic effect in 1748, but i) Inorganic water soluble osmogenes: magnesium
Pfeiffer (1877) had been the pioneer of quantitative sulphate, sodium chloride, sodium sulphate, potassium
measurement of osmotic effect. Van’t hoff established the chloride, sodium bicarbonate.
ideal gas laws by the expression.
ii) Organic polymeric osmogens: sodium CMC, HPMC,
π=n2RT HEMC
iii) Organic water soluble osmogens: sorbitol, mannitol.
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Table 1: List of various osmogens with their osmotic 5) Plasticizers: Plasticizer lower the temperature of the
pressure8 second order phase transition of the elastic modules of the
wall and also increase the workability, flexibility and
Osmotic pressures of saturated Osmotic pressure permeability of the fluids generally from0.001 to 50 parts
solution of commonly used (atm) of plasticizer or a mixture of plasticizers are incorporated
osmogens into 100 parts of wall forming materials. E.g dialkyl
Sodium Chloride 356 phthalates and phthalates, trioctyyl phosphates,
Fructose 355 benzoates, sulphonamides, glycerolates
Potassium Chloride 245 6) Pore forming agent: .0These agents are particularly
Sucrose 150 used in the pump development for poorly water soluble
Dextrose 82 drug and in the development of controlled porosity
Potassium Sulphate 39 osmotic pump these pore forming agent cause the
formulation of microporous membrane these
Mannitol 38
microporouse wall may formed in situ by a pore-former by
Sodium Phosphate Dibasic 36 leaching during the operation of the system. The pores
Sodium Phosphate tribasic 31 may also be formed in the wall prior to operation of the
Sodium phosphate monobasic 28 system. By gas formation within coating polymer solutions
Lactose-fructose 500 which result in void and pore in the final form of wall. The
pore formers can be inorganic or organic and solid or liquid
Dextrose-Fructose 450
in nature. E.g. sodium chloride sodium bromide, potassium
Sucrose-Fructose 430 chloride, potassium sulphate, potassium phosphate etc.
Mannitol-Fructose 415
7) Solubilizing Agents: Non - swellable solubilizing agent
Lactose-Sucrose 250 are classified into three groups
Lactose-dextrose 225
• Agents that inhibit crystal formation of the drug or
Mannitol-dextrose 225
otherwise act by complexation of drug (e.g PVP, PEG,
Dextrose-Sucrose 190 cyclodextrins),
Mannitol-sucrose 170
• a high HLB micelle forming surfactant, particularly
Mannitol-lactose 130 anionic surfactant (e,g Tween 20,60,80,poly oxy
2) Wicking agent: It is defined as a material with the ability ethylene or polyethylene containing surfactants and
to water into the porous network of delivery device. The other long chain anionic surfactants such as SLS)
function of wicking agent to or to attract carry water to • Citrate esters and their combination with anionic
surfaces inside the of t center he tablet, there by making surfactants ([Link] esters particularly triethyl
channels or network of increased surface area .example:- citrate)
colloidal silicon dioxide, kaolin, titanium dioxide, alumina
niacinamide, SLS, low molecular weight poly vinyl 8) Flux regulators: Flux regulating agents or flux enhancing
pyrrolidone, m-pyrol, bentonite, polyethylene. SLS, agent or flux decreasing agent are added to a wall forming
Colloidal silica and PVP and non swellable wicking agents. material it assists in regulating the fluid permeability
through membrane.
3) Surfactants: Surfactants are particularly useful when
added to wall forming material they produce an integral Poly hydric alcohols such as poly alkylene glycols and low
composite that is useful for making the wall of the device molecular weight glycols such as poly propylene, poly
operative the surfactants act by regulating the surface buylene and poly amylene, etc. can be added as flux
energy of material to improve their blending in to the reguators.
composite and maintain their integrity in the environment 9) Coating solvents: Solvent suitable for making polymeric
of use during the drug release period. Typical surfactants solution that is used for manufacturing the wall of the
such as poly oxyethyenated glyceryl recinoleeate, osmotic device include inert inorganic and organic
poloxythlenated castor oil having ethylene oxide, glyceryl solvents.
laureates, glycerol etc.
Example: methylene chloride, acetone, methanol, ethanol,
4) Semi permeable membrane: The semi permeable isopropyl alcohol, ethyl acetate, cyclohexane, etc.
membrane should be a stable both to the outer and inner
environment of the device. The membrane must be 10) Hydrophilic and hydrophobic polymers: Used in the
adequate unbending in order to hold its dimensional formulation development of osmotic systems containing
uprightness during the operational lifetime of the device. drug matrix core.
The membrane must be biocompatible. E.g cellulose Selection of polymer is based on:-
acetate, agar acetate, amylosetriacetate, betaglucan
acetate, etc. ➢ solubility of drug

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➢ the amount and rate of drug to be

released from the pump
Example of hydrophilic polymers
➢ HEC (hydroxyl ethyl cellulose
➢ HPMC (hydroxyl propyl methyl cellulose)
➢ CMC (carboxy methyl cellulose)
Example of hydrophobic polymers
➢ EC (ethyl cellulose) Figure 2: The elementary osmotic pump

➢ Wax materials etc. 3,4 Mechanism: Imbibes water through the SPM because of
osmotic pressure gradient and forms the saturated
CLASSIFICATION OF OSMOTIC PUMP medication solution inside the device. This increases the
1. Oral osmotic pump hydrostatic pressure inside the tablet forces the saturated
drug solution through the hole present in film.
A. Single chamber osmotic pump
Advantages: suitable for delivery of drug having moderate
i. Elementary osmotic pump water solubility. (5).
B. Multi chamber osmotic pump B. Multi chamber osmotic pump
i. Push pull osmotic pump, I. Push –pull osmotic system (ppop):
ii. Osmotic pump with non-expanding second chamber Composition: they contain a few compartments isolated by
2. Implantable osmotic pump versatile stomach upper compartment contains medicate
with or without osmogen (sedate compartment nearly (60-
i. The Rose and Nelson Pump 80%) and lower compartment push compartment contain
ii. Higuchi Leeper Pump osmogen at 20-40%.it bilayer tablet coated semi
permeable membrane.
iii. Higuchi Theeuwes pump
Mechanism: when dosage form come in contact with
iv. Implantable Mini osmotic pump aqueous environment, both compartments imbibe water
3. Specific types osmotic pump simultaneously because lower compartment is avoid of
any orifice, it expands and pushes the diaphragm into
i. Controlled porosity osmotic pump upper drug chamber, there by delivering the drug via the
ii. Osmotic bursting osmotic pump drug orifices.
iii. Liquid OROS Advantages: deliver both highly water soluble (oxybutynin
hydrochloride) and practically insoluble.6
iv. Delayed delivery osmotic pump
E.g. Procardia XL for nifidipine12
v. OROS CT (colon targeting) osmotic system
ii Osmotic pump with non expanding second chamber:
vi. Sandwiched oral therapeutic system
Composition: Multi-chamber devices comprise of systems
vii. Osmotic pump for insoluble drugs containing a non – expanding second chamber.
viii. Monolithic osmotic system and OSMA Mechanism: purpose of second chamber is either dilution
Xi. Telescopic capsule for delayed release4, 7 of drug solution leaving the device (particularly useful in
handling drugs with high incidence of GI irritation) or
1. Oral osmotic pump
simultaneous delivery of two drugs.
A. Single chamber osmotic pump
Advantages: Relatively insoluble drug can also be
i. Elementary osmotic pump: delivered.
Composition: It contains an active agent having a suitable 2. Implantable osmotic pump
osmotic pressure .it fabricate as a tablet coated with semi
i. Rose and nelson osmotic pump
permeable membrane usually semi-permeable
membrane. Composition: This pump is composed of three chambers:
drug chamber, salt chamber, holding solid salt and water
chamber.
Mechanism: a semi permeable membrane separates the
salt from water chamber. The movement of water from

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Int. J. Pharm. Sci. Rev. Res., 62(1), May - June 2020; Article No. 27, Pages: 160-167 ISSN 0976 – 044X

water chamber towards the salt chamber is influenced by

difference in osmotic pressure membrane. Conceivably
volume of salt chamber increase due to water flow which
descends the latex diaphragm the salt and drug chambers,
eventually the drug is pumped out of device. (7).

Figure 5: Higuchi Theeuwes pump

Mechanism: The release of the drug from device is
governed by the salt used in the salt chamber and the
permeability characteristics of outer membrane.
Figure 3: Rose and Nelson osmotic pump Diffusional loss of the device is minimized by making the
delivery port in shape of a long thin tube.
ii. Higuchi Leeper pump
Application: They are used frequently as implantable
Composition:- Number of variation of rose nelson pump controlled release delivery system in experiment studies
and these design have been described in U.S patents first requiring continuous administration of drug.7, 8, 9
series of simplifications of the rose nelson pump made by
the Alza corporation Higuchi leeper pump has no water iv. Implantable mini osmotic pump
chamber, this pump contains a rigid housing, and a Composition: It is composed of three concentric layers the
semipermeable membrane supported on a perforated drug reservoir, the osmotic sleeves and the rate controlling
frame. A salt chamber containing a fluid solution with an semi permeable membrane. The additional component
excess of solid salt is usually present in this type of pump. called flow moderator is inserted into the body of the
Mechanism: Higuchi leeper pump has no water chamber, osmotic. The inner most compartment of drug reservoir
and activation of the device occurs after imbibition of which is surrounded by an osmotic sleeve, a cylinder
water from the surrounding environment. This variation containing high concentration of osmotic agent. The
allows the device to be prepared loaded with drug and can osmotic sleeve is covered by a semi permeable membrane.
be stored for long prior to use. (figure no .6)
Application: - Higuchi-leeper pump is widely employed for
veterinary use.
These pumps are intended to be implanted in animal to
deliver the hormones.

Figure 6: Theeuwes miniature osmotic pump

Mechanism: When the system is placed in aqueous
environment water enters the sleeve through semi
permeable membrane, compresses the flexible drug
reservoir and displaces the drug solution through the flow
moderator. These pumps are available with variety of
delivery rates between .25to 10 ml per hour and delivery
Figure 4: Higuchi Leeper pump
duration between one day and four week. 10
iii. Higuchi Theeuwes pump
3. Specific types
Composition: - the rigid housing is consistent of a semi
i. Controlled porosity osmotic pumps (CPOP)
permeable membrane. The drug loaded in the device only
prior to its application, which extends advantages for Composition: - CPOPs are similar to EOP, the only
storage of device for longer duration. difference being that the delivery orifice from which the

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drug release takes place is formed by incorporation of a barrier layer, osmotic layer and the release rate-controlling
water-soluble additive in the coating. membrane.13
Mechanism: After coming in contact with water, water b) Liquid OROS hard cap
soluble additives present in the coating dissolves and it
Composition: In hard cap ,it consists of a liquid drug layer
results in an in-situ formation of a microporouse
and anosmotic engine,all encased in a hard gelatin capsule
membrane as shown in figure. The release f drug takes
and coatedwith semi permeable membrane.
place through this micrporous channels as shown in figure
7.
Advantages: Eliminates the need for a separate
manufacturing step (creating an orifice using a laser drilling
machine). Suitable for delivery of drugs having
intermediate water solubility and extremes of water
solubility by some modifications.11, 12

Figure 9: Liquid OROS hard cap

Mechanism:-The expansion of the osmotic layer result in
the development of hydrostatic pressure, there by forcing
the liquid formulation to break throughthe hydrated
gelatin capsule shell at the delivery orifice.
Figure 7: Controlled Porosity Osmotic Pump Water is imbibed across the SPM,expanding the osmotic
ii. Osmotic bursting osmotic pump engine, which pushes against the barrier, releasing the
drug through the delivery orifice.
Composition: This system is similar to an EOP expect
delivery orifice is absent and size may smaller. Advantages:-To deliver APIs are as liquid formulations and
combine the benefits of extended release with high
bioavailability. Suitable for controlled delivery of lipophilic
API13.
iv. Sandwiched osmotic tablet (SOTS)
Composition:- Tablet core consisting of middle push layer
and two attached drug layer is is coadted with a semi
permeable membrane (SPM).
Figure 8: Osmotic Bursting Osmotic Pump Mechanism: After coming in contact with the aqueouse
Mechanism: When it is placed in an environment, the middle push layer containing swelling
aqueouseenvironment, water is imbibed by hydraulic agent sweels and thedrug is released from the delivery
pressure is built up inside untill the wall rupture and the orifices.
content are released to the environment. Varying the Advantages: System delivers drug from two opposite
thickness as well as the area the area semipermeable orifices, rather in from the single orifice of the push- pull
membrane can control release of drug. osmotic pump.(PPOP).14
Application:-This system is usefl to provide pulsated
release. Liquid OROS:are designed todeliver drugsas liquid
formulations and combine the benefits of extended
release with high bioavailability.8,12
iii. Liquid OROS controlled release system (L-OROS)
a. Liquid OROS Soft Cap
b. Liquid OROS hard cap
a. Liquid OROS Soft Cap:-
Composition:-In soft cap, liquid drug formulationis present Figure 10: Sandwiched osmotic tablet
in a soft gelatin capsule, which is surrounded with the

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v. Monolithic osmotic system type of apparatus. Dissolution media is generally distilled

water as well as simulated gastric fluid (for first 2-4 h)and
Composition: The monolithic osmotic system consistsnof a
intestinal fluids (for subsequent hours)have been used the
simple dispersion of water-soluble agentin polymer matrix.
standard specifications,
The drug particles are encapsulated by polymers.
Which are as followed for oral controlled drug delivery
Mechanism: When the MOS comes in contact with the
system are equivalently applicable for oral osmotic
aqueous environment, the water imbibitions by the active
pumps16.
agent takes place rupturing the polymer matrix capsule
surrounding the drug , thus liberating drug to the outside Marketed Study
environment. Initially this process occurs at the matrix in a
In the market, there are thirty – one product has been
serial fashion.
developed and marketed based on oral osmotic drug
Advantages: these systems govern the zero order drug system. all these products are under the therapeutic areas:
delivery kinetics. The principleenergy is osmotic cardiovascular (35%), neurological (25%) seasonal (25%)
pressure.14 and metabolic disorders (15%). These products have been
mainly developed by two companies; the former Alza corp.
vi. Telescopic capsule for delayed release
which was later acquired by Johnson & Johnson developed
Composition:This device consists of two chambers, the 20 products (53%).17
first containsthe drug and an exit port, and the second
CONCLUSION
contains osmotic engine .layer of wax –like material
separates the two sections. In the osmotic delivery system, osmotic pressure provides
the driving force for drug release. Increasing pressure
inside the dosage form from water incursion causes the
drug to release from the system. The major advantages
include precise control of zero-order or other patterned
release over an extended time period. The osmotic drug
delivery has travelled long way right from time discovery it
undergoes various type of lift up. The osmotic drug
delivery is slightly expensive drug delivery system still it is
used because it attends to provide as good rate of drug
release which tend to raise it acceptance in the
pharmaceutical world.
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Source of Support: Nil, Conflict of Interest: None.

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