Journal of Advanced Drug Delivery (JADD) ISSN NO: 2348-3278

Volume 3, Issue 2 March- April -2016

ISRA IMPACT FACTOR: 0.46

MICROEMULSION: A NOVEL APPROACH FOR DRUG DELIVERY SYSTEM

Deshmukh P.D. *1, Salunkhe K.S.1, Patil W.S. 2, Chaudhari S. R1 Davange R.M.1, Varpe U.D.1

ABSTRACT : Microemulsions are one of the best candidates as novel drug delivery system because of their
long shelf life, improved drug solubilization with ease of preparation and administration. Microemulsions are
isotropic system, which are difficult to formulate than ordinary emulsions because their formulation is a
highly specific process involving spontaneous interactions among the constituent molecules. Microemulsions
are clear, thermodynamically stable, isotropic liquid mixture of oil, water and surfactant, frequently in
combination with a cosurfactant. An API has high solubility and oil may also have more or less
pharmacological property, so it may assist the therapeutic action of API. Microemulsions have an advantage
easily prepared and require no energy contribution during preparation this is due to better thermodynamic
stability. Microemulsion evaluated by various methods. The main objective of this review paper is to discuss
microemulsion as drug carrier system.

Key words: Microemulsion, novel drug delivery, thermodynamic stability, cosurfactants.

1. INTRODUCTION
Microemulsions are isotropic system, which are difficult to Microemulsions have specific physical and chemical
formulate than ordinary emulsions because their properties such as transparency, low viscosity, and
formulation is a highly specific process involving homogeneity. Hence, since their discovery, several
spontaneous interactions among the constituent applications for microemulsions have been implemented
molecules. Microemulsions are clear, thermodynamically in the in industry which includes pharmaceutical drug
stable, isotropic liquid mixtures of oil, water and delivery, enhanced oil recovery and nanoparticle synthesis
surfactant, frequently in combination with a cosurfactant. (25). Microemulsions have been widely studied to enhance

The aqueous phase may contain salt and/ or other the bioavailability of poorly water soluble drug. They offer
ingredients, and the oil may actually be a complex mixture a cost effective approach in such cases (26). Poorly aqueous
of different hydrocarbons and olefins. In contrast to soluble drug need to have solubility in dispersed oil phase
ordinary emulsions, microemulsions form upon simply to form efficient o/w microemulsion system. Even with
mixing of the components and do not require the high increase in oil content in o/w microemulsions leads to
shear conditions generally used in the formulation of increase in droplet size (27). The aqueous phase may contain
ordinary emulsions (1). The solubility potential of salt(s) and/or other ingredients, and the oil may actually
microemulsion is a major factor in enhancing absorption be a complex mixture of different hydrocarbons and
of drugs. Mostly microemulsions have favorable solvent olefins. In contrast to ordinary emulsions, microemulsions
properties due to the potential incorporation of large form upon simple mixing of the components and do not
fraction of lipophilic and/or hydrophilic phases (18). In require the high shear conditions generally used in the
contrast to ordinary emulsions, microemulsions form formation ordinary emulsions. In ternary systems such as
upon simple mixing of the components and do not require microemulsions, where two immiscible phases (water and
the high shear conditions generally used in the formation oil) are present with a surfactant, the surfactant molecules
of ordinary emulsions (20). In case of emulsion, it contains may form a monolayer at the interface between the oil and
three components, namely oil, water and surfactant; water, with the hydrophobic tails of the surfactant
whereas microemulsions generally require a forth molecules dissolved in the oil phase and the hydrophilic
component that is co-surfactants, which include alcohol of head group in the aqueous phase. In a microemulsion the
medium chain length that is miscible with water (24). domains of the dispersed phase are either globular or
------------------------------------ interconnected (to give a bicontinuous microemulsion) (2).
Deshmukh P.D. *1, Salunkhe K.S.1, Patil W.S. 2, Chaudhari S. R1
Davange R.M.1, Varpe U.D.1 Department of Pharmaceutics, 2. MICROEMULSIONS: POST AND CURRENT
Amrutvahini College of Pharmacy Amrutnagar, Sangamner, STATE
Maharashtra, India. The word microemulsion was originally proposed by
2Mylan Lab. LTD, Sinner, Nashik, Maharashtra, India.
Schulman et al. They prepared a quaternary solution of
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water, benzene, hexanol, and K-oleate which was stable, C) Bicontinuous microemulsion
homogenous and slightly opalescent. These systems In bicontinuous microemulsion system the amount of
became clear as soon as a short chain alcohol was added. water and oil present are similar, in case, both water and
In the years between 1943 and 1965 Schulman and co- oil exist as a continuous phase. An irregular channel of oil
workers described how to prepare these transparent and water are combined, and looks like a “sponge-phase”.
systems. Basically a macroemulsion was prepared and the Transitions from o/w to w/o microemulsions may pass
system was then titrated to clarify by adding a second through this bicontinuous state. Bicontinuous
surface active substance (co-surfactant). When the microemulsion, may show non-Newtonian flow and
combination of the four components was right, the system plasticity. These properties make them especially useful
cleared spontaneously. Most of the work reported by for topical delivery of drug or for intravenous
Schulman dealt with four component system. Schulman administration.
had previously published extensively in the field of
monolayer’s and applied what he had learnt in that field
to explain the formation of microemulsions. He proposed
that the surfactant and co-surfactant, when properly
selected, form a mixed film at the oil/water interface,
resulting in an interfacial pressure exceeding the initial
positive interfacial tension. To summarize, the basic
observation made by Schulman and co-workers that when
a co-surfactant is titrated into a coarse microemulsion
composed of a mixture of water/surfactant in a sufficient
quantity to obtain micro droplet, the result may be a
system which is low in viscosity, transparent, isotropic,
and very stable. The titration from opaque emulsion to Fig no. 1. Type of microemulsion (28)
transparent solution is spontaneous and well defined. It
was found that these systems are made of spherical micro 4. THEORIES OF MICROEMULSION FORMATION
droplets with a diameter between 600 and 8000 nm. It was
only in 1959 that Schulman proposed to call these systems Historically, three approaches have been used to explain
microemulsions. Previously he used terms such as microemulsion formation and stability. They are as
transparent water and oil dispersion, oleophatic follows: BASIS OF MICROEMULSIFICATIONS23
hydromicelles or hydropathic oleomicelles (3).  Interfacial or mixed film theories.
 Solubilization theories.
3. TYPES OF MICROEMULSIONS  Thermodynamic treatments.
These are stable system that are broadly categorized into The free energy of microemulsion formation can be
three types considered to depend on the extent to which surfactant
A) Oil-in-water (O/W) microemulsions lowers the surface tension of the oil water interface and
B) Water-in-oil (W/O) microemulsions change in entropy of the system such that,
C) Bicontinuous microemulsions
Gf= γa - Ts
A) Oil-in-water (O/W) microemulsions: Where,
In Oil-in-water type of microemulsions droplets of oil Gf = free energy of formation; A = change in interfacial
is surrounded by a surfactant (and may be co- area of microemulsion; S = change in entropy of the system
surfactant) film that forms the internal phase T = temperature ;γ = surface tension of oil water interphase
distributed in water, which is the continuous phase. It should be noted that when a microemulsion is formed
This type of microemulsion generally has a larger the change in A is very large due to the large number of
interaction volume than the w/o microemulsion. very small droplets formed. In order for a microemulsion
B) Water-in-oil (W/O) microemulsions to be formed (transient) negative value of was required, it
In water-in-oil type microemulsion droplets of water is recognized that while value of is positive at all times, it
surrounded by a continuous oil phase. These are is very small and it is offset by the entropic component.
recognized as “reversemicelles”, where the polar head The dominant favorable entropic contribution is very large
groups of the surfactant are facing into the droplets of dispersion entropy arising from the mixing of one phase in
water, with the fatty acid tails facing into the oil phase. the other in the form of large number of small droplets.
A w/o microemulsion used orally parenteralyy may be However there are also expected to be favorable entropic
destabilized by the aqueous biological system. contributions arising from other dynamic processes such
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 Journal of Advanced Drug Delivery (JADD) Volume 3 Issue 2 Mar- Apr 2016

as surfactant diffusion in the interfacial layer and 3) For intravenous use, the demand of toxicity on the
monomer-micelle surfactant exchange. Thus a negative formulation is rigorous and very few studies have
free energy of formation is achieved when large reductions been reported so far.
in surface tension are accompanied by significant 4) Use of those surfactants which are included in
favorable entropic change. In such cases, microemulsion is “generally regarded as safe” (GRAS) category can
spontaneous and the resulting dispersion is reduce toxicity (22).
thermodynamically stable (5).

Table no. 1. Physical characteristics of micelles,

5. ADVANTAGES OF MICROEMULSION SYSTEM microemulsion, emulsion, and liposomes (17)
1) Microemulsions are easily prepared and require no Delivery Advantages Disadvantages
energy contribution during preparation this is due to system
better thermodynamic stability.
Micelles Low viscosity Low
2) The formation of microemulsion is reversible. They
Small droplet solubillization
may become unstable at low or high temperature but
size Potential toxicity
when the temperature returns to the stability range,
Easy of surfactant
the microemulsion reforms.
preparation
3) Microemulsions are thermodynamically stable system
Long shelf life
and allow self-emulsification of the system.
Microemulsion High solubility Large amount of
4) Having the ability to carry both lipophilic and
of drug surfactant
hydrophilic drugs.
Small droplet Potential toxicity
5) Microemulsions act as super solvents for drug, can
size of surfactant
solubilise both hydrophilic and lipophilic drugs
Easy Drug solubility
including drugs that are insoluble in both aqueous and
preparation influenced by
hydrophobic solvents.
Long shelf life environmental
6) The dispersed phase, lipophilic or hydrophilic (O/W,
conditions
or W/O microemulsions) can act as a potential
reservoir of lipophilic or hydrophilic drugs, Emulsion Small amount High viscosity
respectively. of surfactant Instability
7) The use of microemulsion as delivery systems can High solubility Short shelf life
improve the efficacy of a drug, allowing the total dose of drug into Larger droplets
to be reduced and thus minimizing side effects(6). carrier
8) It has low viscosity compared to primary and multiple Liposomes Made from High viscosity
emulsions. lecithin and Difficult to
9) It can improve the efficacy of a drug, minimizing side cholesterol prepare
effects with reduced total dose (22). also present in Often disintegrate
the body once administered
6. DISADVANTAGES OF MICROEMULSION
SYSTEM Nanoparticles Long storage Limited solubility
1) Microemulsion having limited solubilizing capacity life of drug
for high melting substances. In vaccination, Difficult to
2) Microemulsion require large amount of Surfactants for slow prepare
stabilizing droplets. degradation in Difficult to control
3) Microemulsion stability is influenced by body size
environmental parameters such as temperature and Polymer which
pH (6). represents
constituent are
7. LIMITATIONS OF MICROEMULSIONS SYSTEM usually not
bioacceptable
Factors which limit the use of microemulsion in
pharmaceutical applications.
1) The concentration of surfactants and co-surfactants
used must be kept low for toxicological reasons.
2) Microemulsion also suffers from limitations of phase
separation (21).

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Table no 2. Comparison of microemulsion with 8. PHARMACEUTICAL FORMULATION OF

macroemulsion: MICROEMULSIONS:
Emulsions Microemulsions
(Macroemulsions) Components of microemulsion formulations

A large number of oils and surfactants are available which

can be used as components of microemulsion system but
their toxicity, irritation potential and unclear mechanism
of action limit their use. One must choose formulation
components that are biocompatible, non-toxic, and
clinically acceptable. Again the use of those formulation
components is limited to acceptable concentration range.
The emphasis is, therefore, on the use of generally
regarded as safe (GRAS) excipients.
Emulsions consist of They constantly evolve 1 Oils:
roughly spherical between various These constitute of the oil phase of the emulsions. Various
droplets of one phase structures ranging from externally applied emulsions, mineral oils, either alone or
dispersed into the other. droplet like swollen in combination with soft paraffin or hard paraffin, are
micelles to bi-continuous widely used for their occlusive and sensory characteristics
structure. as well as used as vehicle for the drug. The non-
They are lyophobic. They are on the biodegradable mineral and castor oils are widely used in
borderline between the oral preparations and these provide a local laxative
lyophobic and lipophilic effect, and fish liver oils or various fixed oils of vegetable
colloids (24). origin (e.g., arachis, cottonseed, and maize oils) as
Droplet diameter: 1 – 20 10 – 100 nm nutritional supplements. Microemulsion for transdermal
mm. delivery of terbina fine was developed by employing oleic
Require intense agitation Generally obtained by acid as oil phase (7).
for their formation. gentle mixing of 2 Surfactants:
ingredients The amount of surfactant in emulsions is very small, 0.1%
They may remain stable More thermodynamically to 1.0% of the total emulsion weight. The amount of
for long periods of time, stable than surfactant in a microemulsion is a minimum of 10% of the
will ultimately undergo macroemulsions and can total ME weight. Such large surfactant levels are essential
phase separation on have essentially infinite because of the large increase in interface area between the
standing to attain a lifetime assuming no aqueous and oil phase. Selection of a proper surfactant is
minimum in free energy. change in composition, the key to the formation of any Microemulsion. In general,
They are kinetically temperature and hydrophobic surfactants will be suitable for the formation
stable pressure, and do not tend of w/o microemulsions (ME), and the hydrophilic
thermodynamically to separate. surfactants will form o/w ME. In industrial applications,
unstable. it is common to use inexpensive ionic surfactants but in
Ordinary emulsion Microemulsion droplet food, pharmaceutical, and cosmetic applications, the ionic
droplets, however small may disappear within a surfactant toxicity limits their use. The most common
exist as individual fraction of a second anionic surfactants are the sodium di-
entities until coalescence whilst another droplet isooctylsulfosuccinate (AOT) and the sodium
or Ostwald ripening forms spontaneously dodecylsulfate (SDS). Nonionic surfactants are very often
occurs. elsewhere in the system. used in pharmaceutical microemulsion formation. Tweens
Most emulsions are Microemulsions are (ethoxylatedsorbitan esters) are well known and widely
opaque (white) because transparent or used. They are water-soluble and have high HLB values
bulk of their droplets is translucent as their and, therefore, are used mainly for making o/w
greater than wavelength droplet diameter are less microemulsions. Ethoxylated (with up to 40 EO units
of light and most oils than ¼ of the wavelength castor oil, ECO-40) and hydrogenated ethoxylated castor
have higher refractive of light; they scatter little oil (HECO) with 8 to 40 EO group attached to the hydroxyl
indices than water. light (20). group on the side chain of the triglyceride are regarded a
very efficient surfactants (8).

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 Journal of Advanced Drug Delivery (JADD) Volume 3 Issue 2 Mar- Apr 2016

Table no 3: Showing HLB ranges and the typical oily dispersion) depending on the chemical composition
application of surfactant related to it (19) and concentration of each component. The understanding
HLB value Application of their phase equilibrium and demarcation of the phase
boundaries are essential aspects of the study. As quaternary
1-3.5 Antifoams
phase diagram (four component system) is time consuming
3.5-8 Water in oil emulsion and difficult to interpret, pseudo ternary phase diagram is
often constructed to find the different zones including
7-9 Wetting and spreading Microemulsion zone, in which each corner of the diagram
agent represents 100% of the particular component. The region
can be separated into w/o or o/w Microemulsion by simply
8-16 Oil in water emulsion considering the composition that is whether it is oil rich or
13-16 Detergents water rich. Observations should be made carefully so that
metastable systems are not included (11).
15-40 Solubilizers
B) Phase inversion method
3 Co-surfactant
Phase inversion of microemulsions is formed either by
Co-surfactants play a very important role in
adding excess of dispersed phase (Phase Inversion
microemulsions. They help the surfactant reduce the
Concentration) or in response to temperature (Phase
interfacial tension to very low values to achieve
Inversion Temperature). The phase inversion method
thermodynamic stability. They both modify the curvature
makes drastic physical changes in the system such as
of the interface by incorporating additional polar groups
changes in particle size. In phase inversion temperature
and provide more fluidity to the film, preventing
(PIT) method, the interfacial tension is the key factor. On
crystallization of the tails of the surfactants, which could
cooling, the interfacial tension get lowered and can be
result in the formation of lyotropic liquid crystals. Co-
found in the phase inversion region from water-in-oil
surfactants are considered to be liquid crystal structure
(W/O) microemulsion to an oil-in-water (O/W)
breakers. They are of less help to surfactants with
microemulsion. In the phase inversion region, this low
unsaturated (double) bonds in their tails. However, they
interfacial tension helps in the spontaneous formation of
are especially essential when the surfactant has a saturated
finely dispersed, blue shining O/W PIT microemulsion. In
tail. In most cases, the co-surfactants are short (ethanol)
case of nonionic ethoxylated surfactants, as the
and medium-chain (propanol, octanol) alcohols. In some
temperature increases, their hydrophobicity increases
pharmaceutical applications (transdermal, ocular), we use
strongly therefore all practical applications of PIT
mostly those that do not present irritation. Other
microemulsions are based on the use of ethoxylated
molecules, such as amino acids and short organic acids,
surfactants. Further, changing the water volume fraction
have also been utilized (9).
causes a transition in the spontaneous radius of curvature.
By continuously adding water into oil, initially water
4 Aqueous phase
droplets are developed in a continuous oil phase. As the
This form the aqueous phase of the microemulsion.
water volume increases, the changes occurred in the
Commonly used agents are water, alcohol etc. For drugs
spontaneous curvature of surfactant causes transition
that cannot be formulated as an aqueous solution,
from a W/O microemulsion to an O/W microemulsion at
emulsions and microemulsions have typically been cost-
the inversion point. Since the phase inversion occurs at
effective and provided for ease of administration (10).
definite water concentration within the intermediate
9. METHOD OF PREPARATIONS:
A) Phase titration method microemulsion like phase, the resulting emulsion is called
B) Phase inversion method phase inversion concentration (PIC) microemulsion. A
bicontinuous microemulsion is formed at the inversion
A) Phase titration method points because of the flexible monolayer of short chain
Microemulsions are prepared by the spontaneous surfactants at the O/W interface (23).
emulsification method (Phase titration method) and can be
depicted with the help of phase diagrams. Construction of 10. PSEUDO TERNARY PHASE DIAGRAM
phase diagram is a useful approach to study the complex
series of interactions that can occur when different Microemulsion domains are usually characterized by
components are mixed. Microemulsions are formed along constructing ternary phase diagrams. Three components
with various association structures (including emulsions, are the basic requirement to form a microemulsion: two
micelles, lamellar, hexagonal, cubic, and various gels and immiscible liquids and a surfactant. The emulsion regions

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 Journal of Advanced Drug Delivery (JADD) Volume 3 Issue 2 Mar- Apr 2016

are usually characterized by constructing ternary-phase 11. DILUTION METHOD

diagrams as shown in Figure no. 2. Three components are Ternary mixtures with varying compositions of surfactant,
the basic requirement to form nano-emulsion: an oil phase, co-surfactant and oil will be equipped. The surfactant
an aqueous phase and a surfactant. If a co-surfactant is concentration will diverge from 30 to 75% (w/w), oil
used, it may sometimes be represented at a fixed ratio to concentration will diverge from 25 to 75% and co-
surfactant as a single component, and treated as a single surfactant concentration will diverge from 0 to 30% (w/w).
"pseudo-component". The relative amounts of these three For any mixture, the total of surfactant, co-surfactant and
components can be represented in a ternary phase oil concentrations always added to 100%. For example, in
diagram. Gibbs phase diagrams can be used to show the the experiment, first mixture consisted of 75% of
influence of changes in the volume fractions of the surfactant, 25% of the oily phase and 0% of co-surfactant
different phases on the phase behavior of the system. The (14). Further, the co-surfactant was increased by 5% for each

three components composing the system are each found at composition, oily phase concentration will keep constant
an apex of the triangle, where their corresponding volume and the surfactant concentration will adjust to make a total
fraction is 100 %. Moving away from that corner reduces of 100%. Forty-two such mixtures with varying surfactant,
the volume fraction of that specific component and co-surfactant and oil concentrations will prepare. The
increases the volume fraction of one or both of the two percentage of surfactant, co-surfactant and oil used herein
other components. Each point within the triangle will decide on the basis of the requirements. Compositions
represents a possible composition of a mixture of the three are evaluated for nano-emulsion formation by diluting
components or pseudo-components, which may consist appropriate amount of mixtures with appropriate double
(ideally, according to the Gibbs' phase rule) of one, two or distilled water. Globule size of the resulting dispersions
three phases. These points combine to form regions with will be determined by using spectroscopy technique.
boundaries between them, which represent the "phase Dispersions, having globule size 200 nm or below will
behavior" of the system at constant temperature and consider desirable. The area of nano-emulsion formation
pressure (12). in Ternary phase diagram will identified for the respective
The series of concentrations of oils, Surfactants, and system in which nano-emulsions with desire globule size
Co-surfactants were used to construct the system. A visual were obtain (15).
observation was made immediately for spontaneity of
emulsification, phase separation and precipitation. 12. CHARACTERIZATION OF MICROEMULSION:
Twenty compositions of each group with varying a) Viscosity:
concentrations were prepared in this investigation. The Viscosity is measure by Brookfield rotational viscometer.
methods are used to plot Ternary phase diagrams are Viscosity provides an indication of rod like or worm like
namely Dilution method and Water Titration method (13). micelles and type of microemulsion.
b) pH
Digital pH meter is the instrument use for measurement of
pH of microemulgel and results are taken into triplicate
then averages of the results are taken into consideration.
The pH of microemulsion is also required to because
change in pH may affect zeta potential and finally affect
the stability of product.
c) Drug content determination:
Drug content in microemulgel will be measured by
dissolving 1gm of microemulgel in solvent by sonication.
Absorbance will be measured after dilution at λmax nm
using UV Spectrophotometer.
d) Centrifugation:
Centrifugation will be measured to evaluated physical
stability of microemulsion. Microemulsion will be
centrifuged at ambient and 500 rpm for 10-60 min to
evaluated the system for creaming pr phase separation.
System will be observed visually for appearance.
e) Conductivity:
Conductivity measurement using Digital conductometer
provide a means of determining whether the
Fig no. 2: Constructing ternary-phase diagrams

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 Journal of Advanced Drug Delivery (JADD) Volume 3 Issue 2 Mar- Apr 2016

microemulsion is oil continuous or water continuous. The 2) Www.En.Wikipedia.Org/Wiki/Microemulsion

results are taken into triplicate and average is taken (29).
f) Dilution test: 3) Maqsood A.M., Mohammad Y.W., Mold A.H.,
If continuous phase into microemulsion, it will not crack Microemulsion Method: A Novel Route To Synthesize
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g) % Transmittance Measurement Media As Novel Drug Delivery System, Advanced Drug
The % transmittance of formulation was measured using Delivery Review, 2000,(45), 89-121.
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phase as blank. Microemulsion will be diluted 50-100 with Carrier For Improved Drug Delivery, Asian Journal Of
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h) Zeta potential and particle size analysis:
6) Singh P.K, Iqubal M.K. Shukla V.K, Microemulsion:
Particle size, size distribution and potential of
Current Trends In Novel Drug Delivery System, Journal
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14. ACKNOLEDGEMENT
Emulsifying Drug Delivery System: Formulation
Authors are thankful to the management of Amrutvahini
Techniques And Dosage Forms – A Review; Asian
College of Pharmacy, Sangamner for providing the
Journal Of Pharmacy And Life Science, 2012(2), 214-224.
necessary service in collecting the several data needed for
the preparation of this article.
13) Balakumar K, Raghavan C.V, Selvan N.T, Rahman S.M,
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