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Nanoemulgel: A Process Promising in Drug Delivery System

Article in Research Journal of Pharmaceutical Dosage Forms and Technology · May 2020
DOI: 10.5958/0975-4377.2020.00022.1

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 Research Journal of Pharmaceutical Dosage Forms and Technology. 12(2): April - June, 2020

ISSN 0975-234X (Print) Available online at

0975-4377 (Online) www.anvpublication.org
DOI:
Research Journal of Pharmaceutical Dosage
Vol. 12 | Issue-02|
April-June| 2020 Forms and Technology
Home page www.rjpdft.com

RESEARCH aRTICLE

Nanoemulgel: A Process Promising in Drug Delivery System

V. Harshitha*, M. Venkata Swamy, D. Prasanna Kumar, K. Sai Rani, A. Trinath
Vishnu Institute of Pharmaceutical Education and Research, Vishnupur, Narsapur, Medak District– 502313,
Telangana, India
*Corresponding Author E-mail: mvenkataswamyviper@gmail.com

ABSTRACT:
Nanoemulsion was described as a promising delivery system for various drugs, including biopharmaceuticals.
Nanoemulsion is a heterogeneous network consisting of one immiscible liquid that was distributed within
another liquid as droplets. This study aimed to investigate the nanoemulgel as a transdermal delivery system for
a drug that is poorly water-soluble. Different components of nanoemulsion (oil, surfactant, and cosurfactant)
were selected based on the solubility and emulsification capacity. A high-pressure Homogenization technique
was used for Nanoemulsion preparation. The gelling agent was applied to transform nanoemulsion to
nanoemulgel as a gel matrix. Nanoemulgels loaded with drugs were characterized for particle size, SEM,
viscosity, spreadability, extrudability, pH, Stability.

KEYWORDS: Nano emulsion, gelling agents, nanoemulgel.

INTRODUCTION: Nanoemulsion:
The emulsion is a dispersed system consisting of small For most medicines, the nanoemulsion method is an
droplets well distributed in a vehicle that is immiscible. ideal drug delivery to optimize effectiveness while
Macroemulsion (droplet of 1 to 100 μm of diameter) is reducing toxicity. Researchers have excogitated the
also known as the conventional emulsion/colloid, the simple delivery of drugs in advancing research into
types of emulsions that classified according to their eminently refined novel dosage forms.
droplets. It is usually unstable with water droplets or
floats with virtually the dispersing phase and medium Nanoemulsion system consists of combining nano ranges
phase, volatile with the absorption of solid particles on of two immiscible liquids (water and oil) to form a
the surface [1]. Whereas microemulsion (droplet homogeneous solution by adding appropriate
between 10-100nm) is an isotropic liquid system with surfactants/cosurfactants with an acceptable HLB value.
more uniform size and excellent physicochemical This stable, thermodynamic system ranges from 10-100
properties and more stable nanoemulsion (droplet nm. Figure 1 describes the various compartments of a
diameter 20-200nm). nanoemulsion that has been stabilized. Nanoemulsion is
a promising option for enhancing the penetration of the
Nanoemulgel is known as the formation of hydrogel drug delivery system and targeting poorly soluble drugs
based on nanoemulsion by adding the integrated by increasing their absorption through the skin,
nanoemulsion system to the hydrogel matrix, which improving drug processing time in the target area and
influences a better penetration of the skin. eventually leading to less side effect [2]. The effects of
nanoemulsion with globules in an emulsion's nano-scale
size do not transmit on the physical properties of the
Received on 29.01.2020 Modified on 10.02.2020 emulsion itself. yet, the bioavailability of therapeutic
Accepted on 20.02.2020 ©AandV Publications All right reserved drugs as a whole was encountered. Research on the
Res. J. Pharma. Dosage Forms and Tech.2020; 12(2): bioavailability of lacidipine via transdermal route has
DOI:
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 Research Journal of Pharmaceutical Dosage Forms and Technology. 12(2): April - June, 2020

been 3.5 times higher than that of an oral course which Emulgel is not a new type of formulation and is already
was thought to be due to the avoidance of the first-pass present in the market, as shown in Table 1. On the other
metabolism. hand, Table 2 shows the example of nanoemulgel or
microemulgel formulations that have been prepared
Also, Nanoemulsion improves drug permeation across before.
the skin, which interacts with researchers' interests.
Moreover, the small size of particles, the more The formulation of nanoemulgel for the topical delivery
medication can be introduced into the mixture, which system acts as drug reservoirs which, influence the
then enhances the thermodynamics towards the skin. The release of drugs from the inner stage to the outer phase
drug-affinity for partitioning enhances skin permeation. and then further onto the skin. These release mechanisms
depend on the composition of the network polymer
One of the studies consequently narrates the implications
chains and the crosslink density [4]. Besides that, the
of Nile red (NR) dye loaded in lecithin nanoemulsion
ability of a drug to permeate the skin and successfully
was able to penetrate the skin 9.9-fold higher than the
release of the therapeutic agent is influenced by drug
NR-loaded general emulsion. Besides that, ingredients
affinity to diffuse out from the vehicle and permeate
used in the formulation consisting of ethyl oleate and
through the barrier.
propylene glycol, also act as permeation enhancers.

The greatest obstacle upon transdermal drug delivery Nanoemulgel on intact with skin will release the oil
refers to barrier properties of the stratum corneum a 10 droplets from the gel network. The oil droplets then will
µm to 20µm thick tissue layer with a great composed, penetrate the stratum corneum of the skin and directly
structured lipid/protein matrix. A recent study, of topical deliver the drug molecules without a transfer via the
delivery lipophilic flurbiprofen in nanoemulsion proves hydrophilic phase of nanoemulsions.
an increase in bioavailability by 4.4 times compared to
oral administration [3]. Hence, the nanoemulsion as a
spontaneous emulsifying method which provides
numerous advantages over another carrier such as
polymeric nanoparticle and liposomes, including low-
cost preparation procedure, high hydrophilic and
lipophilic drug loading system to enhance the longer
shelf lives upon preserving the therapeutic agents.

Nanoemulgel:
Nanoemulgel, which known as the formation of
nanoemulsion based on hydrogel is the addition of the
nanoemulsion system intergraded into the hydrogel
Figure 1: Diagram of Stabilized Nanoemulsion.
matrix which influences better skin penetration. This
mixture of nanomulgel has attracted the attention of
many scientists for the development of numerous drugs
that function to treat various kinds of skin disorders.
Table 1: Product of Emulgel Present in the Current Market
Voltaren Emulgel© Novartis Consumer Active ingredient: 100 g Diclofenac diethylamine corresponding to 1g
Health diclofena sodium, propylene glycol. Base: Fatty emulsion in an aqueous gel to
which isopropanol and propylene glycol have been added.
Reumadep Emulgel© ErbozetaEnergia Verde Arnica, Ashwagandha, Myrrh, Ginger, Rosemary, Cloves, Mint.
Emulgel Levorag Monodose© THD LAB Farmaceutici
Meloxic Emulgel© Provet Meloxicam
Benzolait AzEmulgel© Rordermal Benzoylperossido 10%
Coolnac Gel Emulgel 1 %© Chumchon Diclofenac Diethylammonium

Table 2: Researchers on Nanoemulgel Formulations

Author Year Formulation
Huabinget al. 2007 Micro emulsion-based hydrogel formulation of ibuprofen.
Mouet al. 2008 Hydrogel-thickened Nano an emulsion system (HTN) of a mixture of
camphor, menthol and methyl salicylate.
Gannuet al. 2010 Lacidipine microemulsion-based gel
Fouad et al. 2013 Poloxamermicroemulsion-based gel
Khuranaet al. 2013 Nanoemulsion-based gel of meloxicam
Eid et al. 2014 Swietenia macrophylla Nanoemulgel.

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 Research Journal of Pharmaceutical Dosage Forms and Technology. 12(2): April - June, 2020

Advantages of nanoemulgels: Table 3: List of oils used in nanoemulsion.

The nanoemulgel offers various advantages over other Oils Botanical Names
Arachis oil (Peanut oil) Arachis hypogaea
investigated topical formulations which are: Brahmi oil Baopa monnieri
• Avoid first pass metabolism. Clove oil Syzygium aromaticum
• Easy acceptable for the patient Linseed oil (Flax seed oil) Linum usitatissimum
• Suitably for self-medication. Eucalpytus oil Eucalyptus globules
• Provide local drug delivery. Jojoba oil Buxus chinensis
Peppermint oil Mentha piperita
• Easy termination of medication [5]. Neem oil Azadirachta oil
• Easily acceptable for the skin environment. Tea tree oil Melaleuca alternifolia
• Proven efficacy for a controlled and sustained drug
delivery system. Surfactant:
Surfactants are vital components used for stabilizing the
METHODOLOGY: nanoemulsion system. The anionic, cationic, and
A high-pressure homogenization method was used for nonionic types of surfactants were used in this system
the formulation of nanoemulgel. There are three steps [7]. Due to their different chemical nature, proper
involved in the formulation of nanoemulgel, which are selection of surfactants (Table 4) becomes a crucial
given fallows. factor in obtaining a stabilized delivery system. For the
1. Preparation of Nanoemulsion, formation of a stable nanoemulsion, surfactants having
2. Preparation of hydrogel and decent HLB value are required.
3. Finally, nanoemulgel will be produced by the
incorporation of Nanoemulsion into the gel with Cosurfactant:
continuous stirring [6]. Cosurfactant plays an essential role in reducing the
polarity of surfactant to obtain a stabilized nanoemulsion
The production process of nanoemulgel is
[8]. There are varieties of cosurfactants (Table 5), which
diagrammatically presented in Fig.2.
acts on surfactant interface, such as short- to medium
chain length alcohols (C3-C8). These are also helpful in
increasing the penetrability of oil to get a stabilized
formulation.

Gelling agents (hydrogels):

The unique physical properties of hydrogels have
reflected a particular interest in drug delivery
applications. These are the semisolid system with three–
a dimensional, cross-linked network of organic and
inorganic molecules and inhibition by liquid due to high
porosity.

Due to rapid researches in nanotechnology, there is a

sudden change that welcomes the new nanogel systems
Fig.2: Steps of Formulation of Nanoemulgel. [9]. Table 4 has proven its potential to deliver drugs in a
controlled, sustained and targetable manner. They have
Components of Nanoemulsion: high drug loading capacity, biocompatibility, and
The main components of Nanoemulsion are as follows: biodegradability, which are the key points to design an
effective drug delivery system. (Table 6).
Oil:
The selection of the oil phase is the most crucial Table 4: List of surfactants used in Nanoemulsion.
Surfactants Chemical Names
parameter to obtain a stabilized Nanoemulsion so that Kolliphor RH 40 Macrogolglycerol hydroxystearate
the maximum amount of drug could solubilize it. Ursolic acid 3β-Hydroxy-12-ursen-28-ic acid
Usually, the oil which has maximum solubilizing Labrafil M 1944 CS Oleoyl polyoxylglycerides
potential for a selected drug candidate is selected as an Lauroglycol FCC Propylene glycol monolaurate
oily phase for the formulation of nanoemulsions. This PEG MW>4000 Carbowax, polyglycol
Plurol Oleique CC 497 Polyglyceryl-3 dioleate
helps to achieve maximum drug loading in the Poloxamer 188 Poly(ethyleneglycol)-block-poly
Nanoemulsions. A mixture of oils can also be used to (propylene glycol)- block-poly (ethylene
soubise the maximum amount of drug. The different oils glycol)
used for the nanoemulsion formulation were enlisted in
(Table 3).

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 Research Journal of Pharmaceutical Dosage Forms and Technology. 12(2): April - June, 2020

Table 5: List of co-surfactants used in nanoemulsion. Ultrasonication:

Cosurfactants Molecular Molecular weight In the case of ultrasonication technique, ultrasonic
Formula
Transcutol P C6H14O3 134.175 g/mol vibrations are used to obtain stabilized nanoemulsion
Glycerol C3H8O3 92.09382 g/mol with reduced particle size [12]. In this, cavitation is the
Propylene glycol C3H8O2 76.095 g/mol preferred mechanism for obtaining desired nanosized
Ethanol C2H6O 46.068 g/mol formulation.
Propanol C3H8O 60.095 g/mol
Phase inversion method:
Table 6: Examples of gelling agents A stabilized nanoemulsion is obtained using the phase
Name of the gelling Molecular Molecular weight
agent formula (g/mol)
inversion method which, with the aid of the
Poloxamer C5H10O2 102.133 emulsification process, endorses chemical energy for
Polyacrylamide C3H5NO 71.077 phase transition under constant temperature.
Hydrin rubber, neoprene C4H5Cl 88.534
HPMC 55 C3H7O 59.087 CHARACTERIZATION:
Carbomer 934 C3H4O2 3,000,000APPEARANCE:
The prepared nanoemulgel formulations were inspected
Preparation of nanoemulgel formulation: visually for their color, homogeneity, consistency, and
Nanoemulsion based gels were prepared by the pH. The pH values of 1% aqueous solutions of the
incorporation of 1g of gelling agent in a sufficient prepared Gellified Emulsion is measured by a pH meter
quantity of distilled water. (Digital pH meter DPH 115 pm).

This gelling agent solution is a place under dark SPREADABILITY:

conditions for 25 hours until the complete swelling Spreadability is determined by the apparatus suggested
system obtained. by Mutimer et al (1956) which is suitably modified in
the laboratory and used for the study [13]. It consists of a
Then the drug-loaded nanoemulsion is slowly added to wooden block, which is provided by a pulley at one end.
the viscous solution of a gelling agent under magnetic By this method, spreadability is measured. An excess of
stirring. nanoemulgel (about 2 gm) under study was placed on
this ground slide. The nanoemulgel is sandwiched
Aqueous phase: between this slide and another glass slide having the
The nature of aqueous phase mainly influenced the dimension of the fixed ground slide and provided with
droplet size and the stability of nanoemulsion [10]. The the hook. A 1 Kg weight is placed on the top of the two
physiological milieu has diverse pH ranges varying from slides for 5 minutes to expel air and to provide a uniform
pH 1.2 (pH in the stomach) to 7.4 and greater (pH of film of the nanoemulgel between the slides. The excess
blood and intestine). Also, the presence of various ions of the nanoemulgel is scrapped off from the edges. The
in the physiological milieu can have a considerable top plate is then subjected to a pull of 80 grams. With the
effect on the properties of nanoemulsions. help of string attached to the hook and the time (in
seconds) required by the top slide to cover a distance of
Methods for preparing stabilized nanoemulsions: 7.5 cm is noted. A shorter interval indicates better
To get clear and stabilized nanoemulsion formulations, Spreadability. Spreadability is calculated by using the
proper fabrication procedures should be adopted [11]. formula,
The techniques are mandatory in reducing the droplet
size to the nanoscale. S= M.L/T

Homogenization using high pressure: Where,

For the preparation of stabilized nanoemulsion with
particle size 1 nm, the high-pressure homogenizer piston
is used by applying several forces, such as cavitation,
etc. This process will continue until a desired nanosize
formulation was obtained.
Microfluidization:
Microfluidization of the prepared formulation is done by
the use of a device known as microfluidizer. The use of
high pressure forces the product into microchannels to
get a submicron range particle. The process was repeated
until a stabilized nanoemulsion was obtained.
4
S = spreadability,
M = Weight tied to upper slide,
L = Length of glass slides
T = Time taken to separate the slides from each.
RHEOLOGICAL STUDIES:
The measurement of viscosity of the prepared jellified
nanoemulsion formulations was done with Brookfield
viscometer (Brookfield DV-E viscometer). The jellified
nanoemulsion was rotated at 10 (min.) and 100 (max.)
rotations per minute with spindle 6. At each speed, the
corresponding dial reading was noted16. The viscosity of
the formulation was determined.
 Research Journal of Pharmaceutical Dosage Forms and Technology. 12(2): April - June, 2020

DRUG CONTENT DETERMINATION: EXTRUDABILITY STUDIES (tube test):

The drug content in nanoemulgel was measured by a UV This test was used to measure the force required to
spectrophotometer. Ketoconazole content in extrude the material from the tube. The evaluation of
nanoemulgel was measured by dissolving the Known extrudability was based upon the quantity of
quantity of nanoemulgel insolvent (methanol) by nanoemulgel extruded from the lacquered aluminum
Sonication. Absorbance is measured after suitable collapsible tube on the application of weight in grams
dilution at 226 nm in the UV/VIS spectrophotometer required to eject at least 0.5cm ribbon of nanoemulgel in
(UV-1700 CE, Shimadzu Corporation Japan). The Drug 10 seconds [17]. The better extrudability is depended
content of the formulations was determined. upon the quantity ejected. The extrudability is than
calculated by using the following formula.
IN- VITRO RELEASE STUDY:
Franz diffusion cell (with effective diffusion area 3.14 Extrudability=Applied weight to extrude nanoemulgel from the
cm2 and 15.5 ml cell volume) was used for the drug tube (in g)/Area (in cm2).
release studies [14]. Nanoemulgel (200 mg) was applied
onto the surface of the egg membrane evenly. The egg SKIN IRRITATION TEST (patch test):
membrane is clamped between the donor and the The preparation is applied to the properly shaven skin of
receptor chamber of the diffusion cell. The receptor rat, and undesirable changes in color, change in skin
chamber was filled with freshly prepared PBS (pH 5.5) morphology should be checked up to 24 hours. If no
solution to solubilize the drug. The receptor chamber irritation occurs, the test is passed.
was stirred by a magnetic stirrer. The samples (1.0 ml
aliquots) were collected at a suitable time interval. pH DETERMINATION:
Samples were analyzed for drug content by UV visible The pH of the prepared formulations is determined by
spectrophotometer at 226 nm after appropriate dilutions. pH using the meter. In this, the formulations are placed
Cumulative corrections are made to obtain the total in a 250 ml beaker and immersing the pH meter into the
amount of drug release at each time interval. The formulation and record the readings [18]. The same
aggregate amount of drug released across the egg process was repeated three times with the same wording.
membrane is determined as a function of time.
DRUG RELEASE KINETIC STUDY:
GLOBULE SIZE AND ITS DISTRIBUTION IN To analyze the mechanism of drug release from the
NANOEMULGEL: topical nanoemulgel, the release date is fitted to the
Globule size and distribution were determined by following equations:
Malvern zeta sizer. A 1.0 gm sample was dissolved in
purified water and agitated to get homogeneous Zero-order equation:
dispersion. The sample was injected into a photocell of
zeta sizer. Mean globule diameter and distribution were Q=K0t
obtained.
Where Q is the amount of drug released at time t, and K0
SCANNING ELECTRON MICROSCOPY: is the zero-order release rate.
The morphology of nanoemulsion can be determined by
scanning electron microscopy (SEM). SEM gives a First-order equation:
three-dimensional image of the globules [15,16]. The
samples are examined at suitable accelerating voltage, In (100-Q) =In 100 – K1t
usually 20 kV, at different magnifications. The
functional analysis of surface morphology of the Where Q is the percentage of drug release at time t, and
disperse phase in the formulation is obtained through K1 is the first-order release rate constant.
SEM. Image analysis software may be employed to get
an automatic analysis result of the shape and surface Higuchi's equation:
morphology.
Q=K2√t
STABILITY STUDIES:
The prepared nanoemulgel formulations were stored Where Q is the percentage of drug release at time t, and
away from light in a collapsible tube at 25±2°C, 40±2°C K2 is the diffusion rate constant.
and 4±2°C for three months. After storage, the samples
were tested for their physical appearance, pH,
rheological behavior, drug release.

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 Research Journal of Pharmaceutical Dosage Forms and Technology. 12(2): April - June, 2020

ACCELERATED STABILITY STUDIES OF
GELLIFIED NANOEMULSION:
Stability studies were performed according to ICH
guidelines. The formulations were stored in a hot air
oven at 37±2°, 45±2° and 60±2° for 3 months [19]. The
samples are analyzed for drug content every two weeks
by UV‐Visible spectrophotometer. A stability study was
carried out by measuring the change in pH of the
formulation at a regular interval of time.
CONCLUSION:
Nanoemulsions are non-equilibrium, optically
transparent thermodynamically stable, metastable
dispersion of nano-sized particles having established
surface tension produced by certain shears, consisting of
an appropriate oil and a definite mixture of surfactants
and co-surfactants and having the capacity to dissolve
large quantities of hydrophobic drugs. The nanoemulsion
mechanism can be accomplished by means of
homogenizers, low energy emulsification and methods
for the inversion of phase temperatures. On top of that,
there are so many controversies concerning the
appropriate method of nanoemulsion preparation and it
was later proved that nanoemulsions can be formulated
by low-energy emulsification process along with high
shear homogenizer method. Nanoemulgel is also known
as hydrogel-thickened nanoemulsion (HTN), as the
system shows an increase in viscosity compared to the
nanoemulsion system. A stable formulation of
nanoemulsion is enhanced by nanoemulgel, by
decreasing surface and interfacial tension leading to
increased viscosity of the aqueous phase.
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