World Journal of Pharmaceutical Research

Shaik et al. World Journal of Pharmaceutical Research

SJIF Impact Factor 8.084

Volume 12, Issue 15, 592-601. Research Article ISSN 2277– 7105

FORMULATION, DEVELOPMENT AND EVALUATION OF

MICROEMULSION USING NATURALLY PREPARED LEAF
EXTRACT OF AEGLE MARMELOS(Bael) BY HIGH PRESSURE
EMULSIFICATION METHOD

S. Harika*, B. Deepika, E. Chandrashekhar, M. Ramakrishna, Maskur Ahamed,

Md. Rafi Shaik and D. Madhan

Department of Pharmaceutics, Pulla Reddy Institute of Pharmacy, Sangareddy 502313,

Telangana, India.

ABSTRACT
Article Received on
06 June 2023,
This study, aimed to develop a microemulsion formulation utilizing
Revised on 27 July 2023, sesame oil, Aegle marmelos leaf extract and decyl glucoside surfactant
Accepted on 17 August 2023
and propylene glycol co-surfactant for potential applications in
DOI: 10.20959/wjpr202315-29248
pharmaceutical and cosmetic industries. The microemulsion system
was prepared using a spontaneous emulsification method. The pseudo
*Corresponding Author – ternary phase diagram was constructed to determine the optimal
S. Harika
composition of microemulsion, considering different ratios of sesame
Department of
oil, Aegle marmelos leaf extract and decyl glucoside surfactant and
Pharmaceutics, Pulla Reddy
Institute of Pharmacy, propylene glycol co-surfactant. The results demonstrated that the
Sangareddy 502313, microemulsion formulation composed of 10% sesame oil, 20% Aegle
Telangana, India. marmelos leaf extract and 70% decyl glucoside surfactant exhibited the
smallest droplet size (less than 100nm) characterization of prepared
microemulsion were done by stability studies, viscosity, pH, optical transmission, dye
solubility test. Moreover, the optimized microemulsion exhibited enhanced solubility and
encapsulation efficiency for the bioactive components present in Aegle marmelos leaf extract.

KEYWORDS: Aegle marmelos, Decyl-glucoside, Pseudo-ternary phase diagram, Bio-active

compounds, Sesame oil.

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Shaik et al. World Journal of Pharmaceutical Research

INTRODUCTION
In the 1940s, Hoar and Schulman pioneered the concept of a microemulsion by titrating a
milky emulsion with hexanol to produce a clear single-phase solution. Schulman coined the
term "microemulsion" in 1959, and it has since undergone several definitions and even
redefinitions. However, for the purposes of this review, the microemulsion definition
proposed by Danielson and Lindeman in 1981 will be used. A microemulsion is a system of
water, oil, and amphiphile that is a single optically isotropic and thermodynamically stable
liquid solution.[1-2]

A microemulsion is a bi-continuous system made up of bulk phases of water and oil

separated by an interfacial region rich in surfactants and co-surfactants. Droplet sizes can
range between 10 and 200nm. Microemulsions are fascinating tools because they contain
delivery systems that allow both types of drugs to be released in controlled and sustained
doses for use in a number of administration modalities. The main advantages of using
microemulsions as a delivery mechanism are that they are less toxic, make it easier to boost
medicine absorption, and allow you to adjust the rate at which medications are delivered.

Microemulsions have been extensively studied as a method of increasing the bioavailability

of drugs that are poorly water soluble.[2-3] The amazing therapeutic potential of
microemulsions makes them a unique pharmaceutical treatment. These structures also have
several advantages for oral delivery, including as increased clinical potency, improved
absorption, and lower toxicity. The unique ability of microemulsions to dissolve immiscible
liquids accounts for a considerable portion of the value and promise that researchers place on
them.

Bael is a medicinal herb found in India. It is also known as the Bengal golden apple. Bael has
been around since prehistoric times in India. It is a plant described in ancient Sanskrit
medicinal treatises by CHARAKA SAMHITA. Aegle marmelos is a healing miracle for
humans. All dermatophyte fungus is strongly inhibited by Aegle marmelos leaf extract.
Shigellosis, a diarrhoeal sickness used to treat cholera, is combated by Bael's antibacterial,
antiparasitic, and tannic content. Consuming ripe Bael in the form of juice or just the pulp has
been shown in trials to cure cholera and diarrhoea in humans. Bael is a good fruit for treating
numerous digestive ailments due to its anti-bacterial and anti-fungal properties. It is
recommended for people who have stomach ulcers because the high tannin content in its

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Shaik et al. World Journal of Pharmaceutical Research

leaves reduces inflammation. Bael's laxative properties aid in intestinal cleaning and prevent
constipation.[3-4]

Sesame oil improves sagging skin and reduces the formation of wrinkles and fine lines. It has
potent anti-aging properties. It stimulates blood flow and exfoliates dead skin cells, both of
which contribute to skin that appears young and beautiful. Sesame oil has numerous skin
benefits. The oil helps to prevent and treat existing acne by reducing redness, irritation,
blemishes, and marks. It aids in extracting impurities from the pores, thereby preventing
future breakouts. It aids in extracting impurities from the pores, thereby preventing future
breakouts. It also protects the skin from allergens and bacterial growth, boosting the
appearance of healthy skin. In the current study, a sesame oil-based microemulsion is
generated to provide synergistic effects.[4-5]

Decyl glucoside, a moderate non-ionic surfactant, is used in the formulation of newborn

shampoo and products for people with sensitive skin., Because it is compatible with cationic
surfactants and polymers, decyl glucoside is recommended for conditioning shampoo
formulations. Decyl glucoside is believed to be very gentle and gentle on the skin. It also
causes no allergies or irritation, which is why it is used in a wide range of cosmetic and
personal care products. Decyl glucoside is well known for improving the ability of a product
to wet surfaces and build stable, long-lasting lather.[5-6]

It aids in the formation of microemulsions by reducing interfacial tension. It is used to

promote the flexibility and fluidity of the interface by inserting themselves between the
surfactant tails. Many synthetic and natural chemicals can be dissolved in it. It is used as a
surfactant to prevent water beading on surfaces. For this reason, it is used in photography to
reduce the probability of mineral deposits or water spots created by water used to treat film or
paper.

Homogenizers employ severe pressure(or)shear forces to the emulsion, causing bigger

droplets to split up into smaller ones. Typically, the emulsion is pushed through a gap or
nozzle, creating high velocity and imparting shear forces that disrupt the droplets.[6-7]

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MATERIALS AND METHOD

Materials
Aegle marmelos leaves (PRIP College) sesame oil (Ayuna Ayurvedic Product) Decyl
glucoside (BRM Chemicals, Mumbai) Propylene glycol (S.D.Fine Chemicals, Mumbai)
Methanol(seccosoly).

Method to extract Aegle marmelos (Bael)leaf extraction

Fresh leaves (300g) were picked and shade dried for the entire day in the winter morning
[25ºc]. Using a motor and pestle, dried leaves [100gms] were pounded to powder. Cold
extraction with water [5ml] of 10gms of Aegel marmelos powder. The total weight ofthe
obtained component is 7ml. The dried extract was placed in a hot air oven for [30minutes170
degrees Celsius]. A total of 8gms of total component was collected. The dried extract was
dehydrated for two days before being stored in an airtight container.[7-8]

Fig. 1: Extract of aegle marmelos (Bael).

Construction of pseudo ternary phase diagram

To determine the existence range of a microemulsion, a pseudo ternary diagram was created
using the water titration method at room temperature (25°C). Based on the predictions made
by the phase diagram, an optimum proportion of aqueous phase and oil phase, Surfactant
concentration can be adjusted. These diagrams are used to determine the region of
microemulsion existence and study the effect of different Surfactant mixture weight ratios on
the extent of stable microemulsion area. As an oil phase, sesame oil was used, and Decyl
glucoside and propylene glycol were utilised as surfactant and co-surfactant, respective.

The Smix ratio was chosen to be 3:1w/w. For each phase diagram at a particular Smix
Concentration and sesame oil were added in the proportions of 1:1,2:1,3:1 (%w/w), and the
mixture was diluted with distilled water by sequential addition. At room temperature, water
was added drop by drop while mixing on a magnetic stirrer, and the sample was labelled as
optically clear or muddy. The microemulsion was identified as a clear, isotropic mixture.

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Shaik et al. World Journal of Pharmaceutical Research

From the end point of titration of samples, the percentage of three different phases oil, water,
mixture of surfactant and co-surfactant was calculated. The mass percent composition of the
components like oil, Smix, and Water was calculated and then plotted on triangular
coordinates to construct the pseudo ternary diagram.[8-9]

Determine the weight proportion of each system component. Determine the weight % of oil
and water and Surfactant mixture, using a triangle coordinate system, draw the Pseudo
ternary Phase diagram. The triangle vertices represent the three system components [Sesame
Oil, Water, and Surfactant]. Divide the triangle into regions that represent the various phases.
Begin by selecting a composition point within the triangle and determining the phase
behaviour of the system at that point empirically [by visually inspecting the sample or using
another characterisation technique]. Repeat the preceding process for many composition
locations within the triangle to map out the system's phase behaviour. Connect the phase
boundaries to form the pseudo ternary phase diagram, which represents the system's multiple
regions and phase transitions.[9-10]

Table 01: Titration chart used in construction of pseudo-ternary phase diagram.

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Shaik et al. World Journal of Pharmaceutical Research

Fig. 2: Pseudo ternary diagram of microemulsion formulated with sesame oil (oil
phase), decyl glucoside(Surfactant), propylene glycol(co-surfactant) and water.

FORMULATION OF MICROEMULSION
1. Collect the ingredients: sesame oil, Decyl glucoside, propylene glycol, and aegle
marmelos leaf extract.
2. Prepare the oil phase: Combine sesame oil (20l) and aegle marmelos (0.5gms) leaves
extract in a beaker. Gently stir to ensure even mixing.
3. Prepare the water phase by combining decyl glucoside and propylene glycol in a separate
beaker. Gently combine the items in a mixing bowl.
4. Mix the phases: Slowly add the water phase [a combination of decyl glucoside and
propylene glycol] to the oil phase [sesame oil and aegle marmelos leaf extract]. To avoid
excessive foaming, carefully stir the mixture.
5. Emulsification: Run the combination phase through a high energy emulsifier, such as a
high-speed homogenizer or sonicate. In order to break down the oil droplets and enhance
emulsification, apply a strong energy input to the mixture.
6. Using any online statistical software such as XLSTAT, construct the pseudo ternary
phase diagram at certain concentrations of 1:1,2:1,3:1 (%w/w).
7. Evaluation: Once emulsification is complete, assess the stability and appearance of the
microemulsion, as well as the sign of phase separation, pH, and viscosity.[10-14]

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Fig. 3: Appereance of microemulsion with certain concentration 1:1,2:1,3:1(%W/W).

CHARACTERIZATION
pH determination
pH value of the microemulsion was determined at 25°c by pH meter (digital pH meter) the
obtained value is 6.42±0.04.[14-15]

Percentage transmittance
Transparency of microemulsion was determined by measuring the percentage transmittance
at 650nm against distilled water as blank using UV-Visible spectrophotometer 3000+ T60.[15-
16]

Centrifugation test
In this sample were centrifuged at 3000rpms for 60 minutes and then were examined for
whether the system is monophasic or biphasic.[16-18]

Viscosity measurement: Rheological behaviour of the formulation was evaluated using

Brookfield viscometer at a room temperature.[18-19]

Staining test/dye solubility test: water soluble dye, methylene blue solution of 10µl was
added to the emulsion. If the continuous phase is water (o/w emulsion), the dye will dissolve
uniformly throughout the system. If the continuous phase is oil (w/o emulsion) the dye will
remain cluster on the surface of the system.[19-20]

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Shaik et al. World Journal of Pharmaceutical Research

CONCLUSION
This study successfully developed a stable microemulsion formulation using sesame oil,
Aegle marmelos leaf extract, decyl-glucoside surfactant. The optimized microemulsion
exhibited improved solubility, encapsulated efficiency, controlled release. These findings
suggest that the developed microemulsion could be a promising vehicle for the enhanced
delivery of bioactive compounds, with potential applications in pharmaceutical and cosmetic
industries, further studies are warranted to explore its therapeutic efficacy and evaluate its
performance in various formulations and applications.

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