*Corresponding author,
e-mail : patihul.husni@unpad.ac.id (P. Husni)
https://doi.org/10.24198/idjp.v1i3.23715
© 2019 Husni et al
Vol 1, Issue 3, 2019 (79-83)
http://journal.unpad.ac.id/idjp
Formulation and Physical Evaluation of Cream containing Neem Oil 5%
Patihul Husni
1,2*
, Anggia D. Amalia
1
, Soraya R. Mita
1
, Norisca A. Putriana
1
, Melinda Januarti
3
1. Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas
Padjadjaran, Jatinangor 45363, Indonesia
2. Major of Industrial and Pharmaceutical Science, College of Pharmacy, Chung-Ang University, 84
Heukseuk-ro, Dongjak-gu, 06974, Seoul, South Korea
3. Klinik Padjadjaran, Jatinangor 45363, Indonesia
Received: 22 Sep 2019/ Revised: 23 Sep 2019/ Accepted: 24 Sep 2019/ Published: 1 Oct 2019
ABSTRACT
Permethrin Cream 5%, a topical scabicidal agent, is usually used for the treatment of infestation with
Sarcoptes scabiei (scabies). Nowadays, neem oil, a vegetable oil pressed from the fruits and seeds of
the neem (Azadirachta indica A.Juss), is reported having an antiscabies eect. The aim of the study
was to formulate and evaluate the physical properties of cream containing neem oil 5%. Methods of
the study were characterization of physicochemical properties of neem oil, preparation and physical
stability study at room temperature (25
o
C) and 40
o
C for three months storage of the neem oil 5%
cream. Physical evaluation involved organoleptic, homogeneity, pH, tipe of cream and viscosity.
The study results showed that all of the physicochemical properties of neem oil met the requirement.
The cream were white to yellowish white, characteristic neem oil odor, homogenous cream, pH ± 8,
viscosity approximately 2000-8000 cps and o/w cream. Three months storage of the cream showed that
the formula resulted a stable cream physically.
Keywords: neem oil, permethrin, scabies, Azadirachta indica A.Juss
1. Introduction
Scabies, one of the infectious skin diseases,
can infect more than 130 million people every
year globally [1]. Scabies is caused by infection
of the female mite Sarcoptes scabiei var hominis.
The mites live and deposit eggs into the skin. The
symptoms of scabies are due to an allergic reaction
to the mites [2].
The highest incidence rate of scabies occurs in
tropical countries, high population and low socio-
economic condition [1-5]. Scabies is the 3
rd
of 12
common skin diseases in Indonesia [6,7]. Scabies
can occur in both men and women, in all age groups,
races and social classes. The mite caused scabies can
travel from the infected person to another person
and can be transmitted through direct or indirect
physical contact with the patient [8]. The mite can
survive for about 2 to 3 days at room temperature
and average humidity [2].
First line therapy of scabies is 5% permethrin
topical cream [9] but the price of the permethrin
cream is quite expensive. This is a problem of
scabies treatment for the patient with low economy.
Anti-scabies cream containing neem oil is an
approach to solve the problem.
Neem oil is a vegetable oil pressed from the
fruits and seeds of the neem (Azadirachta indica
A.Juss). Neem oil had been used as anti-parasite
and anti-scabies [10-12]. Previous research
reported that the use of paste containing mixture of
neem oil and turmeric in scabies patients showed
a 97% improvement in 814 patients after 3 to 15
days of therapy [13]. The eectiveness of neem
oil for anti-scabies had also been tested using
clinical trial before and after the use of cream and
showed clinical cure [14]. Scabies can be treated
systemically or topically. The systemic treatment is
only indicated for the treatment of severe scabies.
P. Husni et al / Indo J Pharm 3 (2019) 79-83
80
Topical treatment is the main choice for scabies
therapy [15].
2. Method
2.1. Physicochemical test of neem oil
Neem oil used in this study came from PT.
Happy Green Pakar Barat No. 3, West Jakarta,
Indonesia. Physicochemical properties of the
neem oil was checked to ensure its originality.
The physicochemical properties determined
were organoleptic, specic gravity, refractive
index, acid value, iodine value, peroxide
value, and saponication value. The result of
the physicochemical properties determination
was compared to the specication at certicate
of analysis and literature specication. The
organoleptic was done by visually observing the
consistency, color and odor of the neem oil. Specic
gravity and refractive index was determined using
picnometer and refractometer ABBE, respectively.
Acid, iodine, peroxide, and saponication value
was calcute using titration method.
2.2. Formulation of cream
Formulation of the cream was done by mixing
the vanishing cream base and neem oil 5%. Cream
formula is listed in table 1.net
Table 1. Formula of cream
Ingredients F1
Neem Oil (% w/w) 5
Adeps Lanae (g) 1
Stearic Acid (g) 14.2
Glycerin (g) 10
Sodium Tetraborate (g) 0.25
Triethanolamine (g) 1
Nipagin (% w/w) 0.1
Aquadest (g) 75
2.3. Preparation of cream
The cream were made by mixing the water
component (glycerin, sodium tetraborate,
triethanolamine, nipagin and aqua destillata) and
oil component (adeps lanae, and stearic acid)
which had been heated at 60-70
o
C under stirring
using super mixer (Erweka). Furthermore, neem oil
was added and stirred until the homogenous cream
was formed . The cream was packaged into divided
containers for three months physical stability study.
2.4. Physical stability study of cream
The physical evaluation was done at room
temperature (25
o
C) and at 40
o
C. Physical
evaluations involved organoleptic, homogeneity,
pH, type of cream and viscosity were done at day-
0, 7, 14, 21, 30, 60 and 90. The organoleptic and
homogeneity evaluations were done by visually
observing the consistency, color and odor of
the cream. pH and viscosity were determined
respectively using pH meter and Brookeld
viscometer. Type of cream was checked visually
using methylen blue solution. The evaluation was
done triplo (n = 3) and the data was presented in
average ± standard deviation.
3. Result
3.1. Physicochemical test of neem oil
Physicochemical properties determination
results of neem oil were listed in Table 2.
3.2. Formulation and Preparation of cream
The cream were prepared using safonication
method. Stearic acid was reacted to triethanolamine
(TEA) and emulsifying agent (TEA-stearat)
was formed. This emulsifying agent caused the
mixing of oil phase and water phase and formed
a white to yellowish white, neem characteristic
odor, homogenous cream, pH ± 8, viscosity
approximately 2000-8000 cps and o/w cream.
3.3. Physical stability study of cream
The result of physical evaluation of cream was
shown in table 3.
P. Husni et al / Indo J Pharm 3 (2019) 79-83
81
4. Discussion
4.1. Physicochemical test of neem oil
Table 2 showed that all of the physicochemical
properties of neem oil used in this study met the
specication. Specic gravity is one of the important
criteria in determining the quality and purity of oil
content. Specic gravity is aected by the degree
of unsaturation and the molecular weight of the oil.
The greater average of fatty acid molecule is in the
oil, the greater specic gravity is found [16,17].
The refractive index is used for oil purity testing.
The refractive index values are inuenced by the
fatty acid component of the vegetable oils, the
free fatty acid content, the oxidation process and
the temperature. The longer carbon chain and the
more double bonds will increase the value of the
refractive index [18].
Acid value is used to measure the amount of
free fatty acids present in oil or fat. The higher fatty
acid content is in the oil, the lower quality of the
oil is got because it will speed up the process of
rancidity [19]. Iodine value represents the degree
of unsaturation of oil or fat. The greater of iodine
value is checked, the higher degree of unsaturation
is in the oil , and the higher the quality of the oil is
resulted. Peroxide value is used to determine the
degree of oil or fat damage. Saponiaciton value
represents the size of the fat molecule. The greater
saponication value is in the fat or oil, the smaller
it is molecule. All of the test results showed that
physicochemical properties of neem oil met the
literature specication [19].
4.4. Formulation and preparation of cream
The cream preparations were white to yellowish
white, neem characteristic odor, homogenous
cream, pH ± 8, viscosity approximately 2000-8000
cps and o/w cream.
4.5. Physical stability study of cream
Organoleptic and homogeneity test was done
Table 2. Physicochemical properties results of neem oil
Physicochemical properties Specication Result
Organoleptic Brown colored, oily liquid with
a neem characteristic odor
a
Brown colored, oily liquid with
a neem characteristic odor
Specic gravity (T = 30
o
C) (g/cm
3
) 0.908-0.934
a
0.920
Refractive index (T = 40
o
C) 1.4615-1.4705
a
1.4700
Acid value (meq/g) < 40
a
21.62
Iodine value (mg/100g) 65-80
a
79.65
Peroxide value (meq/g) < 20
a
17.84
Saponication value (mg/g) 175-205
a
190.3
b
a
(www.neemuses.com)
b
(Certicate of analysis)
Table 3. Odor, colour, homogeneity and type of cream after three months storage at room temperature (25
o
C) and
40
o
C (n=3)
Day Odor Colour Homogeneity Type of Cream
0 Neem characteristic odor Yellowish white Homogenous cream o/w
7 Neem characteristic odor Yellowish white Homogenous cream o/w
14 Neem characteristic odor Yellowish white Homogenous cream o/w
21 Neem characteristic odor Yellowish white Homogenous cream o/w
30 Neem characteristic odor Yellowish white Homogenous cream o/w
60 Neem characteristic odor Yellowish white Homogenous cream o/w
90 Neem characteristic odor Yellowish white Homogenous cream o/w
P. Husni et al / Indo J Pharm 3 (2019) 79-83
82
by visually observation involved odor, color, and
consistency of cream. This was done to nd out the
cream made in accordance with the color and odor
of the oil used and to result a homogenous cream.
The observation result of the tests either at room
temperature (25
o
C) or at 40
o
C showed that cream
containing neem oil was stable in organoleptic and
homogeneity for 90 days of storage.
The neem oil cream should have a pH in
accordance with the topical preparation pH range
(5.5-10) so it does not cause irritatition on the skin
and may increase user acceptance. Fig. 1 showed
that pH of the cream was approximately 8 and met
the pH specication for topical preparation. The pH
of the cream was stable for three months storage
(Fig.1).
Figure 1. pH of cream after three months storage (n=3)
Viscosity test using Brookeld viscometer
was performed to check the cream viscosity. The
viscosity of the cream preparation should be in
accordance with the criteria required by SNI 16-
4399-1996 (2000-50.000 cPs). During 90 days of
storage, Fig. 2 showed that the cream viscosity was
in the range 2000-50.000 cPs. It means that the
viscosity of the cream met the requirement required
by SNI 16-4399-1996.
The type of cream was determined using the
phase dilution method and the color method. The
result showed that type of the cream was oil in
water (o/w) and it was stable on storage for 90 days
at room temperature (25
o
C) and 40
o
C (Table 3).
Physical stability study result of the cream
containing neem oil showed that the cream was
stable in organoleptic, homogeneity, pH, type of
cream and viscosity after three months storage at
room temperature (25
o
C) and 40
o
C. This result
indicates that the cream potentially developed
as anti-scabies cream using neem oil as an active
ingredient. Long term and accelerated stability
study is needed to prove the physical stability of
the cream containing neem oil [20].
Figure 2. Viscosity of cream after three months storage
(n=3)
5. Conclusion
The physicochemical properties of neem oil
met the requirement and three months storage
of the cream showed that the formula resulted a
stable cream physically. Cream containing neem
oil is potentially developed as an anti-scabies
preparation.
6. Acknowledgments
This project is nancially supported by the
Internal Grant of Universitas Padjadjaran.
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