International Journal of Bioassays

ISSN: 2278-778X
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Research Article

RICE BRAN WAX-A NOVEL EXCEPIENT FOR PHARMACEUTICAL TOPICAL DOSAGE FORMS
Basarkar UG*
PG Department Of Botany, G. E. Societys, H.P.T. Arts & R.Y.K. Science College, Nashik 422 005 (Ms), India
Received for publication: October 27, 2012; Accepted: January 12, 2013.

Abstract: The crude rice bran wax was obtained from M/S Bajaj rice mills, Gondia (MS) which was dark brown in
color & contains nonwaxy impurities & fixed oil. After purification around 38gm wax obtained which was almost
white, light in weight and non-sticky. No instances of skin irritation or sensitization symptoms such as edema /
rending of the skin were observed on the skin of Albino rabbits even after 24 hrs. Therefore wax was nontoxic &
safe to use in pharmaceutical preparations. In the present study the melting range of rice bran wax was found to
be 78840 which is higher, may reduce the diffusion of drug across the layers of skin. Therefore, in the present
study efforts will be made later on to reduce the melting range by addition of low melting point fats like mango
kernel fat (M.P. 34.7oC). Solubility studies reveal that the wax is soluble in organic solvents like chloroform &
petroleum ether showing typical solubility properties of waxes. Refractive index of a compound gives an idea of
purity of the compound & the refractive index of the test sample was found to be 1.44 at 70oc. Sap value of rice
bran wax is 68 72. The acid value of rice bran wax is 12 14. The iodine value of rice bran wax is 9 11. From the
above data the physicochemical properties of rice bran wax was found to be within the range of other waxes used
in topical preparations. Therefore rice bran wax may be utilized as a base in topical preparations. Different topical
formulations such as ointments (oleaginous, modified hydrophilic ointment and modified bellers ointment base)
were formulated with purified rice bran wax and compared with simple ointment (control) and marketed
formulation. All these formulations contain 2% diclofenac sodium. All the formulations were evaluated for p H
rheological studies like apparent viscosity, spread ability and diclofenac sodium content. P H of all formulations
was found to be 5.98 7.30, thus indicating the suitability for application on the skin. Diclofenac sodium content of
all the formulations was found to be above 95% indicating the suitability of the method adopted for preparing the
formulations. Shelf life and release of diclofenac sodium content in vivo study will be made further.
Keywords: Rice bran wax, Topical, Pharmaceutical

INTRODUCTION
Many fats and oils contain a number of minor
components, which are referred as nonglycerides or
waxes. Many of these nonglycerides play an
important role in providing pharmaceutical and
industrial benefits. In fact the recent trends are
directed to explore and establish proper usage of
nonglycerides occurring in the natural lipid materials
like oils and fats. Such trends are considered extremely
important to improve the economy of the lipids and to
meet also the newer possibilities of utilization of the
nonglycerides and derivatives of oils and fats. Many
investigations around the world have already shown
newer pathways for utilizing the nonglycerides in some
specific fields. R and D efforts are still pursued to find
out newer technologies for utilizing the nonglycerides
in a diversified manner. Although waxes are abundant
in nature, a limited numbers only are commercially
used.
During the past few decades a number of non
conventional vegetable oils have been accepted as
good quality edible oils in India and in other countries.
Since India is one of the principle producers of rice in
the world enormous stress is laid upon the extraction
*Corresponding Author:
Dr. Basarkar UG,
Assistant Professor,
P. G. Department Of Botany, G. E. Societys,
H.P.T. Arts & R.Y.K. Science College,
Nashik 422 005 (Ms), India

828

of oil from rice bran. Rice bran is the brown layer

between the rice and outer husk of the paddy. The
bran is obtained as the by-product in rice milling. Rice
bran contains around 15 20% of oil, which can be
economically obtained only by solvent extraction
process. Rice bran oil is now gaining importance as one
of the edible oils in India because of its nutritional
property. It contains vitamin E, which is not only has a
antioxidant property but also has a antifertility activity.
Crude rice bran wax is dark brown in color and has
its own typical physical and chemical composition. The
literature survey reveals that rice bran wax has been
used in cosmetics and toiletries. Unfortunately the
details of this literature are not available. Rice bran wax
is also utilized as an ingredient for coating candy and
chewing gums. But the utilization of rice bran wax in
pharmaceuticals is meager or hardly there is any report
inspite of large production. Therefore the rice bran wax
utilization in pharmaceuticals is worth investigating.
Keeping in view the potential availability of rice, its
contents such as oils and wax an attempt is made to
utilize rice bran wax as pharmaceutical aid.

International Journal of Bioassays, 2013, 02 (05), 828-832

Basarkar UG:

MATERIALS AND METHODS

Procurement of Crude Rice Bran Wax:
The crude rice bran wax was obtained from M/S
Bajaj rice mills, Gondia (MS).
Purification and Bleaching Of Crude Rice Bran Wax:
Evaluation of Physicochemical Properties of
Bleached Rice Bran Wax (Table.1): Melting range,
Solubility, Refractive index, Specific gravity & Skin
sensitivity test.
Table.1: Evaluation of physicochemical properties of
bleached rice bran wax
S. NO.

PROPERTTIES

RESULT

1
2

Melting range
Solubility

3
4
5

Refractive index
Specific gravity
Saponificable value

78 84 0C
Soluble in chloroform, Petroleum
ether, Insoluble in Acetone&
Water
1.44 at 70oc
0.93
68 72

6
7

Acid value
Iodine value

12 14
09 11

Unsaponificable
matter

60 - 62

- 43%
- 30%
- 25%
- 02%

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PH

Apparent
viscosity
at 100rpm
(cps)

Spreadibility
(Sec)

Diclofenac
sodium
content (%)

6.23

32,200

16

96.20

7.30

22,800

18

95.80

6.72

285,600

45

97.85

5.98

24,250

33

98.04

6.04

16,200

15

98.20

Release of Diclofenac sodium from rice bran wax

ointment (Table-3, 4, 5, 6, 7, 8: Fig 1- 6)
Table.3: Cumulative % of Diclofenac sodium released
from simple ointment IP (Control) in vitro
Hour

- 20
- 20
- 12
- 01
- 0.025
- 0.015
- 0.10

Formulation
Simple
ointment IP
Rice bran wax
ointment
(Oleaginous
base)
Rice bran wax
ointment
(Modified
hydrophilic
ointment
base)
Rice bran wax
ointment
(Modified
Bellers
ointment
base)
Marketed
formulation

1
2
3
4
5
6
7
8
9
10

Cumulative % of Diclofenac
sodium released *
4.81
8.14
10.73
15.54
19.98
23.31
28.12
30.48
33.74
34.92

Std. Dev.
(+ SD)
0.50
0.30
0.55
0.76
0.74
0.50
1.00
0.57
1.04
0.90

Std. Error
(+ SE)
0.46
0.31
0.42
0.50
0.49
0.40
0.57
0.43
0.58
0.54

Average of three determinations

Table.4: Cumulative % of Diclofenac sodium released
from Rice bran wax ointment (Oleaginous base) in vitro
Hour

- 100
1
2
3
4
5
6
7
8
9
10

iii) Modified Bellers ointment base (% w/v)

Rice bran wax
Cetyl alcohol
Propylene glycol
Sod. Lauryl sulphate
Methyl paraben
Propyl paraben
Sodium metabisulphite
Diclofenac sodium
Purified water q. s.

Sr.
No.

The following ingredients used in the present work

in fusion method in the preparation of modified
hydrophilic ointment base.
ii) Modified hydrophilic ointment base (%w/v)
Rice bran wax
Stearyl alcohol
Propylene glycol
Sod. Lauryl sulphate
Methyl paraben
Propyl paraben
Sodium metabisulphite
Diclofenac sodium - 02
Purified water q. s.

Table.2: pH, Viscosity, spreadibility and Diclofenac

sodium content of different topical preparations
containing rice bran wax

Rice bran wax as an ointment base and its effect

in release of Diclofenac sodium
a) Trituration method and fusion method are used in
the preparation of ointments. The following oleaginous
ingredients are used in the preparation of present
ointment
i)
Oleaginous BaseRice bran wax (bleached)
Mango kernel fat
Arachis oil
Diclofenac sodium

Determination of Diclofenac sodium content and

Determination of Viscosity and pH of Ointments
(Table.2)

- 03
- 15
- 10
- 01
- 0.025
- 0.015
- 0.10
- 02
- 100

Cumulative % of Diclofenac
sodium released *
4.29
6.069
8.95
11.24
14.50
16.42
19.61
22.57
25.97
29.82

* Average of three determinations

829

Std. Dev.
(+ SD)
0.05
0.10
0.60
0.30
0.09
0.20
0.60
0.35
0.80
0.35

Std. Error
(+ SE)
0.13
0.18
0.44
0.32
0.17
0.26
0.44
0.34
0.52
0.34

International Journal of Bioassays, 2013, 02 (05), 828-832

Basarkar UG:

Table.5: Cumulative % of Diclofenac sodium released

from Rice bran wax ointment (Modified hydrophilic
ointment base) in vitro
1
2
3
4
5
6
7
8
9
10

Cumulative % of Diclofenac
sodium released *
6.06
10.43
19.68
22.94
28.34
34.18
39.51
42.18
45.73
48.61

Std. Dev. (+
SD)
0.05
0.08
0.08
0.13
0.27
0.06
0.05
0.20
0.12
0.07

Fig - 1 Cum ulative % of diclofenac sodium

rele as ed from sim ple ointm ent IP (Control) in
vitro

Std. Error (+
SE)
0.13
0.16
0.16
0.21
0.30
0.14
0.13
0.26
0.20
0.15

40
35
30
25
20
15
10
5
0

Cumulative %

Hour

Figure.1- 6: Release of Diclofenac sodium from rice bran

wax ointment

* Average of three determinations

Std. Dev. (+
SD)
0.50
0.58
1.52
0.58
1.02
1.15
1.21
1.15
1.53
1.58

Std. Error (+
SE)
0.41
0.44
0.71
0.44
0.58
1.73
1.78
1.73
0.50
0.44

10
0
1

10

Hours

Fig - 3 Cumulative % of diclofenac sodium from

rice bran wax ointment (Modified hydrophilic
ointment base) in vitro

Std. Dev. (+
SD)
1.04
1.15
1.04
1.53
0.52
1.00
1.53
1.00
1.53
0.58

Std. Error (+
SE)
0.59
0.42
0.59
0.71
0.41
0.58
0.71
0.58
0.71
0.44

60
Cumulative %

1
2
3
4
5
6
7
8
9
10

Diclofenac

11

20

Table.7: Cumulative % of Diclofenac sodium released

from Marketed formulation in vitro
Cumulative % of
sodium released *
9.69
17.98
26.34
38.33
45.06
54.61
64.38
71.63
78.36
84.50

10

30

* Average of three determinations

Hour

40
Cum ulative %

1
2
3
4
5
6
7
8
9
10

Cumulative % of Diclofenac
sodium released *
5.77
11.84
18.64
28.12
31.22
38.33
43.06
46.40
51.94
59.94

Fig - 2 Cumulative % of diclofenac sodium

released from rice bran wax ointment (Oleaginous
base) in vitro

Table.6: Cumulative % of Diclofenac sodium released

from Rice bran wax ointment (Modified Bellers
ointment base) in vitro
Hour

Hours

50
40
30
20
10
0
1

10

Hours

Fig - 4 Cumulative % of diclofenac sodium

released from rice bran wax ointment
(Modified bellers ointment base) in vitro

*Average of three determinations

70

1
2
3
4
5
6
7
8
9
10

Rice bran
wax
ointment
(Oleaginous
base)

4.81
8.14
10.73
15.54
19.98
23.31
28.12
30.48
33.74
34.92

4.29
6.06
8.95
11.24
14.50
16.42
19.61
22.57
25.97
29.82

5.77
11.84
18.64
28.12
31.22
38.33
43.06
46.40
51.94
59.60

Rice bran
wax
ointment
(Modified
Bellers
ointment
base)
6.06
10.43
19.68
22.94
28.34
34.18
39.51
42.18
45.73
48.61

50
40
30
20
10

Marketed 0
formulation

9.69
17.98
26.34
38.33
45.06
54.61
64.38
71.63
78.36
84.50

*Average of three determinations

10

Fig - 5 Cumulative % of diclofenac sodium released

from marketed formulation in vitro
100
80
60
40
20
0
1

Hours

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Hours

C u m u la t iv e %

Hour

Simple
ointment
IP
(Control)

Rice bran
wax
ointment
(Modified
hydrophilic
ointment
base)

60
Cumulative %

Table.8: Cumulative % of Diclofenac sodium released

from different formulations in vitro

830

10

International Journal of Bioassays, 2013, 02 (05), 828-832

Basarkar UG:

after 24 hrs. Therefore wax was nontoxic and safe

to use in pharmaceutical preparations.

Fig - 6 Cumulative % of diclofenac sodium

released from different formulations in vitro

Cumulative %

100
80
60
40
20
0
1

10

Hours
Simple ointment IP (Control)
Rice bran wax ointment (Oleaginous base)
Rice bran wax ointment (Modified hydrophilic ointment base)
Rice bran wax ointment (Modified Bellers ointment base)
Marketed formulation

In vitro release studies:

Preparation of skin and estimation of drug:
Excised abdominal skin of 15 20 weeks old albino mice
of either sex was used. The skin on the epidermal side
was shaved. While the tissues on the dermal side
including blood vessels were removed after which the
skin was washed with distilled water and mounted on
Franz diffusion cell (Franz, 1975). It is a simple glass
instrument made of two pieces with an o ring of
rubber which links both the parts by a clamp. The top
portion is for retaining the ointment with a capacity of
3 gm. The receptor phase (phosphate buffer, p H 7.2)
constituting the lower part is receptacle of 7.4 ml
capacity was completely filled into the cell without air
bubbles. It is provided with a sampling part, a
temperature jacket and an enlarged portion for the
revolving movement of a string lead by a magnetic
stirrer. In vitro studies of all rice bran wax formulations
were studied up to 10 hrs.
Around 0.5 gm of prepared test ointments was
used on the top portion of the Franz diffusion cell and
whole assembly was placed on organ bath and the
receptor phase was agitated using a magnetic stirrer
(100 rpm) and its temperature was regulated at 37oc +
1. Aliquots were (1ml) withdrawn at one hour intervals
for 10 hours and were replenished with fresh buffer
solution (1ml). This was diluted properly, mixed
thoroughly and drug content was determined with a
spectrophotometer (Systroniocs, Model 103).

RESULTS AND DISCUSSION

Procurement of Crude Rice Bran Wax: The crude

rice bran wax was obtained from M/S Bajaj rice
mills, Gondia (MS) which was dark brown in color
and contains non waxy impurities and fixed oil.

Purification and Bleaching of Crude Rice Bran Wax:

Around 38 gm wax was obtained which was almost
white, light in weight and non sticky.

Skin Sensitivity Test (Patch Test) Of Rice Bran Wax:

No instances of skin irritation or sensitization
symptoms such as edema / rending of the skin
were observed on the skin of Albino rabbits even

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831

In the present study the melting range of rice bran

wax was found to be 78840c. Kokate et al., (1994)
reported the melting range of lanolin (34 40oc),
yellow bees wax (60 65oc) and hard paraffin (5057oc). Trease and Evans (1983) reported the melting
range of lanolin (36 42oc) and spermaceti (46-50oc).
According to IP (1996) the melting range of lanolin is 34
-44oc. Yellow bees wax is 61-65oc and yellow soft
paraffin is 50- 57oc. From the above comparisons the
melting range of rice bran wax was found to be higher,
which may reduce the diffusion of drug across the
layers of skin. Therefore, in the present study efforts
were made to reduce the melting range by addition of
low melting point fats like mango kernel fat (M.P.
34.7oC) as reported by Thampi and Schroff (1962).
Vegetable oils (William, 1995) like arachis oil in different
ratios when added in formulations also reduce melting
range.
Solubility studies reveal that the wax is soluble in
organic solvents like chloroform and petroleum ether
showing typical solubility properties of waxes.
Refractive index of a compound gives an idea of purity
of the compound and the refractive index of the test
sample was found to be 1.44 at 70oc.
Sap value of rice bran wax is 68 72 while sap
value of other waxes reported by Kokate et al., (1994)
is lanolin (92 105) and yellow bees wax (90 103). As
per Wallis (1985) the sap values of lanolin is 90 102
and spermaceti is 125 136. While IP (1996) gives sap
values of lanolin (90 105) and yellow bees wax (87
104). The acid value of rice bran wax is 12 14. Trease
and Evans (1983) report the acid value of lanolin (NMT
1) and yellow bees wax (18 24). According to Wallis
(1985) the acid value of bees wax is 18 24 and
spermaceti is NMT 1.
The iodine value of rice bran wax is 9 11. Trease
and Evans (1983) reports the iodine values of lanolin (18
- 32) and yellow bees wax (8 11) while according to
Wallis (1985) the iodine value of lanolin is 18 32 and
spermaceti is NMT 1.
From the above data the physicochemical
properties of rice bran wax was found to be within the
range of other waxes used in topical preparations.
Therefore rice bran wax may be utilized as a base in
topical preparations.
The literature reports reveals that the rice bran
wax has been employed in various external
preparations like cosmetics (Buffa, 1976) but no further
details could be traced. To evaluate the use of rice bran
wax as an ointment base, the studies would be

International Journal of Bioassays, 2013, 02 (05), 828-832

Basarkar UG:

inconclusive if the report of the skin irritation test is not

reported. No instances of skin irritation or sensitization
were observed in skin sensitivity test carried out on
albino rabbits by the rice bran wax so the wax is
harmless to the skin and can be used in topical
formulations.

6.

Sable V, Sable PM and Lakhotiya CL (2007) Invitro studies on

rice bran wax as skin moisturizer. Ind. J. Pharmaceutical Sci., 69
(2): 215-218.

7.

Mangold H, (1969) Thin layer chromatography, edited by E.

Sthal, Springer, V and Berlin, H., Newyork: 377.

8.

Sule S and Joshi SB (1994) Formulation and Invitro evaluation of

albumin micro spheres containing diclofenac sodium, M. Pharm.
Thesis, Nagpur University, Nagpur.

9.

Thampi PP & Schroff ML (1962) Utilization of mango seed fat as

suppository base. The Indian J. OF Pharmacy, 24, 9: 213 214.

10.

Trease GE & Evans WC, (1983) Drugs of biological origin, acids,

alcohols & esters. Pharmacognosy, 12th Edition: 320.

11.

Warth HA, The chemistry and technology of waxes, Chapman

and Hill LTD., London (1956): 237.

12.

Wallis TE, (1985) Fi9xed oils, fats & waxes. Textbook of

Pharmacognosy, 5th Edition, 519 525.

13.

William JR. Jr. (1995) Pharmaceutical necessities. Remington:

The science & practice of Pharmacy, Vol 1, 19th Edition, 1400.

REFERENCES
1.

2.

3.

Buffa CW, (1976) Rice bran wax A new wax for cosmetics,
drugs & toiletries. Cosmet. Toiletries, 91, 10: 14 16.
Draize JH, Woodward C, Calvery HO, J. Pharmacol. Exp. Therap.,
(1944) Ph. D. Thesis Nagpur Univ., (1990) Comparative
evaluation of rosin & abietic acid derivatives as cosmetic
materials. 82, 377.
Edwin RC, Fore SP, Janseen HJ and Feuge RO (1953) Rice bran
oil. VII. Tank settlings from crude rice bran oil as a source of
wax. J. Am. Oil Chem. Soc., 30: 9 14.

4.

Indian Pharmacopoeia, (1996) Ministry of Health, Govt. of India.

5.

Kokate CK, Purohit AP & Gokhale SB, (1994) Pharmacological

grouping of crude drugs. Pharmacognosy, Nirali Prakashan, 3rd
Edition, 280.

Source of support: Nil

Conflict of interest: None Declared

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