Advance Pharmaceutical Journal 2016; 1(4): 108-113 108

Research Article
Preparation and characterization of a Unani Transdermal Antiemetic Emulgel: A
novel approach
1 2
Mohd Nauman Saleem , Mohammad Idris
1
Research Associate, Central Council for Research in Unani Medicine, New Delhi
2
Professor and HOD, Departments of Ilmul Advia and Ilmul Saidla, A & U Tibbia College, Karol Bagh, New Delhi

Received: 4 December 2016 Revised: 22 December 2016 Accepted: 22 December 2016

Abstract
Objective: Emesis is an emergent condition which requires urgent medical attention. Since oral route of drug
administration is often not suited in this condition and due to certain limitations of conventional parenteral therapy an
alternate transdermal route was explored. A novel drug delivery dosage form was designed i.e. an emulgel. The aim of
the present study was to formulate and evaluate a Unani transdermal antiemetic emulgel (UTAE). Materials and
methods: The ingredients of emulgel formulation were Khardal (Brassica nigra), Zanjabeel (Zingiber officinale),
Podina (Mentha arvensis) and Sirka (Vinegar). After the preformulation phase, a suitable emulsion and gel base was
prepared and optimized. The emulgel was prepared by a previously reported method and was evaluated for organoleptic
characteristics and other physico-chemical properties such as pH, viscosity, spreadability, extrudability, drug content
and stability. The in-vitro permeation study of UTAE was carried out using Franz Diffusion Cell and egg shell
membrane was used as the barrier membrane. Results and conclusion: Phosphate buffer pH 7.4 was used as
dissolution medium and the temperature was maintained at 37 ± 1°C. The in-vitro permeation study of UTAE indicated
a time dependent increase in drug release throughout the study. The percentage of cumulative drug release after 24
hours was 73.31 %. The study leads to a novel exploration in Unani pharmaceutics. A clinical study should also be
envisaged to evaluate therapeutic efficacy of the prepared emulgel.
Keywords: Unani emulgel, Antiemetic emulgel, Transdermal delivery

Introduction new in conventional pharmacology but the Unani classical

Emesis or vomiting is an emergent condition in which the upper
gastro-intestinal tract rids itself of its contents by expelling them
out through the mouth (Guyton and Hall, 2007). The oral route
of drug administration is often not suited in this condition. In
such cases parenteral therapy is preferred, but there is no such
provision in Unani system of medicine. Moreover, since it is an
invasive technique, so in conventional system also it is nothing
short in terms of poor patient compliance, availability and
safety. Thus, an alternate transdermal route was explored for
drug administration (Saleem and Idris, 2015). Inter alia the
main advantage of transdermal drug delivery system is that it
bypass the first pass hepatic metabolism (Pant et al., 2015).
Though the concept of transdermal drug delivery appears to be
*Address for Corresponding Author:
Mohd Nauman Saleem
Central Council for Research in Unani Medicine, New Delhi
Phone No.: 91-9871505359
E-Mail: nauman.saleem14@gmail.com
literature has ample evidence of it. The Unani physicians
had devised various topical formulations in the form of
zimad (paste), marham (ointment), tila (liniment), roghan
(oil), etc for localized as well as systemic therapy (Saleem,
2015). But these forms are usually very sticky causing
uneasiness to the patients when applied. Moreover, they
have less spreading coefficient and need to be rubbed
thoroughly and also exhibit stability problems (Khunt et al.,
2012). To overcome such shortcomings a novel drug
delivery dosage form was envisaged i.e. an emulgel. When
gels and emulsions are used in combined form, the dosage
form is known as Emulgel (Khullar et al., 2011). It is a
unique dosage form which has been developed for a number
of drugs in recent years, intended for topical or systemic
action. It is prepared by mixing an oil-in-water type or
water-in-oil type emulsion with a gelling agent.
Incorporation of an emulsion into a gel base enhances its
stability (Prajapati et al., 2013). Transdermal emulgels have
several favorable properties such as being thixotropic,
greaseless, easily spreadable, easily removable, emollient,

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 Advance Pharmaceutical Journal 2016; 1(4): 108-113
non-staining, water soluble, longer shelf life, bio-friendly and
pleasing appearance (Jain et al., 2010). Furthermore, the
transdermal emulgel have high patient compliance.
The aim of the present study was to formulate and evaluate a
Unani transdermal antiemetic emulgel (UTAE). The
formulation was based on four ingredients, namely Khardal
(Brassica nigra), Zanjabeel (Zingiber officinale), Podina
(Mentha arvensis) and Sirka (Vinegar). Khardal was the main
ingredient of the formulation and Sirka was used as an excepient
(Kabiruddin, ynm). Zanjabeel and Podina were added to the
formulation as these drugs act as permeation enhancers (Singla
et al., 2011; Wungsintaweekul et al., 2004), and at the same time
they produce suitable synergistic effect too (Khan, 1892; Tate,
1997; Vishwakarma, 2002).
Materials and methods
Materials
The ingredients of the formulation were procured from the open
market. The impurities from herbal drugs were inspected with
naked eyes and removed. Samples of all the herbal drugs were
identified by the experts of National Institute of Science
Communication and Information Resources (NISCAIR), CSIR,
New Delhi. All other chemicals and reagents used were of
analytical grade.
Methods
Formulation of UTAE
Extraction of Volatile Oils of Khardal, Zanjabeel, and Podina:
The volatile oils from Khardal seeds, Zanjabeel rhizomes, and
Podina leaves were extracted using Clevenger apparatus
(Kumar, 2010).
Preparation of Calibration Curve for Khardal Oil: A standard
calibration curve for volatile oil of Khardal was prepared by
dilution method. The absorbances were determined
spectrophotometrically at λmax of 304nm (Saleem and Idris,
2016).
Screening and selection of surfactant and co-surfactant: Acacia
gum, Tween 20 and Tween 80 were the different surfactants
screened and ethanol was selected as the co-surfactant due to its
wider acceptance.
Optimization and preparation of emulsion: An oil-in water (o/w)
emulsion was prepared using different surfactants. The oil phase
was made by taking 75% of Khardal oil and 25% of mixture of
equal parts of Zanjabeel oil and Podina oil. The aqueous phase
used was 5% and 10% solution of Sirka. Emulsions were
prepared in different ratios of oil phase: surfactant: aqueous
phase (O: S: A) and kept at room temperature for one month to
check their stability.
Optimization and preparation of gel: The gel base was prepared
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109
by using carbopol-940 as gelling agent. Different
concentrations of gel base i.e. 1%, 1.5%, 2%, 2.5% and 3%
(w/v), respectively, were prepared and optimized.
Preparation of emulgel: After optimization and selection of
suitable gel base, the stable emulsion was incorporated into
the gel base. The emulsion was incorporated in gel base in
different percentage, i.e. 1%, 1.5%, 2%, 2.5% and 3%
(w/w), respectively, and the emulgel which remained stable
was finally selected as UTAE and evaluated.
Evaluation of UTAE
Organoleptic characteristics: The prepared UTAE was
physically inspected for its appearance, colour,
homogeneity, consistency, grittiness and phase separation.
pH measurement: The pH of prepared UTAE was
determined by using pH meter. 1 gm and 10 gm of emulgel
was dissolved in 100 ml of distilled water separately, i.e. 1%
and 10% solution of formulation was prepared and was kept
aside for 2 hrs. Then, the measurement of pH was done six
times and average values were calculated (Haneefa et al.,
2014).
Viscosity: The viscosity of UTAE was determined using
Brookfield viscometer (Haneefa et al., 2014).
Spreadability: Two sets of glass slides of standard
dimensions were taken. The UTAE was placed over one of
the slides. The other slide was placed on the top of UTAE,
such that it was sandwiched between the two slides in an
area occupied by a distance of 7.5 cm along the slide.
100gm weight was placed upon the upper slide so that the
UTAE between the two slides was pressed uniformly to
form a thin layer. The weight was removed and the excess of
UTAE adhering to the slides was scrapped off. The two
slides in position were fixed to a stand without slightest
disturbance and in such a way that only the upper slide to
slip off freely by the force of weight tied to it. A 20 gm
weight was tied to the upper slide carefully. The time taken
for the upper slide to travel the distance of 7.5 cm and
separated away from the lower slide under the influence of
the weight was noted (Oswal and Naik, 2014). The
experiment was repeated three times and the mean time
taken was calculated by using the following formula:
S=m×l/t
where,
S is the Spreadability
m is the weight tied to the upper slide (20gm)
l is the length of the glass (7.5 cm)
t is the time taken in seconds
 Advance Pharmaceutical Journal 2016; 1(4): 108-113 110

Extrudability: The extrudability test was carried out using Initially a standard calibration curve for volatile
hardness tester. A 15 gm of UTAE was filled in aluminium tube. oil of Khardal was prepared as shown in figure 1. Using the
The plunger was adjusted to hold the tube properly. The pressure concentration and absorbance data given in table 1, a
of 1 kg/ cm2 was applied for 30 sec. The quantity of UTAE standard plot was obtained.
extruded was weighed. The procedure was repeated at 3 Table 1. Data for volatile oil of Khardal
equidistant places of the tube (Oswal and Naik, 2014).
Drug content: The drug concentration in UTAE was measured by S. No. Concentration (µg) Absorbance (nm)
dissolving known quantity of UTAE in solvent (ethanol). The
1. 15.625 0.077
absorbance was measured after suitable dilution using UV-
2. 31.25 0.112
Visible spectrophotometer (Oswal and Naik, 2014). 3. 62.5 0.171
Stability study: The stability study of prepared UTAE was done at 4. 125 0.285
room temperature for 1 month, and the formulation was finally 5. 250 0.501
evaluated for appearance, pH and drug content (Khunt et al., 6. 500 0.932
2012).
In-vitro permeation study of UTAE: The in-vitro permeation
study of the prepared UTAE was carried out through Franz
Diffusion Cell and egg shell membrane was used as the barrier
membrane because the egg shell membrane resembles human
stratum corneum as it consists mainly of keratin (Haigh and
Smith, 1994). The membrane was prepared before use according
to a previously reported method (Shah et al., 2010). The water in
the outer jacket of the cell was warmed and set at 37±1°C
throughout the experiments to provide a skin surface
temperature. In the study 250mg sample of UTAE was taken and
applied over the mounted membrane in diffusion cell. After Figure 1. Calibration curve for volatile oil of Khardal
application of drug, the samples were withdrawn from the Formulation of UTAE
receptor compartment at regulated intervals. One ml of the
Selection of surfactant and co-surfactant: After screening
receptor solution was collected as sample each time and
tween 80 was selected as surfactant and the co-surfactant
simultaneously one ml of phosphate buffer solution was added
selected was ethanol.
back to the receptor cell for maintaining the same initial volume
of the receptor cell solution. The sampling schedule was at 0, 15, Optimization and preparation of emulsion: Ten versions of
30 and 60 minutes for the first hour of release and then it was at the emulsions were prepared in different ratios using 5%
th
every hour interval till 6 hour of release. After that the whole and 10% vinegar solution as aqueous phase and were
system was kept in its normal position for overnight and then next analyzed for their stability as given in table 2 and table 3,
th
day reading was taken at 24 hour. The collected samples were respectively. All the emulsions prepared with 10% vinegar
analysed using UV-Vis spectrophotometer (Shah et al., 2010). solution were found to be unstable. Whereas, in the
emulsions prepared with 5% vinegar solution, only the
Results and discussion
emulsions in percentage ratios of 10%:50%:40% and
There are a number of antiemetic formulations mentioned in 15%:50%:35% were found to be stable. Therefore, the
Unani classical literature which are topically applied over the emulsion with higher concentration of oil was selected i.e.
intact skin to achieve desired therapeutic action. So a novel in ratio of 15%:50%:35%.
dosage form was designed in the form of UTAE incorporating
Table 2. Preparation of emulsion with 5% vinegar solution
Unani drug components and pharmaceutically evaluated on the
as aqueous phase
basis of standard parameters. To formulate UTAE, firstly volatile
oils from different ingredients were extracted. The rationale S. No. Different Percentage Ratios of O: S: A Result
behind extraction of volatile oils is that according to literature
1. 10%: 50%: 40% Stable
volatile oil form is best suited for transdermal drug delivery as it
2. 15%: 50%: 35% Stable
can penetrate more through the skin and the dosage is also 3. 20%: 50%: 30% Creaming
reduced. Also in this case volatile oil contained the active 4. 25%: 50%: 25% Creaming
5. 30%: 40%: 30% Phase Separation
constituents of the respective drugs.

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 Advance Pharmaceutical Journal 2016; 1(4): 108-113 111

Optimization and preparation of gel base: Five different

versions of gel bases were prepared using carbopol-940 and
optimization of gel was done on the basis of physical stability.
The results of gel optimization are given in table 4. The gel
prepared with 3% gelling agent was found best in consistency, so
it was selected for incorporation of emulsion.
Table 3. Preparation of emulsion with 10% vinegar solution as
aqueous phase

S. No. Different Percentage Ratios of O: S: A Result

1. 10%: 50%: 40% Creaming

2. 15%: 50%: 35% Creaming
3. 20%: 50%: 30% Creaming
4. 25%: 50%: 25% Phase Separation
5. 30%: 40%: 30% Phase Separation
Figure 2. Sample of prepared UTAE
Table 4. Results of different gel base prepared Table 6. pH of UTAE
S. No. Percentage of Gelling Result
S. No. pH (1%) pH (10%)
Agent
1. 1% Free flowing consistency 1. 6.53 5.96
2. 1.5% Very low viscosity
3. 2% Very low viscosity 2. 6.44 5.89
4. 2.5% Gel consistency less viscous 3. 6.48 5.91
5. 3% Gel consistency good 4. 6.39 5.85
5. 6.49 5.93
Preparation of emulgel: The selected emulsion was incorporated 6. 6.44 5.88
in gel base in different percentages, i.e. 1%, 1.5%, 2%, 2.5% and Mean ± SD 6.46 ± 0.05 5.90 ± 0.04
3% (w/w), respectively as given in table 5. The emulgel in which
maximum amount of emulsion could be incorporated without Viscosity: The mean viscosity of prepared UTAE was 5.93 ×
4
any phase separation was selected. Therefore, the emulgel of 10 ± 0.15 cps as given in table 7.
2.5% (w/w) drug was finally selected as UTAE and further Table 7. Viscosity of UTAE
evaluation was carried out.
Table 5. Results of different emulgels prepared S. No. Viscosity (cps)
1. 5.8 × 104
S. No. Percentage of drug Result
2. 6.1 × 104
(emulsion) 3. 5.9 × 104
1. 1% Stable Mean ± SD 5.93 × 104 ± 0.15
2. 1.5% Stable
3. 2% Stable Spreadability: The mean spreadability of prepared UTAE
4. 2.5% Stable was 30.07 ± 2.23 g.cm/ sec as given in table 8.
5. 3% Phase separation Table 8. Spreadability of UTAE
Evaluation of UTAE
Organoleptic characteristics: The prepared UTAE was a S. No. Spreadability (g.cm/sec)
homogenous, viscous, white creamy preparation showing no 1. 32.6
signs of grittiness or phase separation as shown in figure 2. 2. 29.2
pH measurement: The mean pH of 1% and 10% solutions of 3. 28.4
prepared UTAE were 6.46 ± 0.05 and 5.90 ± 0.04, respectively as Mean ± SD 30.07 ± 2.23
given in table 6.

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 Advance Pharmaceutical Journal 2016; 1(4): 108-113 112

Extrudability: The mean extrudability of prepared UTAE was

0.89 ± 0.04 gm as given in table 9.
Table 9. Extrudability of UTAE

S. No. Extrudability (gm)

1. 0.92
2. 0.85
3. 0.89
Mean ± SD 0.89 ± 0.04

Drug content: The mean drug content of the prepared UTAE was Figure 3. In-vitro permeation study of UTAE
25.67 ± 0.76 mg per 100 grams as given in table 10.
In-vitro permeation study of UTAE: The in-vitro permeation
Table 10. Drug content of UTAE study of the prepared UTAE indicated a time dependent
increase throughout the study as shown in figure 3. The
S. No. Drug content (mg) release was rapid during first hour which slowed down as
1. 25 the experiment proceeded. The amount of drug release was
2. 26.5 19.95% in 15 minutes which further increased to 25.48%
3. 25.5 in 30 minutes and reached to 31.07% in one hour. The
Mean ± SD 25.67 ± 0.76 cumulative drug release gradually increased and reached to
50.34% in 6 hours. Finally, at the end of experiment, the
Stability study: The stability study of prepared UTAE was done at
cumulative drug release reached to a significant level, i.e.
room temperature for 1 month, and formulation was finally
73.31% in 24 hours, as given in table 12.
evaluated for appearance, pH and drug content as given in table
11. Conclusion
Table 11. Stability study of UTAE In the current pharmaceutical scenario, specifically in
Unani system of medicine, there is a serious need to
S. No. Day Appearance pH (1%) Drug content envisage studies on dosage form designing and
(mg) development. Accordingly, an effort was made to formulate
1. 0 White 6.46 25.6 and evaluate a novel drug delivery dosage form i.e. a Unani
2. 15 White 6.42 25.5 transdermal antiemetic emulgel (UTAE) for a very common
3. 30 White 6.35 25.2 clinical condition. The UTAE prepared was found to be
physico-chemically stable and showed no signs of skin
Table 12. In-vitro permeation study of UTAE irritation. Significant data has been generated through this
study leading to a novel exploration in Unani
S. No. Time (hours) Concentration % CDR pharmaceutics. Furthermore, clinical studies to evaluate the
(µl/ml)
therapeutic efficacy of the prepared UTAE should also be
1. 0 0 0 envisaged.
Acknowledgement
2. 0.25 1.995 19.95
I gratefully acknowledge to the Director General, Central
3. 0.5 2.548 25.48
Council for Research in Unani Medicine (CCRUM) for his
4. 1 3.107 31.07 skillful guidance and support. I would also like to
5. 2 3.667 36.67 acknowledge the faculty of Post Graduate Department of
Ilmul Saidla, A & U Tibbia College, Karol Bagh, New
6. 3 4.102 41.02
Delhi, for their valuable cooperation.
7. 4 4.475 44.75
Conflict of Interest
8. 5 4.754 47.54 Authors have no conflict of interest to declare.
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