Online - 2455-3891

Vol 10, Issue 7, 2017 Print - 0974-2441

Research Article

FORMULATION AND EVALUATION OF SELF-EMULSIFYING DRUG DELIVERY SYSTEM OF

ETORICOXIB

SURENDRA SINGH SAURABH*, ROSHAN ISSARANI, NAGORI BP

Department of Pharmacy, Lachoo Memorial College of Science & Technology (Autonomous), Pharmacy Wing, Jodhpur - 342 003,
Rajasthan, India. Email: [email protected]
Received: 21 March 2017, Revised and Accepted: 20 April 2017

ABSTRACT

Objective: In the present dissertation work, the aim was to prepare self-emulsifying drug delivery systems (SEDDS) of etoricoxib to improve its
solubility with a view to enhance its oral bioavailability.

Methods: The prepared SEDDS was the concentrate of drug, oil, surfactants, and cosurfactant. The formulation was evaluated for various tests such as
solubility, globule size, thermodynamic stability study, pH determination, ease of dispersibility, uniformity index, drug content, in-vitro release study,
and in-vitro permeation study.

Results: The optimized formulation F6 showed drug release (79.21±2.73%), droplet size (0.546 µm). In vitro drug release of the F6 was highly
significant (p<0.05) as compared to the plain drug.

Conclusion: All formulations of etoricoxib SEDDS were showed faster dissolution than plain drug (p<0.05), mean bioavailability of etoricoxib increase
in respect to the plain drug. The F6 can be further used for the preparation of various solid SEDDS formulations.

Keywords: Dissolution, Self-emulsifying drug delivery systems, Solubility study, Bioavailability.

© 2017 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.
org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ajpcr.2017.v10i7.18612

INTRODUCTION and other chemical and solvents were of analytical grade/IP/equivalent

grade and procured from laboratory.
Etoricoxib is a non-steroidal anti‐inflammatory drug and has anti‐
inflammatory, analgesic, and antipyretic activities. Etoricoxib is a
Formulation development of etoricoxib SEDDS
selective cyclooxygenase 2 inhibitor, having anti-inflammatory and
analgesic effects. It belongs to “BCS” class II and exhibits low & variable Solubility studies
oral bioavailability due to its poor aqueous solubility. Etoricoxib The solubility of etoricoxib in various oils, surfactants, and cosurfactants
absorption through oral route is dissolution rate limited, and so, it was determined. 60 mg of drug was taken in test tube and fixed volume
requires enhancement in solubility and dissolution rate for increasing of oil/ surfactant/cosurfactant was added until the drug dissolved
its oral bioavailability [1,16-20]. completely[5-7].

Self-emulsifying drug delivery systems (SEDDS) is a potential tool for

Construction of pseudo-ternary phase diagram
improving the bioavailability of drugs with poor aqueous solubility [2].
SEDDS is a basically isotropic mixture of drug, oil, surfactant, and The pseudo-ternary phase diagram was constructed by water
cosurfactant. They spontaneously form emulsion on dilution with titration method using oil, surfactant 1, surfactant 2, cosurfactant,
water with little or no energy input. Being hydrophobic, etoricoxib may drug, and water. The mixtures of oil, surfactant 1, surfactant 2, and
be easily incorporated in the oily phase of SEDDS. On the basis of above- cosurfactant at certain weight ratios were diluted with water in a drop
mentioned criteria, it is wise to prepare SEDDS of etoricoxib [3,4]. by drop manner. These diagrams were constructed to identify the
self-emulsifying region and to optimize the concentration of oil. The
In the present study, etoricoxib shall be formulated as SEDDS, and effect pseudo-ternary phase diagram was constructed after normalization of
of different ratios of oil: smix (a mixture of surfactant and cosurfactant) readings by the aid of CHEMIX school 3_60 software. For every phase
in different concentrations was assessed on the release of etoricoxib. diagram, a specific ratio of surfactant 1: surfactant 2: cosurfactant
(1:0.5:1, 1:1:1) was taken and homogenous mixture of oil & drug was
METHODS formed under the mixing by magnetic stirring. The various ratios of
Etoricoxib was procured from Morepen Pvt. Ltd., Himachal Pradesh, oil (containing drug):smix taken are 1:9, 2:8, 3:7, 4:6, 5:5, 6:4, 7:3,
as a gift sample. Soyabean oil (Ases Chemical Works, Jodhpur), Tween 8:2, 9:1, respectively. Then, every mixture was titrated with water
80 (Loba Chemie Pvt. Ltd., Mumbai), Span 80 (Loba Chemie Pvt. Ltd., and visually observed for flowability and phase clarity [8-11]. After
Mumbai), glycerol (Siphon Laboratories, Jodhpur), methanol (Loba the identification of a self-emulsifying region in the phase diagrams,
Chemie Pvt. Ltd., Mumbai), sodium lauryl sulfate (SLS) (S.D. Fine the self-emulsifying formulations were selected at desired component
Chemical Ltd., Mumbai), ethanol (Siphon Laboratories, Jodhpur), ratios. The mixtures of selected surfactant and cosurfactant (Smix),
dialysis membrane (Hi-Media, Mumbai), Whatman’s filter paper-42 i.e., Tween 80, Span 80, and glycerol were prepared in different ratios
(Whatman Int. Ltd, England), deionized water (In-house laboratory), as presented in Table 1.
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Table 1: Ratios of Smix

S.No. Volume of surfactant Volume of surfactant Volume of Ratio of Smix

1 (ml) (Tween 80) 2 (ml) (Span 80) cosurfactant (ml) (glycerol)
Smix 1 30 15 30 1:0.5:1
Smix 2 30 30 30 1:1:1

Evaluation of etoricoxib SEDDS Table 2: Grades for ease of dispersibility

Thermodynamic stability study of formulation
S.No. Observation Grade
The following cycles are carried out for study:
1. Rapidly forming nanoemulsion (bluish ) A
Heating-cooling cycle 2. Rapidly forming microemulsion (blue to B
The prepared etoricoxib SEDDS (undiluted) were kept at a temperature transparent)
3. Fine milky emulsion formed in 2 min C
between 40°C and 45°C and kept at a temperature between 4°C. This
4. Dull oily emulsion formed in>2 min D
cycle is repeated 5 times [12-13]. 5. Poor or minimal emulsification with large oil E
globules on surface
Centrifugation
The prepared etoricoxib SEDDS (undiluted) were subjected to
centrifugation at 3000 rpm for 30 minutes and observed visually for Drug content
phase separation [14]. 5 ml of the prepared formulations were dissolved in 25 ml of methanol
in volumetric flask, and volume was made up to 100 ml by methanol.
Freeze-thaw cycle The mixture is shaken well for 15-20 minutes and kept for 24 hrs. The
The prepared etoricoxib SEDDS (undiluted) were kept at a temperature solution was filtered through 0.45 µm Whatman filter paper. The filtrate
between 0°C and 4°C and then allowed to melt at room temperature [15]. was assayed spectrophotometrically at 232.5 nm using a ultraviolet
(UV)-visible spectrophotometer [28,29].
Homogeneity
The prepared SEDDS were inspected visually for their color and In-vitro release study
homogeneity [21-25]. This study was done to determine release behavior of formulation using
dialysis technique. Dialysis membrane (Hi-media) of pore size 2.4 nm
pH determination and MWCO (Molecular weight cut-off) 12000-14000 was used for
The pH of the prepared SEDDS pre-concentrates was determined by dissolution study. Before the diffusion studies, the dialysis membrane
using a digital pH meter [12]. was soaked overnight in deionized water and for 1 hr in 1% SLS
solution. The hydrated membrane was used for dissolution study. One
Optical transparency end of the dialysis membrane/tubing was tied with a thread, and 1 ml of
The optical transparency of SEDDS formulations was determined by the SEDDS formulation and 1 ml of dialyzing medium (1% SLS solution)
using nepheloturbidometer at nephelometric turbidity units 100 [27]. were filled in the membrane. The other end of the membrane is also
tied with thread and then allowed to rotate in the dialyzing medium at
Globule size and shape 50 rpm using USP dissolution apparatus II. Samples were withdrawn at
The globules of the prepared formulations were observed under different time intervals and then after suitable dilution were analyzed.
a trinocular upright microscope, and the size of globules was The volume of samples withdrawn was replaced with the fresh dialyzing
determined [27]. medium. The diffusion study was performed at 37±2°C to different
time intervals for 2 hrs for formulated batch. Samples taken were then
analyzed using UV spectrophotometer at 233.5 nm wavelength [30,31].
Ease of dispersibility
The prepared mefenamic acid pre-concentrates are diluted (1 ml in In vitro permeation study
100 ml) of water and then stirred on a magnetic stirrer at 50-100 rpm Franz diffusion cell (with effective diffusion area 3.14 cm2 and 15 ml
and visually observed for the ease of dispersibility and assigned cell volume) was used for the drug release studies. Egg membrane was
following grades as shown in Table 2. used for the release study. The egg membrane was obtained from hen’s
egg (Gallus gallus; Genus: Gallus; Species: G. gallus) by keeping an egg
Uniformity index in a 5 N HCl solution (200 ml). It was kept until the egg shell dissolved
Uniformity index is calculated to determine whether the prepared completely in HCl solution. Further, the egg was punctured, and egg yolk
emulsion is monodispersed or polydispersed. It is the ratio of average was discarded, and egg membrane was obtained, washed completely
weight diameter to average number diameter. with de-ionized water and used.

Averageweight diameter(Dw ) Egg membrane was placed between donor and receptor compartments.
Uniformity index = In the receptor compartment of Franz diffusion cell, 1% SLS solution was
Averagenumberdiameter (Dn )
filled, and 1 ml of SEDDS pre-concentrate with the same volume of 1%
SLS solution was placed on the membrane through donor compartment.
Where, The release study was performed at 37±2°C to different time intervals for
5 hrs for formulated batch. 1 ml of recipient fluid was withdrawn at time

Dw =
∑n d4
i i
and Dn =
∑n d i i intervals as shown in Table 15 and replaced with equal volume of fresh
medium. Samples were analyzed spectrophotometrically at 233.5 nm [31].
∑n d3
i i ∑n i
RESULTS AND DISCUSSION

di=Mean diameter of particles; ni=Number of particles with diameter di. The self-emulsifying formulations consisted of oil, surfactant,
cosurfactant, and drug should be a clear and monophasic liquid at
If uniformity index is one, then the sample is monodispersed. ambient temperature when introduced into an aqueous phase and

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should have good solvent properties to allow presentation of the drug

in solution. The solubility of the drug in various vehicles is presented centrifugation, and freeze-thaw cycling. The observations for phase
separation after heating-cooling cycle, centrifugation, and freeze-
in Table 3.
thawing are shown in Tables 5-7, respectively.
Amongst oils, soyabean oil provided the highest solubility, then other
and amongst surfactants Tween 80, Span 80 and amongst cosurfactants
glycerol provided the highest solubility than other vehicles.

For the development of an SEDDS formulation, a right combination

of low and high hydrophilic-lipophilic balance (HLB) surfactant is
compulsory for the formulation of the stable microemulsion. Therefore,
a high HLB surfactant (Tween 80) and low HLB surfactant (Span 80)
were selected. Soyabean oil was found to be good with Tween 80 and
Span 80; hence, it was selected for the optimal SEDDS formulation.

The pseudo-ternary phase diagram of the system comprising the

surfactant 1, surfactant 2, cosurfactant, and the oily phase was
constructed for Smix 1 and Smix 2 and is shown in Figs. 1 and 2. Pink
area represents the region of self-emulsification. Within this area, a
ternary mixture converts into fine oil in water emulsion with only
gentle agitation. This is possible as the surfactant strongly localized
to the surface of the emulsion droplet reduces interfacial free energy
and provides a strong mechanical barrier to coalescence resulting
in a thermodynamically spontaneous dispersion. Furthermore, Fig. 1: Pseudoternary phase diagram for water:soyabean oil
cosurfactants increase interfacial fluidity by penetrating into the containing 100 mg mefenamic acid:smix 1 (Smix 1 - Tween
surfactant film creating void space among surfactant molecules. 80:Span 80:Glycerol - 1:0.5:1)

On the basis of pseudo-ternary phase diagram study, following formulas

have been derived from the area of the pseudo-ternary diagram for the
two ratios 1:0.25:1 (F1, F2, F3), 1:1:1 (F4, F5, F6). The formulation
composition of the etoricoxib SEDDS is presented in Table 4.

It has been found that none of the prepared etoricoxib SEDDS

(undiluted) showed phase separation after subject to heating-cooling,

Table 3: Solubility of etoricoxib in various vehicles

S.No. Oil Volume of Parts of vehicle

vehicle (ml) required to dissolve
1 part of etoricoxib
1. Isopropyl myristate 1 16.66
2. Castor oil 1 16.66
3. Soyabean oil 1 16.66
4. Oleic acid 1 16.66
5. Olive oil 1 16.66
6. Sunflower oil 1 16.66 Fig. 2: Pseudoternary phase diagram for water:soyabean oil
7. Groundnut oil 1 16.66 containing 100 mg mefenamic acid:smix 2 (Smix 2 - Tween
8. Sesame oil 1 16.66 80:Span 80:glycerol - 1:1:1)
9. Octanol 1 16.66
10. Tween 80 1 16.66
11. Span 80 2 33.33
12. Tween 20 1 16.66
13. Span 20 2 33.33
14. Polyethylene glycol 1 16.66
15. Propylene glycol 2 33.33

Table 4: Formulation composition of SEDDS of etoricoxib

Formulation Ingredients
code
Etoricoxib (mg) Soyabean Smix Smix
oil (ml) 1 (ml) 2 (ml)
F1 300 6.25 18.75 ‑
F2 300 5 20 ‑
F3 300 4.16 20.84 ‑
F4 300 6.25 ‑ 18.75
F5 300 5 ‑ 20
F6 300 4.16 ‑ 20.84
SEDDS: Self‑emulsifying drug delivery system Fig. 3: Etoricoxib self-emulsifying drug delivery system

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Table 5: Observations for phase separation (heating‑cooling cycle)

S.No. Formulation code Heating Cooling Duration (minutes) Number of cycles Observations for phase
temperature (°C) temperature (°C) separation
1. F1 40‑45 4 30 5 No
2. F2 40‑45 4 30 5 No
3. F3 40‑45 4 30 5 No
4. F4 40‑45 4 30 5 No
5. F5 40‑45 4 30 5 No
6. F6 40‑45 4 30 5 No

Table 6: Observations for phase separation (after centrifugation)

S.No. Formulation code rpm Duration (min) Observations

1. F1 2000‑3000 30 No phase separation
2. F2 2000‑3000 30 No phase separation
3. F3 2000‑3000 30 No phase separation
4. F4 2000‑3000 30 No phase separation
5. F5 2000‑3000 30 No phase separation
6. F6 2000‑3000 30 No phase separation

Table 7: Observations for phase separation (after freeze‑thaw cycling)

S.No. Formulation code Freezing Thawing temperature Duration (hrs) Number of cycles Observations
temperature (°C)
1. F1 0 Room temperature 18 1 No phase separation
2. F2 0 Room temperature 18 1 No phase separation
3. F3 0 Room temperature 18 1 No phase separation
4. F4 0 Room temperature 18 1 No phase separation
5. F5 0 Room temperature 18 1 No phase separation
6. F6 0 Room temperature 18 1 No phase separation

Table 8: Determined pH of etoricoxib SEDDS Table 10: Mean globule size of prepared formulations

S.No. Formulation code Mean pH±SD* S.No. Formulation code Mean globule size (µm)
1. F1 7.4±0.05 1. F1 1.514
2. F2 7.5±0.05 2. F2 1.481
3. F3 7.1±0.05 3. F3 1.330
4. F4 7.5±0.0 4. F4 0.543
5. F5 7.2±0.1 5. F5 0.593
6. F6 7.3±0.5 6. F6 0.546
*Data indicate mean±SD (n=3). SD: Standard deviation, SEDDS: Self‑emulsifying
drug delivery system
Table 11: Observations for ease of dispersibility

Table 9: Transmittance of etoricoxib SEDDS S.No. Formulation code Grade

S.No. Formulation code Average transmittance±SD* 1. F1 B

2. F2 B
1. F1 87.33±2.08 3. F3 B
2. F2 91±2 4. F4 B
3. F3 81.66±4.04 5. F5 B
4. F4 98.33±0.57 6. F6 B
5. F5 90.66±0.57
6. F6 90.33±0.57
transparent and it was due to low globule size of o/w emulsion which
*Data indicate mean±SD (n=3). SEDDS: Self‑emulsifying drug delivery system
forms after dilution with water. The readings were taken in triplicate,
and the average was calculated as shown in Table 9.
All SEDDS formulations were of yellow color, viscous preparation with
an oily and homogeneous appearance as shown in Fig. 3. The formulation F4 was found to contain smallest mean globule size,
whereas there is a slight increase in mean globule size of formulations
The pH of all the pre-concentrates F1 to F6 was found to be in the range F5 and F6. Furthermore, the globule size of F1 is largest. The mean
of 7.1-7.5, which lies in the normal pH range of the physiological fluids globule size was calculated as shown in Table 10, and the optical
and would not produce any irritation, which is shown in Table 8. microgram is presented in Fig. 4.

The results show that the transmittance for F1, F2, F3, F4, F5, and F6 is On the basis of the visual observations, it has been found that all the
87.33±2.08, 91±2, 81.66±4.04, 98.33±0.57, 90.66±0.57, and 90.33±0.57, formulations of Smix 1 and Smix 2 are of B grade (Table 11), i.e., they
respectively, from which it can be inferred that F4, F5, and F6 are most rapidly form a transparent microemulsion.

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The uniformity index of F1, F2, F4, and F5 formulations found to be near size of Smix 2 formulations as compared to Smix 1. Hence, it can be
1 to 2; hence, these formulations can be considered as monodispersed. inferred that decreasing the globule size of the drug can increase the
The observations of uniformity index are shown in Table 12. release of the drug and it might suggest that release rate of the drug
can be controlled by regulating the mean globule size. Furthermore, it
The percentage content was found to range between 87.14±6.24% and has been found that the release of etoricoxib is high in case of all the
105.36±5.08% which is within the acceptable range of 100±15% which formulations (F1 to F6) as compared to the plain drug. All formulations
indicated the homogeneous distribution of drug throughout the SEDDS. of etoricoxib SEDDS were showed faster dissolution than plain drug
The observations of drug content are shown in Table 13.

The release of etoricoxib from Smix 1 (F1, F2, F3) formulations is quite
low as compared to all the formulations of Smix 2 (F4, F5, F6). The
reason accountable for the above observation is the small mean globule

Table 12: Observations for uniformity index

Formulation Average Average Uniformity

code weight number index Dw/Dn
diameter diameter

Dw =
∑n d 4
i i
Dn =
∑n d i i

∑n d 3
i i ∑n i

F1 1.597782 1.514184397 1.055209774

F2 1.49916069 1.481854839 1.011678506
F3 1.912771619 1.330508475 1.437624529
F4 1.053475936 0.54389313 1.936917159
F5 1.235 0.593155894 2.082083333
F6 1.069724771 0.546747967 1.956522629

Table 13: Drug content of the prepared etoricoxib SEDDS

S.No. Formulation code Drug content±SD*

1. F1 87.14±6.24
2. F2 89.15±3.37
3. F3 105.36±5.08
4. F4 93.92±5.88
5. F5 99.86±1.7
6. F6 97.17±7.73
Data indicate mean±SD (n=5). SD: Standard deviation, SEDDS: Self‑emulsifying Fig. 4: Optical micrograph of etoricoxib self-emulsifying drug
drug delivery system delivery system at ×40 magnification

Table 14: In-vitro release of etoricoxib from prepared SEDDS pre‑concentrates

%Cumulative drug release±SD

Time (minutes) F1 F2 F3 F4 F5 F6 Plain drug
0 0 0 0 0 0 0 0
5 3.14±2.15 2.42±2.11 10.07±0.74 9.96±6.71 9.50±5.51 15.21±4.13 0.58±2.51
15 8.25±6.80 7.32±7.61 9.50±5.51 23.07±3.77 22.53±8.32 38.60±6.55 1.03±5.71
30 26.32±8.60 25.60±5.30 22.53±8.32 40.21±2.67 35.28±6.41 58.71±4.85 2.84±4.33
45 31.67±4.71 30.53±5.36 35.28±6.41 59.14±4.77 44.64±9.43 68.67±2.002 4.15±7.12
60 47.64±6.52 45.32±8.81 44.64±9.43 65.85±2.72 59.28±10.21 72.17±5.86 8.96±2.01
120 51.42±5.66 51.78±5.49 59.28±10.21 72.17±5.86 70.85±13.48 79.21±2.73 10.51±1.29
Data indicate mean±SD (n=3). SD: Standard deviation, SEDDS: Self‑emulsifying drug delivery system

Table 15: In vitro release of etoricoxib through egg membrane

% In vitro release of etoricoxib through egg membrane±SD

Time (min) F1 F2 F3 F4 F5 F6 Plain drug
0 0 0 0 0 0 0 0
30 0.92±1.24 3.28±1.92 3.30±2.06 4.0±2.710 1.07±1.07 5.42±2.14 0
60 4.46±2.73 5.75±0.59 7.07±1.40 5.92±1.03 4.82±2.15 7.0±0.97 0
120 9.07±3.90 16.39±0.32 16.28±5.57 14.31±3.07 14.6±4.10 13.25±3.76 0
180 17.67±2.10 17.46±1.51 27.67±3.97 32.71±2.76 20.46±5.47 32.0±1.6 0
240 22.42±2.01 30.42±2.78 41.75±3.38 40.82±3.49 29.10±2.64 39.39±1.64 0
300 27.39±1.66 34.75±7.62 43.53±1.45 50.39±6.55 40.89±3.02 53.964±10.13 0
*Data indicate mean±SD (n=3). SD: Standard deviation

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