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ISSN No. 2321-2705 | DOI: 10.51244/IJRSI |Volume XII Issue IX September 2025
Page 3953
Formulation and Characterization of Ketoconazole Transferosomal
Gel for Effective Topical Fungal Treatment
Neelu Vishwas
1
, *Rakhee Kapadia Jain
2
, Jitendra Banweer
3
1
PG Scholar, SIRT-Pharmacy, Sanjeev Agrawal Global Educational University, Bhopal, Bhopal (MP),
India
2
Professor, SIRT-Pharmacy, Sanjeev Agrawal Global Educational University, Bhopal, Bhopal (MP),
India
3
Professor (Dean) SIRT-Pharmacy, Sanjeev Agrawal Global Educational University, Bhopal, Bhopal
(MP), India
*Corresponding Author
DOI: https://doi.org/10.51244/IJRSI.2025.120800354
Received: 06 Sep 2025; Accepted: 12 Sep 2025; Published: 14 October 2025
ABSTRACT
study focuses on the formulation and characterization of a ketoconazole-loaded transferosomal gel for effective
topical management of fungal infections. Transferosomes, ultra-deformable vesicular carriers, were employed
to enhance drug penetration through the skin and improve therapeutic efficacy. Ketoconazole transferosomes
were prepared using the thin-film hydration method and optimized based on vesicle size, entrapment
efficiency, and deformability. The optimized formulation was incorporated into a Carbopol-based gel and
evaluated for physicochemical properties including pH, spreadability, viscosity, and drug content. In vitro drug
release and ex vivo skin permeation studies demonstrated sustained and enhanced release compared to
conventional formulations. Antifungal activity against Candida albicans confirmed improved efficacy of the
transferosomal gel. Stability studies revealed good formulation stability under refrigerated conditions. Overall,
the developed ketoconazole transferosomal gel presents a promising alternative to conventional topical
preparations, offering improved skin penetration, sustained release, and enhanced antifungal activity for
effective topical fungal treatment.
Keywords: Ketoconazole, Transferosomes, Topical gel, Fungal infection, Skin permeation, Antifungal
activity.
INTRODUCTION
Infections caused by pathogenic fungi and limited to the human hair, nails, epidermis, and mucosa are referred
to as superficial fungal infections. Despite the fact that these infections are rarely dangerous or life threatening,
they are important because of their worldwide distribution, frequency, person-to-person transmission, and
morbidity.
1
Dermatophytes are pathogens, which cause superficial fungal infection. The dermatophytes have
the capacity to invade skin, hair and nails of humans and other animals to produce an infection. The
dermatophytes have a saprophytic presence. They cause the surface infections through colonization
individually of skin, hairs and nails in human beings known as ringworm, jock itch etc.
2
Most dermatophyte infections are not serious in healthy people, although some conditions are easier to treat
than others. Infections in glabrous skin usually resolve within 2- 4 weeks with treatment. Common fungal
agents are itraconazole, miconazole, ketoconazole and terbinafine
3-5
.
Transferosomes
6-10
Transferosomes represent an innovative approach in pharmaceutical research, particularly for topical drug
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ISSN No. 2321-2705 | DOI: 10.51244/IJRSI |Volume XII Issue IX September 2025
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delivery in fungal treatment. These advanced vesicular carriers are unique lipid-based structures composed of
phospholipids and edge activators, which provide remarkable flexibility and penetration capabilities. Unlike
traditional topical formulations, transferosomes can navigate through the skin's intricate barriers with
exceptional ease, offering a promising solution for more effective antifungal treatments.
The structural composition of transferosomes is what makes them particularly remarkable. Typically ranging
from 50 to 1000 nanometers in size, these microscopic vesicles are designed with an incredibly elastic
membrane that allows them to pass through narrow intercellular spaces. This exceptional characteristic enables
them to transport both hydrophilic and lipophilic antifungal agents directly to the site of infection, dramatically
improving drug penetration and efficacy compared to conventional topical preparations.
MATERIALS AND METHOD
Materials
The seeds of Cassia tora were purchased from Nutriveda Xpotim Enterprises, Ketoconazole (Provided by
SARACA Laboratories), HPMC K15, Carbopol 940, Propylene Glycol (Merck Limited), Triethanolamine,
Isopropyl Alcohol, Soya phosphatidylcholine, Cholesterol (S.D. Fine Chem Ltd.), Dicetyl phosphate (DCP),
Methanol (Merck Limited). All the chemicals and reagents used were of analytical grade.
Extraction and Isolation of Chrysophanic acid 9 anthrone from Cassia tora seed.
Seeds were washed with tap water; shade dried, powdered in a kitchen blender and was stored in an air tight
plastic bag. Then powdered seeds passed through sieve # 10 was defatted by the whatman filter paper and
introduced into the soxhlet apparatus using petroleum ether (60-80) as a solvent. After complete defatting,
powder was air dried for removing trace of the petroleum ether then packed in whatman filter paper and
introduced into the soxhlet apparatus and extract with benzene as a solvent for complete extraction. The extract
was filtered, concentrated and dried in water bath. Dried extract was transferred into air tight bottles and the
percentage yield was calculated and stored at cool place
11
.
Preformulation Studies
Organoleptic properties
Take a small quantity of sample and spread it on the white paper and examine it visually for Color, odour, and
texture.
Determination of Melting point
The melting point of Ketoconazole and Chrysophanic acid 9 anthrone was determined by capillary tube
method according to the USP. A sufficient quantity of Ketoconazole powder was introduced into the capillary
tube to give a compact column of 4-6 mm in height. The tube was introduced in electrical melting point
apparatus and the temperature was raised. The melting point was recorded, which is the temperature at which
the last solid particle of Ketoconazole in the tube passed into liquid phase.
Solubility Studies
Drug sample (10mg) was suspended separately in a 10 ml of different solvents at room temperature in tight
closed test tube and shaken by wrist action. The samples were filtered through Whatman filter paper and
diluted appropriately with same solvent and concentration was determined by UV- vis spectroscopy. For
Chrysophanic acid 9 anthrone, the solubility test was based on the visualization of the presence or absence of
drug extract precipitation in the oil phase. Approximately 5-10 mg of extract was weighed accurately and
transferred in 5 different 10 ml volumetric flasks. Different solvents (water, ethanol, chloroform, methanol,
ether, and acetone) were added to the flask respectively and solubility was determined.
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Determination of maximum absorbance (λ max) of Ketoconazole
A solution containing the concentration 10 μg/ml drug was prepared in 6.8 phosphate buffer and UV spectrum
was taken using Lab India Double beam UV-vis spectrophotometer (Lab India UV 3000+). The solution was
scanned in the range of 200 400 nm.
Construction of standard graph
100 mg of Ketoconazole was dissolved in 100 mL of pH 6.8 phosphate buffer to give a concentration in
1mg/mL (1000μg/mL), 1 ml was taken and diluted to 100 ml with pH 6.8 phosphate buffer to give a
concentration of 0.01 mg/ml (10μg/ml). From this stock solution aliquots of 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, 1
ml, were pipette out in 10 ml volumetric flask and volume was made up to the mark with pH 6.8 phosphate
buffer to produce concentration of 2, 4, 6, 8 and 10 μg/ml respectively. The absorbance of each concentration
was measured at respective λmax.
Determination of maximum absorbance (λ max) of Chrysophanic acid 9 anthrone
Organic molecules when exposed to light in UV region they absorb light of particular wavelength depending
upon the type of electron transition associated with the absorption. The absorption maximum was determined
by scanning the drug solution in suitable solvent with double beam ultraviolet spectrophotometer in the range
of 300-400 nm.
Preparation of standard stock solution:
1 mg of extract was accurately weighed and dissolved in 10 ml of volumetric flask and dissolved in 10 ml of
methanol to give a standard solution of 100µg/ml. 0.1 ml of solution was pipetted out from the stock solution
and transferred into the 10 ml of volumetric flask. Absorbance was recorded by using UV-Visible
spectrophotometer.
Procedure for standard calibration curve:
The standard solution were prepared by proper dilutions of the primary stock solution with methanol and
phosphate buffer pH 6.8 to obtain working standard in the concentration range of 1-10µg/ml. the absorbance
was measured at 320nm against a solvent blank and calibration curve was plotted. Similarly absorbance of
sample solutions was measured and the amount of Chrysophanic acid 9 anthrone was determined.
Drug excipient compatibility study: FTIR
The formulations were subjected to FTIR studies to find out the possible interaction between the drug and the
excipients during the time of preparation. FTIR analysis of the pure drug and optimized formulation were
carried out using an FT-IR spectrophotometer (Bruker FT-IR -Germany).
Formulation development Ketoconazole and Cassia tora seed extract loaded transferosomes- thin film
hydration method
11
Start by creating a thin film, this film is likely composed of phospholipids and a surfactant. The mixture of
vesicles forming ingredients, that is phospholipids, surfactants and the drug and extract were dissolved in
volatile organic solvent (chloroform + methanol). The organic solvent is then evaporated, this is typically done
above the lipid transition temperature using a rotary evaporator, leaving behind a lipid film. Any remaining
traces of the organic solvent were removed under vacuum conditions overnight. This step ensures that the final
vesicle product is free from solvent residues. The deposited lipid films were hydrated with buffer (pH 6.8) by
rotation at 60 rpm/min for 1hour at the corresponding temperature. The resulting vesicles were allowed to
swell for 2 hours at room temperature. This swelling process helps the vesicles reach their optimal size and
stability. To prepare small vesicles, the resulting LMVs were probe sonicated for 30 min at room temperature.
The sonicated vesicles were homogenized by manually extruding them through a membrane filter. This step
aids in achieving a uniform size and structure for the final vesicles.
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Table No. 2.1 Formulation of transferosomes.
Ingredients
F1
F2
F3
F4
F5
F6
F7
F8
Ketoconazole (%)
0.1
0.2
0.1
0.2
0.1
0.2
0.1
0.2
Soya phosphatidylcholine (mg)
20
40
60
80
20
40
60
80
Cholesterol (mg)
20
20
20
20
40
40
40
40
Tween-80 (mg)
30
30
30
30
60
60
60
60
Dicetyl phosphate (mg)
8
8
8
8
8
8
8
8
Extract (mL)
4
4
4
4
4
4
4
4
Methanol (mL)
5
5
5
5
5
5
5
5
Chloroform (mL)
10
10
10
10
10
10
10
10
Preparation of Transferosomal gel
Optimization of Transferosomal gel was done on the basis of concentration of Carbopol-940 (0.2% to 0.8%)
as described in the table 6.2 Carbopol-940, a polymer, was dispersed in distilled water to form an aqueous
dispersion. The dispersion was subjected to stirring until it exhibited increased viscosity, indicating thickening.
Once complete dispersion was achieved, 10 ml of propylene glycol was slowly added to the Carbopol-940
dispersion, along with additional ingredients including 10 ml of isopropyl alcohol and 5 ml of triethanolamine.
Furthermore, 10 ml of transfersomes dispersion was incorporated into the Carbopol gel with continuous
stirring. To achieve a final volume of 100 g of gel, an appropriate quantity of distilled water was added.
Table No. 2.2 Formulation of transferosomal gel.
F1 Concentr
ation %
F2 Concen
tration%
F3 Concentr
ation %
F4 Concent ration
%
1
1.5
2
1
2
2.5
3
3.5
1
1
1.5
1
0.5
1
1.5
0.5
0.5
1
1.5
2
0.1
.25
0.35
0.45
q.s.
q.s.
q.s.
q.s.
Characterization of Transferosomes
Particle Size and Zeta Potential
12
Zeta sizer was used to measure the mean particle size and Zeta potential (ZP) of the transferosome. The mean
particle size is an important parameter that governs the degree of permeation through the skin. The stability of
the colloidal system in terms of particle size was evaluated based on Zeta Potential values and was established
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based on a Dynamic light scattering technique. For each formulation, three replicate analyses were performed,
and data were presented as mean± S.D.
Polydispersity index
13
PDI is a measure of heterogenicity of a sample based on size, polydispersity can occur because of
agglomeration of sample. PDI can be obtained by Dynamic light scattering microscopy (DLS). PDI of less
than 0.1 is considered as homogenous and ≥0.4 as heterogenous.
Entrapment efficiency
14
The entrapment efficiency was determined by using direct method. Detergents are used to break the
transferosome membranes 1 ml of 0.1% Triton X- 100(Triton X-100 dissolved in phosphate buffer) was added
to 0.1 ml Transfersomes preparations and made up to 5 ml with phosphate buffer then it was incubated at 37oC
for 1.5 hrs to complete breakup of the transfersome membrane and to release the entrapped material. The
sample was filtered through a Millipore membrane filter (0.25) μm and the filtrate was measured at 240 nm for
Mometasone furoate. The amount of Lamivudine was derived from the calibration curve.
The entrapment efficiency is expressed as:
% Entrapment efficiency = Amount of the drug entrapped/Total amount of the drug × 100.
Evaluation of Transferosomal Gel
Physical appearance
All prepared gel formulations have been observed for their visual appearance, such as transparency, colour,
texture, grittiness, greasiness, stickiness, smoothness, stiffness, and tackiness. The prepared gels were also
evaluated for the presence of any particles. Smears of gels were prepared on glass slide and observed under the
microscope for the presence of any particle or grittiness.
pH of Formulation
15
pH measurement of the gel was carried out by using a digital pH meter. pH of the topical gel formulation
should be between 4-6 to treat the skin infections.
Determination of viscosity
Viscosity of the gels were determined by using Brookfield Viscometer (model- RVTP). Spindle type, RV-7 at
100 rpm.
Spreadability
16
A modified apparatus suggested was used for determining spreadability. The spreadability was measured on
the basis of slip and drag characteristics of the gels. The modified apparatus was fabricated and consisted of
two glass slides, the lower one was fixed to a wooden plate and the upper one was attached by a hook to a
balance. The spreadability was determined by using the formula:
s=ml/t,
where s, is spread ability, m is weight in the pan tied to upper slide and t is the time, l is the distance travelled.
for the practical purpose the mass, length was kept constant and ‘t’ was determined.
Homogeneity
17
All developed gels were tested for homogeneity by visual inspection after the gels have been set in the
container for their appearance and presence of any aggregate.
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Drug Content
Gel formulations (100 mg) was dissolved in suitable solvent and filtered and the volume was made. The
resultant solution was suitably diluted with solvent and absorbance were measured at 240 nm using UV-
Visible spectrophotometer. Drug content was determined from calibration curve.
In-vitro diffusion studies
18
An In-vitro drug release study was performed using modified franz diffusion cell. Dialysis membrane (hi
media, molecular weight 5000 Daltons) was placed between receptor and donor compartments.
Transferosomal gel was placed in the donor compartment and the receptor compartment was filled with
phosphate buffer, pH 6.8 (24 ml). The diffusion cells were maintained at 37±0.5°c with stirring at 50 rpm
throughout the experiment. At different time intervals, 5 ml of aliquots were withdrawn from receiver
compartment through side tube and analyzed for drug content by UV visible spectrophotometer and analyzed
at 240 nm using phosphate buffer pH 6.8 as blank.
Stability Studies
19
Stability studies have been carried to point out any physical visual or chemical stability of optimized batch at
25°C ± 2°C/ 60% RH ± 5% RH as per ICH guidelines for 3 months. Samples are taken out at various days 0th,
30th, 60th and 90th and checked their physical property and drug content.
In Vitro Anti-Fungal Activity
20
The in vitro antifungal activity was assayed through screening of Aspergillus niger, by disc diffusion technique
on SDA growth medium at pH 6.8. In the study, dilutions of test samples were prepared at various increasing
concentrations (25,50,75 and 100 µg/ml).These prepared concentrations were loaded into the well and
incubated in inverted positions at 35 °C for 48 h. The size of the zone of inhibition is usually related to the
level of antimicrobial activity present in the sample or product, and a larger zone of inhibition usually means
that the antimicrobial formulation is more potent. For comparison, amphotericin was used as a standard
(10µg/ml). Amphotericin B (Amp B) is one of the best antifungal drugs. It is nephrotoxic. Sample was
analysed in triplicate. The test sample at 100 µg/ml concentration showed significant antimicrobial activity
against Aspergillus niger. Observed results were in concentration dependent manner.
RESULTS AND DISCUSSION
Extraction from Cassia tora seeds:
The initial weight of the powder before extraction 30 gm.
After defatting by petroleum ether (for 3 hours) weight of the powder was 29.44 gm.
After defatting by benzene (for 2 hours) weight of the powder was 27.8 gm.
Organoleptic properties
Table 3.1: Physical properties of Ketoconazole
Parameters
Remarks
General appearance
Crystalline powder
Colour
White to slightly beige-colored
Odour
Odorless crystalline powder
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Taste
Slightly bitter
Table: 3.2 Organoleptic and physical properties of Drug extract
Test
Observation
Colour
Brown Powder
Taste
Bitter and astringent
Odour
Characteristic
Solubility Studies
Table 3.3 Solubility of ketoconazole
S. No.
Surfactant
Solubility
1.
Water
Sparingly soluble
2.
Methanol
Sparingly soluble
3.
Ethanol
Slightly more soluble in ethanol than in methanol
4.
Chloroform
Insoluble
Table: 3.4 Solubility of Cassia tora seed extract
S.No
Solvent
Solubility observed
1.
Water
Practically insoluble
2.
Methanol
Sparingly soluble
3.
Petroleum ether
Slightly soluble
4.
Benzene
Very soluble
Melting point
Table: 3.5 Solubility of Cassia tora seed extract
Material
Observation
Chrysophanic acid 9 anthrone
195°C
ketoconazole
148°C
FTIR study
The FTIR study of drug and excipents mixture was studied and found to be no any other peaks. The results of
FTIR peaks revealed that drug and excipents mixture was not show any interaction and suitable for the
formulation and development. The FTIR spectra of ketoconazole, Chrysophanic acid 9 anthrone are shown in
figure 3.1, 3.2 & 3.3.
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Fig no. 3.1 FTIR Spectra of Ketoconazole
Fig.3.2 IR Spectrum of Chrysophanic acid 9- anthrone (Drug sample)
Fig.3.3: FTIR of Drug with Excipients
Determination of Absorbance Maxima of Ketoconazole and Chrysophanic acid 9 anthrone
UV-vis spectra of Mometasone Furoate were measured from 200 to 400 nm and the absorption spectrum was
found to be sharp and maximum at wavelength of 240 nm.
After scanning drug solution under UV spectrophotometer it was found that Chrysophanic acid 9 anthrone
shows maximum absorbance at 320 nm therefore max of Chrysophanic acid 9 anthrone was found to be 320
nm.
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Table: 3.6 Absorbance Maxima of Ketoconazole and Chrysophanic acid 9 anthrone
Material
Lambda max
Ketoconazole
240nm
Chrysophanic acid 9 anthrone
320 nm
Fig.3.4: Lambda max of Ketoconazole
Fig 3.5 Lambda max of Chrysophanic acid 9- anthrone
Calibration curve of Ketoconazole
Table 3.6: Construction of Calibration curve:
Concentration (µg/ ml)
Absorbance
0
0
2
0.228±0.10
4
0.424±0.05
6
0.636±0.12
8
0.811±0.09
10
0.999±0.03
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Fig 3.6 Standard calibration curve of Ketoconazole in methanol
Calibration curve of Chrysophanic acid 9 anthrone in methanol
Table 3.7 Calibration curve of Chrysophanic acid 9 anthrone in methanol
Concentration µg/ml
Absorbance nm
3
0.0099
6
0.0210
9
0.0310
12
0.0420
15
0.0520
18
0.0630
Fig. 3.7 Calibration curve of Chrysophanic acid 9 anthrone in methanol
Characterization of prepared Transferosomes:
Table 3.8: Particle size, PDI, Zeta potential and entrapment efficiency of all formulations
Formulation
Particle Size
PDI
Zeta Potential
Entrapment efficiency
Drug content
F1
171.57±2.10
0.503
-5.44
60.31±1.15
75.43±0.05
F2
162.61±2.35
0.378
-20.62
72.39±0.26
82.19±5.10
CONCENTRATION (ΜG/ML)
12
10
8
6
4
2
0
0
y = 0.0597x + 0.008
= 0.9989
1
0.5
C A L I B R A T I O N C U R V E
1.5
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F3
160.38±4.13
0.313
-12.93
79.05±3.02
87.76±1.26
F4
152.48±2.61
0.252
-32.55
87.16±2.10
97.45±2.12
F5
192.89±3.16
0.987
-18.21
59.22±1.24
66.31±1.41
F6
197.93±2.27
1.235
-10.46
61.79±5.87
78.14±0.25
F7
182.54±1.20
1.503
-16.67
75.63±2.11
88.01±3.40
F8
171.68±3.32
1.378
-15.10
85.48±1.30
91.35±2.09
SD±(n=3)
IN-VITRO Diffusion Studies:
Table 7.9: In-vitro diffusion studies of F1-F8 Transferosomes formulations in percentage
Time
(hour)
CUMULATIVE PERCENT DRUG RELEASE
F1
F2
F3
F4
F5
F6
F7
F8
0
0
0
0
0
0
0
0
0
1
21.16±0.07
28.10±0.10
32.93±0.02
40.52±0.08
36.60±0.05
28.42±0.11
25.93±0.09
20.40±0.06
2
36.02±0.01
32.36±0.02
43.30±0.12
49.89±0.02
44.56±0.01
35.97±0.05
30.47±0.02
26.99±0.09
3
52.97±0.12
40.29±0.06
49.02±0.06
55.54±0.06
51.06±0.13
42.68±0.15
36.65±0.05
31.02±0.10
4
50.24±0.09
48.95±0.05
56.91±0.15
65.26±0.10
60.30±0.00
48.99±0.09
40.24±0.19
38.87±0.09
5
67.11±0.05
56.61±0.12
65.65±0.12
72.72±0.09
73.49±0.01
59.47±0.02
48.76±0.06
42.24±0.10
8
78.69±0.01
69.61±0.25
72.72±0.09
83.14±0.15
78.20±0.08
64.26±0.06
52.34±0.16
50.34±0.15
9
90.19±0.11
78.20±0.14
82.53±0.12
86.63±0.18
86.16±0.06
76.97±0.04
60.87±0.10
56.91±0.13
10
86.97±0.01
90.26±0.10
95.43±0.05
90.78±0.09
82.34±0.05
71.51±0.15
65.80±0.05
12
91.36±0.14
91.59±0.09
97.14±0.10
95.36±0.02
92.92±0.09
85.01±0.12
80.69±0.02
Figure 8: In-vitro diffusion studies of F1-F8 Transferosomes formulations in percentage
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Observation: The Transferosomes F4 showed a better release profile of 97.14% by 12 hours. The prolonged
release at 12 hours can be attributed to slow diffusion of drug from lipid matrix.
Characterization of Optimized Formulation
Table 3.10: Gel evaluation Parameters
Polymer
Formulation
pH
Viscosity
(centipoise)
Extrudabilit
y
Homogeneit
y
Drug
Content
Skin
Irritation
test
Carbopol-
940
F4 optimized 0.5 %
6.5
52325
+
Satisfactory
93.29
No
F4 optimized 1%
6.2
53425
+
Satisfactory
95.56
No
F4 optimized 1.5%
5.9
54360
+
Satisfactory
96.06
No
F4 optimized 2%
5.8
55417
++
Excellent
98.90
No
Table 3.11: Physical evaluation of Transferosomal gel
Polymer
Formulation
Colour
Spreadability (g.cm/sec)
Carbopol-940
F4 optimized 0.5 %
White to off white
0.456±0.01
F4 optimized 1%
White to off white
0.320±0.12
F4 optimized 1.5%
White to off white
0.258±0.09
F4 optimized 2%
White to off white
0.229±0.01
In-vitro diffusion studies:
Table 3.12: In-vitro diffusion studies of Transferosomal gel
Polymer
Carbopol-940
Time
F4
F4
F4
F4
(hrs)
optimized
optimized
optimized
optimized
0.5 %
1%
1.5%
2%
0
0
0
0
0
1
40.62±0.01
34.89±0.09
35.96±0.11
30.99±0.04
2
45.10±0.05
40.92±0.02
41.60±0.08
38.06±0.13
4
71.91±0.09
46.06±0.05
48.14±0.05
45.36±0.00
5
76.82±0.13
53.86±0.04
55.30±0.02
56.12±0.05
6
80.86±0.10
69.11±0.03
70.82±0.09
60.79±0.02
INTERNATIONAL JOURNAL OF RESEARCH AND SCIENTIFIC INNOVATION (IJRSI)
ISSN No. 2321-2705 | DOI: 10.51244/IJRSI |Volume XII Issue IX September 2025
Page 3965
8
94.01±0.04
75.70±0.01
78.14±0.10
75.66±0.09
10
82.59±0.08
85.97±0.09
80.90±0.15
11
97.05±0.10
90.36±0.02
95.36±0.10
12
93.75±0.04
98.22±0.12
Stability Studies:
Table 3.13: Stability Study of F4 Transferosomal Gel
Formulation
F4
Storage Condition
25℃± 2℃/ 60 % RH ± 5 % RH
Time interval (days)
0
30
60
90
Colour
White to off white
White to off white
White to off white
White to off white
Homogeneity
+++
+++
+++
+++
pH
5.8
6.0
6.0
6.1
Viscosity (cP)
55417
54120
54012
52059
Spreadability (g.cm/sec)
0.229±0.01
0.226±0.05
0.225±0.02
0.224±0.06
Extrudability
++
++
++
++
Drug content uniformity (%)
98.90
98.82
98.72
98.60
+++ Excellent, ++ Good, + Satisfactory, - Poor, -- Fail
DISCUSSION
There was not much more variation in the properties of transferosomal gel F4 under stability study as the
formulation retained all the properties when stored at specified storage conditions over a while, indicating that
the transferosomal gel was very much stable.
In-Vitro Antifungal activity
Table 3.14: In-Vitro Antifungal activity of Transferosomal gel
S. No.
25ug/ml
50ug/ml
75ug/ml
100ug/ml
Amphotericin B (10μg/ml)
1.
08.00
13.00
14.00
23.00
26.00
2.
09.00
13.00
14.50
23.00
3.
09.00
11.00
17.00
20.00
Mean
08.66±0.57
12.33±1.15
15.16±1.60
22.00±1.73
INTERNATIONAL JOURNAL OF RESEARCH AND SCIENTIFIC INNOVATION (IJRSI)
ISSN No. 2321-2705 | DOI: 10.51244/IJRSI |Volume XII Issue IX September 2025
Page 3966
Fig 3.6 Zone of inhibition (mm) at various concentrations.
This study shows that Transferosomal gel had a potential source for inhibition of fungi and could be used as
efficient drug with minimum side effects.
SUMMARY AND CONCLUSION
Summary: A transferosomal gel was formulated using ketoconazole and Cassia tora seed extract
(Chrysophanic acid 9-anthrone). Extraction and characterization confirmed their purity, solubility, and
compatibility with excipients. Among all formulations, F4 showed the best properties with smallest particle
size (152.48 nm), highest entrapment efficiency (87.16%), and maximum drug release (97.14%) over 12 hours.
The optimized F4 was incorporated into Carbopol 940 gel, with the 2% gel showing the best spreadability,
drug content (98.90%), and stability over 90 days. In-vitro antifungal testing confirmed strong activity with
increasing concentrations.
Conclusion: The developed F4 transferosomal gel with 2% Carbopol 940 is stable, shows excellent drug
release, and effective antifungal activity. It is a promising formulation for topical antifungal treatment with
sustained release and minimal side effects.
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