Original Article

A Research Article on Nanogel as Topical Promising

Drug Delivery for Diclofenac sodium
Swati Talele1*, Preetam Nikam1, Braja Ghosh1, Chaitali Deore2, Ashwini Jaybhave2, Anil Jadhav2
1
Department of Pharmaceutics, Sandip Institute of Pharmaceutical Sciences, Nashik, INDIA.
2
Department of Quality Assurance, Sandip Institute of Pharmaceutical Sciences, Nashik, INDIA.

ABSTRACT
Background: Transdermal delivery of drug is promising but challenging system is available
for local as well as systemic effect of drug. The prolonged residence of drug formulation
in the skin is important for transdermal drug delivery. Objective: The objective of the
present investigation was to develop a nanogel with reduced particle size in order to
improve the bioavailability of the anti-inflammatory drug, Diclofenac sodium. Methods:
The present study is to formulate nanosizes dispersion of diclofenac sodium by emulsion-
solvent diffusion method and incorporation of gelling agent to produce nanogel. The
formulation are characterized for particle size ranging from 100-400 nm. A drug named
diclofenac sodium used in rheumatoid disorders and chronic inflammatory diseases.
Results: Glycerol: Water (20:80) co-solvent system is selected for preparing diclofenac
sodium nanogels using different polymers and has better permeability coefficient than
alcohol: water co-solvent. Permeation through cellophane membrane was carried
using 0.9% w/v sodium chloride using receptor fluid in franz diffusion cell (1.74 cm2).
Gels containing diclofenac sodium with eudragit polymer shown better permeability
coefficient. Conclusion: Diclofenac sodium nanogels formulated using carbopol with
permeation enhancer has shown better flux enhancement in comparison with nanogels
formulated using HPMC and methyl cellulose. It has been concluded that diclofenac
sodium nanogels using carbopol 940 as gelling agent and Eudragit S-100 has shown
better flux enhancement with propylene glycol as permeation enhancer.
Key words: Diclofenac sodium, TDDS, Eudragit S-100, Glycerol, Carbopol-940,
Cellophane membrane.

INTRODUCTION
Submission Date: 23-03-2017;
Transdermal delivery of drug is promising but of active targeting sites. Nanogels combine Revision Date: 18-05-2017;
challenging system is available for local as the advantage of hydrogels inherting the Accepted Date: 25-07-2017

well as systemic effect of drug. The entry property of nanoscale size. Nanogel network DOI: 10.5530/ijper.51.4s.86
Correspondence:
of drug through the stratum corneum may provide high specific form can host and Swati Talele*,
follow the intercellular, transcellular or protect drug molecules. The release of the Assistant Professor,
Department of Pharma-
appendageal route. The intercellular route is drug molecules can be incorporated by ceutics, Sandip Institute of
the more common pathway 1 of the drug providing high-affinity functional groups. Pharmaceutical Sciences,
Nashik,-422213, INDIA.
permeation through the skin. Nanogel can Nanogels are able to carry encapsulated Phone: 9850165808
be termed as dispersion of hydrogel by drug molecules to targeted tissues or cell E-mail: swatitalele77@gmail.
com
physical and chemical cross-linking polymer structures without premature leakage of
at nanoscale size. Nanogel exhibit properties the drug into the blood stream or other
between those of solids and liquids. It con- tissues. Nanogel has been the form having
sist of small amount of solid components size ranging from 1-100 nm. In oral drug
entangled with polymers dispersed in large delivery, nanogels have been used to protect
volume of liquid in which solids form 3D unstable peptides from harsh manufacturing
network forming the nanoscale size leading and physiological environments and to
to high surface area providing biconjugation enhance the drug absorption at specific www.ijper.org

S580 Indian Journal of Pharmaceutical Education and Research | Vol 51 | Issue 4S | Oct-Dec (Suppl), 2017
 Talele et al.: Nanogel as Topical Drug Delivery

3
sites. The nanogel of Diclofenac sodium has been used Measurement of particle size of formulation
as Non-Steroidal anti-inflammatory drug (NSAID’s) for The mean size of the selected nanogels were determined
its anti-inflammatory and analgesic effect. Oral route by using Malvern Mastersizer 2000 MS. The mean
causes irritation and ulceration of GIT. An improved particle size was recorded.
Diclofenac formula with high degree of skin perme-
ation can be useful in treatment of not only inflamed PH measurement
tissues but also inflammatory pain. The pH measurement was carried out by using calibrated
The present study was conducted to design and evaluate digital type pH meter by dipping the glass electrode and
Diclofenac sodium nanogel which provides prolonged the reference electrode completely into gel system so as
release, increase the residence time of drug on the skin to cover the electrodes.
thereby enhance bioavailability. Drug content
For the estimation of the drug in gel, Diclofenac
MATERIALS AND METHOD sodium was extracted from 1 gm of gel formulation
Diclofenac sodium and Eudragit S-100 was purchased with 50 ml of phosphate buffer 6.8 and mixture was
from Evonik industries, Mumbai. Carbopol 940 and filtered through membrane filter (pore size 0.45 µm).
Glycerol was gift sample from Loba Chemie Pvt. Ltd., From this, 2 ml was pipette out and made upto 10 ml.
Mumbai. Tween 80 was purchased from S.D. Fine The absorbance of the sample was determined spec-
chemical Ltd., Mumbai. Triethanolamine was purchased trophotometrically at 276 nm. The concentration of
from Spectrochem, Mumbai. Diclofenac sodium was estimated from the calibration
curve.
METHOD In vitro Release studies
Preparation of Diclofenac Sodium Nanogel The drug release from the formulation was determined
Accurately weighed quantity of Drug, Eudragit S-100 by using the apparatus known as Franz Diffusion Cell,
(polymer), and Tween-80 as stabilizer are dissolved in which consist of a cylindrical glass tube which was
glycerol while stirring. Prepared aqueous phase contain- opened at both the ends. 1 gm of gel equivalent to 10 mg
ing Carbopol-940 dissolved in water with continuous of Diclofenac sodium was spread uniformly on the
stirring and heat. These drug containing phase is surface of cellophane membrane (previously soaked in
sonicated on Ultra sonic bath sonicator. The drug phase medium for 24 hrs) and was fixed to the one end of
is added drop by drop into the aqueous phase during tube. The whole assembly was fixed in such a way that
homogenization to form emulsion. The emulsion the lower end of tube containing gel was just touches
converted into nanodroplets by homogenizer which (1-2 mm deep) the surface of diffusion medium i.e. 100 ml
formed O/W emulsion. Homogenization was continued of pH 6.8 phosphate buffer contained in 100 ml beaker.
for one hour. Triethanolamine added to form the gel The assembly was placed on thermostatic hot plate with
with continuous stirring to nanogel. Batch A1, A2, A3 magnetic stirrer and maintained at temperature 37°±2°
was prepared at highest rpm 8000 with variation in com- the contents were stirred using magnetic bar at 100 rpm
position. Whereas prototype batches B1, B2, B3 and C1, for a period of 24 hrs, 5 ml of samples were withdrawn
C2, C3 prepared at different rpm 5000, 6000, 7000 using at different time intervals. This 5 ml was diluted upto 10
homogenizer respectively. As shown in Table 1, Table ml of fresh phosphate buffer (pH 6.8) and sample were
2, Table 3. analyze at 276 nm in UV-Vis spectrometer for diclofenac
sodium.
Evaluation Parameters Skin irritation test: Test for irritation was performed on
Appearance: The prepared gel bases were inspected human volunteers. For each gel, four volunteers were
visually for clarity, colour and presence of any particles. selected and 1.0 g of formulated gel was applied on an
area of 2 square inch to the back of hand. The volun-
Homogeneity
teers were observed for lesions or irritation.
All developed gels were tested for homogeneity by visual
inspection after the gels have been set in the container. Spreadability
They were tested for their appearance and presence of Spreadibility is determined by apparatus suggested by
any aggregates. Mutimer. It consist of wooden block, which is provided

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 Talele et al.: Nanogel as Topical Drug Delivery

by a pulley at one end. By this method, spreadibility is RESULTS AND DISSCUSIONS

measured on the basis of “Slip” and “Drag”. A ground
glass slide is fixed on this block. A sample of 0.1 g of FTIR Spectroscopy7
nanogel under study is placed on this ground slide. The The FTIR spectrum for is shown in Figure 1 and in
gel is fixed on the beach formula was pressed between Diclofenac sodium interpretation of FTIR spectra is
two slides and a 1 kg weight is placed on the top of two given in Table 4.
slides and left for about 5 min to expel air and to provide FTIR spectrum of drug sample showed all the peaks
a uniform film of the nanogel between two slides. corresponding to the functional groups present in the
Excess of the gel is scrapped from edges. The top plate structure of Diclofenac sodium. From FTIR spectrum
is then subjected to pull the weight. With help of string it was concluded that the drug sample was in pure form.
attaches to the hook and the time required by top slide Differential Scanning Calorimetry Studies8
to cover the distance is noted. A shorter interval indi-
cate better spreadibility, spreadability was calculated by Pure drug- Diclofenac sodium
using the formula, Polymer- Eudragit S-100 Binary Mixture- Drug + Polymer
S=M.L/T, DSC thermogram of Diclofenac sodium is shown in
the Figure 2. DSC studies indicate a sharp endothermic
Where, S=spreadability, L=Length of glass slide,
peak at 282ºC corresponding to the melting point of the
M=weight tied to upper slide,
sample which matches with the melting point of Diclofenac
T=Time taken to separate the slides. sodium indicating the purity of drug.
Extrudability: From the DSC overlay thermogram of pure drug and
It is a usual empirical test to measure the force required physical mixture with Eudragit S-100; it can be con-
to extrude the material from tube. The method applied cluded that the excipients and drug doesn’t have any
for determination of applied shear in the region of the interaction with each other. Also the drug did not form
rheogram corresponding to a shear rate exceeding the a complex with the excipients as the endothermic peaks
remained unchanged in position.
yield value and exhibiting plug flow. The method adopted
for evaluating nanogel formulation for extrudability is UV Spectroscopy8,9
based upon the quantity in percentage of nanogel and After studying the UV spectra of diclofenac sodium,
nanogel extruded from lacquered aluminium collapsible it was found that drug shows absorbances at 226 and
tube on application of weight in grams required at least 276 nm but maximum absorbance was at 276 nm when
0.5cm ribbon of nanogel in 10 sec. The measurement solution is prepared in distilled water. So, 276 nm was
of extrudability of each formulation shows the triplicate considered as λmax. UV spectra diclofenac sodium is
and averages value is presented. shown in Figure 3.
Extrudability = Applied weight to extrude the nanogel
Effect of change in pH on λmax9
from tube (in gm)/ Area (in cm2).
Rheological Studies: Brookfield viscometer was used λmax of drug was observed by making its solution in
for the studies. First, the spindle was dipped into the different pH to check the effect of pH on λmax. Result of
gel till the notch on the spindle touched the gel surface. the same is given in Table 5.
3gm each of gel I and gel II (Stability chamber and There was no significant change in λmax of Diclofenac
Room temperature) was used in the study. The spindle sodium at different pH. So calibration plot can be
no.61, 63, 64 was selected based on viscosity of gel. The constructed by using distilled water and can be used for
dial readings were taken at 50, 100, 150, 250rpm and quantitative evaluation purpose; though the medium of
evaluation of release is phosphate buffer pH 7.4.
viscosity was measured.2,4,5,6,7
From the evaluation parameter performed for the Calibration curve of Diclofenac sodium10
three prototype batches, the result for the batch A-1 The calibration curve for diclofenac sodium in phosphate
was found to be satisfactory in all attributes and hence buffer 6.8 is shown in Figure 4 and its observation val-
selected for trial batches. As shown in Table 7, Table 8, ues in Table 6. The graph of absorbance vs. concentration
Table 9. was found to be linear in the concentration range of
The evaluation parameter was performed on marketed 4-24 μg/ml at 276 nm. The R2 of the calibration curve
product as shown in Table 11. was found to be 0.999.

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 Talele et al.: Nanogel as Topical Drug Delivery

Trial batches Table 3: Diclofenac Sodium Nanogel (Composition of

Batch C)
Table 1: Diclofenac Sodium Nanogel (Composition of
Composition C-1 C-2 C-3
Batch A)
Diclofenac sodium (g) 100 100 100
Comosition A-1 A-2 A-3
Eudragit S-100 (g) 0.15 0.15 0.15
Diclofenac sodium (g) 100 100 100
Tween-80 (ml) 0.1 0.1 0.1
Eudragit S-100 (g) 0.15 0.2 0.25
Glycerol (ml) 5 5 5
Tween-80 (ml) 0.1 0.3 0.5
Carbopol (g) 0.1 0.1 0.1
Glycerol (ml) 5 10 15
Water (ml) 30 30 30
Carbopol (g) 0.5 0.1 0.3
Triethanolamine (ml) 2 2 2
Water (ml) 70 30 50
Triethanolamine (ml) 2 3 4

Table 2: Diclofenac Sodium Nanogel (Composition of

Batch B) Table 4: Interpretation of FTIR spectrum of pure
Composition B-1 B-2 B-3 Diclofenac sodium.
-1
Diclofenac sodium (g) 100 100 100 Peaks cm Groups
Eudragit S-100 (g) 0.15 0.15 0.15 3351 O-H
Tween-80 (ml) 0.1 0.1 0.1 1208 C-O
Glycerol (ml) 5 5 5 2936 Aliphatic C-H
Carbopol (g) 0.1 0.1 0.1 1179 Asymmetric C-O-C
Water (ml) 30 30 30 1042 Symmetric C-O-C
Triethanolamine (ml) 2 2 2

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 Talele et al.: Nanogel as Topical Drug Delivery

Table 6: Calibration curve values of Diclofenac sodium.

Sr. No. Concentration (µg/ml) Absorbance
1 0 0
2 4 0.1548
Table 5: Effect of pH on λmax
3 8 0.3173
Drug solution in pH λmax
4 12 0.4842
6.8 276 nm
5 16 0.6303
7.4 276 nm
6 20 0.7963
7 24 0.9237
R 2
1
Slope 25.61
Trial batches evaluation
Intercept -0.1020

Table 7: Evaluation Parameters for Batch A

Evaluation parameters A-1 A-2 A-3
Appearance Clear Clear Clear
Homogenicity Homogeneous Homogenous Homogenous
Particle size (nm) 165 189 213
pH 6.9 ± 0.00 6.5 ± 0.02 6.2 ± 0.20
Drug content±SD 98.8 ± 0.02 96.5 ± 0.02 97.8 ± 0.04
In vitro drug release (%) 96.72 ± 0.0784 94.75 ± 0.963 92.78 ± 0.77
Skin irritation test No irritation No irritation No irritation
Spreadability (g.cm/s) 6.3 ± 0.5 6.7 ± 0.6 6.0 ± 0.6
Extrudability (g) 279 ± 0.7 268 ± 0.5 254 ± 0.7
Viscosity in cp at 50 (rpm) 9563 8562 8000

Table 8: Evaluation Parameters for Batch B

Evaluation parameters B-1 B-2 B-3
Appearance Clear Clear Clear
Homogenicity Homogenous Homogenous Homogenous
Particle size (nm) 165 175 220
pH 6.8 ± 0.00 6.7 ± 0.02 6.5 ± 0.20
Drug content±SD 98.8 ± 0.02 98.5 ± 0.02 98.8 ± 0.04
In vitro drug release (%) 96.72 ± 0.0784 95.75 ± 0.963 95.78 ± 0.77
Skin irritation test No irritation No irritation No irritation
Spreadability (g.cm/s) 6.6 ± 0.5 6.5 ± 0.6 6.7 ± 0.6
Extrudability (g) 279 ± 0.7 270 ± 0.5 260 ± 0.7
Viscosity in cp at 50 (rpm) 9863 9582 9888

Table 9: Evaluation Parameters for Batch C

Evaluation parameters C-1 C-2 C-3
Appearance Clear Less clear Clear
Homogenicity Homogeneous Homogeneous Homogeneous
Particle size (nm) 165 160 160
pH 6.5 ± 2 6.7 ± 1 6.2 ± 2
Drug content±SD 98.2 ± 0.029 98.6 ± 0.04 98.5 ± 0.072
In vitro drug release (%) 93.25 ± 0.903 95.72 ± 0.861 94.3 ± 0.85
Spreadability (g.cm/s) 6.3 6.4 6.3
Extrudability (g) 254 243 254
Viscosity in cp at 50 (rpm) 9585 9588 8500

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 Talele et al.: Nanogel as Topical Drug Delivery

Table 10: Stability data of Optimized Formulation the optimized batch and further experimental design is
Time period Particle Total drug content(%)
formulated. As shown in Table 10.
size(nm)
Initial 165 98.2 ± 0.029 CONCLUSION
After storage (40°C ± 2°C and 75% ± 5%RH)
Nanogel formulation containing Diclofenac sodium
1 Month 162 95.72 ± 0.861
was successfully prepared and shows effective as well as
2 Month 160 94.3 ± 0.85 better carrier for the transdermal/topical preparation.
3Month 164 93.25 ± 0.903 The formulated nanogel was optimized for homogenicity,
particle size, pH, drug content, in vitro drug release,
Table 11: Evaluation Parameter of marketed product skin irritation test, spreadability, extrudability, and
Evaluation Parameters Market product (Serrini) viscosity. Administration of this through dermal route
Appearance Clear bypass the disadvantages of oral route and maintain
Homogenicity Homogenous the consistently plasma levels for the therapy for single
Particle size (nm) 168 dose. The initial release rate from each formulation was
pH 6.5 ± 0.2 very rapid, this may be due to incomplete gel formation
Drug content±SD 96.8 ± 0.02 in the earlier time period, but the release became slow in
In vitro drug release (%) 95.72 ± 0.0784 latter period after complete gel formation. The release
Skin irritation test No irritation
profiles exhibited an inflection point, which indicated
Spreadability (g.cm/s) 6.6 ± 0.5
gel formation on the diffusion membrane in donor
compartment of diffusion cell. During gel formation,
Extrudability (g) 275 ± 0.7
formulation got converted into the gel phase and thus
Viscosity in cp at 50 (rpm) 9400
drug release became slow. The results showed that the
formed gels had the ability to retain diclofenac sodium
for the duration. The production of the formulation is
Stability batches evaluation also proved to be better and cost effective in comparison
The stability studies were carried out on optimized for- with oral dosage forms.
mulation. The samples were stored at 40oC±2oC and
75%±5% relative humidity for three months as per ICH ACKNOWLEDGEMENT
guidelines. After 1, 2 and 3 months samples were with-
The authors are thankful to the management, principal
drawn and tested for appearance, pH, particle size, drug
and the staff of Sandip Institute of Pharmaceutical Sci-
content, spreadability, extrudability, viscosity.
ences for their kind help and support.
Stability data of Optimized Formulation
The evaluation parameter performed for the trial CONFLICT OF INTEREST
batches (B and C) are the same as done for the above There are no conflict of interest.
prototype batch (A) and they are appearance, homo-
geneity, particle size measurement, pH measurement,
ABBREVIATION USED
drug entrapment efficiency, drug content, in vitro drug
release, skin irritation study, spreadibility, extrudability, nm: Nanometer; GIT: Gastrointestinal tract; gm:
rheological study, stability batches From the evaluation Gram; ml: Milliliter; kg: Kilogram; cm: Centime-
parameter result of trial batches we found Batch-A1 as ter; rpm: Revolutions per minute; ICH: International
the optimized batch and further experimental design is Conference on Harmonisation; μm: Micrometer; mm:
formulated. Figure 5. Milimeter; sec.: Second; μg/ml : Microgram per milili-
The evaluation parameter performed for the trial ter; g.cm/s: Gram centimeter per second; RH: Relative
batches (B and C) are the same as done for the above Humidity.
prototype batch (A) and they are appearance, homo-
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PICTORIAL ABSTRACT SUMMARY

• Diclofenac sodium has been used as Non-
Steroidal anti-inflamma¬tory drug (NSAID’s) for its
anti-inflammatory and anal¬gesic effect. Oral route
causes irritation and ulceration of GIT. An improved
Diclofenac formula with high degree of skin permeation
can be useful in treatment of not only inflamed tissues
but also inflammatory pain.
• Nanogel combines the advantage of hydrogel
inherting the property of nanoscale size. Nanogel
network provide high specific form can host and
protect drug molecules. The release of the drug
molecules can be incorporated by providing high-
affinity functional groups. Diclofenac sodium nanogel
which provides prolonged release.
• The present study is to formulate nanosize
dispersion of diclofenac sodium by emulsion-solvent
diffusion method and incorporation of gelling agent
to produce nanogel. Diclofenac sodium nanogel
About Authors formulated using carbopol with permeation enhancer
has shown better flux enhancement in comparison with
Swati Talele: She is working as an
nanogel formulated using HPMC and methyl cellulose.
Assistant Professor, in the Department
Gels containing diclofenac sodium with Eudragit
of Pharmaceutics at Sandip Institute
polymer shown better permeability coefficient.
of Pharmaceutical Sciences, Nashik.
• The formulated nanogel was optimized for
Currently she is pursuing her Ph D.
homogenicity, particle size, pH, drug content, in
programme at Savitribai Phule Pune
vitro drug release, skin irritation test, spreadability,
University, Pune, Maharashtra. Mrs.
extrudability, and viscosity.
Swati has research experience in
the area of Pharmaceutical analysis,
Phytochemical analysis, Formulation
of Nanoparticle for Drug delivery
applications.

Preetam Nikam: Obtained his post-graduate in 2013 from Department of Pharmaceutics, Savitribai
Phule Pune University, Pune, Maharashtra.

S586 Indian Journal of Pharmaceutical Education and Research | Vol 51 | Issue 4S | Oct-Dec (Suppl), 2017
 Talele et al.: Nanogel as Topical Drug Delivery

Dr. Ghosh: Has accomplished his Doctorate in Chemistry from the University of Mississippi,
USA after completion of M. Sc. from Indian Institute of Technology, Kanpur. He has 5 years
of postdoctoral research experience from the renowned universities of the USA along with
teaching experiences. Dr. Ghosh has total 16 international publications and presentations in high
impact international journals & conferences. Dr. Ghosh has research experience in the area of
electrochemistry, polymer sciences, and advanced materials for renewable energy applications,
spectroscopy and analytical chemistry.

Chaitali Deore: She is a student of Master Degree in Quality Assurance Department of Savitribai
Phule Pune University, Pune, Maharashtra.

Ashwini Jaybhave: She is a student of Master Degree in Quality Assurance Department of

Savitribai Phule Pune University, Pune, Maharashtra.

Dr. Anil Jadhav: Is currently working as Principal at Sandip Institute of Pharmaceutical Sciences,
Nashik, Maharashtra. He is Gold medalist of RGUHS during M.Pharmacy . Dr.Jadhav has 48
National and International publications in high impact factor journals, also has 2 books in his credit.
Dr.Jadhav is reviewers of many National and International journals. He has research experience in
the area of Phytochemical investigation and pharmacological activity.

Cite this article: Talele S, Nikam P, Ghosh BD, Deore C, Jaybhave A, Jadhav AG. A Research Article on Nanogel
as Topical Promising Drug Delivery for Diclofenac Nanogel. Indian J of Pharmaceutical Education and Research.
2017;51(4S):S580-S7.

Indian Journal of Pharmaceutical Education and Research | Vol 51 | Issue 4S | Oct-Dec (Suppl), 2017 S587