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Sridhar et al. European Journal of Biomedical and Pharmaceutical Sciences
www.ejbps.com │ Vol 8, Issue 3, 2021. │ ISO 9001:2015 Certified Journal │
271
DESIGN, PREPARATION AND IN VITRO CHARACTERIZATION OF DULOXETINE
THE TRANSDERMAL PATCH
*B. Sridhar and Dr. G. Praveen Kumar
Pharmaceutics, Sahasra Institute of Pharmaceutical Sciences, Hasanparthy Mandal, Vangapahad Village, Warangal,
Telangana India.
Article Received on 05/01/2021 Article Revised on 25/01/2021 Article Accepted on 15/02/2021
INTRODUCTION
Transdermal drug delivery (TDD) is an appropriate mode
of medicine distribution for administering the medicine
right into the body across the skin. TDD is not a new
idea; for hundreds of years, people make use of drug on
the skin for recovery local injuries.[1]
Nevertheless, it
takes even more emphasis current age as a valuable
mode of medicine delivery. It is becoming prominent in
medical practice each day as a result of its potentiality of
using the option of oral and injectable dose forms.
Numerous advantages are noticed for TDD prep work,
such as- evasion of first-pass metabolic rate, delivery of
stable mixture of the medicine for an extended time,
decrease of adverse effects, easy application and
elimination of TDD films/patches, person approval, and
so on.[2,3]
Moreover, it is possible to reduce the potential
hazards (side effects) of the medication by instilling
TDD medication via skin rather than intravenous mixture
(a remarkable setting of drug delivery).[4]
Duloxetine is a twin serotonin as well as norepinephrine
reuptake inhibitor. It was initially discovered in 1993 as
well as established by Eli Lilly and Business as
LY248686.[5]
Duloxetine initially received approval from
the FDA in August, 2004 as Cymbalta for the therapy of
Major Depressive Disorder. It has given that gotten
approval for a range of signs including the treatment of
neuropathic discomfort, Generalized Anxiety disorder,
osteo arthritis, and stress urinary incontinence.
Duloxetine remains to be explored for the therapy of pain
in cancer cells, surgery, as well as more. IUPAC name is
methyl [(FOUR)-3-(naphthalen-1-yloxy)-3-(thiophen-2-
yl)propyl] amine. Molecular weight is 297.417.
Duloxetine hydrochloride (DXH) struggles with
inadequate solubility and consequently inadequate
absorption, which eventually causes inadequate
bioavailability.
Fig 1: Chemical structure of Duloxitine.
MATERIALS
The Duloxetine was supplied by Sunpharma, Hyderabad,
India, Ethyl cellulose N45 from Colorcon Asia Pvt. Ltd,
Hpmck15m from Loba Chemie, Methanol was of high
SJIF Impact Factor 6.044 Research Article ejbps, 2021, Volume 8, Issue 3, 271-282.
European Journal of Biomedical AND Pharmaceutical sciences
http://www.ejbps.com
ISSN 2349-8870
Volume: 8
Issue: 3
271-282
Year: 2021
*Corresponding Author: B. Sridhar Pharmaceutics, Sahasra Institute of Pharmaceutical Sciences, Hasanparthy Mandal, Vangapahad Village, Warangal, Telangana India.
DOI: https://doi.org/10.17605/OSF.IO/KF5XJ
ABSTRACT
Transdermal drug delivery (TDD) is an acceptable mode of drug delivery for administering the drug into the body
across the skin. Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor. The formulation developed
by using polymers such as Ethyl cellulose n45, HPMCk15m polymers are used in different trails in different
quantity is used. The Dibutyl phthalate is used as plasticizer and DMSO (Dimethyl sulfoxide) used as permeation
enhancer. The formulation s F1-F9 are formulated. After completion of formulation the evaluation parameters are
performed. The evaluation parameters values for optimized formulation such as, The Thickness of the transdermal
patch is found to be,0.28, The drug content study was found to be, 98.89 %, The moisture loss studies found to be,
7.68%, The moisture absorption studies found to be, 10.46%, The weight variation of patch was found to be,
199mg, The In-vitro drug release studies found to be, 99.34, The all performed evaluation parameters are found to
be values within the limits of range.
KEYWORDS: Duloxetine, Transdermal patch, Ethyl cellulose N45, Hpmck15m.
Sridhar et al. European Journal of Biomedical and Pharmaceutical Sciences
www.ejbps.com │ Vol 8, Issue 3, 2021. │ ISO 9001:2015 Certified Journal │
272
performance liquid chromatography (HPLC) grade. All
other reagents and solvents were of analytical reagent
grade
METHODOLOGY
PREFORMULATION STUDIES[6-13]
ORGANOLEPTIC CHARECTERS
Preformulation studies like organoleptic characters such
as taste, odour, color can be observed by visually.
SOLUBILITY STUDIES
The drug solubility parameter carried out by water,
ethanol, methanol, DMSO, acetone, the results are kept
in Results.
FTIR STUDIES: The pure drug, Duloxetine and the
physical mixtures of drug and polymers were mixed
separately with IR grade KBr and corresponding pellets
were prepared and scanned in wavelength region
between 4000 to 400 cm-1. The spectra of the drug were
compared with polymers.
CALIBRATION OF DULOXETINE IN
METHANOL
PREPARATION OF STANDARED STOCK
SOLUTION
10mg of Duloxetine drug was taken and dispensed the
drug was dissolved in 10ml of volumetric flask it is
1000ppm.
Preparation of 2nd
stock solution
Take 1ml of sample from 1st stock solution and diluted
with medium make up to mark in 10 ml of volumetric
flask it is 100ppm.
To take 1ml of from 2nd
stock solution and make up to 10
ml of volumetric flask with medium it is 10ppm this is
kept under absorbance in U.V visible spectroscopy at
224 nm. The absorbance is high the serial dilutions are
prepared like 2,4,6,8,10 and check absorbance in U.V
visible spectroscopy.
CALIBRATION OF DULOXETINE IN WATER
PREPARATION OF STANDARED STOCK
SOLUTION
10mg of Duloxetine drug was taken and dispensed the
drug was dissolved in 10ml of volumetric flask it is
1000ppm.
Preparation of 2nd
stock solution
Take 1ml of sample from 1st stock solution and diluted
with medium make up to mark in 10 ml of volumetric
flask it is 100ppm.
To take 1ml of from 2nd
stock solution and make up to 10
ml of volumetric flask with medium it is 10ppm this is
kept under absorbance in U.V visible spectroscopy at
224nm. The absorbance is high the serial dilutions are
prepared like 2,4,6,8,10 and check absorbance in U.V
visible spectroscopy.
FORMULATION TABLE OF DULOXETINE TRANSDERMAL PATCH
Table No: 1: Formulation design of the Duloxetine patches.
Ingredient’s F1 F2 F3 F4 F5 F6 F7 F8 F9 Duloxetine 80 80 80 80 80 80 80 80 80 HPMC k15m 10 - 10 20 20 30 30 40 40 Ethyl cellulose N45 - 10 10 - 20 - 30 - 40 DBP (plasticizer) 2ml 2ml 2ml 2ml 2ml 2ml 2ml 2ml 2ml DMSO (permeation enhancer) 3ml 3ml 3ml 3ml 3ml 3ml 3ml 3ml 3ml Water q.s q.s q.s q.s q.s q.s q.s q.s q.s Methanol q.s q.s q.s q.s q.s q.s q.s q.s q.s
PROCEDURE
The Duloxetine transdermal patch prepared by solvent
casting method.
Polymer solution: The polymers which are selected for
Duloxetine patch dissolved in respective solvents such as
water and methanol. Kept under for stirring at 500rpm
for 1hr.
Drug solution: The drug solution was added after
formation viscous nature and keeps stirring for
homogeneous mixing of polymer and drug solution.
Then add plasticizer DBP (dibutyl phthalate) and add
permeation enhancer such as dmso. The drug and
polymeric mixture poured into the petriplate and dry it
24hrs for at 450c. After drying by using sharp blades the
patch was removed.
EVALUATION PARAMETERS
PHYSICAL APPEARANCE
All the prepared Duloxetine films were observed for
color, clarity, flexibility, and smoothness.
FOLDING ENDURANCE
The folding endurance is one of the evaluation
parameters. Folding endurance of the patches was
resolved by repeatedly folding at the same place till it
broke. The number of folding of patch was done till
Sridhar et al. European Journal of Biomedical and Pharmaceutical Sciences
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273
without braking of prepared transdermal patch. This was
repeated for all formulated Duloxetine patches for 3
times and the mean values plus standard deviation was
calculated.
THICKNESS OF THE FILM The thickness of each film was measured by using screw
gauze. The thickness was measured at three different
places on each film and the average thickness of the film
was taken as the thickness of the film.
WEIGHT UNIFORMITY: - The prepared patches are
to be dried at 600C for 4hrs before testing. A specified
area of 4.52 cm2
of patch is to be cut in different parts of
the patch and weigh in digital balance. The average
weight and standard deviation values are to be calculated
from the individual weights.
FLATNESS
Flatness was estimated by randomly selected five
longitudinal strips were cut out from mediated patch of
each formulation; the length of each strip was calculated
before and after kept at room temperature for 30 minutes.
Variation in length due to non uniformity of flatness was
calculated by percent constriction, with 0% constriction
as 100% flatness.
DRUG CONTENT
The buccal films (2 cm2) were added to conical flask
containing 100 ml of phosphate buffer pH 7.4 contain
0.5%SLS. This was then stirred with magnetic bead at
400 rpm for 2 hrs. The contents were filtered and the
filtrate was analysed spectrophotometrically for drug
content at 268 nm. Similarly, a blank was prepared from
buccal films without drug.
Where, DT = Total amount of the drug in the patch
Da = the amount of drug released
Conditions
Medium: Phosphate buffer pH 7.4 containing 0.5% SLS
RPM: 200
Temperature: 37 ± 0.50C
Time intervals: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12hours
MOISTURE ABSORPTION STUDIES
The films were dispensed accurately and kept in a
aluminum chloride containing desiccators to maintain
79.50% RH. After 3 days, the films were taken out and
weighed. The percentage of moisture uptake was
calculated using the following formula.
%moisture uptake content=Final wt-Intial wt/Intial
wtΧ100
MOISTURE LOSS STUDIES
Three films were weighed individually and kept in a
desiccator containing calcium chloride at 370C for 24
hrs. Then the final weight was noted when there was no
further change in the weight of the patch. The percentage
of moisture loss was calculated using the following
formula.
IN-VITRO DRUG RELEASE STUDIES: In-vitro
dissolution studies carried out by using A modified Franz
diffusion cell was used for Duloxetine transdermal patch.
The dissolution medium is 7.4 ph phosphate buffers. In
Franz diffusion cell the medium was poured about 10ml
the semipermeable membrane kept around the Franz
diffusion cell. The dissolution studies kept for 12 hours.
The time intervals minted for 1hr. The 1ml of aliquoted
was withdrawn and same amount of sample replaced in
diffusion cell. The withdrawn aliquot was diluted with
7.4 ph phosphate buffer. The absorbance analyzed under
U.V visible spectroscopy at the 224nm.
KINETIC PROFILE
Kinetics and mechanism of drug release from all
formulation was evaluated on the basis of zero order,
Higuchi equation and Pappas model. Correlation
coefficient (r2) and slop value for each equation was
calculated from Microsoft excel. Zero order plot for all
formulations were found to be linear in both dissolution
medium. That indicates it may follow zero order
mechanism. Higuchi plot was found to be linear, which
indicates diffusion may be the mechanism of drug
release for each formulation. Peppas plot was found good
linear, n > 0.5 for all formulations, indicated that drug
release may follow anomalous diffusion. Zero order plot
for F4 formulation was found to be linear in both
dissolution medium, it considered as a best fit for drug
release.
STABILITY STUDIES: - Stability of a drug has been
defined as the stability of a particular formulation,
specific container, to remain within its physical,
chemical, therapeutic and toxicological specifications
throughout its shelf life. The purpose of the stability
testing is to provide information on the quality of a drug
substance or its product, which varies with time under
the effect of environmental factors such as temperature,
humidity and light. Recommended storage conditions,
re-test periods and shelf lives are to be established.
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RESULTS
PRE- FORMULATION STUDIES
ORAGANOLEPTIC CHARACTERS
Table No: 2: Organoleptic characteristics of the Duloxetine drug.
Properties Results
Description White crystals
Taste Tasteless
Odor Bitter
Color White colour
Discussion: The organoleptic properties of Duloxetine
were found to be white to off white in colour, odourless
and slightly unpleasant in taste and were as per the
specifications.
SOLUBILITY
Table no 3: Solubility studies of the Duloxetine.
Solvent Solubility properties of drug (1gm) Water Soluble
Discussion: Duloxetine was found to be soluble in water.
CALIBRATION CURVE IN METHANOL
Table no: 4: Calibration curve values of the
Duloxetine in methanol.
S.NO Concentration (µg/ml) Absorbance(nm)
1 0 0
2 10 0.18
3 20 0.35
4 30 0.51
5 40 0.69
6 50 0.89
Fig.No: 2 picture showing calibration curve in acetone.
CALIBRATION CURVE IN WATER
Table no: 5: Showing table calibration curve values of the Duloxetine in water.
S.NO Concentration (µg/ml) Absorbance(nm) 1 0 0 2 10 0.19 3 20 0.35 4 30 0.49 5 40 0.65 6 50 0.82
Sridhar et al. European Journal of Biomedical and Pharmaceutical Sciences
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275
Fig. No: 3 showing picture of calibration curve in water.
FTIR STUDIES
Fig.no: 4. FTIR study of pure drug of Duloxetine.
Fig.no:5 The FTIR spectra of the Duloxetine drug +ethyl cellulose N45+hpmc k15m.
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Compatibility studies were performed using FTIR
spectrophotometer. The FTIR spectrum of Pure drug and
physical mixture of drug and polymers were studied. The
characteristic absorption peaks were observed at
1146.57cm-1
, 1087.98 cm-1
, cm-1
, 687cm-1
, 2934cm-1
for
the pure Duloxetine and absorption peaks were observed
at 1148.650 cm-1
, 1085cm-1
, 680 cm-1
, 1716 cm-1
, 2850
cm-1
for drug and polymer mixture show that how they
were in official limits (±100 cm-1
) the drug is compatible
with excepients.
EVALUATION STUDIES FOR DULOXETINE TRANSDERMAL PATCH F1-F4
Table no: 6: Showing table evaluation values of the Duloxetine patch.
Formulation code F1 F2 F3 F4
Thickness (mm) 0.26± 1.2 0.26± 1.3 0.25±1.7 0.26±1.6
Weight variation (mg) 181 ± 1.2 184 ± 1.2 191±1.4 197±1.2
Drug content Uniformity 97.41±0.3 97.56 ±0.4 98.24±0.6 98.52±0.5
Folding endurance 304 ± 2 302±1 301±8 300±8
Swelling index 27.22 31.53 30.62 32.60
% of moisture loss 5.61 6.53 7.79 7.88
% of moisture absorption 11.23 11.78 12.12 11.22
EVALUATION STUDIES FOR ATENLOOL TRANSDERMAL PATCH F5-F9
Table no: 7: Showing table evaluation values of the Duloxetine patch.
Formulation code F5 F6 F7 F8 F9 Thickness (mm) 0.27± 1.2 0.29± 1.3 0.28±1.7 0.31±1.6 0.30±1.8 Weight variation (mg) 194 ± 1.2 197 ± 1.2 199±1.4 199±1.2 201±1.8 Drug content Uniformity 98.51±0.3 97.26 ±0.4 98.89±0.6 97.82±0.5 98.44±0.8 Folding endurance 299 ± 2 298 ±1 301±8 300±8 300±9 Swelling index 21.22 29.53 32.62 29.60 30 %of moisture loss 7.8 6.98 7.68 7.2 5.65 % of moisture absorption 11.6 11.43 10.46 11.56 11.23
The above all the formulations under kept for the
evaluation studies such as the weight variation, folding
endurance, drug content, swelling index all F1-F9
formulations come under within range of limits.
IN VITRO DRUG RELEASE STUDIES OF ALL FORMULATIONS F1-F9
Table no: 8: Showing table In-vitro drug release values of the Duloxetine patch.
Time F1 F2 F3 F4 F5 F6 F7 F8 F9
0 0 0 0 0 0 0 0 0 0
1 21.52 23.22 19.5 14.45 17.65 16.82 19.31 17.2 18.86
2 33.53 31.53 20.65 24.45 27.65 29.56 27.52 23.56 35.75
3 46.6 48.40 31.65 34.85 36.65 42.78 40.46 42.33 45.85
4 59.5 67.52 42.87 47.65 48.52 57.54 60.75 52.90 67.22
5 78.6 81.75 56.32 57.88 61.75 67.28 74.78 65.54 78.65
6 96.56 97.52 68.65 69.71 74.88 77.93 90.78 76.88 87.83
7 - 105.85 72.56 77.83 77.82 87.75 94.32 87.12 91.85
8 - - 82.86 89.78 88.54 94.65 99.34 95.76 94.74
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10.5. ALL COMPARATIVE DRUG RELEASE PROFILE GRAPH
Fig.No:6 showing picture of the all comparative graphs of F1-F9.
COMPARATIVE DRUG RELEASE PROFILE OF GRAPH F1-F3
Table no: 9: Comparative In-vitro values of the Duloxetine patch F1-F3.
Time F1 F2 F3 0 0 0 0 1 21.52 23.22 19.5 2 33.53 31.53 20.65 3 46.6 48.40 31.65 4 59.5 67.52 42.87 5 78.6 81.75 56.32 6 96.56 97.52 68.65 7 - 105.85 72.56 8 - - 82.86
Fig.No:7 showing picture of comparative graphs of F1-F3.
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COMPARATIVE DRUG RELEASE PROFILE FOR F4-F6
Table no: 10: Comparative In-vitro values of the Duloxetine patch F4-F6.
Time F4 F5 F6 0 0 0 0 1 14.45 17.65 16.82 2 24.45 27.65 29.56 3 34.85 36.65 42.78 4 47.65 48.52 57.54 5 57.88 61.75 67.28 6 69.71 74.88 77.93 7 77.83 77.82 87.75 8 89.78 88.54 94.65
Fig.No:8 Showing picture of comparative graphs of F4-F6.
COMPARATIVE DRUG RELEASE PROFILE FOR F7-F9
Table no: 11: Comparative In-vitro values of the Duloxetine patch F7-F9.
Time F7 F8 F9 0 0 0 0 1 19.31 17.2 18.86 2 27.52 23.56 35.75 3 40.46 42.33 45.85 4 60.75 52.90 67.22 5 74.78 65.54 78.65 6 90.78 76.88 87.83 7 94.32 87.12 91.85 8 99.34 95.76 94.74
Sridhar et al. European Journal of Biomedical and Pharmaceutical Sciences
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279
Fig. No: 9 Showing picture of comparative graphs of F7-F9.
KINETIC STUDY FOR THE OPTIMIZED FORMULATION(F7)
Table no: 12: Kinetic values of the Duloxetine patch optimized F7.
Time %cdr Log T √T Log%cdr ARA Log%ARA 0 0 1 0 1 100 2 1 19.31 0 1 1.26 81.79 1.912 2 27.52 0.30103 1.414 1.45 71.38 1.853 3 40.46 0.47712 1.732 1.61 58.44 1.766 4 60.75 0.60206 2 1.77 40.38 1.606 5 74.78 0.69897 2.236 1.87 24.35 1.386 6 90.78 0.778151 2.449 1.95 10.47 1.019 7 94.32 0.845098 2.645 1.98 4.35 0.634 8 99.34 0.90309 2.828 1.99 0.35 -0.455
ZERO ORDER PLOT
Fig.No:10 zero order equation.
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FIRST ORDER PLOT
Fig.No:11 First order equation.
HIGUCHI PLOT
Fig.No:12 higuchi equation.
KROSS MAYER PEPPAS
Fig.No:13 krossmayer peppas equation.
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Table no: 13: Showing table kinetic values of the Duloxetine patch optimized F7.
S.no Zero
oreder First
order Higuchi
Krossmayer
peppas Code R
2 R2 R
2 R2
F7 0.980 0.806 0.934 0.108
It was concluded that the optimized formulation F7,
followed zero order release where the regression value
was found to be 0.980 It was also found that the drug
was released by diffusion as the regression in Higuchi’s
plot was 0.934.
STABILITY STUDIES
There was no significant change in physical and
chemical properties of the Duloxetine of Optimized
formulation F-7 after 3 Months of stability studies.
Parameters quantified at various time intervals were
shown;
Table 14: Results of stability studies of optimized formulation F-7.
Formulation
Code Parameters Initial 1
st Month 2
nd Month 3
rd Month
Limits as per
Specifications
F-7 25
0C/60%RH
% Release 99.34 98.64 98.57 99.18
Not less than
85 %
Table 15: Stability dissolution profile of F-6 for 1st, 2nd & 3rd months.
S.NO. TIME(Hrs) intial F-7 1M F-7 2M F7 3M
1 0 0 0 0 0
2 1 19.31 15.50 16.26 17.50
3 2 27.52 26.50 27.20 28.30
4 3 40.46 44.48 40.45 41.75
5 4 60.75 62.10 57.65 58.46
6 5 74.78 77.27 74.24 76.32
7 6 90.78 88.36 87.52 88.82
8 7 94.32 94.58 94.55 93.47
9 8 99.34 98.64 98.57 99.18
Stability dissolution profile of F-7for 1st, 2nd & 3rd months
STABILITY STUDY GRAPH
Fig.No:14 Stability graph.
SUMMARY
The main aim and objective are to development and
characterization of Duloxetine patch. The Duloxetine
transdermal patch is formulated by using different
polymers the plasticizer and permeation enhancers are
also used in the formulation. First the review literature is
Sridhar et al. European Journal of Biomedical and Pharmaceutical Sciences
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282
carried out for the selection of drug and selection of
polymers and all excipients.
Before going to develop the formulation the pre
formulation studies are carried out. They are appearance,
color, odor. The compatibility studies carried out such as
FTIR studies the drug and excipient compatibility study
carried out they are compatible with each other.
The formulation developed by using polymers such as
Ethyl cellulose n45, HPMCk15m polymers are used in
different trails in different quantity is used. The Dibutyl
phthalate is used as plasticizer and DMSO (Dimethyl
sulfoxide) used as permeation enhancer. The formulation
s F1-F9 are formulated. After completion of formulation
the evaluation parameters are performed.
The evaluation parameters values for optimized
formulation such as,
The Thickness of the transdermal patch is found to be,
0.28
The drug content study was found to be, 98.89 %
The moisture loss studies found to be, 7.68%
The moisture absorption studies found to be, 10.46%
The weight variation of patch was found to be, 199mg
The In-vitro drug release studies found to be, 99.34%
The all performed evaluation parameters are found to be
values within the limits of range.
After completion of drug release studies, the kinetic data
was calculated for optimized formulation it fallows the
zero order and fallows higuchi equation.
The stability studies are performed for optimized
formulation for 90days at accelerated stability studies.
There is no degradation in drug release and drug content
studies.
CONCLUSION
The development and characterization of Duloxetine
transdermal patch is developed by using synthetic
polymers such as HPMC k45, Ethyl cellulose n45 were
used. The Di butyl phthalate is used as plasticizer and Di
methyl sulfoxide is used as permeation enhancer. The
patch is formulated by applying by solvent casting
method. After formulation development the evaluation
parameters performed all came under the range of limits.
The drug release the optimized formulation F7 was
found to be 99.34%. The kinetic profile performed for
optimized formulation they follow the zero order and
higuchi equation. The stability studies carried out for 90
days there is no degradation in optimized formulation in
drug release and drug content studies.
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