Wound Healing Gel - Dr. Amrish Chandra

Report
Wound Healing Gel
A Silver nanoparticle based hydrogel
prepared by green synthesis
1
Novelty/Inventive component
The product uses nanoparticle of silver formed by green
synthesis
Social Relevance
Its an OTC product with vast market potential
Use of herbal product has better market acceptability
Hence very much required by the society
Commercial Potential
The new product uses 0.02% silver nitrate while the
traditional ones like Silverex® (Ranbaxy) uses 0.2% w/w. It’s a
10 times reduction in the quantity of silver used.
2
Proof of concept: Wound healing activity in Swiss
Albino Wistar Rats.
100
Percentage wound healing
Control
Standard
Formulation
80
60
40
20
0
0
7
Days
14
21
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PROPOSAL AIMS AT
Aim: Seeking approval for further investigation
regarding safety & stability of the product & conduct
clinical trial
Key deliverables:
•Evaluation of safety & stability of the product using analytical/bioanalytical method following ICH guidelines
•Evaluation of microbial load in final product & identification of suitable
preservative.
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•Conducting Phase – I clinical trial.
OBJECTIVES
To establish safety, stability and efficacy through clinical trials
Work Plan
Step 1 – Assessment of safety of the product: Skin irritation studies will be
carried out using rabbits by Drazie test. The irritancy score shall be computed and
based on response of skin.
Step 2 - Stability of the product: Effect of varying storage conditions on
product stability/efficacy will be evaluated using suitable analytical/ bio-analytical
method as per ICH guideline.
Step 3 – Evaluation and reduction of microbial load: Microbial load of the
formulation will be assessed and attempt will be made to reduce the microbial
load by incorporating preservative at optimum concentration.
Step 4 – Clinical trials: The safety/efficacy of the product will be proven through 5
clinical trials.
ENVISAGED OUTCOME OF THE STUDY
 The outcome of the project would be a comparatively
cost effective formulation for treatment of wound
healing that will be based on newer nanotechnology.
The product will demonstrate adequate stability &
safety.
 After successful safety & stability test and DCGI
approval, this project will go to Phase-2 for clinical trail
study.
6
PRELIMINARY WORK
UNDERTAKEN
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Microbial efficacy by Agar Well diffusion Assay
Concentration
Average zone of inhibition (mm)
Average zone of inhibition (mm)
(µg/ml)
E.coli
S.aureus
10
16
15
20
17
16
40
18
17
80
20
19
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Characterization of nanoparticles: UV Spectroscopy
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Crystallinity Studies: XRD
10
Electron microscopy (SEM)
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Infrared Spectroscopy
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Wound healing Activity : ays 7 & 14
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Wound healing Activity: Days 14 & 21
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Preparation of formulation
Silver Nitrate
Addition of herbal extract
Formation of colloidal nanoparticles after heating
Addition of gelling polymer & preservative
Allow to stand overnight
Product
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ENVISAGED OUTCOME OF THE STUDY
 The outcome of the project would be a comparatively cost
effective formulation for treatment of wound healing that will be
based on newer nanotechnology. The product will demonstrate
adequate stability & safety.
 After successful safety & stability test and DCGI approval, this
project will go to Phase-2 for clinical trail study.
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List or marketed product
Name of
Product
Label drug content
Manufac
turer
Price &
quantity
Silverex
Ionic
0.2% Silver nitrate
Ranbaxy
Rs. 47 for
10g
BURNHEAL
oint:
Silver sulphadiazine 1 % w/w, chlorhexidine
0.6 % w/w.
Cipla
15g per
20g
HYDROHEAL Propylene glycol 4.96 % w/w, carbomer 0.76
-AM topical % w/w, silver colloid 32 ppm,
gel:
triethanolamine 0.32 % w/w.
Dr.
Reddy’s
Rs. 69.5
for 15g
SILVINDON
cream
Zydus
(Indon)
Rs. 11.53
for 20g
1% w/w silver sulfadiazine
ALOEDERM- Aloe vera juice 30 % w/w, vitamin E acetate
B cream:
0.5 % w/w, allantoin 0.5 % w/w, sodium
pyrrolidone carboxylic acid 1 % w/w, silver
sulfadiazine 1 % w/w, chlorhexidine
gluconate 1 % w/w
Fem Care Rs. 33 for
15g
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RATIONALE
S.No.
Limitation of Marketed products
1
Silver sulphadiazine costs Rs. 13756 per Silver Nitrate costs Rs. 4143 per 25 g
25 g
http://www.sigmaaldrich.com/catalog/product/aldrich/481181?lang=en&region=IN
Advantage of Proposed Product
http://www.sigmaaldrich.com/catalog/search?interface=All&term=silver+nitrate&N=0&mode=match%20partialmax&focus=product&lang=en&region=IN
2
Formulation containing silver nitrate in Silver nanoparticle based product does
ionic form cause skin staining
not cause skin staining
3
Uses Silver sulphadiazine in 1%w/w or Uses 10-3 M Silver nitrate which is
Silver nitrate 0.2%
0.016987% w/w
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INFORMATION REGARDING IPR
Background IP details: Complete Patent Filled
IP owned by: Chandra, A., et al. c/o Amity University, Noida
Licensing details, if any: Nil
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FUTURE PLANS
The success of the clinical trial would lead to the scale up,
process validation, large scale manufacture and finally
commercialization and marketing of the product. This activity
would be taken up in the next phase.
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Thank You
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