1. A Silver nanoparticle based hydrogel prepared by green synthesis
Wound Healing Gel
A Silver nanoparticle based hydrogel
prepared by green synthesis

2. 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.

3. Proof of concept: Wound healing activity in Swiss Albino Wistar Rats.

4. 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/bio-analytical method following ICH guidelines
Evaluation of microbial load in final product & identification of suitable preservative.
Conducting Phase – I clinical trial.

5. To establish safety, stability and efficacy through clinical trials
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 clinical trials.

6. 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.

7. PRELIMINARY WORK UNDERTAKEN

8. Microbial efficacy by Agar Well diffusion Assay
Concentration (µg/ml)
Average zone of inhibition (mm)
E.coli
S.aureus 10 16 15 20 17 40 18 80 19

9. Characterization of nanoparticles: UV Spectroscopy

10. Crystallinity Studies: XRD

11. Electron microscopy (SEM)

12. Infrared Spectroscopy

13. Wound healing Activity : ays 7 & 14

14. Wound healing Activity: Days 14 & 21

15. 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

16. 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.

17. List or marketed product
Name of Product
Label drug content
Manufacturer
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-AM topical gel: 
Propylene glycol 4.96 % w/w, carbomer 0.76 % w/w, silver colloid 32 ppm, triethanolamine 0.32 % w/w.
Dr. Reddy’s
Rs for 15g
SILVINDON cream
1% w/w silver sulfadiazine
Zydus (Indon)
Rs for 20g
ALOEDERM-B cream:
Aloe vera juice 30 % w/w, vitamin E acetate 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

18. RATIONALE S.No. Limitation of Marketed products
Advantage of Proposed Product 1
Silver sulphadiazine costs Rs per 25 g
Silver Nitrate costs Rs per 25 g 2
Formulation containing silver nitrate in ionic form cause skin staining
Silver nanoparticle based product does not cause skin staining 3
Uses Silver sulphadiazine in 1%w/w or Silver nitrate 0.2%
Uses 10-3 M Silver nitrate which is % w/w

19. 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

20. 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.

21. Thank You