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

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Presentation on theme: "A Silver nanoparticle based hydrogel prepared by green synthesis 1 Wound Healing Gel."— Presentation transcript:

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

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. 2

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

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. 4

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

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. 6

7 PRELIMINARY WORK UNDERTAKEN 7

8 Microbial efficacy by Agar Well diffusion Assay Concentration ( µ g/ml) Average zone of inhibition (mm) E.coli Average zone of inhibition (mm) S.aureus

9 Characterization of nanoparticles: UV Spectroscopy 9

10 Crystallinity Studies: XRD 10

11 Electron microscopy (SEM) 11

12 Infrared Spectroscopy 12

13 Wound healing Activity : ays 7 & 14 13

14 Wound healing Activity: Days 14 & 21 14

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 15

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. 16

17 List or marketed product Name of Product Label drug contentManufac turer Price & quantity Silverex Ionic 0.2% Silver nitrateRanbaxyRs. 47 for 10g BURNHEAL oint: Silver sulphadiazine 1 % w/w, chlorhexidine 0.6 % w/w. Cipla15g 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 sulfadiazineZydus (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 CareRs. 33 for 15g 17

18 S.No.Limitation of Marketed productsAdvantage 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 M Silver nitrate which is % w/w RATIONALE 18

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 19

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. 20

21 Thank You 21


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