A Silver nanoparticle based hydrogel prepared by green synthesis

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Wound Healing Gel

Novelty/Inventive component The product uses nanoparticle of silver formed by green synthesis Social Relevance Its an OTC product with vast market potentialUse of herbal product has better market acceptabilityHence very much required by the society

Commercial PotentialThe 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.

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

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Control Standard Formulation

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

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.

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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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PRELIMINARY WORK UNDERTAKEN

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Microbial efficacy by Agar Well diffusion Assay

Concentration

(µg/ml)

Average zone of inhibition (mm)E.coli

Average zone of inhibition (mm)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

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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 formulationSilver Nitrate

Addition of herbal extract

Formation of colloidal nanoparticles after heating

Addition of gelling polymer & preservative

Allow to stand overnight

Product 15

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 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. 69.5 for 15g

SILVINDON cream

1% w/w silver sulfadiazine Zydus (Indon)

Rs. 11.53 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

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S.No. Limitation of Marketed products Advantage of Proposed Product

1 Silver sulphadiazine costs Rs. 13756 per 25 ghttp://www.sigmaaldrich.com/catalog/product/aldrich/481181?lang=en&region=IN

Silver Nitrate costs Rs. 4143 per 25 ghttp://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 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 0.016987% w/w

RATIONALE

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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 PLANSThe 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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