Presentation on theme: "A Silver nanoparticle based hydrogel prepared by green synthesis"— Presentation transcript:
1 A Silver nanoparticle based hydrogel prepared by green synthesis Wound Healing GelA Silver nanoparticle based hydrogelprepared by green synthesis
2 Novelty/Inventive component The product uses nanoparticle of silver formed by green synthesisSocial RelevanceIts an OTC product with vast market potentialUse of herbal product has better market acceptabilityHence very much required by the societyCommercial 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.
3 Proof of concept: Wound healing activity in Swiss Albino Wistar Rats.
4 PROPOSAL AIMS ATAim: Seeking approval for further investigation regarding safety & stability of the product & conduct clinical trialKey deliverables:Evaluation of safety & stability of the product using analytical/bio-analytical method following ICH guidelinesEvaluation 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 OBJECTIVESTo establish safety, stability and efficacy through clinical trialsWork PlanStep 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.
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 ProductLabel drug contentManufacturerPrice & quantitySilverex Ionic0.2% Silver nitrateRanbaxyRs. 47 for 10gBURNHEAL oint: Silver sulphadiazine 1 % w/w, chlorhexidine 0.6 % w/w. Cipla15g per 20gHYDROHEAL-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’sRs for 15gSILVINDON cream1% w/w silver sulfadiazineZydus (Indon)Rs for 20gALOEDERM-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/wFem CareRs. 33 for 15g
18 RATIONALE S.No. Limitation of Marketed products Advantage of Proposed Product1Silver sulphadiazine costs Rs per 25 gSilver Nitrate costs Rs per 25 g2Formulation containing silver nitrate in ionic form cause skin stainingSilver nanoparticle based product does not cause skin staining3Uses 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 FilledIP owned by: Chandra, A., et al. c/o Amity University, NoidaLicensing details, if any: Nil
20 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.