Transdermal T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

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Dr. Zoltán DÁRDAI h.c. Transdermal Therapies and Medicaments Dr. Zoltán DÁRDAI h.c. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary

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Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary. Transdermal T herapies and Medicaments Dr. Zoltán DÁRDAI h.c. Technology Description. - PowerPoint PPT Presentation

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Page 1: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Transdermal Therapies and Medicaments

Dr. Zoltán DÁRDAI h.c.

Name of the Technology

TechnologyDescription

Technology Status

Potential Market

Opportunities

Intellectual Property

Status

Stakeholder Support

Resource Requirements

Potential Challenges

Summary

Page 2: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

Technology Status

Potential Market

Opportunities

Intellectual Property

Status

Stakeholder Support

Resource Requirements

Potential Challenges

SummaryThis is the normal structure of the skin, this needs to be

changed if we want to apply transdermal technology.

Page 3: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

Technology Status

Potential Market

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Summary

The main points of this technology:

Solubilisation of the medically active molecule

How to dissolve the barrier in a reversible way?

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary In order to change the barrier we need to apply amfipathic tenside (=surfce active molecule). This tensid has to ensure

the solubilisation of the active molecule.

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

Technology Status

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Summary

Tenside molecules in solvent

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

Technology Status

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Summary

Opening the pores with using the van de Waals effect

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary

Dissolving the barrier opens up the following problem:

How to prevent harmful materials from entering the body?

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary

Harmful material (i.e. bacteria, chemicals)

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary

Enlarging the harmful agents

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary

Insulin is mostly an association

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary

Linearisation of the associated insulins with tenside

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary

Bio-colloidical chemistry=

Bio-nano-technology

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary

3D representation

Page 14: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

Technology Status

Potential Market

Opportunities

Intellectual Property

Status

Stakeholder Support

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Summary

Page 15: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

Technology Status

Potential Market

Opportunities

Intellectual Property

Status

Stakeholder Support

Resource Requirements

Potential Challenges

Summary

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

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Potential Market

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SummaryThe effect of selective tenside adsorpion on the barrier and

antibarrier (only for medicaments) function

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Dr. Zoltán DÁRDAI h.c.

Technology DescriptionTransdermal Technologies

and Medicaments

TechnologyDescription

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Summary

Barrier and antibarrier in practice

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Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

TechnologyDescription

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Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

TechnologyDescription

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Summary

Insulin Patch:

All in vitro and in vivo preclinical experiments were ready before the agreement between EU and Hungary. That is why now GLP, GMP and GCP are needed.

Phasis I. research: self testing

Missing:Phasis II and Phasis III trials

Esimated time until application:If using permited insulin: cca. 1 years

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Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

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Aspirin Patch:

All in vitro and in vivo preclinical experiments were ready before the agreement between EU and Hungary. That is why now GLP, GMP and GCP are needed.

Phasis I. research: self testing

Missing:Phasis II and Phasis III trials

Esimated time until application: cca. 6-8 months

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Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

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Myocardial Infarct Prevention Patch :

Preclinical in vitro experiments are ready.In vivo animal experiments could begin at university level this year. In this case results would be available within one year.

Phasis I. research: self testing

Missing:Phasis I, II, III trials

Esimated time until application: cca. 1-2 years

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Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

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Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

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Gels, Creams, Emulsions

Mobilis Gel

Curative therapy for rheumatic problems.

All in vitro and in vivo clinical experiments were ready with a significant result of 97% before the agreement between EU and Hungary. That is why now GLP, GMP and GCP are needed.

Estimated time until application: 6 months.

Page 24: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

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Page 25: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

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Summary

Gels, Creams, EmulsionsOsteoporosis Cream

All in vitro and in vivo clinical experiments were ready with a significant result of 90% before the agreement between EU and Hungary. That is why now GLP, GMP and GCP are needed.

Estimated time until application: 4-5 months.

Page 26: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Technology StatusName of the Technology

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Page 27: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Gels, Creams, Emulsions:

Hepa Mix EmulsionAnti Fet emulsionDivertic EmulsionPsori Crem familyAll permissions available.Missing: capital.

Technology StatusName of the Technology

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Page 28: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Potential Market OpportunitiesName of the Technology

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Summary

The pains and problems that application of transdermal technology can address:- consertative approach of administring medicaments- competitive companies applying per os, intramuscular or subcutan drug administration

Services enabled by transdermal technology: improving the patients’ quality of life (i.e. no fridge needed; indicates the time of new administration-colour coded)

Benefits:- administration of the drug is more human- less side effects because doses can be lower

Page 29: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Potential Market OpportunitiesName of the Technology

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Summary

Scientific merit:- new pharmaco-chemical and medical view - re-evaluating the function of the skin

Market:all patients

Chanels to customer:- education of doctors and pharmacologists- informing the health insurance system about this more economical solution- informing the patients

Barriers to market: competitive companieslack of information

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Dr. Zoltán DÁRDAI h.c.

Intellectual Property StatusName of the Technology

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Summary

All intellectual properties are either under PCT, Hungarian licence, or secret know-how of Dr. Zolán DÁRDAI h.c.

Development partners:Eötvös Lóránd Tudomány Egyetem: Prof. Dr. Nagy Miklós, Állatorvos Tudományi Egyetem: Prof. Dr. Rudas Péter, Prof. Dr. Sótonyi Péter, Debreceni Egyetem: Prof. Dr.Tosaky Árpád, Kaposvári Mezőgazdasági Egyetem: Prof.Dr. Szendrő Zsolt, Semmelweis Egyetem:Prof. Dr. Sótonyi Péter II., Prof.Dr. Pogácsa Gábor, Prof. Dr. Kéry Ágnes, Magyar Honvédség Egészségügyi Intézet: Prof. Dr. Fűrész József, Gyógyszeripari Minőségellenőrző Intézet: Dr.Financsek István, Dr.Horváth Katalin, Állategészségügyi Intézet: Dr.Sályi Gábor. Roche Diagnostics: Dr.Békésy Mariann, Országos Élelmiszeripari és Táplálkozástudományi Intézet: Dr.Kontraszti Mariann, Országos Tiszti Főorvos: Dr.Bujdosó László, Szent László Kórház, Prof. Dr.Mészmer Zsófia, ITW Dynatech GmbH: Kishonti Attila, ICI National Adhesives AG: Zsíros Viktor.

Partners:Egészségügyi Minisztérium Prof.Dr.Huszár András Főosztályvezető, Gazdasági Minisztérium Egyed Géza államtitkár, Dr.Balogh Tamás Főosztályvezető, Nemzetvédelmi Minisztérium: Prof.Dr.Fűrész József, Miniszterelnöki Hivatal: Dr.Angelusz Róbert főtanácsadó.

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Dr. Zoltán DÁRDAI h.c.

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• Economical data

• Inzulin patch (piece)• 5 UI 10 UI 20 UI• Price of main materials • 30 HUF 60 HUF 120 HUF• Price of production • 95 HUF 175 HUF 200 HUF• Market value

150 HUF 240 HUF 280 HUF

Page 32: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Resource RequirementsName of the Technology

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• MOBILIS OSTEOPOROSIS HEPAMIX PSORI Crem• gel cream emulsion cream• Price of main materials, HUF/100g 600 400 500 600• Price of production 1400 1100 1300 1400• Market value 2100 1800 2000 2100

• Hungary’s population is 10.000.000. Counting maximally 20% economic participation the expected result is:

• Nr of patients 20 % of this Result, HUF/year• Diabetes mellitus 700.000 140.000 1,5 milliard HUF 3,2 M.EUR• Infarctus prevention 3.500.000 700.000 1,5 milliard HUF 3,2 M.EUR• Aspirin patch 3.000.000 600.000 1,5 milliard HUF 3,2 M.EUR• Rheumatology 1.300.000 260.000 0,7 milliard HUF 1.7 M.EUR• Osteoporosis 600.000 120.000 0,6 milliard HUF 1,6 M.EUR• Hepatology 500.000 100.000 0.5 milliard HUF 1.3 M.EUR• Psoriasis 350.000 70.000 0.3 milliard HUF 1 M.EUR

• Total amount of income only after one year of sale just in Hungary: • 6.100.000.000 HUF, 16 M.EUR• At the EU market we have to consider the population of 320.000.000, the

export counting only 5% of the whole market, the yearly result is 50.000.000 EUR.

Page 33: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

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• Estimated amount of grand capital for finishing researches and starting production:

• Laboratory instruments 400 MHUF• Personal 20 persons• Brutto salary 250 MHUF• Material costs 100 MHUF• Regie 150 MHUF• Extern research costs 100 MHUF• Total costs 1.000 MHUF• Starting costs for production• Patches factory 15 M Euro• Gel, cream, emulsion factory 15 M Euro• Laboratory, clinic 10 M Euro• Laboratory of nano-technology 5 M Euro• Total investment 45 M Euro• PR, promotion 15 M Euro• The new firm is profitable after one year.

Page 34: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Name of the Technology

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Summary

Potential ChallengesMarket: The big pharmaceutical companies are not

interested in heeling, but in keeping the potential customers. Our goal is heeling. Our partners are the insurance companies and the govermental health organisations.

Technology: changing the traditional production of medicaments both qualitatively and quantitatively.

Political: improvement of health level especially in the developing countries.

Page 35: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

SummaryName of the Technology

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Summary

We solved our main aim with solubilisation of the medical agents by using nano-technology with bio-colloidics. Applying this technique we

developed transdermal technology to a level where we can lower the amount of medicine

needed for a treatment and reduce the number of side effects at the same time.

Page 36: Transdermal  T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Dr. Zoltán DÁRDAI h.c.

Thank you for your kind attention.