Dr. Zoltán DÁRDAI h.c.
Transdermal Therapies and Medicaments
Dr. Zoltán DÁRDAI h.c.
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Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
TechnologyDescription
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SummaryThis is the normal structure of the skin, this needs to be
changed if we want to apply transdermal technology.
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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The main points of this technology:
Solubilisation of the medically active molecule
How to dissolve the barrier in a reversible way?
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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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.
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Tenside molecules in solvent
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Opening the pores with using the van de Waals effect
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Dissolving the barrier opens up the following problem:
How to prevent harmful materials from entering the body?
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Harmful material (i.e. bacteria, chemicals)
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Enlarging the harmful agents
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Insulin is mostly an association
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Linearisation of the associated insulins with tenside
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Bio-colloidical chemistry=
Bio-nano-technology
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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3D representation
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
TechnologyDescription
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Summary
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
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
TechnologyDescription
Technology Status
Potential Market
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SummaryThe effect of selective tenside adsorpion on the barrier and
antibarrier (only for medicaments) function
Dr. Zoltán DÁRDAI h.c.
Technology DescriptionTransdermal Technologies
and Medicaments
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Technology Status
Potential Market
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Summary
Barrier and antibarrier in practice
Dr. Zoltán DÁRDAI h.c.
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Dr. Zoltán DÁRDAI h.c.
Technology StatusName of the Technology
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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
Dr. Zoltán DÁRDAI h.c.
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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
Dr. Zoltán DÁRDAI h.c.
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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
Dr. Zoltán DÁRDAI h.c.
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Dr. Zoltán DÁRDAI h.c.
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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.
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, 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.
Dr. Zoltán DÁRDAI h.c.
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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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Dr. Zoltán DÁRDAI h.c.
Potential Market OpportunitiesName of the Technology
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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
Dr. Zoltán DÁRDAI h.c.
Potential Market OpportunitiesName of the Technology
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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
Dr. Zoltán DÁRDAI h.c.
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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.
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
Dr. Zoltán DÁRDAI h.c.
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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.
Dr. Zoltán DÁRDAI h.c.
Resource RequirementsName of the Technology
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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.
Dr. Zoltán DÁRDAI h.c.
Name of the Technology
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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.
Dr. Zoltán DÁRDAI h.c.
SummaryName of the Technology
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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.
Dr. Zoltán DÁRDAI h.c.
Thank you for your kind attention.