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CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER

CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER. Elena Guseva 1 Natalia Menshutina 1 , Hans Leuenberger 2 1 D.I. Mendeleev University of Chemical Technology of Russia 2 University of Basel, Switzerland. In the beginning….

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CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER

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  1. CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER Elena Guseva1 Natalia Menshutina1, Hans Leuenberger2 1D.I. Mendeleev University of Chemical Technology of Russia 2University of Basel, Switzerland

  2. In the beginning… Russian-Swiss science and education center for transfer of biopharmaceutical technologieshas been established on the basis of MUCTR as the result of team-workbetween the Instituteof Pharmaceutical Technology, University of Basel and MUCTR. The Russian-Swiss science and education center hasthe official status of the structural unit of MUCTR. The Center is a new basis to enhance the Russian-Swiss relationship in education, science and technology transfer for mutual benefit. The center was founded under support of: • Russian Ministry of Education and Science • State Secretariat for Education and Research SER • Swiss Embassy in Moscow

  3. MAIN AIMS AND TASKS • co-ordination of students education on special master courses using the Centre’s facilities, equipment and materials in accordance with European standards and technical requirements; • organisation of specialised laboratories within the university for the purpose of conducting scientific studies profile; • advanced training of specialists from appropriately profiled enterprises; • publication of relevant successes and popularization of intellectual achievements of Russian and Swiss research organization to improve commercial appeal to the international market.

  4. EDUCATIONAL ACTIVITY “We grow people for you” • graduate unique specialists • promote knowledge to practice • cultivate understanding of technology Technology + Equipment INDUSTRY UNIVERSITIES (Masters, PhDs) Competent specialists

  5. TRAINING OF SPECIALISTS Improvement of skills and training courses were developed for Russian pharmaceutical specialists: • «Technologies and equipment for pharmaceutical industry» • Granulation, Drying, Coating • (together with Glatt, Huettlin, BASF, Evonik) • Quality management • PAT • …

  6. Availability Quality Usability WEB-PORTAL «PHARMACEUTICSONLINE» http://www.muctr.edu.ru/~cache/claroline A lot of classified information, useful for education of specialists in pharmaceutics technology area: • Videos (with audio explanations) • High-quality photos • 2D and 3D animations, explaining physical and chemical processes, processes taking place inside apparatus • Schemes of general types of apparatus • Textual information with binding hyperlinks • Technical descriptions of all the processes, useful in pharmaceutics technology

  7. COURSE MATERIALS. LECTURES • Dosage dispersed forms (671 slides) • Solid drugs forms (~400 slides) • Liquid sterile drug forms (~250 slides) • Equipment and Technologies of Pharmaceutical Industry (~700 slides, 18 lectures)

  8. OUR BOOKS • «Nanoparticles and nanostructured materials for pharmaceutics» Menshutina N.V. • «Information systems and databases for pharmaceutics» MenshutinaN.V., MesheryakovaT.V., GoncharovaS.V., MishinaY.V., LeuenbergerH. – M., MUCTR 2002 • «E-learning on chemical engineering and pharmaceutical specialities» Menshutina N., Mishina Ju., Guseva E., Leuenberger H., Chelnokov V. – М., publishing house of scientific literature, Kaluga 2007

  9. EXCHANGE OF KNOWLEDGE Visits, AbroadStudying, Lectures LAST 2 YEARS: Students - 8 Ph.D. Students – 14 Lecturers – 18 Abroad studying – 2

  10. EQUIPMENT • HUTTLIN Mycrolab/HUTTLIN GmbH/ • Mini-Glatt/GLATT International GmbH/ • Spray drying equipment/NIRO/ • Equipment for production micro- and nanoparticles by dispersion /Own development/ • AMETEK Proline Process Mass Spectrometer • Reverse osmosis equipmentR02-50/CP-HR • Oil-Free compressorAtlas-Copco • CompressorF.F. • Vacuum compressor • Bioreactor • SKAN Isolator equipment • Sonotec Ultra-sonic nozzle

  11. RESEARCH AND CONSULTING Development of new technologiesand Scaling-up: • Pharmaceutics • Freeze, Spray, Supercritical drying • Dispersion • Coating • Granulation • Encapsulation • Biotechnology • stress of microorganism • protein production • Nanotechnology • drug delivery • Information technology • PAT, LIMS • Software development

  12. ENCAPSULATION Protein encapsulation to biodegradable microspheres using freeze drying technologies Encapsulation by coating in fluidized layer under super critical conditions

  13. Atmospheric freeze-drying with active hydrodynamics … is alternative process to classical vacuum freeze-drying Mannitol Spraying Freezing Sublimation of fluidized bed particles Dextran

  14. The main stages and description of the process The process has two stages: • the initial freezing at spraying of the solution • the sublimation of frozen particles at their fluidization The initial freezing is done in a freezing cabinet, which is equipped with an ultrasonic nozzle that is capable of producing particles of 150 mm. The freezing temperature inside the cabinet was held at –60C. The 15% aqueous solution of mannitol is sprayed top-down against a cold air stream. At sublimation drying stage of the process the frozen particles are held by fluidization, and this was performed in the modified Glatt apparatus. The process was carried out at a drying temperature of about -20ºC. The average time of the process was about 3 hours.

  15. The advantages of the atmospheric freeze drying with active hydrodynamics • intensive heat and mass transfer, high moisture removal rate due to active hydrodynamic regime • reduced time of the process • energy effectiveness in comparison with classical freeze drying under vacuum • better control of the residual moisture content and temperature, important for pharmaceutical products • product size and shape design for manufacturing of solid dosage forms and production of injection and inhalation dosage form • possibility of continuous operation

  16. The properties of the pharmaceutical products • preserved of natural structure and nutrients • pre-specified particle size (nano- or microparticles) • high porosity • high specific and internal surface area of particles • solubility and bioavailability • free flowing powder • spherical particle shape • …

  17. Comparison of spray drying and atmospheric spray-freeze drying Spray drying particles Spray-freeze drying particles

  18. Comparison of vacuum freeze- drying and atmospheric spray-freeze drying • pre-specified particle size (nano- or microparticles) • high porosity • free flowing powder • spherical particle shape • product size and shape design for manufacturing • of solid dosage forms and production of injection • and inhalation dosage form • possibility of continuous operation

  19. Shape and Structure of Particle Spray drying particles Vacuum-freeze drying particles

  20. Atmospheric Spray Freeze Drying as an Alternative Advantages: The result is a highly porous free flowing powder (pellets) with instant solubility properties. The high porosity of the pellets (up to 85%) and the nanostructured internal surface is ideal for the formulation of novel drug delivery systems for the lung.

  21. Atmospheric Spray Freeze Drying as an Alternative Advantages: Process is faster due to the better heat transfer and has a lower variability. It is possible to combine the advantages of Nano- and Microtechnology.

  22. Atmospheric Spray Freeze Drying as an Alternative Advantages: ideal for the preparation of nanocomposite pellets for low water soluble drugs to enhance bioavailability of the drug. ideal for the formulation of temperature and structure sensitive drugs such as Biologicalsi.e. Pharmaproteins such as Interferons, Insulin.

  23. equipment selection design and scaling-up process flowsheet optimization modeling tools mathematical models TECHNOLOGY TRANSFER

  24. KINETICS • Drying driving force • Combined heat and mass • transfer inside particle • Interface processes HYDRODYNAMICS HEAT AND MASS TRANSFER IN APPARATUS DETERMINATION OF STABLE OPERATION MODE OPTIMIZATION DESIGN SCALING-UP CONTROL Modelling of the atmospheric freeze drying with active hydrodynamics

  25. The equations of mass, concentration preservation are: Additional correlations are: The equations of impulse preservation are: Velocity, m/s The equations of energy preservation are: Height, m Modeling of hydrodynamics, heat-and mass-transfer in apparatus

  26.  The drying rate: J = b∙X The effective mass transfer coefficient: b = Nu∙D/l The driving force of process: 1> 2 The main influencing factor on the value of the driving force of atmospheric freeze drying is the flow of injected heat into the product, and outflow of water at sublimation. The drying kinetics

  27. The mathematical model solution • The solution of equations system allowed to investigate the hydrodynamic and temperature regimes (gas and particle velocities, temperature, void volume etc.), heat and mass transfer in any point of the apparatus, as well as to determine the drying rate. • Moreover, on the basis of the mathematical model it is possible to find parameters for stable operation of a dryer, for example the height of a fountain.

  28. The example of the drying kineticsmodelling in apparatus II for d=150 mm, V1inlet=0,30 m/s

  29. The apparatus design and scale-up the process

  30. Instantaneous energy efficiency Atmospheric freeze drying Vacuum freeze drying Time, min The comparison of energy efficiency of atmospheric and vacuum freeze-drying 12.07.2005 7th WORLD CONGRESS of CHEMICAL ENGINEERING 24

  31. Conclusions • the atmospheric freeze-drying with active hydrodynamics is an innovative technology for production of pharmaceutical nano- and micro- powders with pre-specified structure and properties • the mathematical model based on the mechanics of heterogeneous media and non-equilibrium thermodynamics has been developed and verified to define main operation parameters • on the basis of a mathematical model the drying simulator has been developed • also, a energy efficiency analysis of atmospheric freeze drying was carried out; in comparison with classical freeze-drying it is more energy efficient • the approach proposed allows modeling, design and control of the processes described

  32. TECHNOLOGY TRANSFER AND PROMOTION • Conferences • Seminars • Round tables • Exhibitions • Publications • Website • …

  33. The Third Russian-Swiss seminar “Pharminnovations” 5-6December, 2006

  34. NOVARTIS (Switzerland) HÜTTLIN GmbH (Germany)

  35. BIOTECHNOLOGY 200916-20 March «Quality management ─ key factor in the development of pharmaceutical industry»

  36. Московская медицинская академия им И.М. Сеченова Our Partners Join us! Welcome to Russian-Swiss Center!

  37. Thank you for your attention!

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