Presentation on theme: "CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER"— Presentation transcript:
1CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER Elena Guseva1Natalia Menshutina1, Hans Leuenberger21D.I. Mendeleev University of Chemical Technology of Russia2University of Basel, Switzerland
2In the beginning…Russian-Swiss science and education center for transfer of biopharmaceutical technologies has been established on the basis of MUCTR as the result of team-work between the Institute of Pharmaceutical Technology, University of Basel and MUCTR.The Russian-Swiss science and education center has the 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 ScienceState Secretariat for Education and Research SERSwiss Embassy in Moscow
3MAIN AIMS AND TASKSco-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“We grow people for you” Competent specialists EDUCATIONAL ACTIVITY“We grow people for you”graduate unique specialistspromote knowledge to practicecultivate understanding of technologyTechnology + EquipmentINDUSTRYUNIVERSITIES(Masters, PhDs)Competent specialists
5TRAINING 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 managementPAT…
6WEB-PORTAL «PHARMACEUTICS ONLINE» AvailabilityQualityUsabilityA lot of classified information, useful for education of specialists in pharmaceutics technology area:Videos (with audio explanations)High-quality photos2D and 3D animations, explaining physical and chemical processes, processes taking place inside apparatusSchemes of general types of apparatusTextual information with binding hyperlinksTechnical descriptions of all the processes, useful in pharmaceutics technology
7COURSE 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, lectures)
8OUR BOOKS«Nanoparticles and nanostructured materials for pharmaceutics»Menshutina N.V.«Information systems and databases for pharmaceutics»Menshutina N.V., Mesheryakova T.V., Goncharova S.V., Mishina Y.V., Leuenberger H. – 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
9Visits, Abroad Studying, Lectures EXCHANGE OF KNOWLEDGEVisits, Abroad Studying, LecturesLAST 2 YEARS: Students - 8 Ph.D. Students – 14 Lecturers – 18 Abroad studying – 2
10EQUIPMENT 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 SpectrometerReverse osmosis equipment R02-50/CP-HROil-Free compressor Atlas-CopcoCompressor F.F.Vacuum compressorBioreactorSKAN Isolator equipmentSonotec Ultra-sonic nozzle
11RESEARCH AND CONSULTING Development of new technologies and Scaling-up:PharmaceuticsFreeze, Spray, Supercritical dryingDispersionCoatingGranulationEncapsulationBiotechnologystress of microorganismprotein productionNanotechnologydrug deliveryInformation technologyPAT, LIMSSoftware development
12ENCAPSULATIONProtein encapsulation to biodegradable microspheres using freeze drying technologiesEncapsulation by coating in fluidized layer under super critical conditions
13Atmospheric freeze-drying with active hydrodynamics … is alternative process to classical vacuum freeze-dryingMannitolSprayingFreezingSublimation offluidizedbed particlesDextran
14The main stages and description of the process The process has two stages:the initial freezing at spraying of the solutionthe sublimation of frozen particles at their fluidizationThe 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 –60C. 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.
15The advantages of the atmospheric freeze drying with active hydrodynamics intensive heat and mass transfer, high moisture removal rate due to active hydrodynamic regimereduced time of the processenergy effectiveness in comparison with classical freeze drying under vacuumbetter control of the residual moisture content and temperature, important for pharmaceutical productsproduct size and shape design for manufacturing of solid dosage forms and production of injection and inhalation dosage formpossibility of continuous operation
16The properties of the pharmaceutical products preserved of natural structure and nutrientspre-specified particle size (nano- or microparticles)high porosityhigh specific and internal surface area of particlessolubility and bioavailabilityfree flowing powderspherical particle shape…
17Comparison of spray drying and atmospheric spray-freeze drying Spray-freeze drying particlesSpray drying particles
18Comparison of vacuum freeze- drying and atmospheric spray-freeze drying pre-specified particle size (nano- or microparticles)high porosityfree flowing powderspherical particle shapeproduct size and shape design for manufacturingof solid dosage forms and production of injectionand inhalation dosage formpossibility of continuous operation
19Shape and Structure of Particle Vacuum-freeze drying particlesSpray drying particles
20Atmospheric 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.
21Atmospheric 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.
22Atmospheric 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 Biologicals i.e. Pharmaproteins such as Interferons, Insulin.
23TECHNOLOGY TRANSFER equipment selection design and scaling-up process flowsheet optimizationmathematical modelsmodeling tools
24Modelling of the atmospheric freeze drying with active hydrodynamics KINETICSDrying driving forceCombined heat and masstransfer inside particleInterface processesHYDRODYNAMICSHEAT AND MASS TRANSFER IN APPARATUSDETERMINATION OF STABLE OPERATION MODEOPTIMIZATION DESIGN SCALING-UP CONTROL
25Modeling of hydrodynamics, heat-and mass-transfer in apparatus The equations of mass, concentrationpreservation are:The equations of impulse preservation are:The equations of energy preservation are:Height, mVelocity, m/sAdditional correlations are:
26The drying kinetics The drying rate: J = b∙X The driving force of process:The drying rate:J = b∙XThe effective mass transfer coefficient:b = Nu∙D/l1 > 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.
27The 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.
28The example of the drying kinetics modelling in apparatus II for d=150 mm, V1inlet=0,30 m/s
30The comparison of energy efficiency of atmospheric and vacuum freeze-drying Instantaneous energy efficiencyTime, minVacuum freeze dryingAtmospheric freeze dryingth WORLD CONGRESS of CHEMICAL ENGINEERING
31Conclusionsthe atmospheric freeze-drying with active hydrodynamics is an innovative technology for production of pharmaceutical nano- and micro- powders with pre-specified structure and propertiesthe mathematical model based on the mechanics of heterogeneous media and non-equilibrium thermodynamics has been developed and verified to define main operation parameterson the basis of a mathematical model the drying simulator has been developedalso, a energy efficiency analysis of atmospheric freeze drying was carried out; in comparison with classical freeze-drying it is more energy efficientthe approach proposed allows modeling, design and control of the processes described
32TECHNOLOGY TRANSFER AND PROMOTION ConferencesSeminarsRound tablesExhibitionsPublicationsWebsite…
33The Third Russian-Swiss seminar “Pharminnovations” 5-6 December, 2006