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![Page 1: CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER Elena Guseva 1 Natalia Menshutina 1, Hans Leuenberger 2 1 D.I. Mendeleev University of Chemical Technology.](https://reader031.fdocuments.in/reader031/viewer/2022013011/55154837550346a87d8b61f6/html5/thumbnails/1.jpg)
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
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In 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 Science•State Secretariat for Education and Research SER •Swiss Embassy in Moscow
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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.
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EDUCATIONAL ACTIVITY
• graduate unique specialists
• promote knowledge to practice
• cultivate understanding of technology
“We grow people for you”
INDUSTRYINDUSTRY UNIVERSITIESUNIVERSITIES
Technology + Equipment
Competent specialists
(Masters, PhDs)
![Page 5: CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER Elena Guseva 1 Natalia Menshutina 1, Hans Leuenberger 2 1 D.I. Mendeleev University of Chemical Technology.](https://reader031.fdocuments.in/reader031/viewer/2022013011/55154837550346a87d8b61f6/html5/thumbnails/5.jpg)
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
• …
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WEB-PORTAL «PHARMACEUTICS ONLINE»
http://www.muctr.edu.ru/~cache/claroline
Availability
Quality
Usability
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
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БлокБлок наполнения грануламинаполнения гранулами БлокБлок наполнения грануламинаполнения гранулами
Схема
Сканер колпачков капсул
Блок наполнения гранулами
ФункционированиеФункционирование
СтадияСтадия 4, 6, 8:4, 6, 8: Блок наполнения гранулами или таблеткамиБлок наполнения гранулами или таблетками((дополнительнодополнительно))
NextBack
Блок наполнения таблеткой
Открытие капсул
Удаление дефектных капсул
Сканер тела капсул
Блок закрытия капсул
Блок очистки
Варианты заполнения
Перенос капсул
Блок выгрузки капсул
Выравнивание капсул
Блок наполнения порошком
Main menu
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Схема
Блок наполнения порошком
ФункционированиеФункционирование
Бункер
Винтовая мешалка
Набивающие поршни
Датчик уровня
Дозирующий диск
Агитатор
Кольцо порошка
ДвигательДатчик уровня/(опционально)
СтадияСтадия 5:5: Блок наполнения порошкомБлок наполнения порошком
Back
Удаление дефектных капсул
Сканер тела капсул
Блок закрытия капсул
Блок очистки
Варианты заполнения
Перенос капсул
Блок выгрузки капсул
Выравнивание капсул
Открытие капсул
Сканер колпачков капсул
Блок наполнения гранулами
Блок наполнения таблеткой
Main menu
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)
01.04.2003 317
5.7 Rheogramm plastischer Systeme
D
D
Fliessgrenze Fliessgrenze
Bingham Körper Casson Körper (wird immer flüssiger)
01.04.2003 399
7.7 Franz Diff usionszellsystem
01.04.2003 336
6.2 Wasserabgabe über die Haut
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Схема
Блок наполнения гранулами
ФункционированиеФункционирование
СтадияСтадия 4, 6, 8:4, 6, 8: Блок наполнения гранулами или таблеткамиБлок наполнения гранулами или таблетками((дополнительнодополнительно))
Back
Гранулы через дозирующий диск (вместо блока загрузки порошка):
Гранулы под действием тяготения опускаются в дозирующее отверстие. При изменении стадии гранулы не изменяются до тех пор пока не наполнится дозирующая ёмкость. Потом дозирующая ёмкость закрывается. Когда блок с капсулой становится для обмена, открывается заслонка и гранулы поршнем уплотняют в капсулы.
Характеристики системы: 140 ударов/мин
Back
Блок наполнения таблеткой
Открытие капсул
Удаление дефектных капсул
Сканер тела капсул
Блок закрытия капсул
Блок очистки
Варианты заполнения
Перенос капсул
Блок выгрузки капсул
Сканер колпачков капсул
Выравнивание капсул
Блок наполнения порошком
Main menu
![Page 8: CENTER OF KNOWLEDGE AND TECHNOLOGIES TRANSFER Elena Guseva 1 Natalia Menshutina 1, Hans Leuenberger 2 1 D.I. Mendeleev University of Chemical Technology.](https://reader031.fdocuments.in/reader031/viewer/2022013011/55154837550346a87d8b61f6/html5/thumbnails/8.jpg)
OUR 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
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Visits, Abroad Studying, Lectures
LAST 2 YEARS:LAST 2 YEARS:
Students - 8
Ph.D. Students – 14
Lecturers – 18
Abroad studying – 2
EXCHANGE OF KNOWLEDGE
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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 equipment R02-50/CP-HR
• Oil-Free compressor Atlas-Copco
• Compressor F.F.
• Vacuum compressor
• Bioreactor
• SKAN Isolator equipment• Sonotec Ultra-sonic nozzle
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RESEARCH AND CONSULTING
• Pharmaceutics– Freeze, Spray, Supercritical drying– Dispersion– Coating– Granulation– Encapsulation
• Biotechnology– stress of microorganism– protein production
• Nanotechnology– drug delivery
Information technology– PAT, LIMS– Software development
Development of new technologies and Scaling-up:
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ENCAPSULATIONENCAPSULATION
Encapsulation by coating in fluidized layer under super
critical conditions
Encapsulation by coating in fluidized layer under super
critical conditions
Protein encapsulation to biodegradable
microspheres using freeze drying technologies
Protein encapsulation to biodegradable
microspheres using freeze drying technologies
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Mannitol
Dextran
Spraying
Freezing
Sublimation of fluidized
bed particles
Atmospheric freeze-drying with
active hydrodynamics
… is alternative process to classical vacuum freeze-
drying
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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 –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.
The main stages and description of the process
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• 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
The advantages of the atmospheric freeze drying with active hydrodynamics
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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
• …
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Comparison of spray drying and atmospheric spray-freeze drying
Spray drying particlesSpray-freeze drying particles
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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
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Shape and Structure of Particle
Spray drying particlesVacuum-freeze drying particles
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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.
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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.
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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 Biologicals i.e. Pharmaproteins such as Interferons, Insulin.
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TECHNOLOGY TRANSFER
equipment selectiondesign and scaling-up process flowsheet optimization
mathematical models
modeling tools
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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
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Modeling of hydrodynamics, heat-and mass-transfer in apparatus
t 1 1 1
0
div V f dmM
;
t m
f div f V f
2 0;
t
C div C V f dmV V
M
10
;
The equations of mass, concentration preservation are:
1
d V
dtP
fmf dm F f V V dm
k k
MM
1 11 1
12 1 1 2 100
;
D V
Dt
Pf F2 2
20 12 2
The equations of impulse preservation are:
;dmiifqdmTTfa4
dm2
VVfdmVVffme
dt
dP
dt
Ud
M
0211
M
021T
2
M
0
212
M
02112
kl1
kl1
011
01
11111
2121T2
022
02
2222 iifTTfa4Dt
DP
Dt
UDmf
The equations of energy preservation are:
P T P T P RT
d
dt tV
D
Dt tV
mk k k k
1 10
1 2 20
2 10
1 2 10
1
11
22
1 1 2
, , ; ;
; , ;
;
P
/ ; i
Additional correlations are:
Height, m
Vel
ocit
y, m
/s
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The drying kinetics
The driving force of process:
The drying rate: J = ∙X
The effective mass transfer coefficient: = Nu∙D/l
1 > 2 V
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.
1
2
12
212
1
1
2
2
T2
VV
T
1
T
1i
TTX
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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.
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The example of the drying kinetics modelling in apparatus II for d=150 m, V1inlet=0,30 m/s
0
10
20
30
40
50
60
70
80
90
0 50 100 150 200
Time (min)
W, %
experimental data
freeze-drying stage calculated data
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The apparatus design and scale-up the process
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The comparison of energy efficiency of atmospheric and vacuum freeze-drying
Ins
tant
aneo
us e
nerg
y ef
ficie
ncy
Time, min
Vacuum freeze drying
Atmospheric freeze drying
12.07.2005 7th WORLD CONGRESS of CHEMICAL ENGINEERING 24
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• 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
Conclusions
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TECHNOLOGY TRANSFER AND PROMOTION
• Conferences• Seminars • Round tables• Exhibitions• Publications• Website• …
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The Third Russian-Swiss seminar “Pharminnovations”
5-6 December, 2006
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HÜTTLIN GmbH (Germany)
NOVARTIS (Switzerland)
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BIOTECHNOLOGY 2009 16-20 March
«Quality management ─ key factor in the development of pharmaceutical industry»
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Our Partners
Московская медицинская академия им И.М. Сеченова
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