Transcript Big Research Equipment - Univerza v Ljubljani, Fakulteta

Big Research Equipment
Spray Dryer
Büchi B-290
Büchi B-290 spray dryer is an equipment
that enables transformation of liquid
samples (solutions, nanosuspensions and
suspensions, emulsions, etc) to solids. The
drying can be performed from aqueous or
organic solvents in an inert atmosphere
with organic solvent recycling. Product size
can be controlled with independent setting
of liquid feed rate and atomization pressure.
The machine is customized to be suitable for
hot-melt technology such as spraycongealing. High performance cyclone
separates the product. The quantity of
produced solid may vary between few
grams and a few hundred grams.
Lokacija:
Department of Pharmaceutical Technology
Qualities:
- drying from aqueous and organic solvents
- allows spray-congealing
- visual insight into the process
- automatic nozzle cleaning
Encapsulator Inotech IE 50R
The production of beads with encapsulator Inotech IE 50R is based on the principle that a laminar liquied jet is broken
into equally sized droplets by a superimposed vibration. It enables encapsulation of animal and plant cells, microorganisms, enzymes, drugs (liquid or solid), flavors and fragrances in beads or capsules. A wide range of hydrogel
polymers are compatible with the Encapsulator Inotech IE 50R such as alginate, carrageen, cellulose sulphate,
chitosan, gelatine and pectin.
• single nozzle or concentric nozzle (for co-extrusion method) kit with nozzle diameter 100 – 1500 μm
 reproducible bead formation (0,15 - 2 mm) with narrow bead size distribution
 high cell viability doe to low shear stress during bead formation
 short production time (50 – 3000 beads/s)
 sterile working contitions in an avtoclavable reaction vessel (when necessary)
 delivery of the shell/core phase by the integrated syringe pump or by air pressure (flow rates: 70-2500 ml/h)
 appropriate for low viscous liquids
Location: Department of Pharmaceutical Technology
Freeze dryer
Beta 1-8K, Martin Christ
Freeze drying is the process by which
water is removed from a frozen
material by sublimation. It is used for
drying delicate, heat-sensitive materials
of high value or to achieve a porous
structure.
Features:
- ice condenser temperature: - 54°C
- ice condenser performance: max.
6kg/24h
- drying in round bottom flasks or in vials
on the thermoregulated shelves
Location: Department of Pharmaceutical Technology
Fluid-bed coater, granulator
Brinox d.o.o., BX CGD 1
BX CGD 1 is a novel fluid-bed equipment,
which can be used for wet granulation, film
coating, layering and drying procedures.
Equipment can be successsfuly used also for
hot-melt fluid-bed procedures. Technological
processes can be performed in one of two
inovative process chambers:
- Wurster coating chamber with swirl
generator;
- process chamber “Tornado” with bottom
spraying .
Advantages:
- semi/automatic and programmed handling;
- recording of process history;
- ports for FBRM in-line probe usage.
Location:
Department of Pharmaceutical Technology
Batch size: 300 g – 3000 g
Fluid-bed coater, granulator
Glatt GmbH., GPCG1
GPCG1 is a fluid-bed equipment, which can be
used for wet granulation, film coating,
layering, direct rotor pelletization, powder
layering and drying procedure. Minor
modification of process equipment enables
hot-melt fluid bed procedures. Technological
processes can be performed in one of three
process chambers:
- Top spray chamber
- Wurster coating chamber
- rotor insert.
Advantages:
Location:
Department of Pharmaceutical Technology
- easy operation and handling;
- broad range of technological procedures;
Batch size: 300 g – 2000 g
Differential Scanning Calorimeter(DSC)
Mettler Toledo DSC 1, Stare System
DSC 1 offers a qualitative and quantitativ follow and
measurement of physical and chemical processes and
changes in solids, semisolids and liquids.
DSC 1 ensures:
1. Measurement in temperature range between -100
and + 450°C.
2. Resolution from 0.04 µW( FRS 5) to 0.01 µW ( HSS7).
3. It might be used either as conventional DSC or as
MT DSCDSC.
Scope of DSC usage in Pharmacy:
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Location:
Department of Pharmaceutical Technology
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Measurement of 1. (i.e. melting) ali 2. order ( glassy
state temperature) phase transitions
Study of polymorphic transitions and of amorphous
solid state
Oxidative stability
Compatibility studies of APIs and excipients
Others
FBRM “in-line” probe
Mettler Toledo, FBRM C35
Location:
Department of Pharmaceutical Technology
FBRM “in-line” probe is intended for real-time
following of the technological process within
the fluid-bed equipment by enabling us to
assess the evolution of particle size change
during specific phase of technological
procedure. Probe can be used with the BX
CGD 1 process equipment (Brinox).
Assessment of the particle size is performed
by measuring of the time of interruption of
laser beam with constant circumferential
speed, which gives us distribution of particle
chord lenghts.
Advantages:
- measurement without sample preparation;
- measurement is possible in solids volume
fractions as high as 70 % v/v ;
- pneumatic wiper is cleaning the optical
window of the probe.
Measurement range: 0.5 mm do 3 mm
Single-punch tableting press
IMA Killian SP300
Single-punch tableting press SP300 is fully
instrumented machine and enables
measurments of upper and lower punch
forces, ejection force and displacement of
the upper punch. It is well suited for
advanced studies of compressibility, as well
as analysis of force-displacement curves. It
is equiped with gravity and forced filling
shoes. The machine has a wide spectrum of
applicability from manual production of only
a few tablets to batch production on semiindustrial scale.
Qualities:
- full instrumentation
- high flexibility
Most often used EU-B and EU-D tooling can
be mounted on the tableting press.
Location:
Department of Pharmaceutical Technology
Reciprocating Cylinder - Apparatus III (BioDis)
VanKel, Bio-Dis 3 Testing Station / USP Apparatus 3, 25-1100
BioDis apparatus enables observation of drug release
from oral dosage forms with modified release: delayed,
prolonged, pulsative. The apparatus is accompanied
by auto-sampler.
Qualities:
1.Within the single test 6 different media can be used
mimicking conditions in gastrointestinal tract (GIT).
2. The influence of different hydrodynamic conditions on
the release from dosage forms can be studied.
Frequent pharmaceutical usage:
Location: Department of Pharmaceutical
Technology
•Determination of the media and hydrodynamic
conditions on the release from different modified release
dosage forms.
•Optimization of dosage form formulations
•Usage in end control of the products
•Simulation of physiological conditions in GIT.
•etc.
Modular rheometer
Anton Paar, Physica MCR 301
Rheometer enabled qualitative and quantitative
determination of rheologic parameters of semisolid or
fluid systems. It is equipped with different module
enabling positioning of polarised microscope, module
for interfacial rheological characterization etc.
Qualities:
1.Temperature interval from -40 to 200° C
2. Modular way of performing measurements
3. It can be used as rotational or oscillatory rheometer
Location: Department of Pharmaceutical
Technology
Frequent pharmaceutical usage :
•Determination of viscosity of fluid and semisolid
systems in development or in stability control
•Mimicking of different technological procedures and
simultaneously studying the rheological parameters
•Study of visco-elastic characteristics of hydrogels –
correlation with drug release from matrix tablets.
•Study of cross-linking process of different polymeric
solutions
•etc.
LC/MS/MS
Location:
Chair for Biopharmacy and pharmacokinetics
LC-MS-MS enables detection
and quantification of analytes,
drugs and thier metabolites in
complex biologcial samples
from in vitro and in vivo
studies:
a. preclinical studies of solubility,
stability, permeability, transport
and metabolism,
b. clinical studies,
c. therapeutic drug monitoring
(TDM),
d. drug metabolite identification,
chraracterization of degradation
product, impurities and related
substances,
e. toxicology research, detection
and quantification of drugs and
their degradation products in
living organisms and in
environment.
Sweetana - Grass
diffusion chambers
(Physiologic instruments, USA)
Sweetana Grass diffusion cells are used for
the permeability determination of active
substances through the absorption barriers –
usually through the mucosa of the small
intestine.
With these chambers one can determine the
permeability coefficients (Papp) of substances
and
monitor the electrophysiologic parameters of
the tissue during the experiment.
At the Faculty of Pharmacy we have two
systems of these diffusion cells from
Physiologic instruments.
Location:
Chair for Biopharmacy and pharmacokinetics
Systems for evaluation of drug
dissolution / release from dosage
forms
Enable drug dissolution and release
testing which is the most important
biopharmaceutical evaluation tool in
quality control of drug delivery systems
as well as in development of new
generic and innovative pharmaceutical
products.
Different pharmacopeial apparatuses
might be used: basket (app. I.), paddle
(app. II.) and flow through cell (app. IV.)
with automatic sampling and possible
connection to spectrophotometer for
direct measuring of released drug.
Location:
Chair for Biopharmacy and pharmacokinetics
MICROCALORIMETER
Micro DSC III, Setaram
Micro/calorimetry measures the
heat changes associated with
chemical or physical processes.
It is characterized by unspecificity,
noninvasivity, sensitivity in µW
range, and needs no special sample
preparation.
Location:
Chair for Biopharmacy and pharmacokinetics
It is used for studying physical
processes (amorphycity, dissolution,
protein denaturation), chemical
reactions (stability and compatibility
of drugs and drug formulations), and
living systems (cells,
microorganisms).