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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: • Location: Department of Pharmaceutical Technology • • • • 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).