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Krka,d.d., Novo mesto Brinox inženiring d.o.o .

Development of new generic bioequivalent and stable pharmaceutical products based on the new generation of fluid bed technologies - FBD. Krka,d.d., Novo mesto Brinox inženiring d.o.o. About project partners. Krka, d.d., Novo mesto

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Krka,d.d., Novo mesto Brinox inženiring d.o.o .

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  1. Development of new generic bioequivalent and stable pharmaceutical products based on the new generation of fluid bed technologies - FBD Krka,d.d., Novo mesto Brinox inženiring d.o.o.

  2. Aboutprojectpartners • Krka, d.d., Novo mesto • Pharmaceutical company dealing with research and development, manufacturing and marketing & sales of pharmaceutical and veterinary products. • Belongs to top 5 European and top 10 world generic pharmaceutical companies. • Krka’s products and services are sold in more than 70 countries worldwide. • Intensively involved in the development of innovative generic pharmaceutical and veterinary products. • Brinox inženiring d.o.o. • European family company with more than 40 year tradition. • Specialised in the field of process systems for pharmaceutical, chemical and food industry.

  3. Project description • Purpose of the project was to set, by developing new pelletising and granulation technologies in the pilot scale, the starting points for the development of the new generation products based on the fluid-bed granulation and coating processes. • Project objectives • to develop three new bioequivalent and stable products based on the new generation of the fluid bed (FB) technology • to develop a coating process that enables uniform coating of pellets and low agglomeration • to develop agglomeration process that enables optimisation of the physical properties of granulates • to develop a new generation of the FB equipment that enables repeatability of processes and products • to develop two-component nozzles for simultaneous spraying of two liquids • to optimise the agglomeration and coating process with regard to the yield of the processes

  4. Project results • Within the project, all the planned products have been realised, including the following ones: • Group of products based on pellets/granulates produced using new-generation of luid bed equipment • Compact laboratory-scale granulation and coating device • Semi-industrial granulation and coating device • Nozzle for simultaneous spraying of two components • Krka, d.d., Novo mesto • 3 innovations • 6 patent applications were filed. On 31.8.2011, the Slovenian patent was granted from the mentioned group of products developed within the FBD project. On 30.9.2011 the second granted Slovenian patent was published. • 7 newly employed in the project • Brinox d.o.o. • 2 innovations • 2 patents • 3 newly employed in the project

  5. Pictures Thenewtwocomponentnozzle SEM micrographofcrossectionofpellet (Productdeveloped as part ofproject FBD) Thenewlaboratory FBD equipment Pellet’s surfacestudyby AFM (Productdeveloped as part ofproject FBD) Pilot FBD equipment

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