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The Medicine Maker / Issues / 2016 / Articles / Sep / The optimization and scale-up of high shear granulation
Manufacture Biosimilars Business Practice Drug Delivery Ingredients Formulation Packaging Standards & Regulation Small Molecules Analytical Science Vaccines Technology and Equipment Dosage Forms Bioprocessing - Single Use Systems Trends & Forecasts Drug Delivery Formulation Packaging Regulation & Standards Small Molecules Facilities & Equipment Technology & Manufacturing Bioprocessing Biopharma

The optimization and scale-up of high shear granulation

09/30/2016 1 min read

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The first step in producing optimized granules for tableting is the wet granulation itself which produces agglomerates that range from a few hundred microns to several millimeters in diameter. These are typically wet milled prior to drying in a fluidized bed dryer. Subsequent milling of a dried particles produces a closely specified granular feed for the tablet press.

  • Applying high shear granulation
  • Using inline particle sizing in granulation scale-up studies
  • Tracking the granulation process
  • Assessing the impact of probe position
  • Assessing the reproducibility of granulation and scalability
  • Assessing the impact of granulation scale on tablet quality
>> Download the full Application Note as PDF

Malvern Instruments provides the materials and biophysical characterization technology and expertise that enable scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern’s materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency. Our products reflect Malvern’s drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment. Malvern systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications. Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, Mexico, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com severine.michel@malvern.com

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