PHARMA

Process technologies for tomorrow.

CONTINUOUS MIXING SYSTEM FOR ER TABLETS

Modulomix continuous mixing system Modulomix continuous mixing system

Research has demonstrated that Hosokawa Micron's Modulomix continuous pharma mixer is suitable to be used in the manufacture of extended release (ER) tablets with desired quality attributes via integrated continuous mixing and direct compression.

The research was conducted by the University of Eastern Finland in Kuopio and pharmaceutical company AstraZeneca. The results were published in the International Journal of Pharmaceutics (Volume 495, Issue 1, 10 November 2015, Pages 290-301).

The study was span out with a challenging formulation design comprising ibuprofen compositions with varying particle size and a relatively low amount of the matrix former hydroxypropyl methylcellulose (HPMC). Standard grade HPMC (CR) was compared to a recently developed direct compressible grade (DC2).

The work demonstrated that ER tablets with desired quality attributes could be manufactured via integrated continuous mixing and direct compression. The most robust tablet quality (weight, assay, tensile strength) was obtained using high mixer speed and large particle size ibuprofen and HPMC DC2 due to good powder flow.

Notably, with HPMC DC2 the processing conditions had a significant effect on drug release. Longer processing time and/or faster mixer speed was needed to achieve robust release with compositions containing DC2 compared with those containing CR. This work confirms the importance of balancing process parameters and material properties to find consistent product quality. Also, adaptive control is proven a pivotal means for control of continuous manufacturing systems.

Modulomix continuous mixer

The Modulomix continuous pharma mixer was developed by Hosokawa Micron specifically for the pharmaceutical industry and can be used for low, medium or high shear applications. The Modulomix can be integrated in a PAT (Process Analytical Technology) environment.

To access the publication, visit www.sciencedirect.com

TESTING & PROCESS DEVELOPMENT

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Our test and process development centre in the Netherlands offers unique possibilities for testing your product to determine the most efficient process, system or plant prior to final design. We can provide laboratory-level as well as production-sized trials.

Whether you wish to test a single machine or a complete powder processing system, the same skilled and experienced staff are here to help ensure that your requirements are met, and that you are entirely satisfied with the results.

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Hosokawa Micron B.V. is certified according to ISO 14001. Our certification covers all environmental themes of ISO 14001: air, soil, energy, waste, water, noise and hazardous substances. In addition, Hosawa Micron was awarded an EcoVadis Silver Medal for its sustainability achievements. EcoVadis determined that the company was among the top 15% of companies rated by EcoVadis in the special machinery industry.

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