PHARMA

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CONTINUOUS MIXING SYSTEMS FOR ER TABLETS

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.

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

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