Several pharmaceutical companies are currently developing bi-layer tablets. For a variety of reasons: patent extension, therapeutic, marketing to name a few. To reduce capital investment, quite often existing but modified tablet presses are used to develop and produce such tablets. This article explains why the development and production of quality bi-layer tablets needs to be carried out on purpose-built tablet presses to overcome common bi-layer problems, such as layer-separation, insufficient hardness, inaccurate individual layer weight control, cross-contamination between the layers, reduced yield, etc. Using a modified tablet press may therefore not be your best approach to producing a quality bi-layer tablet under GMP-conditions. Especially when in addition high production output is required.

Bi-layer tablets: quality and GMP-requirements

To produce a quality bi-layer tablet, in a validated and GMP-way, it is important that the selected press is capable of:

  • Preventing capping and separation of the two individual layers that constitute the bi-layer tablet
  • Providing sufficient tablet hardness
  • Preventing cross-contamination between the two layers
  • Producing a clear visual separation between the two layers
  • High yield
  • Accurate and individual weight control of the two layers

These requirements seem obvious but are not so easily accomplished as this article aims to demonstrate. Click on Adobe icon below to download pdf.

NEW: MODUL™ P Rotary Tablet Press with Bi-layer ECM

Small-scale continuous bi-layer tablet production

GEA Courtoy’s MODUL™ P, the smallest tablet press in the MODUL™range, is now available with an Exchangeable Compression Module (ECM) for bi-layer tablet production. The MODUL™ P with bi-layer ECM is the first press to enter the market that enables continuous bi-layer tabletting on a small scale. It is the perfect solution to your bi-layer formulation development, clinical trial and other small-scale production needs.

The bi-layer ECM can be exchanged with any other type of ECM, so the same basic MODUL™ P can handle all your small-scale production requirements:

  • Contained ECM (C-ECM) for dust-free tablet production
  • High-containment wash-off-line ECM (WOL-ECM) for potent drugs
  • Galenic ECM (G-ECM) with mixed turret for compression of very small powder quantities

The MODUL™ P with bi-layer ECM:

  • Enables continuous bi-layer tablet compression with a fully tooled turret
  • Able to produce up to 30.000 bi-layer tablets/hour
  • Can run with only 1 punch at 600 tablets/hour
  • Available with mixed turret (10 B and 10 D stations)
  • Available in WOL execution for potent drugs

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