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.