Subsidiaries - Amandus Kahl Group

amandus kahl
THE FLAT DIE PELLETING PRESS 14-175
IN GMP/FDA CONFORMING DESIGN
Due to the increase of the world population and the higher life
expectancy combined with the desire for a better quality of life,
the pharmaceutical industry holds a good position in the mar-
ket. The high demand for drugs earned the pharmaceutical en-
terprises high sales and profits. Apart from the drug discovery,
the pharmaceutical enterprises have to attach great importance
to optimising their production processes to meet the demand
for low costs. Yet, the possibilities for cost reduction are limited.
The production costs account for a significant proportion of the
total costs. In connection with optimisation measures, flexibility
and automation are important tools for cost reduction. Also
alternative processes or new machines – even from outside the
industry but well-proven ones, are discussed. All plant components,
however, have to conform to the high requirements on
hygienic standards. This includes also constructional features
such as the absence of dead space, electropolished surfaces,
or validated cleaning concepts. They have to conform to GmP
(Good manufacturing Practice) and FDA (Food and Drug Administration)
standards.
The following description of the process of agglomeration by
compression using flat die pelleting presses explains the advantages
of this process over traditional processes as well as
the experience with the production of granules gained in this
industry, so far. Basically, granules are preparations that consist
of solid and dry grains, each grain being an agglomerate of
powder particles with a sufficient stability to allow for different
manipulations. Granules contain one or more active agent.
They can either be used directly as drugs or as an intermediate
product for the production of other dosage forms such as capsules
or tablets. The granulation of powdery tablet masses is a
common and necessary process.
The goals of granulation are:
• No segregation of the individual components
• Improved flowability
• Improved proportioning accuracy due to small granules
• Good tabletability
• Modification of properties in the tablet (for example
increase of abrasion resistance and improvement of
decomposition characteristics)
mainly, we distinguish between two process variants in the
production of granules:
• Moist granulation
• Dry granulation / melt extrusion.
moist granulation (i.e. of a powder mixed with water or a
water-binder solution) is realised for example with:
• Fluid bed agglomerators
• High shear-intensity mixers (batchwise).
• Extruders (continuously).
However, drying of the wet granules is required. Drying is usually
realised batchwise in the fluid bed (-> see page 24 - Particle
Technology).
The extrusion process is also a proven technology for the compaction
of bulk products. In the pharmaceutical sector, for example
twin-screw extruders with subsequent spheronisation
are used. Due to the cost constraints mentioned above, machines
for agglomeration by compression can be considered.
Apart from roller compactors (production of oblong strands or
flakes), also extrusion presses or flat die pelleting presses can
be used. For this purpose, Amandus Kahl GmbH & Co. KG has
further developed the well-known laboratory machine 14-175.
1 2
Fig. 1 pelleting press type 14-175 Fig.2 pelleting elements pan grinder rollers and die
For many years, the flat die pelleting press has been successfully used for granulation /compaction in the pharmaceutical indus-
try- also on a production scale. It offers important advantages. The latest generation of the flat die pelleting press 14-175 in GmP
/ FDA conforming design has not only been advanced constructionally. Its process technology has also been examined in other
pharmaceutical applications. This press type was extensively examined at the Faculty of Pharmaceutical Technology at the univer-
sity of Düsseldorf (Prof. Kleinebudde) with regard to moist extrusion and melt extrusion processes. The flat die pelleting press was
declared an appropriate machine for pharmaceutical applications. It was also used successfully for processing lipid formulations in
a research project of the university of Düsseldorf. The compression or extrusion of the lipids was realised under pressure and at a
temperature below the melting temperature of the lipids (thermomechanical process). The decisive advantage over melt extrusion
lies in the fact that the lipids are treated gently and thus the lipid structure largely remains intact.
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