GEA Pharma Systems (GPS), part of the GEA Group, has helped develop
a complete process line for one of Europe’s most successful pharmaceutical
companies for the manufacture of generic medicines.
The ‘Pellet Processing’ project includes the supply and integration of;
granulation technology with a Collette™ UltimaGral™ and Aeromatic-Fielder™ NICA™ Pelletizing System, Coating technology with GPS’s unique
PRECISION COATER™ and Fluid Bed Drying.
Synthon BV
Based at Nijmegen in the Netherlands, Synthon manufactures a
range of products for worldwide distribution through its marketing partners in
Europe, the USA, Canada, Australia, New Zealand, Chile, Argentina and South
Africa. The development of the generic version of a drug will usually begin
several years before the expiration of the patent with the aim of introducing
it to the market within a few hours of the protected period ending. Synthon
focuses on the more complex pharmaceuticals as fewer of its competitors have
the human and technical resources to replicate them.
Development of the generic version of a drug
Initially small batches of the drug are produced in the laboratory
before up-scaling production to meet the demands of the market. Up-scaling
production from a laboratory batch size of 200g to a typical production batch
size of 500kg while maintaining the exacting standards of the formulation
represents a major challenge to drug manufacturers. The choice of equipment and
the expertise available from its manufacturers plays a key role in getting the
product to market quickly and maintaining the required standards in production.
Investment in GPS equipment to manufacture and coat tiny
pellets
After evaluating the systems offered by the GPS group,
Synthon approached the company in 2002 when new equipment was required for a
partner manufacturing plant in Greece to up-scale production of one of its
products. The first requirement was for the NICA™ extrusion/spheronization
equipment to manufacture tiny pellets containing the active ingredient followed
by the PRECISION COATER™ with its unique airflow characteristics, giving a very
exact and even coating of product both technologies supplied by
Aeromatic-Fielder. Coating of the tiny pellets, which can be less than 1 mm
diameter, is necessary for several reasons, for example to mask unpleasant
tastes, improve appearance or, as in this case, to provide controlled release
of the drug in the body. The aim is to evenly coat the pellets with just enough
material to achieve the desired result and no more.
Why Synthon
chose the Nica™ System
Additional NICA™ pelletizing equipment was
subsequently supplied and integrated with the system to manufacture the pellets
themselves. Synthon chose the NICA™ equipment, partly because of its
exceptional performance and flexibility, but the co-operation of GPS as a
business partner played an important role. “We looked carefully at what
equipment was available commercially to do the development work,” said Synthon’
s director of technology Derk Sanders. “After looking at all the possibilities
we decided on the GPS Nica™ system for our development and up-scaling
activities. GPS allowed us to rent the necessary equipment to produce batches
under GMP requirements. The whole exercise went very well and we subsequently
upgraded the systems to the largest available from GPS. We now have three NICA™
integrated extruders/Spheronizers producing a total of 2700kg a day”
Derk Sanders sited the simplicity of the GPS equipment as being a key
factor in the successful development of the process. “Production has now been
underway for just over a year with around 300 batches of the drug produced,” he
said. “So far not a single batch has been rejected due to failure of the
equipment.”
One of the main obstacles for pharmaceutical companies
in the development of drugs is the cost of trials. The use of the test centre
in Bubendorf significantly reduces these risks giving manufacturers confidence
that critical manufacturing processes are viable without major capital
expenditure.
GPS test centre facilities … an “important resource”
The GPS technology centre in Bubendorf Switzerland, which opened in 2003,
has been used extens
ively by Synthon to develop its production processes. The technology centre
provides pharmaceutical companies with a one-stop GMP environment to enable
them to develop new solid dose products using the latest equipment. The centre
is equipped with the full range of GPS equipment from powder mixing, through
granulation and drying to tablet pressing and coating.
“The technology
centre is a very important resource for Synthon. One of the main benefits is
that it enables us to test our processes using small quantities of API (Active
Pharmaceutical Ingredient),” continued Derk Sanders. “We need to know that the
equipment we select for production will produce the formulation in large batch
sizes and the facilities at the centre allow us to do that. To do the same test
here in the factory would require API test batches of 500kg which would be a
huge risk and prohibitively expensive. Our R&D department is using the
centre more and more to help develop processes for future products.”
“We have a very good relationship with the technology centre and they’
ve been very flexible in accommodating us, often at short notice. We’re a
dynamic company and we have to move quickly to stay ahead, they have always
given us excellent service: it is a partnership.”
GPS added, “Having
the technology centre means that we can work closely with customers to conduct
tests and make sure the equipment is suitable for an application before they
place an order. This safeguards the customer’s interests and allows us to prove
the system we are recommending. It’s a perfect tool for us.”
The vast
practical experience of the machine operators is a further advantage of using
the test centre. During testing, conditions are often taken to levels far
beyond those experienced in normal production. The data collected often shows
that conventional processing techniques can be modified with beneficial
results.
Sharing valuable information for use in future
projects Development engineers from Aeromatic-Fielder’s factory in
the UK make frequent visits to the test centre to see at first hand the
machines working in a production environment. This provides Synthon’s R&D
engineers with the opportunity to share information and give feedback to the
equipment manufacturers. This regular close contact provides Synthon with
valuable information for use in future projects.
A strong
future for GEA Pharma Systems and Synthon
GPS’s relationship with
Synthon has grown during the last 4 years and looks set to become even stronger
in the future. “Our experience of working with GPS has been very favourable,”
said Derk Sanders. “Business is always a two-way thing and both companies have
worked together to achieve excellent results. I am very comfortable with GPS
and I look forward to working with them in the future.”
All business enquiries to:
Mark Rowland
Product Manager NICA™
Pelletizing System
GEA Pharma Systems Ltd.
Tel: +44 2380 242
232
Email: mark.rowland@geagroup.com
www.gea-ps.com
For further editorial information contact:
Kris De Baere
Marketing
Manager
GEA Pharma Systems
Tel: +32 3 350 12 41
Email: kris.debaere@geagroup.com
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