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2005-11-23 News Headlines
Plastics by Prescription
Purity, biocompatibility and sterilizability top list of specifications
for high technology grade plastics from Ticona used in medical devices.
Products for patient safety and quality of life
Ticona has recently started producing Hostaform® MT® at Kelsterbach in
a new first-of-its-kind POM production line, which is completely separate
from the manufacturing facilities for other industrial grades. This gives
customers in the pharmaceutical and medical device industries a crucial
competitive edge, while guaranteeing patients the highest standards of
safety. Hostaform® and Hostaform® MT® are registered trademarks of Ticona .
The requirements specified for active pharmaceutical ingredients and their
delivery systems are becoming increasingly tough. Pharmaceutical manufacturers,
processors and materials specialists have to work closely together to
comply with the strict requirements of the regulatory agencies. Their
common goal is to offer patients enhanced safety and quality of life.
High purity – long-term traceability
Ticona’s first-of-its-kind production line for the medical technology
grades of Hostaform, a polyacetal copolymer (POM), is making an important
contribution to the achievement of this goal. Improved production conditions
ensure purity and traceability of the individual formulation components
right back to source. Two crucial factors here are the smooth, easy-to-clean
walls and floors and a cleverly devised quality management system. Regular
quality checks are carried out during production and before dispatch.
In addition, samples are taken from each batch and tested by the analytical
methods used in the pharmaceutical industry. The background to this is
a Guidance for Industry published by the US regulatory agency, the FDA.
This defines a medical device as being the device (i.e. delivery system)
with all of its parts, including any protective packaging, and imposes
the same high requirements on the plastics and starting materials used
as on the drug formulation itself.
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Hostaform® POM MT 24U01, Celanex®
PBT 2401 MT -
Dry powder inhaler made by Hagepharm GmbH
By: Thomas Dietz, Bierhausweg 3, D-61273 Wehrheim, Germany
(provided by © Ticona) Click on photo for larger image.
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Versatile POM – key role in metering systems
Purity, biocompatibility and sterilizability head the list of specifications
for plastics used in medical devices. Other important requirements include
first-class mechanical properties, resistance to chemical media and corrosion
resistance. In metering mechanisms for dry powder inhalers used, for example,
in asthma treatment, another essential criterion is absolute dimensional
stability. “POM makes it possible to produce accurate delivery systems,
which meter drugs very precisely,” explains Stefan Disch, POM Product
Manager at Ticona. “A valve made from Hostaform MT in the new metering
aerosols accurately controls droplet dispersion and size – and so ultimately
guarantees the required clinical efficacy.”
Hostaform also plays a key role in an insulin pen, ensuring precise dose
administration (accurate to 1/1000 of a droplet) and consistent serviceability
over many years. And while a disposable insulin syringe utilizes the high
toughness and rigidity of POM, another innovative injection device operates
entirely without a needle. In this case, the drugs, for example against
influenza, are “shot” through the skin under high pressure.
Market booming / Common diseases treated more safely
The market potential for new drug delivery systems is enormous. In the
last five years, growth in the European and North American markets has
averaged between 18 and 20 percent per annum. This trend is expected to
continue over the next few years. The reason for this is steadily increasing
numbers of patients suffering from asthma and other respiratory tract
diseases as well as diabetes and cardiovascular complaints. New drug delivery
systems exploiting the advantages of medical-grade plastics can improve
the often unsatisfactory or complicated systems previously used for administering
active pharmaceutical ingredients.
For other common diseases such as osteoporosis, arthritis and hypertension,
pharmaceutical manufacturers, processors and materials specialists are
also cooperating closely to develop suitable therapy options based on
innovative drug delivery systems. New highly durable materials produced
under cleanroom conditions are driving this development. They are helping
to make treatment of sick people safer, more comfortable and far easier
in the future.
An important business of Celanese
Corporation,
Ticona is a solutions-driven company that uses advanced polymer technology
to produce high performance plastic materials that are used in a wide
spectrum of applications - from automotive, appliance components, information
technology, consumer & recreational products, industrial, medical & health,
and others. Ticona's materials are world leaders in acetal polymers, liquid
crystal polymers, long fiber reinforced thermoplastics, and ultrahigh
molecular weight polyethylene.
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