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2006-03-15 News Headlines

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Ticona plastics help patients back to health

One of the leading dry powder inhalers benefits from two high-tech polymers from Ticona engineering plastics ensuring accurate dosage, completely safe use and easy operation.

The requirements are clearly defined – the new generation of inhalers should be easy and reliable to use but also small, lightweight and attractive. That is because these aspects, too, have a crucial influence on the success of a therapy. Physicians and the pharmaceutical and medical technology industries are well aware of this. Innovative plastics are therefore very much in vogue in this sector. One of the leading trendsetters is the SkyeHaler™. This dry powder inhaler benefits from two Ticona high-tech polymers.

Hostaform and Celanex are in tireless action right now, working on behalf of patients. In the SkyeHaler™ dry powder inhaler, these two polymer materials ensure accurate dosage, completely safe use and easy operation. This drug delivery system for the new generation of inhalers was developed by the Swiss company SkyePharma AG in collaboration with the plastics processing system supplier Riwisa AG. The SkyeHaler™ has been specially designed, tested and optimized to meet the requirements of the asthma drug Formoterol produced by the pharmaceutical company Novartis, based in Basle.

Find information about SkyePharma AG.

All included – product quality and medical approval
In the development of this device, the needs of the patient were always paramount. The Swiss development engineers therefore consistently kept the user in mind right from the initial idea – the first draft designs for an all-plastic inhaler were produced in the mid-1990s – through a long series of diverse clinical trials to the final commercial launch. At the same time, Riwisa pressed ahead with setting up a dedicated production process. As the Head of Quality Control at Riwisa explained: "The advantages of Hostaform and Celanex quickly persuaded us to rely on these polymer materials from Ticona – especially since they were already approved for medical applications and had a successful track record."

The Dry Powder Inhaler SkyeHaler (TM) developed by the Swiss company SkyePharma AG with key components made from Hostaform and Celanex. Photo: Ticona Click go for high Resolution image.

The powder inhaler consists of 22 parts and is produced in a cleanroom by a fully automated process in accordance with the US production standard cGMP (current Good Manufacturing Practice). The nine key components made from Ticona materials, such as the powder funnel, funnel cover, carriage and valve shield release, offer the advantages of good wear resistance and surface slip properties, excellent resistance to hydrolysis and chemical media and a long service life. They have extremely high load bearing capacity and absolutely unchanging dimensional stability under all circumstances. The Hostaform POM (polyoxymethylene copolymer) used is a highly crystalline acetal copolymer with a linear structure, Celanex PBT (thermoplastic polyesters) is a semi-crystalline, thermoplastic polyester.

Clear advantages for patients
The specific advantages of the two engineering plastics and the innovative design of the inhaler guarantee that the same amount of drug is dispensed whether the patient is a child, adult or elderly person. Drug delivery does not depend on the inhalation force of the user. In this way, the SkyeHaler™ solves a problem familiar with many conventional dry powder inhalers. The dosage, exactly adjusted to the patient's needs, remains the same under all conceivable conditions.

Phase III studies of the drug in the US, Canada and Europe yielded excellent results. Variable dosage over the wide range of 2-20 milligrams per delivery and controlled suction provide high flexibility in administration by inhalation. The SkyeHaler™ indicates the exact number of doses left. At the same time, the sophisticated SkyeProtect™ Powder Technology with moisture-repelling molecules reliably prevents agglomeration of the drug.

Safety and stylish design are top priority
Comprehensive monitoring options provide a high degree of safety. Each individual "shot" of the drug is confirmed not just by taste but by a clicking sound, and the patient can always keep a check with the countdown "shot" counter. There is no longer anything to prevent exact medication. Double dosing of the drug is therefore just as much a thing of the past as drugless inhalation ("tail-off" effect) when the inhaler is empty. An internal mechanism blocks the SkyeHaler™ automatically after the last dose.

A special feature of this inhaler is its attractive design. Conveniently pocket-sized, the inhaler is light to carry and can be optimally positioned between the lips as a result of its anatomically perfected mouthpiece. All these advantages of the new development go along with enduring robustness and reliability. The innovative Ticona materials are optimally tailored to the differing requirements of medical technology. It is not surprising that the inhaler has been enthusiastically received by both patients and physicians. Despite the advanced nature of this development, the SkyeHaler™ remains competitive on price. This is because of its pragmatic design and the dedicated, economic production process, to which the high-tech polymers from Kelsterbach/Germany make a key contribution.

Inhaler technology for insulin instead of injection
Diabetics, too, will also able to benefit from dry powder inhalers. Leading insulin manufacturers are currently working on inhalable insulins. In the near future, for example, Aventis and Pfizer will launch "Exubera", which will save diabetics having to prick themselves with a pen or syringe several times a day. The combination of the new dry insulin and innovative inhaler will soon increase many patients' quality of life.

The market is large. In Germany alone, it is estimated that there are five to seven million diabetics and the trend is increasing. The majority of these patients are treated with oral antidiabetics. As the disease progresses, this therapy is often not sufficient and patients have to switch to insulin. Many diabetics, however, are reluctant to start insulin therapy. Administration of vital insulin with dry powder inhalers could encourage them to overcome their inhibitions.

Find information about Riwisa AG.

RIWISA AG, based in Hägglingen, was one of the first plastics manufacturing companies to be established in Switzerland, in 1946. Right from the start, the company made a name for itself producing buttons and WC seats from thermosets and, later, articles from thermoplastics. From 1955 to 1999, RIWISA also produced polyethylene, polyamide and multilayer films and has been making disposable packaging since 1957. In 1998, the company started producing medical articles under cleanroom conditions and in 2001 opened a new RIWISA Medical Center. Today, this company with over 300 employees is one of the leading manufacturers in the plastics processing sector.

Ticona, the technical polymers business of Celanese Corporation, produces and markets a broad range of engineering polymers.

Read a recent press release from Ticona about; 'Using Ticona engineering plastics, the technical polymer Hostaform MT meets the special requirements for the new electronic inhalation nebuliser from PARI GmbH.'

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