Novel soft mist COPD inhaler set for EU

By Anna Lewcock

- Last updated on GMT

Related tags Chronic obstructive pulmonary disease

A novel spring-powered inhaler system to deliver the blockbuster
COPD (chronic obstructive pulmonary disease) treatment Spiriva
(tiotropium) has successfully completed the EU approval process,
paving the way for its introduction into the EU market.

Boehringer Ingelheim and Pfizer are jointly responsible for the innovative delivery system, the Respimat Soft Mist inhaler, and if all goes to plan the Spiriva Respimat device should be available in some EU countries by the end of the year, according to a Boehringer spokesperson.

The Respimat inhaler is a propellant-free device, relying on energy released from an internal spring to trigger delivery of the drug.

Already in use with Boehringer's Berodual (ipratropium, fenoterol) treatment, the drug delivery system offers some key advantages over other inhalable drug delivery devices and has been very well received by patients.

The next generation inhaler is used by twisting the base of the device 180° to compress the internal spring, which in turn causes a measured volume of solution to be drawn up through a capillary tube and into a micro-pump.

When the dose-release button on the inhaler is pressed, the energy released from the spring forces the solution into the Uniblock - the core element of the device where the soft mist is generated.

The Uniblock is an extremely fine nozzle system, through which the medication solution is forced to create two ultra-fine jets of liquid.

These jets then converge at a specific angle, with the impact of the two creating a very fine mist (particle fractions around 5.8um).

The mist is very slow-moving, which results in improved delivery in the lungs and reduced deposition in the mouth and throat compared to traditional pressurised metered dose inhalers (pMDIs).

The Respimat soft mist also lasts about six times longer than (1.2 seconds) than conventional MDIs, according to the company, giving the patient more time between actuation and inhalation.

Also, unlike dry powder inhalers, the dose delivered with the Respimat device is not dependent on patients' inspiratory flow.

The once-daily Spiriva Respimat product will contain 2.5 micrograms of drug per puff (a 5 microgram dose therefore requiring two puffs), with therapeutic effect comparable to the 18 microgram Spiriva HandiHaler, the drug's current delivery device.

The product is also equipped with a dose counter, which reaches a red zone when the product is running low.

Each Spiriva Respimat device will provide enough treatment for one month.

The Berodual product was introduced in Germany in 2004, and is currently the only region where the Respimat inhaler is available.

The device is manufactured at Boehringer's Dortmund site in Germany, previously owned by Respimat's original manufacturers, STEAG microParts.

Boehringer clearly has high hopes for the inhaler device and its widespread entry onto the market, as the company last year announced an extensive expansion of the production site in Dortmund, set to double production capacity for the Respimat device by 2009.

Spiriva, first launched in 2002, is the company's lead product and in 2005 became the firm's first blockbuster drug by achieving an annual turnover exceeding $1bn.

The drug is also the firm's fastest growing product, with sales increasing by 45 per cent from 2005 to 2006, hitting €1.4bn.

According to Boehringer, Spiriva is the most prescribed brand in the world for COPD, and the company will be hoping to build on this solid footing with the introduction of this novel drug delivery device.

Final approval and subsequent product launch will now be down to the individual authorities of each country within the EU, with the two companies currently in the process of compiling a dossier to be submitted to the US regulatory authorities later this year.

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