Boehringer sees alternative to Spiriva inhaler device

The results of the study, presented last week at the 16th Annual Congress of the European Respiratory Society in Munich, showed that patients with asthma and COPD are highly satisfied with its Respimat SMI, which is currently used with Berodual (ipratropium bromide/fenoterol hydrobromide) but the company intends to also use it with Spiriva.

With sales up 80 per cent to €951m in 2005, Spiriva dominates the COPD market as the only once-daily long-acting anticholinergic available, yet its success is under threat by similar products that could reach the market by 2011.

COPD, which encompasses a range of conditions including chronic bronchitis and is usually caused by smoking, is the fourth most common cause of death worldwide, with its market tipped to expand to €8bn by 2010.

In order to maintain Spiriva's advantage, Boehringer Ingelheim wants to reformulate the drug with an SMI, as a soft mist travels more slowly and lasts longer than aerosol clouds from pressurised metered dose inhalers (pMDIs), improving the deposition of the active ingredient in the lungs and producing less deposition in the mouth and throat.

At present Spiriva is administered with Handihaler, which, although a dry powder inhaler (DPI) and not a pMDI, is considered complicated to use, particularly by the elderly.

In the twelve-week observational cohort study in Germany, 74 per cent of patients and 75 per cent of physicians rated the treatment of Berodual from the SMI as better or much better than their previous treatment.

This is down to Respimat's extremely fine nozzle system, the so-called uniblock; when the medication solution is forced through it, two fine jets of liquid are produced and converge at an optimised angle, and the impact of these converging jets generates the soft mist.

This mist is extremely fine - the majority of the droplets fall into the fine particle fraction of 5.8 microns - and moves slowly, which is the basis for many of its potential benefits.

The Handihaler, on the other hand, includes a spherical covered plastic chamber and foil blister card of Spiriva capsules.

Each capsule contains the dry powder medication, which the patient loads into the device and then presses a button to pierce the capsule, inhaling deeply and slowly until all the capsule powder is inhaled.

Boehringer Ingelheim has contracted two companies for the production of the Handihaler; the RPC Group, which manufactures the device at its Mellrichstadt facility in South Germany, and Wilden, which makes the product at two production sites in Germany and the US.

Wilden applies turning stack mold technology to the production of the device's two-component housing, as opposed to conventional methods used by RPC, which means there is central application of load, which prevents asymmetric pressure, protects the mold and reduces wear.

HandiHalers are produced and assembled in a 100,000 class cleanroom and checked by means of an integrated flow control device to ensure that the capsule with the medication can rotate freely when the patient inhales.

Wilden has also been involved in the production of Respimat housing components by Boehringer Ingelheim.

The Phase III programme for Spiriva with Respimat has been successfully completed and registration files are under development, Boehringer Ingelheim said.