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Inhaler pact answers FDA mandate


Regulatory demands in the US aimed at improving the devices used to deliver inhaled drugs have spurred an agreement that could see Bespak's specialised inhalers rolled out across the world.

The UK-headquartered company has just forged an alliance with healthcare multinational Cardinal Health that will put the latter's marketing muscle behind its products. In return, Bespak will promote Cardinal's inhalation formulation development, analytical and clinical manufacturing services.

Danna Ross, vice president of inhalation at Cardinal, that customers are increasingly seeking specialised delivery systems, "due in part to a recent US Food and Drug Administration (FDA) mandate requiring dosage counters on devices and for systemic delivery which requires more precise dosing."

The FDA wants companies to add dose-counting mechanisms to MDIs to allow patients to track their usage of inhaled medicines and make sure they do not use them for too long, i.e. when the supply of active ingredient may be exhausted.

Bespak's inhaler devices include valves, actuators and accessories such as dose counters and regimen compliance aids, as well as custom-designed metered dose inhaler and dry powder devices.

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