Dose-by-dose does it for 3M
drug delivery systems business, providing a new solution to recent
regulatory requirements for metered dose inhalers.
The new feature - the Integrated Dose by Dose Counter - provides precise dose counting along with a display to be used in pressurised metered dose inhaler (pMDI) development. The counter is likely to prove particularly popular following regulatory changes in the US and Europe recommending the inclusion of counter devices on inhaler products. In March 2003 the US Food and Drug Administration (FDA) published guidance making it mandatory for new pressurised metered dose inhalers to incorporate dose counters or indicator mechanisms. Guidance in Europe 'encourages' the inclusion of a counter on new products, and according to the company they are "likely to become an expected feature on products in the US and Europe." In line with these recommendations, 3M foresees the dose counter being available initially in the US market, followed by availability in Europe and other markets. "The 3M Integrated Dose by Dose Counter is now available for pharmaceutical companies looking to incorporate a dose counter in future product developments, or to retro fit into existing pMDI products," Louise Righton, global inhalation market development manager for the company, told In-PharmaTechnologist.com. Although adding a small incremental expense to the cost of a standard pMDI, the company also offers a service to aid the integration of the dose counter into partners' product development, provide regulatory documentation and help bring products to market. The counter itself has several features that could make it an attractive option for pharma firms manufacturing pMDIs. The mechanism is compatible with most popular valves on the market, is customisable to partners' requirements, and through integration into the existing actuators the product remains familiar to users, minimises development risk and ensures compatibility with packaging lines. As a result of the regulatory guidance, significant interest and activity has been generated in dosage counters incorporated into inhaler products, which have taken various forms to alert the user when the pMDI is approaching the end of its recommended number of actuations. 3M is already a major supplier of metered dose inhaler components to leading pharmaceutical companies, and although specific firms could not be disclosed, 3M said that several companies have already shown an interest in the new technology. "We expect dose counters to contribute a significant revenue to 3M Drug Delivery Systems in the future," said Righton. "We are confident we have designed a dose counter that will provide real benefits to patients and which meets the needs of our partners and regulatory bodies." The new dose by dose counter is on display at the Respiratory Drug Delivery conference taking place this week in Paris.
