Generic spec for dry-powder inhalers provides regulatory and quality updates

A generic specification template for dry powder inhalers addresses the FDA preference for parametric testing, testing requirement of ISO 20072, and emerging legislation on recyclability. The inclusion of electronics on devices is also addressed.

The free document, available from Cambridge Consultants (Cambridge, UK; US offices in Cambridge, MA), is intended to help shorten product development time not just for those new to the DPI regulatory approval process, but also for those who have not been through the process recently, by bringing them up to speed with “the slow but constant change in regulations and guidance,” says David Blakey, head of drug delivery. “We issue the specification to raise the floor in the market, as well as the bar,” he says. “Everyone developing devices benefits from the energy created by shortened development times, Cambridge Consultants included.”

Although some market leaders anticipate only organic market growth for inhalation devices, Cambridge Consultants disagrees. “There are opportunities for new applications in pain management, and for the treatment of cystic fibrosis, lung disease, and systemic conditions,” Blakey says. “One of the major opportunities for growth relates to the need for biological drug delivery, and another relates to insulin delivery.” In addition, as drugmakers work to maximize their brands’ value and time on the market, many are considering drug delivery technology in their lifecycle management strategies.

“Despite the collapse of Exubera, there is new hope in the patent filed last month by the MannKind Corp. (Valencia, CA) for its Afresa system for inhaled insulin,” says Blakey. “This is likely to kick start significant growth.” (The failed commercialization of Exubera insulin inhalation was a billion-dollar writeoff for Pfizer in 2007.)

User experience, safety and performance

The generic DPI specification describes the requirements that guide the development of inhalers—including marketing needs, user experiences, up-to-date regulatory information, technological considerations such as the use of electronics, and safety and performance needs—speeding device development. Since the publication of the first version by Cambridge Consultants in 2002, the DPI generic spec has been shared with more than a hundred organizations interested in developing better inhalers.

“It’s a high attrition sector,” says Blakey. “Of the many devices developed since 2002, only very few made it market. This is one of the reasons why there are so few—less than 10—DPIs available. We might guess that, of the companies that used our 2002 spec, maybe 10% got to market successfully.”