Bespak has announced further data to support the unique characteristics of its Easi-fill pressurised metered dose inhaler (pMDI) valve
Designed specifically to assist regime assurance and deliver more expensive formulations in a single shot, Easi-fill offers the key advantage over conventional valves of removing the need to prime the device.
Loss of prime is a common issue with all capillary retention valves fitted to pMDI inhalers.
This is because conventional pMDI valves rely on a metering chamber being refilled immediately after the last dose is fired.
This means that a new inhaler, straight out of the box, needs to be primed by firing two or three shots before taking a dose.
Furthermore, because inhalers are used relatively infrequently, are often stored on their side or upside- down and shaken whilst being carried, the chamber may partially empty before the device is used again.
For the inhaler to then deliver an optimum dose, the patient should ideally fire one shot into the air (or to waste) to ensure the valve chamber is completely refilled from the main drug-pack reservoir.
Clearly, these steps results in high levels of waste and assumes that the patient has been told, or ideally shown, how to use the inhaler properly.
The Bespak Easi-fill valve requires no priming and thus ensures a full dose is delivered with a single actuation.
The valve also helps improve dose content uniformity as it incorporates a fast fill/drain feature and a metering chamber that only isolates each dose from the main body just before firing.
This helps ensure that the formulation delivered matches closely that in the drug pack.
This graph summarises the results of a priming study and shows that following the valve being fired in an inverted position (points labelled 5 and 84), pMDIs fitted with Easi-fill valves are able to immediately deliver a full dose (points 10 and 85) whereas a standard HFA valve requires additional actuations to re-prime itself (refill the metering chamber).
By reducing waste and improving compliance, the Easi-fill valve therefore enables pharmaceutical partners to take real competitive advantage, particularly if the device is required to deliver more expensive formulations.
The business case for using the Easi-fill valve is further enhanced when considered in the context of the key benefits of pMDIs as a delivery route ie, the flexibility to deliver to a range of solution and suspension formulations, widespread familiarity, and, historically, a speedier route to market.
Easi-fill valves are now on trial with a number of formulations and pharmaceutical companies.
Full scale industrialisation and manufacture of the valve already underway.
