Bespak and DCA International develop breath activated MDI
50bn drug doses delivered annually via Pressurised Metered Dose Inhaler
It is estimated that of the 50bn drug doses delivered annually via Pressurised Metered Dose Inhaler (pMDI), almost all are administered for the treatment of asthma. Over the next decade, Bespak envisages that the potential to deliver more potent therapeutics directly into the lungs will change how pMDIs are perceived.
Bespak anticipates that by 2010, pain relief and other systemic drugs will account for up to 5% of the pMDI market by volume. With more expensive therapies being delivered, the value of this share will be far higher. This shift increases the need for pMDIs with built-in, fully integrated regimen assurance and assistance features.
Designed to provide accurate information that aids the use of a delivery device, regimen assistance and assurance devices (RADs) can be as simple as dose counters that offer accurate information on the number of actuations left in a pMDI. They can, however, take a more sophisticated form. An example is the inclusion of an aural and visual system to remind patients when specific doses are required. This is operated using a simple interface button for patient feedback. RADs can help patients adhere to prescribed regimes that require regular dosing at specific timed intervals. By limiting the number of doses dispensed within a set time frame, restricted access codes can ensure that the correct dosage is delivered to the prescribed user at the right time of day, reducing the risk of accidental overdosing or abuse by non-authorised users.
One of the main challenges that will face pharmaceutical and drug delivery companies looking to incorporate RADs into pMDIs will be assigning the correct method of regimen assistance and delivery mechanism based on consistent dosing and patient requirements. For this reason Bespak has made allowance for the drug manufacturer to set the RAD dosing regimen, while also allowing for a properly equipped pharmacist to set the regimen at the point of dispensing.
Bespak began working with DCA Design International in 2002 on the joint development of a flexible device design that features a range of novel assistance and assurance features. The device is breath actuated, thus keeping the number of steps required to administer a dose to an absolute minimum. This ensures that the device is suitable for patients who find co-ordinating breathing with firing a pMDI difficult. Breath actuation also limits the risk of misuse as it is more difficult to decant the unit into a separate chamber if the security system is bypassed. While the device incorporates several advanced features, both Bespak and DCA were keen to keep cost premiums as low as possible. This was achieved by limiting the complexity of the design and employing electronic components that, although advanced, are relatively inexpensive in today's market.
Bespak and DCA's device design has already been patented and Bespak is currently seeking commercial collaboration with pharmaceutical partners. Particularly suitable for companies with off-patent drugs, the device enables novel delivery solutions for multi-dose therapies, previously thought hazardous or unsuitable because of complex regimes and subsequent low patient compliance levels.
