A new dry powder inhaler that may cost less than a syringe and deliver 40 per cent more active drug than current inhalers has been unveiled by its maker, Cambridge Consultants.
According to the UK firm, this "revolutionary" new inhaler, called Conix One, is ideal for use in mass vaccinations against chronic diseases and global pandemics, such as avian flu.
"We believe that this inhaler will fundamentally change the way we treat many diseases on a global scale. Designed specifically with global pandemics, like H5N1 (bird flu), in mind, we have combined cutting edge technology with smart product design, enabling us to achieve something that has never been seen before," said Brian Barney, head of drug delivery at Cambridge Consultants.
Although for many chronic diseases inhalation offers the optimum delivery mechanism, large-scale vaccinations are usually delivered via syringe, because up until now, the cost of producing an inhaler economically, and with the necessary performance, has not been possible.
Cambridge Consultants believes it has developed the technology set to change this.
"It [Conix One] is akin to providing the performance of a sports car at a cost comparable with a moped. It is that significant," said Barney.
Based around a novel 'reverse flow cyclone,' Conix One is made from a single piece of plastic and contains no moving parts or propellants.
"The device is incredibly simple," Barney told In-PharmaTechnologist.com.
"Because of this, initial estimates from Finnish-owned contract manufacturer, Perlos, who is manufacturing the device in the UK during the development stages, show the device will cost just four cents to manufacture, based on a manufacturing volume of five million."
This is comparable with syringes, which cost between four and eight US cents, and is substantially cheaper than the asthma inhalers on the market today, which typically compose of around 20 parts and cost at least 40 cents in volume.
"However, a five million run rate is not even that significant when you consider the global volumes required for some mass vaccinations, so with a higher volume, the actual cost could be even less," said Barney.
In addition, further savings could be made by the fact that syringes are more expensive to distribute (drug in liquid form typically requires refrigeration) and they require skill and training to use, said the company.
The inhaler works by folding the device shut, at which point the patient inhales the drug, contained behind a foil seal, and then discards the used device.
This once-only dosing also contributes to the low cost of the device, said the firm.
"Currently, inhalers tend to be focused on specific treatments and are designed to typically contain between 14 and 200 doses. This suits conditions such as asthma, as the patient needs to use it three or four times per day, but when you only require a drug to be delivered once, the cost of current inhaler technology is prohibitive."
However, cost savings are not the only benefits that this new inhaler promises to bring.
"The unique swirling action within the reverse flow cyclone design provides an effective deagglomeration process, enabling a large percentage of drug to be delivered efficiently into the lung," said the firm.
"This action also overcomes the problem that many inhalers have, where the drug is released within just a fraction of a second - before the patient has had time to reach their optimal inhalation rate. The cyclone chamber releases a steady flow of drug over two seconds, enabling better use of a patient's lung power."
According to the Cambridge Consultatnts, the inhaler also allows the drug to be self-administered and eliminates the risk of needle stick injuries, which are huge advantages in regions where pandemics and chronic diseases are typically found.
So far testing of the device is still in the early laboratory stage. The firm has carried out a number of in-house tests using existing drug formulations from commercially available inhalers, comparing the efficacy of its inhaler with the surrogate devices.
"Our device's drug separation mechanism is so efficient that it has shown to be up to 40 per cent more effective than many inhalers on the market today," said Barney.
As far as formulation goes, Barney does not believe that any reformulation of existing compounds will be needed for them to be used in the Conix One.
"We have not tested any drug so far where using its existing formulation has been a problem," he said.
Moving forward, Cambridge Consultants now plans to licence the technology, either to one large company under an exclusive agreement, or to a number of companies under a semi-exclusive therapeutic area-type arrangement.
"We are currently in active discussions with major pharmaceutical and medical device companies who have been universally astounded by the technology," said Barney.
Next week the firm will begin feasibility studies in the laboratory with a number of interested parties to determine whether their drug compounds - either existing or new - could be suitable.
"We will test our device with their drug at two sites, one at our headquarters in the UK and one wherever their facilities are," said Barney.
"After the feasibility studies we will enter further discussions with these companies to see whether we will move with them through to the next stages of development such as pre-clinical and early-phase clinical studies."
Barney said he could not predict a timeline as to when the first Conix One device will be available on the market, as a lot will depend on the timelines of the licensing companies.
If the device indeed manages to live up to all its promises during the clinical trial processs, its launch will be eagerly anticipated.
The initial impressions of Dr Val Perrin, an independent consultant in pharmaceutical medicine, who has seen the Conix technology first-hand, have been encouraging:
"The Conix inhaler is novel both in its overall design and simple mode of operation. This bodes well for its use in clinical trials and patient handling studies."
"Laboratory tests show that it also works well at low inspiratory flow rates, which will be additionally important for subjects such as the elderly and young children."