DOSE ONE: THE FUTURE FOR DPI’S, A HUGE OPPORTUNITY FOR COMMERCIAL PARTNERSHIP
9/10/13 An opportunity exists for a device / pharmaceutical manufacturer to partner with us to bring to market a revolutionary new singe-dose powder inhaler. DoseOne™ has been prototyped, tested, benchmarked, and is ready for pilot production and the support of a qualified partner to realize market potential. DoseOne™ is simple, inexpensive, and can be brought to market quickly as it is already designed, molded and ready for the incorporation of minor modifications depending upon particular drug/excipient molecule size.
The Market for DPIs. Powder inhalers deliver drugs in the form of dry powder directly to the lungs, and are typically used in the treatment of respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD), asthma, and emphysema. However, due to many of their innate characteristics and advantages as a drug delivery mechanism, there is burgeoning interest around the use of dry powder inhalers (DPIs) in the pharmaceutical and medical device sectors.
In many ways, DPIs have become more prevalent as they have been tailored for markets previously catered for by Metered Dose Inhalers (MDIs), which many patients find difficult to use, which rely on propellants that have come under more and more legislative scrutiny, and — from the device manufacturers and pharmaceutical company’s perspective — are often expensive to make. It is generally agreed that DPIs are easier to use as they simply rely on patient inspiration to deliver the drug, and are less likely to lead to side-effects such as irritation of the airways.
However, despite the inherent advantages DPIs have, there are also drawbacks, which can critically impact upon — among other things — vital issues such as patient compliance. For example, as DPIs require the patient to undertake an efficient and deep inhalation to administer the required dose, there is the opportunity for failure of the effectiveness of the device and therefore the efficaciousness of the inhaled drug. In terms of markets at which they are aimed, therefore, they are typically restricted to use in adults and older teenagers. In addition, as many DPIs are multi-dose devices, they need to overcome issues such as dose-to-dose inconsistency and the requirement for expensive dose-counting technology.
As with all families of drug delivery devices, the balance for drug companies is between affordability and functionality. Unit cost per device is obviously critical, as is the ability for the drug to be delivered in the correct dose, and for there to be minimum drug wastage.
The Solution is DoseOne™ . DoseOne™ is a single-use disposable DPI, and as such overcomes many of the problems associated with multi-use DPIs and MDIs. As a single dose device, for example, it minimizes dose-to-dose consistency risk, and also negates the requirement for priming needed by many devices, with all this implies in respect of drug wastage.
In addition, as DoseOne™ is a single use disposable device — and therefore a new device is used for each dose — it eliminates the frequent problem of powder caking and flaking which can affect dose volumes in multi-dose devices.
Also, as a single use device, the issue of, and problems associated with, dose counting — which preoccupies the FDA and other health organizations around the world — is made redundant. In its current state, DoseOne™ contains a simple dose readiness indicator as well as a dose delivery indicator in the form of a viewing window, therefore promoting patient compliance by confirming the dose is ready and has been completely administered. As such, DoseOne™ satisfies the regulatory demands previously only achieved by complicated and expensive designs.
DoseOne™ Design Characteristics. DoseOne™ is currently a three component inhaler, each component being simple to manufacture, with the long-term choice of material being determined by drug chemistry. The device design prohibits the use of very few available materials. Performance data at present is available using pharmaceutical grade/USP Class VI resins.
DoseOne™ has been designed in order to promote ease-of-use, there effectively being three steps, removal from packaging, actuation, and patient inspiration. Actuation is a simple compressive snap, the inherent simplicity of use making the device an ideal fit for the administration of vaccines in third-world and emerging countries, where simply, safe, and efficient self administration devices are so vital. It is vaccine ready and easy to carry and package for epidemics and pandemics.
The simplicity of the device makes it an inexpensive drug delivery option, costing $0.30 USD per unit in full volume.
DoseOne™ Design Status. US patent #7,832,399 has been granted to DoseOne™. Tools are constructed for the current DoseOne™ designs (Sizes #2 and #4), and Sizes #0 and #1 design embodiments are ready for tooling kick-off. Feasibility, optimization, and Design-for Manufacture details are all complete. Current single cavity tools are Phase I clinical ready, and devices are currently molded and fully functional.
DoseOne™ Partnering Opportunities. Micro Engineering Solutions (MES) has the exclusive worldwide rights to sell DoseOne™ and is now actively seeking serious and interested partners. The market is ready for a simple to use, cheap, and easy to manufacture single dose powder inhaler. There is a massive and immediate business opportunity, as well as the chance to be involved with the commercialization of a drug delivery device that can truly revolutionize and make accessible to all the treatment of numerous potentially fatal diseases.
For more details contact Donna Bibber on tel. +1 (774) 230-3459 or via email at donna@microengineeringsolutions.com directly.
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