A Single Dose Powder Inhaler Is Pilot-Production And Ripe For An Active Partner To Bring It To Market

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A Single Dose Powder Inhaler Is Pilot-Production And Ripe For An Active Partner To Bring It To Market

9/17/12:   A single dose powder inhaler is pilot-production and ripe for an active partner to bring it to market. 

Introducing DoseOne™, a single dose powder inhaler that is already prototyped, tested, recently benchmarked, and ready for pilot production and a partner to move it forward.  The design is SO simple it’s something that makes you say, “Darn, I wish I thought of that, it’s so simple!”

Simple means inexpensive (~$0.30 USD in Full Volume) and fast to market and can be tested in pilot production immediately because it is already designed, molded, and ready for slight modifications to fit a particular size molecule.

Dose-One Patent #7,832,399

DoseOne™ is a single use disposable dry powder inhaler that is:

–       Vaccine-ready

–       Easy to Carry & package for epidemic/pandemic necessity

–       Fills a unique niche in the dry powder inhaler market

Achieves new demanding regulatory requirements previously only achievable using complicated device designs such as:

  • Dose counting
  • Powder holdup
  • Dose readiness indication
  • Dose completion / user feedback

DoseOne™ is extremely easy to use and requires minimal training

–       The device, as currently designed, requires three steps to use

  • Removal from over-pack
  • Actuation
  • Inspiration

–       Actuation is a simple compressive snap

–       As a result of it’s simple operation, DoseOne™ has an excellent application in the delivery of drugs (such as vaccinations) to third-world countries

DoseOne™ is currently a three component inhaler with:

  • All three components are highly manufacturable.
  • Long term material selection which can be determined by the customer as a function of drug chemistry as the device design requires very few material constraints.
  • Current performance data which utilized pharmaceutical grade/USP Class VI resins.

Regulatory Advantages:

  • DoseOne™ is a single dose device, minimizing dose-to-dose consistency risk.
  • No device priming.  Many inhalation systems require a prime of the device of a number of shot before use.
  • DoseOne™ uses a new device for each dose and thus eliminates the issue of powder “caking and flaking” (deposition during inspiration adding to dose volumes of later doses).
  • No dose counting!  The FDA and other world health organization strongly recommend the use of dose counters or indicators to increase patient compliance. DoseOne™ is one device, one use, and disposable.
  • The current device design contains a very simple dose readiness indicator as well as dose delivery indicator.  This comes in the form of a viewing window to allow the user confirmation that the dose is ready, and that the dose has been delivered.

Development Status

  • DoseOne has constructed tools for the current DoseOne™designs (Size #2 and Size #4)
  • Size #0 and Size #1 design embodiments are tooling kick-off ready.  Feasibility, optimization, and DFM details are complete.
  • Current single cavity tools are Phase I clinical ready
  • Devices are currently in a molded and fully functional state
  • US Patents are granted

–       US PAT #7,832,399

Partnering Expectations/Goals for DoseOne, LLC:

–       Partner with successful formulations development/OEM companies interested in providing patients with effective treatment

–       Develop mutually beneficial milestone based license arrangements which results in an expeditious time to market

–       Continuously adjust and improve device performance as new formulations become available

–       Supply the marketplace with a unique device partnered with an effective drug

Focus groups / Market Studies / Manufacturing Partners

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