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
