Partnership in Drug Delivery Powder Inhalers
6/13/16 Dry Powder Inhaler: development of the DoseOne™ single dose powder inhaler (US Patent #7,832,399) required a multi-disciplinary team approach, as any such drug delivery device needs to combine not just design skills, but also software and mechanical engineering capabilities, and expertise in analytical science and industrialization. MES has the exclusive worldwide rights to sell DoseOne™ and is actively seeking serious and interested partners. The design of this powder inhaler is sympathetic to the requirements for mass manufacture and regulatory compliance.
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.
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.
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
– 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
• 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.
– 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
• 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.
• 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
• WWW.DOSE-ONE.COM
• 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
• WWW.DOSE-ONE.COM
Partnering Expectations/Goals for DoseOne, LLC:
Micro Engineering Solutions has the exclusive rights to sell DoseOne™. Call us today to discuss your options
– 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
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Micro Engineering Solutions has the exclusive rights to sell DoseOne™. Call us today to discuss your options
– 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