micro parts to market... faster

A True Platform Single Dose, Disposable Dry Powder Inhaler

10/26/17     DoseOne is a patient friendly single dose inhaler. It is compact, simple and easy to use. It is actuated with a simple compressive snap and gives visual cues for ‘dose ready’ and ‘dose completed’. Just three easy steps, including inhalation!

Just as attractive as its simplicity of use is its competitive performance at a competitive cost. Its simple three-part assembly composed of all injection molded plastic parts makes it highly manufacturable. The assembled unit costs less than $0.10USD at 100MM quantities. It has a capsule based drug storage making filling lines, loading and drug handling efficient and flexible. The simple design also allows for a huge range of material selections based on manufacturing needs. Along with the ease of manufacturability, the emitted dose and respirable fractions are competitive with, if not better than, most current marketed devices. The capsule based technology allows for a wide range of dose volumes and weights of less than 5mg up to 100mg without major design changes. In addition, it is evaluated and optimized for both lactose carrier blends and low density spray dried formulations.

Its simple elegance means faster time-to-market and inherent opportunities. The inherent regulatory advantages include:

• The simplicity and reduced part count reduces complexity, development time and product development risk
• The single dose disposable eliminates complex dose counting requirements
• The capsule based storage is well understood and low risk
• A unique device for each dose eliminates powder holdup and reduces dose consistency concerns
• The simple three component assembly allows for use of almost any USP class VI materials tailored for cost or API compatibility

The simple nature of this device and lack of complex mechanism allows for a huge assortment of industrial designs and branding opportunities for the product design and shape.

The markets and opportunities are endless. DoseOne is a perfect platform for delivery of vaccines, biologics, and single dose rescue or prevention therapies. The simple operation means minimal to no training is needed, which makes it ideal for third world countries or fast acting rescue. Its high efficiency and large dose load capability allow for delivery of large doses such as antibiotics or hormone therapy. In fact the simple assembly and capsule based nature of this device make it the ideal device for use as a clinical development platform for all dry powder inhaler programs for pivotal clinicals or powder development.

The DoseOne is a combination of prior art and new intellectual property fully covered by the following patents: 7,832,399 – 8,360,399 – 8,464,712. The multiple filing and grant patents cover the basic technology in addition to multiple engine configurations, blister packing options, multi dose configurations and dual drug delivery options.

DoseOne is considering all business opportunities including license arrangements or a sale of the intellectual property as a whole. DoseOne is wholly owned by the inventors with no additional ownership interests or silent partners. Previous licensing opportunities have resulted in successful freedom to operate evaluations and pre-phase I device analysis. DoseOne currently has single cavity tools and is Phase I clinical ready. Donna Bibber is the Director of Global Relations for DoseOne and is ready to speak with you about your project. Please email her at DBibber@Dose-One.com.

•Compact, simple, easy to use
•Actuated with a simple compressive snap
•Visual user cues for dose ready and dose completed
•No complex mechanism or user manipulation required
•Three easy steps including inhalation

Dry Powder Inhaler Makes Patient Use Easy

10/6/17     Pulmonary drug delivery has the potential to produce maximum therapeutic benefit to patients by directly targeting drugs to the lungs. The dry powder inhaler (DPI) is the preferred device for the treatment of an increasingly diverse range of diseases. Do to the fact that drug delivery from a DPI involves a complex interaction between the device and the patient, the engineering development of this medical technology is key.

DPI systems target the delivery of fine drug particles to the deeper airways in the lungs using a combination of improved drug formulations and enhanced delivery device technologies. These factors contribute to the overall performance of the aerosol system. There are a large range of devices that are currently available, or under development, for clinical use, but a major concern is that the daily patient use of this device may result in under-dosing. That is one of the factors that makes the DoseOne™ DPI is different from the others.

The DoseOne™ is equipped with a simple dose readiness indicator and a dose delivery indicator, and its size and ease of use (relying on patient inhalation rather than propellant technologies) make it well suited to environments where local health services are sub-optimal. As a single dose device it minimizes the dose-to-dose consistency risk and also negates the requirement for priming needed by many devices.

In addition, as DoseOne™ is a single use disposable device, a new device is used for each dose, eliminating 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.
To learn more about DoseOne™ and how to partner up with us, please visit the website: www.Dose-one.com and contact Donna Bibber at 774-230-3459 with any questions you may have.