Unit dose dry powder inhaler

ICOoneTM is a unit dose disposable dry powder inhaler based on a novel proprietary technology, patents pending.

ICOone is designed to be an ultra low cost device equally suitable for high volume fully automated manufacturing for commercial products e.g. vaccines. ICOone is also suitable for low volume fully manual manufacturing for Phase I & II clinical trials. ICOone is fully injection molded and available for licensing.

ICOone Features

  • Disposable unit dose dry powder inhaler
  • Carrier-based, spray-dried, freeze dried or other types of engineered formulations
  • One dose up to 50 mg (100 mm3)
  • Two user operations: Load-Inhale
  • Visual indication when used
  • Extending mouthpiece
  • Small size
  • Intuitive
  • Hygienic
  • High delivered dose uniformity
  • Factory filling using conventional equipment
  • Designed for fully automated assembly and low-cost manufacturing
  • Designed for manual assembly and manufacturing
  • Adaptable platform

Options

  • Active humidity protection with integrated desiccant
  • Built-in mouthpiece cover
  • Two cavities. Two different drug formulations with two different API

Applications

  • Orally inhaled dry powder vaccines
  • Replacing nebulization in early clinical trails (Phase I & II)
  • High cost drugs with individually tailored dose regimen or need for cold storage
  • Replacement for traditional multi-dose devices to reduce cost e.g. in emergency rooms, ambulances, short time hospitalization
  • Supplement to traditional multi-dose devices when a unit-dose device would be more convenient e.g. on travel, sports/recreational activities, in the office, in the car.

Iconovo can offer a comprehensive service package including device design, formulation development, analytical testing, documentation etc. together with a complete supply chain.

Vaccine

Dry powder vaccine delivery does not require

  • Needles
  • Sterility
  • Sterile water
  • Preparation before use
  • Medical trained staff
  • Cold storage
  • Wastage of excess doses
  • Management of high risk waste and proliferation of used needles

A dry powder vaccine is

  • Safe
  • Easy to use
  • Low cost
  • Prepared for long shelf-life in high temperature and high humidity
  • Simple to manufacture
  • Simple to handle in bulk
  • Environmentally friendly materials
  • Simple handle and dispose of after use

Facts about injectable vaccine

Throughout the world an estimated 16 000 million injections are administered every year. Not all needles and syringes are properly disposed of, creating a risk of injury and infection and opportunities for illegal re-use.

WHO estimates that, in the year of 2000, injections with contaminated syringes caused 21 million hepatitis B virus (HBV) infections, 2 million hepatitis C virus infections and 260 000 HIV infections worldwide. Many of these infections would be avoidable if the syringes had been disposed of safely. The re-use of disposable syringes and needles for injections is particularly common in certain African, Asian and Central and Eastern European countries.

In developing countries, additional hazards occur from scavenging at waste disposal sites and the manual sorting of hazardous waste from health-care establishments. These practices are common in many regions of the world. The waste handlers are at immediate risk of needle-stick injuries and exposure to toxic or infectious materials.

Cost of providing the expanded programme on immunization: findings from a facility-based study in Vietnam. 2005, Bulletin of the World Health Organization.

Early clinical trials

ICOone is suitable for early clinical trials Phase I and Phase II. If the commercial product is intended to be a dry powder inhaler then all clinical trials should be performed using a dry powder inhaler instead of a nebulizer.

ICOone can be used for first-time-in-man-studies and will be much more predictive than nebulization. ICOone will be using the same type of formulation as in the intended commercial product. When using nebulization for Phase I, a special liquid formulation must be developed with its own inherent challenges as chemical stability, liquid properties etc. A nebulizer will always produce a different particle size distribution and a different lung dose than a dry powder inhaler. This leads to a more challenging bridging to the intended commercial product.

Iconovo can provide a ready to use unit dose inhaler together with a set of filling and assembly equipment. Together with our partners, Iconovo can also provide formulation development and manufacturing of the clinical supplies. For Phase I, manual manufacturing is sufficient, see example below. If needed the filling and assembly can be made semi-automatic for higher capacity.

Example of manual GMP manufacturing capacity:

Assumptions

  • Fully manual assembly
  • 3 assembly stations (filling and 2 x assembly)
  • Parts delivered 200/bag
  • Foil pre-cut on reel
  • Drug formulation in bulk container
  • 3-4 operators
  • Working day: 6 hours and 2 hours break etc.

Output per day

  • Up to 200/h or 1 000/day
  • Including cleaning and documentation

Commercial high-volume product

ICOone us also suitable for high volume fully automated manufacturing for commercial products. For example:

  • High cost drugs with individually tailored dosing regimen or need for cold storage
  • Replacement for traditional multi-dose devices to reduce cost in emergency rooms, ambulances, short time hospitalization etc
  • Supplement to traditional multi-dose devices when a unit-dose device is suitable on travel, sports/recreational activities, in the office, in the car etc.

Some inhaled drugs are not suitable for a multi-dose device with 60-120 doses. For example, a multi-dose device is neither practical nor cost effective if the prescription would be one dose/day for 11 days.

If the drug has a room temperature stability of one day and therefore requires cold storage, it is more practical to store all individual doses in a refrigerator and only take out the dose for the day. Again, it is not practical to use a multi-dose device for such drugs (for example bio-molecules).

To have a unit-dose device for traditional LABA, LAMA and ICS can be of great value in situations when not all doses in a multi-dose device are to be used. This can be the case in an ambulance or emergency room when the patient needs one or very few doses of LABA or LAMA. Often in such situations, a new multi dose device is opened and then, for hygienic reasons, discarded after only few doses taken. 

This is a waste of drug and money and adds to the environmental burden. A unit-dose device effectively reduces this waste.

A unit-dose device can also be very useful for the user in situations when a multi-dose device is not practical. This can be on travel, sports/recreational activities, in the office or in the car. In such situations, the patient would prefer to bring only one dose and not 120. Also, the cost is of significance. A new multi-dose device can cost up to 200 USD. Many patients are reluctant to leave something worth 200 USD unattended in for example a gym bag. An ICOone is significantly smaller than a multi-dose device and will easily fit in any pocket and is also significantly cheaper.