ICOone

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 unit-dose dry powder inhalation device

ICOone features

• Disposable unit dose dry powder inhaler

• Carrier based, spray-dried, freeze dried or other types of engineered

formulations

• One dose @ up to 50mg (100mm3)

• 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 clincal trails (Phase I & II)

• High cost drugs with individually tailored dose regimen or cold storage need

• 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 etc.

 

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

• Long shelf-life in high temperature and high humidity

• Simple to manufacture

• Simple to handle in bulk

• Environmentally friendly materials

• Simple handling and disposal 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 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 were 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.

Vaccine

Doses supplied

Doses administered

Wastage %

BCG

8 780

5 942

32.3

DPT

18 480

14 889

19.4

TT4

18 480

14 222

23.0

Measles.0

7 180

5 942

17.2

OPV

18 660

14 889

20.2

Hepatitis B

15 543

13 902

10.6

Japanese encephalitis

15 000

13 278

11.5

Total

102 123

83064

18.8

 

Early clinical trials

ICOone is also 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 done using a dry powder inhaler and not using 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 leading 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. ICONOVO can, together with its partners also provide formulation development and the 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 2x assembly)

• Parts delivered 200/bag

• Foil precut on reel

• Drug formulation in bulk container

• 3-4 operators

• Working day: 6 hours and 2 hours breaks etc.

 

Output per day

• Up to 200/h or 1000/day

• Including cleaning and documentation

 

Commercial high volume product

ICOone us also suitable for high volume fully automated manufacturing for commercial products. The type of products can be:

 

• High cost drugs with individually tailored dosing regimen or cold storage need.

• 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 is suitable e.g. 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. The prescription could e.g. be one dose/day for 11 days. In this case a multi-dose device is neither practical nor cost effective.

If the drug has a room temperature stability of one day and therefor 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. This can be the case for e.g. bio-molecules.

 

To have a unit-dose device for traditional LABA, LAMA and ICS can be of great value in situations when all the doses in a multi-dose device are not be used. This can the case in an ambulance or emergency room when the patient needs e.g. 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 would effectively reduce 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 a just to bring one dose not 120. Also the cost is of significance. A new multi-dose device can cost up to 200USD. Many patients will not be willing to leave something worth 200USD unattended in a e.g. gym bag. An ICOone is significantly smaller than a multi-dose device and will easily fit in any pocket and is also significantly cheaper.