ICOpre

ICOpre

is a pre-metered inhaler with every individual dose filled and sealed during manufacturing. ICOpreTM is based on a novel proprietary technology, patents pending. ICOpre is designed to have a function, handling and performance equivalent to branded pre-metered inhalers on the market. ICOpre is designed to be robust and easy to manufacture and assemble in a high volume fully automated process.

 

ICOpre features

• Disposable inhalation flow driven pre-metered dry powder inhaler

• Carrier based formulation

• Factory pre-filled drug formulation in sealed cavities

• 30 or 60 doses @ 10-15mg

• Active humidity protection with integrated desiccant

• No Al over wrap

• User sequence of device: Open - Load – Inhale - Close

• Exact dose counter showing each dose.

• No risk of multiple dosing by design

• Suitable for flows between 30 and 90l/min

• Extending mouthpiece

• Built-in mouthpiece cover

• Tactile/audio feedback when loading a dose

• Hygienic and easy to clean

• Flat standing surface

• Filling using conventional equipment

• Suitable for fully automated assembly and low cost manufacturing

 

ICOpre can be designed to be bioequivalent to products on the market according to the EMA therapeutic equivalence for DPI, CPMP/EWP/4151/00 rev 1. In this case the ICOpre is designed to be equivalent in terms of device and performance both In-vitro and In-vivo. The features above are selected to match the originator device.

 

ICOpre can also be optimized to give optimal performance for a given drug formulation. This option is suitable for NCE or products not intended to be registered as a generic drug. The features above are selected to provide optimal performance and the best user experience.

 

Formulations

ICOres is designed for a carrier based formulation, which is a well proven formulation type. A carrier based formulation is the formulation most extensively used in inhalation products and is inherently very robust and uses conventional manufacturing equipment.

 

Performance testing and optimization

During optimization for a specific drug formulation the performance will be assessed in terms of:

• Metered dose, mg

• Metered dose uniformity, MDU %RSD

• Delivered dose@4kPa, DD mg

• Delivered dose uniformity@4kPa, DDU %RSD

• Fine particle dose uniformity@4kPa, FPD %RSD

• Fine particle fraction@4kPa of DD, FPF %

• FPD low kPa and high kPa vs. FPD, %

• FPD at different orientations, %

• FPD at different RH, %

• Retention@4kPa of MD, %

• Emptying time and volume, s and L

 

Customized exterior design

The exterior of ICOpre can be in many different shapes and colours. The exterior can be adapted to meet the specific client requirements in terms of brand identification, drug identification etc.

 

Together with our partners, ICONOVO can offer a comprehensive service package including device, formulation development, analytical testing, documentation etc. together with a complete supply chain