Development programme

Development Programme

A dry powder inhalation product comprises two parts; the device and the drug (API) formulation. ICONOVO provides proprietary, modern and robust devices. The ICONOVO devices are tested and verified with a model API and a model formulation. It is also verified mechanically according to applicable ISO standards (ISO 2027, 14969 and 14971).

 

To achieve the desired features and product performance, a development programme together with the client is required. During the development, the device is adapted for the specific needs and requirement of the client. The exterior is designed to fit with the clients brand identity and intended patient group. The device is also tuned to give the intended dose and performance. The device development work is carried out in parallel with the development of the drug formulation. The drug formulation can either be developed by the client or by ICONOVO’s partners should the client prefer that.

 

There are four different types of development programmes:

• Development of a generic inhalation product. The product is registered based on therapeutic equivalence.

• Development of a new inhalation product based on a generic API with established safety and efficacy. The product is registered

as a NDA with reduced safety and efficacy programme

• Development of a new inhalation product based on a NCE. The product is registered as a NDA with full safety and efficacy programme

• Phase I-II clinical trials using ICOone

 

Generic inhalation product

When developing a generic product, the main objective is to prove therapeutic equivalence to the originator product. According to the European guidance CPMP/EWP/4151/00 rev 1, the equivalence includes a general equivalence i.e. API equivalence, formulation equivalence and device equivalence. The product must also demonstrate either In-Vitro equivalence, PK-equivalence or PD-equivalence.

 

The development programme therefore starts with a selection of a device that can be made equivalent to the originator. If the originator device is e.g. a capsule device ICOcap is selected and a requirement specification is generated to detail how the device must be adapted to match the originator. In parallel with this the drug formulation is developed by either the client or by an ICONOVO partner. The figure below shows a high level description of a development process. All ICONOVO development programmes start by developing a detailed project plan together with the client. The project plan includes all key activities, deliverables, acceptance criteria and milestones.

The ICONOVO activities above are either performed in-house or together with partners or suppliers.

 

Generic API

When developing a product based on a generic API, the target and mechanism of the API are also well known. The efficacy and safety have also already been investigated and proven. A reduced clinical programme may therefore be used. The objective of this development is to develop a product with optimized pharmaceutical and clinical performance.

 

The development programme starts with a selection of an appropriate device. In this case the device can be selected b starts with needed performance, dose size, market, patient population brand identity, competitiveness etc.

 

After selecting a device, a requirement specification is generated to detail how the device should be adapted to meet the client’s needs. In parallel with this, the drug formulation is developed by either the client or by an ICONOVO partner. The figure below shows a high level description of a development process. All ICONOVO development programmes start by developing a detailed project plan together with the client. The project plan includes all key activities, deliverables, acceptance criteria and milestones.

The ICONOVO activities above are either performed in-house or together with partners or suppliers.

 

NCE

When developing a product based on an NCE, a full development programme must be executed. A full clinical programme including Phase I, Phase II and Phase III must be carried out. The objective of this development is to develop a product with optimized pharmaceutical and clinical performance.

 

The first part of the development is done using ICOone. ICOone is suitable for Phase I trials to provide first dose size indications. As the Phase I is done using the same type of formulation, the data will be more predictive and provide a valuable rational in future decisions about device and formulation selection. In parallel with the adaptation of ICOone and the development of the manual or semi-automated manufacturing equipment the first drug formulation is developed by the client or ICONOVO’S partners.

 

In development for Phase II, the device is selected and adapted and optimized for the drug formulation. In this case the device can be selected based on the needed performance, dose size, market, patient population brand identity, competitiveness etc. At this atge the formulation is developed and optimized to the selected device. The Phase II is performed using injection molded devices and semi-automated manufacturing and filling equipment. Phase III performed using the commercial manufacturing and processes.

 

After selecting a device, a requirement specification is generated to detail how the device should be adapted to meet the client’s needs. In parallel with this the drug formulation is developed by either the client or by an ICONOVO partner. The figure below shows a high level description of a development process. All ICONOVO development programmes start by developing a detailed project plan together with the client. The project plan includes all key activities, deliverables, acceptance criteria and milestones.

 

The ICONOVO activities above are either performed in-house or together with partners or suppliers.

 

Phase I clinical trials using ICOone

ICOone is suitable for Phase I trials to provide first dose size indications. As the Phase I is done using the same type of formulation as in the intended commercial product, the data will be more predictive and provide a valuable rational in future decisions about device and formulation selection. In parallel with the adaptation of ICOone and the manufacturing equipment the first drug formulation is developed by the client or ICONOVO’S partners.

 

The ICONOVO activities above are either performed in-house or together with partners or suppliers.