Advisory Services

We bring inhalation expertise to your business

The Iconovo team has extensive experience and expertise in developing inhalation products. We not only develop ready-to-use inhalation products for our customers. To support your development of inhaled products we also offer senior advisory services and project management. As a first step, we would assess your API’s developability to an inhaled product and give advice on the next steps.

Pre-formulation and Biopharmaceutics studies

In a pre-formulation and biopharmaceutical study, we investigate the physicochemical properties of your API. These affect its developability to an effective, stable, inhalable, and reliable dry powder formulation. Based on the results, we give advice on e.g. animal studies and a formulation strategy.

Feasibility studies

We offer to do feasibility studies on your API to de-risk your future product development program. In a feasibility study, we manufacture a few small-scale formulation batches of your API and fill these in our inhalers, typically with various dose sizes. We study dosing and aerosolization properties and stability and give advice on the next steps.

We can design animal PK studies with inhaled administration to determine the potential advantage of inhaled vs. peroral administration. Iconovo can prepare formulations for animal studies and offer to perform animal PK studies through our partners.

Clinical trial support

Running clinical trials with products for inhalation has its own special challenges, especially when considering comparative PK studies with other inhalation products. We have significant understanding of these challenges and the best way to address them.

In pre-clinical phase, we offer to determine in vitro-in vivo correlations (IVIVC) to support product design targets and specifications. The batch selection for the pilot PK studies can be based on the IVIVC model. This increases the chance of successful PK studies, which reduces time to market for your product.

Through our partners, we can offer manufacturing and analysis of clinical trial material for pilot PK studies.

Iconovo offer to take on the role of sponsor for your pilot PK studies.

Manufacturing partners

Iconovo has an extensive network of CMOs with skills and ability to manufacture an inhaled medicine. This includes injection molding of device components, manufacturing and filling of formulation, and final assembly of the finished product.

Advisory Services

We bring inhalation expertise to your business

Pre-formulation and Biopharmaceutics studies

Feasibility studies

Clinical trial support

Manufacturing partners

Possessing a unique combination

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