Iconovo has a long-standing experience from development of inhalation products. The company is well equipped to perform both device development and formulations. Iconovo also has agreements with partners in other areas, which ensure a lean and agile development process from idea to realized solution.
Iconovo’s most comprehensive development experience and capability is in dry powder inhalation products. Members of our staff have been involved in the development of over 13 different dry powder inhaler products (with e.g. AstraZeneca) and many different formulation types (micronized, carrier based, engineered) with different API classes.
Iconovo has the facilities and equipment to perform all device and formulation development tasks. When needed, tasks will be performed in co-operation with other suppliers, e.g. injection molding, filling and process machine, automated assembly and prototyping. Iconovo has well-established relationships with leading suppliers of machinery and has experience from supplier selection and supplier management. Iconovo staff has experience from supply chain definitions and technology transfer from R&D to commercial manufacturers.
Also, Iconovo has a fully developed and established quality system. Our staff works according to the Design Control requirements in ISO 13485 including Design history, Design change and Risk management. We also have extensive experience of GMP, GLP, FDA and EMEA regulations and ISO standards.
A dry powder inhalation product comprises two parts; the device and the drug (API) formulation. The Iconovo devices are tested and verified with a model API and a model formulation. They are also verified mechanically according to applicable ISO standards (ISO 20027, 14969 and 14971).
Iconovo offer four different development programmes:
- Development of generic inhalation products, where the products are registered based on therapeutic equivalence.
- Development of new inhalation products based on a generic API with established safety and efficacy. The products are registered as a NDA with reduced safety and efficacy programme.
- Development of new inhalation products based on a NCE. The products are registered as a NDA with full safety and efficacy programme.
- Phase I-II clinical trials using ICOone.