Comprehensive product development
Achieving a perfect formulation involves controlling the powder’s physicochemical properties, particle size, shape, surface area and morphology. For optimal efficacy, drug administration must be reliable, reproducible and convenient.
At Iconovo, we have extensive experience and capability in designing 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.
We also have the facilities and equipment to perform all device and formulation development tasks. When needed, tasks such as injection molding, filling, automated assembly and prototyping can be performed in co-operation with other suppliers.
Four product development programs
We offer four different development programs:
- 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 program
- Development of new inhalation products based on a NCE. The products are registered as a NDA with full safety and efficacy program
- Phase I-II clinical trials using ICOone
Established quality system
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).
Do you want to know how we can help you develop a tailor-made inhalation solution? Contact us today!