Nanopharm’s utilises an innovative approach for the development of dry powder inhaler (DPI) formulation systems. DPI formulation systems can be formulated as drug-only or carrier-based DPI formulations. Both types of formulations may utilise a range of excipients that include lactose, mannitol, leucine and magnesium stearate. Careful control of the raw material attributes and process parameters are required to enable control, modulation and reproducibility in aerosolised drug delivery performance from a DPI.
Our development approach leverages our scientific understanding of particulate systems and formulation processing operations to design structured formulation systems for DPI formulations. These formulation systems have been successfully applied to a wide variety of APIs from early phase development through to pilot and pivotal scales. Together with our device optimisation team we are able to fully integrate device and formulation. We have successfully applied in formulation development of a range of DPI drug products and have taken formulations through discovery to IND. Our non-proprietary platform has been applied to a wide variety of therapeutic drugs and inhaler devices, to meet the specific target product profiles desired by clients.
In our facilities we have a range of low and high shear blending technologies. In addition, we have an Omnidose TT for filling of capsules and blisters. We can also form and seal blister packs for unit dose and mutli-unit dose DPI drug products. Our capability allows us to work from laboratory and pilot scale. (5 – 1000g).
Our services for DPI development include:
- Physicochemical characterisation and specification setting for raw materials and finished product
- Device selection and optimisation
- API and excipient selection
- Formulation prototyping
- Process development for blend manufacture and powder filling
- Selection of environmental conditions for processing and packaging
- Primary and secondary packaging selection
- Stability investigations