STREAMLINED AND COST-EFFECTIVE WET FORMULATION DEVELOPMENT FOR NEBULIZERS, NASAL AND SOFT MIST INHALER (SMI) PRODUCTS
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Specialised MVIC skills that are integrated in the development program
Project target
Key initial activity is to clearly define the target for the project. Understanding of device performance and influence from the formulation is key input to the formulation development. MVIC has both a long experience related to liquid products and understanding of its preclinical and clinical implications. MVIC can also do various generic product developments.
Analytical method development
MVIC performs analytical method development for material characterization and testing for de-engineering. We also perform specific analytical method development for aerosol instrument with chemical assays and method validation.
Formulation development
We develop formulations considering dose, solubility, selection of excipients, pH, tonicity etc. We also perform tailor-made de-engineering of complex formulations and excipients as a basis for generic product development.
Product testing
A genuine device performance testing through the development process is vital so that the impact of formulation changes is monitored. This enables fulfilment of the project end points and prediction of outcome in e.g. BE PK studies. At MVIC we can offer a wide range of analysis methods and techniques to ensure that the end product meets the predetermined targets.
Project Management
Our dedicated MVIC project manager will engage in the initial design and scope of the program and will drive the project from start to finalisation. The project manager will coordinate the work within MVIC and will be the main contact between the customer and MVIC.