Inhalation formulation development
Inhalation formulation development
MVIC offers streamlined, cost-effective and high-quality performed inhalation formulation development packages. Our offer extends to customers requiring cutting edge input for problem solving, as well as customers without resources to carry out a development program by themselves.
The extent and design of the development program is elaborated in collaboration with the customer. The combined experience from key MVIC companies allows us to lead and assist in all aspects of inhalation product development, from an early pre-clinical and medicinal chemistry phase via CMC with early development and scale-up to phase I and phase II.
For generic product development, MVIC has extensive experience in reverse engineering, being an important initial activity. Throughout the development, the regulatory landscape and requirements will be considered.
COMPREHENSIVE COMPETENCE AND EXPERIENCE ARE INTEGRATED IN OUR OFFER
Formulation development is a complex operation that requires specialist competence in several areas. Working with MVIC means that you have all these skills gathered within one partner. The following competencies for a seamless development of new formulations are included when collaborating with MVIC.
FORMULATION DESIGN, PROCESSING AND SCALE-UP
Compounds intended for inhalation need to be processed with great care, using specialised equipment and environmental conditions (like controlled RH) and fulfilling harsh quality attributes. Within MVIC, we have the right specialist competence to design and carry out various formulation processes with ensured high-quality in every step including size reduction methods for compounds and various mixing methods. Formulation design can include e.g. addition of micronized lactose and/or a ternary agent as magnesium stearate.
INHALER TESTING
MVIC offers state-of-the-art inhaler performance testing including assessment of fine particle dose and delivered dose through the development process to ensure that the impact of any formulation changes is monitored. This enables fulfilment of the project end points and prediction of outcome in Bioequivalence and pharmacokinetic studies.
PROJECT MANAGEMENT
New prerequisites, project objectives or revised business cases require a smooth and swift interaction between customer and service provider. Our dedicated MVIC project managers will engage in the initial design and scope of the program and drive the project from start to finalisation. All work within MVIC will be coordinated by the project manager who will be the customer's most important interface with MVIC.
SOLID STATE CHARACTERISATION
MVIC performs fundamental characterisation of critical inherent and induced material properties all the way from raw material to the final processed formulations.
