Formulation Concept Design

After completion of preclinical safety and efficacy studies, the next step is to establish the best formulation strategy to accelerate entry into early stage clinical development.

After a comprehensive review of the preformulation and preclinical pharmacokinetic and pharmacodynamic data, we ensure a quality by design approach to formulation concept design based upon your clinical targets and resources available.

Utilising state-of-the-art and scalable technologies in particle processing and drug physical form manipulation, we can screen for and manufacture soluble intermediates which can be incorporated into a variety of final conventional dosage forms for either oral or parenteral drug delivery.

Our capabilities and expertise include:

• Drug substance micronisation
• Particle generation by spray drying (aqueous and organic solutions / suspensions)
• Production of crystalline drug nanosuspensions and redispersable nano-powders ( Lena Nanoceutics™)
• Identification of stabilised amorphous dispersions for immediate, modified and targeted drug release (Prorelease™)
• Oral and parenteral liquid formulations (solutions / suspensions)
• Lyophilised powders for reconstitution
• Granules, pellets and mini-tablets, including enteric coating for modified release applications

Projects usually begin with a feasibility agreement for development of customer-specific solutions using either our proprietary drug delivery technologies or non IP related formulation strategies. We will not force one technology to fit your molecule but will evaluate the most suitable options to give your compound the greatest chance of succeeding in the clinic.