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 evaluation. It is estimated that over 70 % of drugs in development have low solubility characteristics (< 0.1 mg / mL), resulting in the need for enabling drug delivery technologies and/or specialist formulation strategies to achieve adequate drug solubility / dissolution and bioavailability.

After a comprehensive review of the preformulation and preclinical pharmacokinetic / 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 stable soluble 'intermediates' which can be incorporated into a variety of final conventional dosage forms suitable for either oral, parenteral or pulmonary drug delivery.

Our capabilities and expertise include:

• Dry micronised powders (air-jet milling or ball milling) 
• Particle generation by spray drying (aqueous and organic solutions / suspensions)
• Production of crystalline drug nanosuspensions and fast dispersing nano-powders (see Lena Nanoceutics™) 
• Manufacture of stabilised amorphous dispersions for immediate, modified and targeted drug release (see Prorelease™)
• Preparation of fast dispersing drug / polymer nano-colloids for solubility and dissolution enhancement (see Solumer™)
• Solubilised liquid formulations (oral and parenteral solutions)
• Suspensions
• Lyophilised powders for reconstitution 
• Granules, pellets and mini-tablets, including enteric coating capabilities for modified / sustained release applications (see Duocoat)

At this development stage, projects are conducted on a contract fee for service basis only. Studies 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.