Early Formulation (Pre-formulation) Screening Services
Addressing Formulation Issues Early
Poor solubility / low bioavailability are significant issues during drug discovery and development. It is reported that up to 75% of compounds currently under development are poorly water-soluble, with this figure rising to 90% for new chemical entities. This is of concern because solubility issues can result in the generation of misleading or inaccurate data, result in project delays and ultimately increase the overall cost of a project. Therefore, it is important to understand and address solubility issues early with appropriate formulation strategies.
Our parent company, Evotec, has considerable expertise in formulation and can expedite early phase formulation development from discovery to clinic. This spans from early formulation assessment through to CMC (Chemistry, Manufacturing and Control) capabilities with support for drug substance and drug product development and GMP manufacturing for Phase I to III clinical development programs.
Evotec’s early formulation group based in the UK is able to tackle your formulation problems during drug discovery and support the selection of prototypes for clinical phase, using small amounts of compound. The group has a wide range of capabilities and expertise to support your project.
Design of complex dose-vehicles in support of toxicological investigations
Film coating (pellets, tablets, capsules) and drug layering
Hot melt extrusion
Micronisation (ball / air jet milling)
Emulsion development (SMEDDs/ SEDDs)
Analytical testing- lipolysis tests, in vitro dissolution tests using dynamic dissolution methods (first CRO in the world)
Ability to work on formulations planned for any route of administration (oral, pulmonary, dermal/transdermal, intra-ocular, parental)
Solid state characterisation ( SEM, XRPD, DVS, PSD, mDSC) and pH solubility profiling