Confarma

Polymorphism screening

Solvias screens substances to identify and characterize new polymorphic forms, hydrates and solvates, and to understand the relationship between the different solid phases.

We offer different study types depending on the development stage of your active ingredient. The project scope will influence the choice of a specific polymorphism screening. Considerations include:

  • Stage of development (pre-clinical, clinical, approved)
  • Special regulatory status (fast track, orphan drug)
  • Desired time to market / potential of drug
  • Already available data, availability of material
  • Required confidence level, risk / benefit assessment
  • Intellectual property aspects

Our flexible study designs and process-relevant planning can be tailored to your needs through a choice of approaches:

Preliminary Study

  • The aim of this study is to identify the thermodynamically stable form and hydrates with a reasonably high probability while keeping the experimental effort limited. One of these forms is generally the optimal one for further development. It is therefore particularly suitable for an early stage of development.

Propensity Screen

  • This is a quick and economical study using our robotic high-throughput screening instrument. It is designed to obtain preliminary information with respect to the propensity of an API to form multiple crystalline forms. This program is very useful to get a first insight into complexity of the polymorphism for a given substance.

Profile Study Type

  • Complete profiling of the polymorphic behaviour can be achieved with this study type. The Micro-HTS study is supplemented with numerous medium-scale crystallization experiments as well as mechanical and thermal experiments with the solid, which gives the highest chance of finding all relevant polymorphic forms. All forms are thoroughly characterized and their relative stabilities evaluated. This offers the best chance for generating intellectual property, minimizing the probability of any unexpected problems with solid forms during development and commercialization. Thorough elucidation of the thermodynamic properties of the various forms also facilitates the crystallization development.

We can also offer customised screens according to your requirements.