Polymorphism Screening

The aim of a polymorphism screening is to search for, to identify and to characterize new polymorphic forms, hydrates and solvates of a substance, and to understand the relationship between the different solid phases. To reliably search for relevant polymorphs, solvates and hydrates, a systematic and smart planning is essential.

Depending on the stage of development of the active ingredient and on the specific details to be investigated, different study types are available. The scope of a study will influence the choice for a specific polymorphism screening. The following points should be considered:

  • 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

Preliminary / Focused Study Type

A first indication of the ability of a substance to show polymorphism is obtained by using the preliminary study type. It provides a reasonable probability of identifying the stable form at room temperature. It is suited as a preliminary type investigation or as a study to investigate specific details of a polymorphic situation. For instance, the focused study type is recommended for, as an example, a hydrate screen and the thermodynamic assessment as a function of water activity.

Micro-HTS

Microscopic screening is used as a tool to provide leads from a large variety of solvent and crystallization conditions. Our robust technology provides the maximum information with the minimum amount of your valuable substance. The Micro-HTS study type is typically the first phase of a complete profiling, see profile study type.

Standard Study Type

A sound description of the ability of a substance to show polymorphism is obtained by using the Standard study type. It provides a high probability of identifying the stable form at room temperature and a reasonable probability of identifying the most relevant forms. Characterization of new forms leads to the understanding of the polymorph landscape.

Profile Study Type

For a complete profiling of the polymorphic behavior of a compound, the Profile study type is the best. It consists of the Micro-HTS study type, supplemented by crystallization experiments not accessible by HTS. The thorough characterization of all relevant new forms will provide the complete transformation scheme and all relevant transformations. This study type gives the highest probability of finding all relevant polymorphic forms.

Flexible study designs and process-relevant planning allows to integrate customers’ needs in any study type.