Polymorph screening and characterization: Selecting the optimal form for development

ANYL 220

Rolf Hilfiker, rolf.hilfiker@SOLVIAS.com, Head of Department Solid State Development, Solvias AG, WKL-127.508, Klybeckstrasse 191, Basel, CH-4002, Switzerland
Solid-state properties have a huge practical and commercial impact on active substances all the way from research to manufacture of the final product. The search for, and more importantly the selection of the optimal solid form (salt, co-crystal, polymorph) is closely linked to the intended application of the drug substance and to the final drug product. Good timing of solid-state development activities ranging from first screenings to crystallization optimization is becoming more and more important in view that CMC failures are one of the most important reasons for delays in drug development. An integrated approach to solid-state development is essential for successful development of a drug substance. The identification of all relevant solid forms, i.e. polymorph screening, is often one of the most laborious and time-consuming steps, and it is therefore very attractive to speed up that process using high throughput methods. In this presentation the development of a powerful high throughput screening system using Raman microscopy as a detection method for the polymorphic form will be discussed. We will highlight important issues in connection with efficient high throughput screening and will discuss practical examples.