Salt and Polymorphism Screening: Introduction

Screening is vital to ensure optimal bioavailability of the active pharmaceutical ingredient, process handling during manufacturing and suitable shelf-life. Moreover, regulatory agencies worldwide require that, as part of any significant filing, a company demonstrates that it has made a reasonable effort to identify the polymorphs of a drug compound and has checked for polymorph inter-conversions. It follows that screening is a MUST, not an option, when developing any API.

Any polymorph forms not cited in the patent application may be copied by a rival company and manufactured in that form without infringing the cited patent. Thus polymorph screening and salt selection are a high priority for the pharmaceutical industry in protecting its intellectual property and the huge investments made in bringing a novel drug to market.

At Pharmaterials, our Resolve Technologies screening platforms enables  high throughput generation of experimental data without consuming large quantities of materials. It can tightly control a number of manually prepared studies in parallel, to simultaneously test many parameters and drive the production of different drug polymorphs and salt forms. We work with a logical selection of conditions to maximize the value of data, automation to speed processes, but importantly we rely on skilled manual intervention to make the observations that robotic systems would miss.