Highlights

Crystallisation by Design

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venerdì 26 febbraio 2016

The development of new pharmaceutical products is often hindered by difficulties in obtaining the drug as a stable crystalline solid. Since 2005 the mission of PolyCrystalLine is to support our clients during drug development, helping them to reduce batch failure, avoiding costly crystallisation issues and overall offering greater confidence in drug quality during manufacturing.

In order to achieve this goal we have perfected and merged two different sides of crystallisation:

  • Crystal-oriented synthetic strategies (prepare the building blocks): Crystal syntheses do not differ from classical chemical experiments in which molecules are modelled, synthetic routes devised, products characterized and their properties evaluated.
  • Understand and control crystal properties (arrange the building blocks in a desired way): It is essential to understand why a crystallization process leads to one crystal form or another, and whether these forms interconvert, in order to be able to reproduce the experimental conditions and product selection on a laboratory or plant scale.

Inspired by the principles of FDA’s Quality by Design we have defined our method as “Crystallisation by Design”. Proper implementation of Crystallisation by Design can provide the following key benefits for pharmaceutical industries:

  • Proactive approach to drug development to quickly get to the root cause and resolution of any issue related to crystal form
  • Better understanding and control of solid form properties of APIs (crystal form, PSD, physical and chemical stability, etc.) and how they affect the final drug product
  • Improve the manufacturing efficiency and product quality

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