Most solid materials are capable of forming different crystalline structures, known as polymorphic forms. These crystalline structures/polymorphs have different physicochemical properties that might have significant impact on the intended use of the material. It is of immense importance to determine the crystalline structure in order to minimise the risk of transformation into other structures during development or, even worse, after introduction to the market.
At Particle Analytical we perform crystal/polymorph screening in two weeks at a fixed price. Please use the contact form to receive a quote.
The crystalline structure/polymorphic form synthesised during development is not necessarily the most stable structure, implying that a potential risk of transformation into a more stable structure exists.
If this transformation suddenly occurs during development, it will be necessary to perform a full analysis program again: Stability, dissolution, compatibility as the new crystalline structure will have different properties. Furthermore, if the transformation occurs during clinical development or after introduction to the market, this might pose a serious risk to patient safety (read more about transformation of crystalline structure). To minimise this risk, a polymorph screening should always be performed – which is also required according to the ICH guidelines.
“The number of polymorphs is proportional to the time spent searching for them”
i.e. there is not such a thing as a “full” polymorph screening, as only imagination sets limits for possible ways of inducing crystal formation. Click to read about how to crystallise new structures. At Particle Analytical we offer different polymorph screening packages in order to investigate the crystallization possibilities of your material. The philosophy is to deliver the needed information at the right time so you get the most value for your money. We have developed these packages to deliver the most economic setup for evaluation of crystalline structures intended for a development project. We can adjust the packages to fit your needs.
- Basic Package
Designed to find polymorphic forms/crystalline structures of the sample. The tendency to form new crystalline structures, solvates and hydrates in typical processing solvents, and under typical process conditions (e.g. drying, milling and compaction) is investigated.
- Quality and Risk Package
Designed to find the most stable crystalline structure of the API and to define the form for clinical development – which includes analysis of the relative stability/solubility of the identified forms.
- Extended Package
Based on results from previous screening: What would be relevant focus areas from here: Special group of solvents, limited temperature range, thermal analysis, etc.
Contact us to get a quote of a polymorph screening. Basis package result will be delivered within two weeks.