Polymorph screening in two weeks at fixed price

Polymorph Screening Packages: Screening + report in two weeks at fixed price 

At Particle Analytical we have developed a slim and scientifically well-founded polymorph screening procedure: A screening that minimizes the risk that the crystal form in development will suddenly transform into another form. Such a transformation could be quite harmful to the patient – and very costly to the company.

Polymorph screening: Why?

According to ICH guideline Q6A, a polymorph screening is required in order to assure that you have your product under control: Transformation of your active ingredient into another crystal form would lead to a change in processing behavior, stability, solubility and dissolution rate – thus a potential risk to the patient (read more).Patient safety

The requirement for performing polymorph screening is described in a decision tree  (ICH Q6A decision tree 4)

A transformation between crystal forms would be very costly, as it usually would require a full repetition of your development program in relation to stability and clinical trials etc. Furthermore, the screening might reveal new polymorphic forms and solvates that should be known in relation to protecting IPR.

Polymorph screening – How?

However, it is not specified HOW you should perform this screening. As only imagination sets the limits for the possible screening conditions, there is in reality no “natural ending point” for such a screening. You can test an unlimited number of solvents/mixtures at various temperatures, nucleation rates etc.

Then, what can you achieve in two weeks?  Of course you cannot test all possible crystallization possibilities within this time frame – but using a scientifically well founded set-up you might be able to catch the most “probable structures”. The goal of our screening procedure is:

  • To examine the most “common risks” that a compound would experience during processing: Changes in temperature, humidity, pressure and precipitation from different solvents.
  • To “stress” the system, leading to crystallization at different concentrations and nucleation rates, which often leads to formation of new crystalline forms. We have developed special experimental procedures where we are able to “freeze” the system under various conditions – making it possible to trap meta-stable forms (contact us at info@particle.dk if you want to know more about these procedures).

Our polymorph screening set up has been tested for a couple of well known compounds. For the compound acyclovir we found 5 of the 6 forms already known from literature using the slim-line screening.

  • This 2-week screening is “an assurance” that minimizes the risk that the crystal form in development will suddenly transform into another form.

Please contact us at info@particle.dk to get more information.

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