Find a research partner or other support function connected to the large scale research facilities, ESS & MAX IV. If you are not ready or not sure what you are looking for start here.
Center Consultation & CRO Laboratory & Lab instruments Large-scale Infrastructure Projects & Networks Research Institute Support organisation University
Clear All
Feedback

Send us your feedback

Here you can sen us feedback on the Maxess-website. Please describe the problem or what’s missing in a clear way, and on what page you found the issue. Thank you so much for your help!

    Investigating tablets

    Magle Chemoswed is a Malmö-based contract development and manufacturing organization that supports companies in the pharmaceutical and medical device industry. In collaboration with SmiLe Incubator and MAX IV Laboratory they have explored the use of synchrotron powder diffraction to find answers to a challenging customer request.

    Optimizing pharmaceutical manufacturing

    When manufacturing a pharmaceutical product, the active pharmaceutical ingredient (API) can frequently exist in different crystalline forms other than the desired one, so called polymorphs. In order to optimize the manufacturing process there is a need to accurately measure the amount of wanted and unwanted polymorphs, even at very low concentrations, in the final product. X-ray powder diffraction (XRPD) is a technique that can be applied to perform such measurements. MagleChemoswed has both extensive experience and in-house capabilities to perform such determinations.

    Lost in the noise

    In lab scale equipment the detection limit pose a challenge with samples with very low concentrations of the API. It is increasingly difficult to detect the different polymorphs with lab-scale X-ray powder diffraction equipment at <30% concentrations of the active ingredient.

    Considering that many pharmaceutical formulations have drug loads well below 10%, this is an important difference between lab scale equipment and large-scale research infrastructures such as the MAX IV synchrotron in Lund. Synchrotron based techniques can be especially useful in cases where you want to study fast processes or measure low concentrations in your sample. The DanMAX beamline at MAX IV has a powder diffraction instrument with fast and low-noise detection.

    The Magle Chemoswed and MAX IV beam line staff attending to the experiement and data output at DanMAX.

    “Based on synchrotron data, the unwanted polymorph can be confirmed in all samples, and a clear ranking for all seven samples can be made.

    Martin Lindsjö, Magle Chemoswed

    Different tools for the job

    After running the experiment at DanMAX, on powdered material from the tablets, it was clear that the signal-to-noise, and consequently the detection capabilities at DanMAX, differed significantly from the company’s in-house laboratory XRPD equipment. The obtained results provided the research team at Magle Chemoswed with significantly greater insight and accuracy regarding the distribution of polymorphs in the tablets and then ultimately the ability to supply the customer with conclusive results

    Overlay of lab instrument (left) and DanMAX (right) data for the seven tablet samples.

    Comparing processes

    Besides the specific client question of relative concentrations of API polymorphs in the tablet samples, Magle Chemoswed also learnt how their own in-house XRPD equipment compare to MAX IV and the DanMAX beamline. With this knowledge they can now better tailor their offers to future customers and will be able to include hitherto unattainable levels of accuracy and detectability when needed.

    Contact Partners

    Smile Incubator
    Per Brunmark
    Facilitator
    +46 768 504427
    per@smileincubator.life
    DanMAX
    Magnus Larsson
    Head of Industrial Relations
    +46-725-546 309
    magnus.larsson@maxiv.se

    Pharma and Biotechnology

    Case Details

    Jan 2022 - Sep 2022

      MagleChemoswed

    Smile IncubatorDanMAX