The use of NIR and Raman Spectroscopy to Predict the Solid-State Form of Medicines made using SLS 3D Printing

Written by Patricija Januskaite

Today, orally administered medicines are the most preferred route of administration, with high acceptability in patients and low costs. However, 40% of these products have low water solubility and therefore require the use of various technologies to formulate new molecules into the amorphous form via solid amorphous dispersions (SADs). SADs contain no long-range structural order and thus dissolve in media more rapidly, improving bioavailability. 3D printing, especially selective laser sintering (SLS), has recently emerged as a novel method for the rapid, single-step production of SADs.

The evaluation of amorphous/crystalline content in dosage forms plays an important role in the pharmaceutical sector, with both x-ray powder diffraction and differential scanning calorimetry being the ‘gold standard’. However, they each come with their own limitations and are unsuitable for the real-time analysis of 3D printed products. In collaboration with Pfizer Ltd., both near-infrared (NIR) and Raman spectroscopy were compared as alternative, non-destructive methods of quantifying amorphous content in SLS 3D printed itraconazole Printlets (3D printed tablets).

It was found that SLS 3D printing is capable of successfully producing SADs of poorly soluble drugs such as itraconazole in combination with hydroxypropyl cellulose (HPC) polymer. Based on the calibration models developed, it was found that both NIR and Raman spectroscopy have the potential to accurately quantify amorphous content in 3D printed formulations, as a non-destructive quality control measure at the point-of-care.

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