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Amorphous Solid Dispersions

As always, APIs with poor aqueous solubility have been a big problem in development of new drug products. Because the aqueous solubility of the stable polymorph can be critically low, a meta-stable crystalline form or an amorphous form may be selected for future development. One attractive solution is the use of an amorphous form of the drug substance rather than a meta-stable polymorph, provided that the glass transition temperature of the amorphous form is sufficiently high.

The amorphous phases are much more soluble than their crystalline counterparts, and can often be formulated to be physically and chemically stable throughout the shelf life of the drug product, by creating an amorphous solid dispersion (ASD) with a pharmaceutically acceptable polymer. In any case, irrespective of whether a crystalline or a meta-stable form is to be developed, very careful kinetic stability studies are required. For amorphous solids, particular attention has to be paid to the lowering of the glass transition temperature due to humidity.

At TeraCrystal, we are able to strictly monitor the processing of drug substances with regards to the generation of amorphous material, as well obtain a comprehensive understanding of its physical and chemical stability. The stability of an amorphous phase is investigated by solid state NMR and RAMAN spectroscopy techniques and we are able to evaluate the conditions of conversion into the crystalline phase.

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