Polymers and API Crystallization: from Controlling Form and Habit to ASD



Solid materials can be either amorphous or crystalline, and this influences their properties significantly. Some materials, such as polymers, are generally amorphous in nature due to their long chain length, while other materials, such as organic small molecules, tend to crystallize in a variety of polymorphs and solid forms. Although due to this, the two are usually regarded as separate scientific fields, the same fundamental intermolecular forces such as hydrogen bonds apply in both cases: polymers and small molecules. The relationship between crystalline and amorphous phases, between polymers and small-molecule APIs, has been a key topic of interest in pharmaceutical processes and formulation. Understanding this properly can lead to formulations as amorphous solid dispersions (ASDs), through the successful inhibition of crystallization, to designing API specific heterogenous nucleation systems and also towards controlling API solid form and crystal habit.

This presentation is brought to you by Dr. Dan Dumitrescu and briefly touches on a few of the recent advances describing this interplay between amorphous polymers and crystalline small-molecules, and how to perform some of the experiments required for understanding complex systems such as amorphous solid dispersions (ASDs). These examples are intended to serve as ideas on how to approach API crystallization in the presence of polymers and best use this for attaining the desired pharmaceutical product properties.

Watch the recording of the presentation below.