Characterizing drug substance properties early can optimize drug development formulation

October 23, 2023

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This article examines the following key points:

1 - Early drug substance (DS) characterization is crucial as changes in the DS process can affect the drug product (DP), including purity, potency, and dissolution rate.

2 - Traditional separate DS and DP development approaches hinder effective collaboration between teams, necessitating an integrated approach for efficiency.

3 - Early systematic DS characterization can anticipate potential formulation issues, preventing problems like DP degradation due to inadequate initial testing.

4 - Essential DS properties for effective formulation include solubility, stability, particle characteristics, and compressibility.

5 - Strong communication between DS chemists and DP formulators is vital to identify critical changes and manage risks during development of complex molecules.