The Developability Classification System as a Guide in Drug Formulation

• Poor solubility is a critical challenge to be overcome during drug formulation
• The root-cause of low solubility can be understood using the developability classification system
• This system can allow a more targeted and cost-effective development of formulations for oral solid dosage forms
• For dissolution limited compounds, incorporation of dissolution enhancers can overcome low solubility
• For solubility limited compounds, amorphous solid dispersions can overcome low solubility

The developability classification system (DCS) was proposed as a modification of the BCS to assist in formulation of poorly soluble compounds. The DCS introduced two new compound categories: dissolution limited (DCS IIa) and solubility limited (DCS IIb). For DCS IIa molecules, particle size reduction and wetting agents can be considered. For DCS IIb compounds, solid state modification can be utilized. Tune in to our webinar on the developability classification system to learn more about this emerging field of research, which is allows more targeted and optimized formulation development of poorly soluble compounds.

Dr Daniel Joseph Price, Director – Head of Excipients Solid Application , MilliporeSigma