Defining and Addressing Solid-State Risks

Pharmaceutical Development: Defining & Addressing Solid-State Risks After the Proof-of-Concept Stage of Pharmaceutical Development

Author: Editor, Drug Delivery & Development, Joanna Bis Ph.D., David Igo, Ph.D.

Summary: Selection of an appropriate solid-state form (non-solvated or hydrated/solvated parent, salt, or cocrystal) is one of the most important decisions in the development of a small-molecule API due to the inherent link between the physico-chemical properties of the solid-state form and factors important to the success of its commercialization.1,2 Although the significance of this decision is generally well appreciated across the pharmaceutical industry, strategies can vary widely between different drug development programs as companies attempt to balance the tension between quality, speed, cost, and risks.

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