The search for a stable polymorph of your drug substance (DS) is a key component of your drug development program. Polymorphs are crystalline materials that have the same chemical composition but different molecular packing. Different polymorphs may differ greatly in terms of solubility, dissolution, hygroscopicity, hardness, compressibility or flow properties.
Poor understanding of DS solid-state properties may lead to unintended and unnoticed solid form conversions during processing or storage, and ultimately affect manufacturability, bioavailability and clinical outcome. Another commonly encountered problem is the use of different polymorphic forms during clinical development, which may require bridging studies to demonstrate to the regulatory authorities that the clinical trial results are valid. It is therefore essential to study DS solid-state properties sooner rather than later. However, discharging more risk than necessary by conducting extensive screens too early can add up to substantial unwarranted costs. Many of our customers struggle with this dilemma, and we often get the question: “When should we invest in a solid-state screening program?”.
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