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Overcoming Early Phase Development Challenges & Optimizing Formulations With a Minimal Amount of API

Summary: Finding the appropriate formulation for a drug is challenging, labor-intensive, and requires a significant amount of API in order for it to be tested in a range of solvent vehicles. In the early phase of drug development, it is common to have a limited amount of API available for reasons such as the complexity of its synthetic route or high manufacturing cost. This article explains how suitable modeling methodologies can predict the solubility of drugs in a range of solvents and mixtures and how this approach is particularly applicable to the early stage development of softgel formulations with minimal amount of API.

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