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No matter how much potential a molecule exhibits for treating a disease or condition, if it doesn’t reach its biological destination, efficacy is weakened. A number of factors influence bioavailability, including the extent of absorption in the gastrointestinal tract, the type of formulation and even the physical characteristics of the patient.
Poor solubility is among the primary causes of low bioavailability for orally administered drugs. Because over 85% of pharmaceuticals are administered orally, improving solubility is a top priority among drug developers.
Converting a crystalline form of a drug to an Amorphous Solid Dispersion (ASD) has improved bioavailability and solubility for many products; to date, the FDA has approved 29 drugs based on ASDs. However, because amorphous forms are thermodynamically unstable, the materials and technologies that enable ASD formation, the subsequent dosage form design and the methods of characterization of these systems all play a critical role in defining quality, stability, processability and performance.
This white paper describes a successful approach for preparing, screening, characterizing and dosing ASDs in preclinical and early clinical development from “mg” to “g” scale.
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