Abstract
Water is ubiquitous during pharmaceutical product development and may interact with the drug substance, formulation additives and the drug product in either solvent or vapor form, resulting in several physico-chemical changes of these materials. Such changes may affect properties of the drug substance, additives and formulation, thereby ultimately affecting product performance. An in-depth knowledge of water-solid interactions as well as their underlying mechanism is therefore integral to formulation development to avoid such adverse reactions. This review focuses on the various water-solid interactions encountered during different stages of product development and discusses analytical methodologies to characterize such interactions. General guidelines on how to develop small molecule pharmaceuticals in light of water-mediated changes (physical and chemical) is also provided with recommendations for form screening, manufacturing, packaging and storage conditions.
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