Formulation Principles

The goal of a formulation scientist is to manipulate the properties and environment of the API to optimize its delivery to the target tissue by a specific route of administration and to do so in a manner compatible with large-scale product manufacture. Excipients are added to solubilize, stabilize, modify dissolution rate, improve ease of administration (e.g., swallowing or taste-masking), enable manufacturing (e.g., ensure sufficient compactibility to make tablets, improve powder flow in a manufacturing line), control release rate (immediate vs. prolonged vs. enteric), or inhibit precipitation (Gennaro, 1995). The formulation is key to a compound's biopharmaceutical profile since the composition, dosage form type, manufacturing process, and delivery route are intimately linked to pharmacokinetic results. A PK assessment cannot be complete without inclusion of the relevant formulation parameters to establish the appropriate context.

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