Predicting and Selecting Formulations for Drug Discovery and Early Development

摘要

There are numerous tools and technologies for formulation scientists to develop the optimal dosage form for a drug. As with many aspects of science, simply having the tools on hand is not enough. Experience plays a crucial part in the development of a drug, interpretation of data, and application of knowledge appropriately to each challenge that arises to ensure progress through developmental phases. But where does one start? Every molecule is unique in its challenges and hurdles. An experienced formulation scientist knows that there will be a number of characteristics of a molecule that determine the path of development, and whether an oral dosage form is appropriate. Even without access to physical API supply, physicochemical properties such as the molecule's solubility, permeability, and stability can be predicted early on in the development process. It is at this point however, where the ideal scientific solution meets real-world realities. In silico predicted characteristics may significantly diverge from experimental results. There is unlikely to be an ample supply of API material for the formulation team to run every test that they would wish to, and explore every possibility in terms of drug form and appropriate delivery system that a patient can tolerate. These two fundamental decisions however, can have a massive impact on the speed and progression of a development program.