Let the Molecule Decide
Formulation techniques and technologies can easily become more habit than science, but a single technology does not work for all compounds. Each new drug is unique and deserves a fresh approach to formulation.
Stephen Tindal and Ronak Savla |
Every molecule – large and small – has a structure that drives its physicochemical and biopharmaceutical characteristics – and its potential as an active ingredient. The smoothest path to market lies in understanding your molecule’s characteristics and applying strategies to overcome any deficiencies as early as possible. With sound expertise and judgment, physicochemical properties, such as the molecule’s solubility, permeability, and stability, can be evaluated at the early stages of development – and from there, you can make decisions about the best formulation approach and what the molecule needs to help it become a commercial success.
Of all the decisions made at the early preclinical stages of oral drug development, there are two that are perhaps the most fundamental. The first is to select the nature of the potential API and its form (salt and polymorph), which requires proper physical characterization and optimization of the API manufacturing process. The second is to select an appropriate drug delivery system, with improved solubility and bioavailability usually being key criteria.
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