Taking a Byte out of Formulation Development
With so much technology at our disposal, it’s time to get smart in formulation by adopting in silico approaches.
Ronak Savla, Julien Meissonnier, Jan Neelissen | | Longer Read
There are a number of technological advances that have helped drive improvements in small-molecule drug design – the sequencing of the human genome, increases in computing power, and high-throughput screening, to name just a few. Receptors and proteins that were once seen as undruggable at the cellular and sub-cellular levels have suddenly become more targetable. But drugs that are ligands for these newer targets are larger and more lipophilic (poorly soluble) than those in the past, introducing more biopharmaceutical and pharmacokinetic (PK) hurdles to optimal oral absorption and bioavailability.
Besides redesigning the chemical structure of the drug molecule, formulation development can help address these challenges. The primary goal of formulation development is to improve drug efficacy and safety by improving solubility and modifying the PK of the drug molecule, particularly absorption.
However, drug formulation is largely an empirical method that requires considerable time, material, and labor. Increasingly, companies want a fast “go/no-go” decision before spending more time and resources on a project. And ideally you want to get the decision right first time. Harnessing the power of in silico modeling and simulation technologies, along with more physiologically relevant, high-quality in vitro studies, should lead to faster formulation development, less attrition, reduced costs, and – most importantly – better treatments for patients. Modeling approaches can identify and predict oral absorption risks or liability factors, so that formulators can address the most pressing issues.
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