Quotient featured in Drug Development & Delivery's Solubility Special Feature Report
Quotient's Vice President of Drug Development Sciences, Dr Sarah Stevens, discusses our integrated approach to accelerating the development of poorly soluble compounds in Drug Development & Delivery's Special Feature article entitled: "Improving Bioavailability & Solubility: Each Molecule Is Unique"
Quotient Sciences: Integrated Approach Accelerates Drug Development
Solving bioavailability and solubility challenges to support successful drug delivery is an ever-enduring challenge (and opportunity) for pharmaceutical formulation scientists. Along with well-established approaches to improving each, there are many emerging platform technologies, providing options in the toolbox. In many ways, though, availability of such formulation and process technology approaches does not present the primary barrier to improving universal solubility and bioavailability challenges. Instead, a key challenge is the continued lack of predictive, clinically relevant models to guide formulation selection early enough in the development process – such that money and time are not unnecessarily expended, and avoidable risks not taken.
“With many examples of misleading nonclinical and in vitro predictability out there, robust predictive models would afford the ability to understand and adapt for successful clinical outcomes from the outset,” says Dr. Sarah Stevens, Vice President of Drug Development Sciences at Quotient Sciences. “Quotient Sciences embodies science-led decision making, therefore not relying simply on potentially unreliable predictive models. A combination of unique development approaches provides the most expeditious means to improve potential bioavailability and solubility challenges.”
Quotient, she says, deploys technologies such as particle size reduction, lipid-based formulation mechanisms, HME, SDD, etc., but more pertinently, drives early formulation selection by cutting through industry silos and integrating across a range of capabilities to accelerate the drug development process. One example is Quotient’s Translational Pharmaceutics® platform, which integrates drug product manufacturing and clinical testing and ensures a continuum among lead compound selection, formulation development, and clinical assessments. “This reduces formulation development timelines and money, and mitigates risk in the development pathway by utilizing real-time clinical data to improve bioavailability and solubility,” says Dr. Stevens.
This integrated approach requires finely tuned project management and processes to ensure the most expeditious path to evaluate new molecules and formulations in the clinic. Prior to any clinical assessment, Quotient deploys a number of approaches based around the Developability Classification System (DCS) to deeply understand molecule properties – physicochemical characterization, the use of biorelevant methods and physiologically-based modelling/simulation to best position the formulation strategy for success. Quotient uses real-time product manufacturing and clinical testing to make, dose, and test new dosage forms within a 14-day cycle time, using arising clinical PK data to adjust formulation compositions.
As an example, she explains how Quotient rapidly screened a range of formulation types, including a micronized API, spray-dried dispersions, and a lipid-based formulation using both biorelevant media and the integrated clinical manufacturing and testing platform.
“Nonclinical data was unable to provide clarity on which formulation strategy would be optimal to address PK issues seen with a simple first-in-human suspension system,” says Dr. Stevens. “Our ability to make decisions based on human PK data allowed identification of a powder-in-capsule formulation containing micronized drug, which demonstrated improved exposure, linear PK, and a reduced food effect, saving time and money for our client. This example supports my assertion that the lack of predictive, non-clinical or biorelevant models is the real barrier to success in the development of bioavailability/solubility enhancing formulations.”
To access the full article click: https://drug-dev.com/special-feature-improving-bioavailability-solubility-each-molecule-is-unique/