Lipid-based formulations are known to enhance the oral bioavailability of lipophilic drugs with poor aqueous solubility.
At the Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology (PBP) conference in March 2022, Quotient Sciences presented a poster analyzing formulation and clinical data from multiple pharmaceutical development programs conducted by Quotient Sciences over 16 years to understand the drivers for, and outcomes from, selecting and dosing different lipidic formulations. The poster also discusses the challenges in using in-vitro characterization methods to predict in-vivo behaviour, and the benefits of using Quotient Sciences’ unique Translational Pharmaceutics® platform to integrate real-time adaptive Good Manufacturing Practice (GMP) manufacturing and clinical testing for the rapid screening of multiple lipidic formulations in Phase I pharmacokinetic (PK) studies.
Data from 34 lipid formulation programs were analyzed for the following features: formulation application, Biopharmaceutics Classification System (BCS), and in-vitro characterization methods. Various lipid-based dosage forms were developed, including solutions, suspensions, spray-dried dispersions (SDDs), and modified-release (MR) tablets.
The poster highlights how lipidic formulations can successfully be used for solubilization, enhancing oral bioavailability, and reducing food effects for BCS Class II and IV drugs. The analysis shows that conventional in-vitro testing methods for different lipidic formulations are poor predictors of in-vivo performance, whereas Quotient Sciences’ integrated Translational Pharmaceutics platform can enable the rapid identification of optimal lipidic formulations based on clinical performance in a reduced timeframe.
- Alaa Hosny, Wu Lin, Peter Scholes