With increased water-insoluble (BCS II/IV) or low permeable (BCS III/IV) new therapeutic entities filling drug pipelines, lipid-based drug delivery systems have become an important tool for formulation development. They enhance the oral bioavailability of drugs, as well as the potential to decrease the food-effect and increase reproducibility of the pharmacokinetic profile of those orally administered drugs.
Ascendia CEO Jim Huang, PhD explains in his Formulation Forum column published in Drug Development & Delivery that an understanding of compound properties and a well-defined quality-by-design and development process ensures successful formulation development of lipid-based dosage forms. Formulation development companies that specialize in poorly soluble molecules using GRAS material platforms, like Ascendia, can provide pharmaceutical companies with a competitive advantage in product formulation without increasing regulatory approval risk.
The column also provides a recent example of how Ascendia developed a hard gelatin capsule type that highlighted the benefits of the process. You can read the entire Formulation Forum column on the Drug Development & Delivery website.