Reducing the attrition rate of New Chemical Entities (“NCE’s”) in today’s shrinking drug development pipelines has become an issue of paramount importance. A significant number of NCE’s offer therapeutic promise for patients, but exhibit limited physio-chemical attributes for conventional, solid oral dose delivery. Recent estimates are that as many as 40% to 50% of NCE’s are poorly water soluble and, as a consequence, prone to oral bioavailabilty problems (BCS Type II and IV). The human gastrointestinal track (“GIT”), a complex biological system, may work for, or against, a formulator’s best intensions to deliver efficacious doses of BCS Type II and IV NCE’s. Today’s formulation scientist must have a sound working knowledge of how to develop orally-delivered, lipid-based systems that can be used advantageously to improve the bioavailability of these classes of compounds.

This webinar will focus on the importance of self-emulsification (dispersion) and lipolysis (digestion) properties for achieving acceptable “in-vivo” performance of lipid-based formulations. Specifically, formulation parameters that are critical in the design of lipid-based fill systems for maintaining poorly water soluble drugs in solution throughout the GIT will be discussed.

An important aspect of this discussion is the use of “in-vitro” methods that can be utilized to assess the dispersion and digestion properties of lipid-based formulations during development.

As a final topic, the selection of a suitable dosage form for the oral administration of lipid-based formulations will be discussed. Given that these formulations often do not lend themselves to conventional dosage form approaches due to their liquid or semi-solid nature, the advantages of the soft gelatin capsule dosage form for encapsulation of lipid-based systems will be presented.

The webinar will provide case studies of BCS Type II and IV compounds that have successfully utilized the formulation approaches presented by the speakers to improve oral bioavailability. A Q&A session will conclude the presentation.