Summary:

Approximately 40% to as much as 70% of new chemical entities entering drug development pipelines today suffer from low aqueous solubility. The poor and variable gastrointestinal absorption afforded these compounds by conventional formulations can be complicated by a significant, positive food effect, potentially resulting in unexpected toxicity while making development more costly and difficult. The use of lipid-based formulations for developing oral dosage forms for these challenging compounds will be reviewed.

Topics that will be covered:

• Formulation rationale and compound selection
• Basic excipient classes and marketed formulations
• Prototype formulation design and evaluation
• Future potential and challenges

Dr. Hauss is a Principal Scientist in Pharmaceutical Candidate Optimization, Bristol Myers Squibb Company, Princeton, New Jersey. He received a B.S. degree in Pharmacy and a Ph.D. degree in Pharmaceutics in 1989 from the Philadelphia College of Pharmacy and Science. He has over 18 years of experience in the pharmaceutical industry in the areas of biopharmaceutics, preformulation, formulation development and nonclinical ADME for small molecule and protein therapeutics.

Dr. Hauss is an active member of the American Association of Pharmaceutical Scientists where in 1996, he founded the Focus Group for Oral Lipid-Based Drug Delivery and has organized several symposia, workshops, and training courses. He has lectured internationally on the subject and most recently, edited the book, ‘Oral Lipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-soluble Drugs’, which was published in June, 2007 in the Informa Healthcare ‘Drugs and the Pharmaceutical Sciences’ series.

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