Advanced in-vitro and in-silico biopharmaceutics tools for oral drug delivery

Objective

During clinical development, new drugs are typically first tested in healthy volunteers before investigating them in the patient population of interest. Understanding the difference in the gastrointestinal physiology of healthy (often male) volunteers in comparison to the actual patient population will help to understand the fate of the dosage form in the specific patient group and support scientists in setting up better PBPK models.
During day 1 of the course we will take a closer look into pediatric patients as well as older adults and geriatric patients. A group of patients that will significantly increase in the next couple of years. The United Nations projected that by 2050 the number of individuals aged 65 years or above across the world will be twice the number of children under age 5 and almost equivalent to the number of children under 12 years.  In addition, we will increase our understanding with respect to overweight and obesity as already today 1 in 8 people in the world are living with obesity and numbers are increasing. If nothing is done, the global costs of overweight and obesity are predicted to reach US$ 3 trillion per year by 2030 and more than US$ 18 trillion by 2060.
On day 2, we will focus on recent advancements in in vitro tools including combined dissolution/permeation assays for the evaluation of solubility enhanced formulations and to investigate the impact of digestion on drug absorption to get useful insights from experts using these highly sophisticated dissolution methodologies. All this will help us in better understanding the fate of different oral dosage forms in the gastrointestinal tract.