ABSTRACT
There are many biotechnology products approved by the Food and Drug Administration (FDA) for either the detection or treatment of human diseases, as presented in Chapter 1. More than 350 biotechnology-produced drugs and vaccines are currently being tested in clinical trials, with hundreds more in earlier stages of development (1). The approved products treat a wide variety of conditions and diseases, including hemophilia, multiple sclerosis, AIDS-related illnesses, growth failure, infertility, cancer, diabetes, hepatitis, anemia, Crohn’s disease, diabetic ulcers, prevention of transplant rejection, stroke, and acute myocardial infarctions. The successful treatment of a disease state requires that the drug be delivered in an active form over a specific timeframe to the location in the body where it is needed. This necessitates development of a suitable formulation and drug delivery system that ensures the stability of the active compound, the delivery of the drug to the site of action, and its presence at the site of action over a desirable timeframe.
