Chapter 1. Overview
In order to address the important issues of drug delivery in the context of insulin, the subject will be divided into three modules:
1.1. Protein and Hormone Properties
Insulin is both a protein and a hormone.
Before you work out the best way to deliver a protein you will need to know the properties of the substance with which you are dealing. What are the properties of proteins and which of these properties will have an impact on your choice of method and route of delivery? How does a hormone act and how is it usually delivered by the body? (This later topic will be a review of material covered in the insulin and Physiology module).
1.2. Pharmacodynamics and Pharmacokinetics
You will also need to know how the body takes up and eliminates drugs. A whole discipline deals with the mathematical treatment of these issues. It develops models for the effects of drugs on the body, and how the body handles a drug. The area is too vast to cover in-depth here. We will concentrate on a brief look at Pharmacokinetics. Essentially this is the uptake and elimination kinetics of a drug.
1.3. Drug Delivery
1.3.1. Drug Delivery Strategies and Modeling
Having identified the protein properties of interest and having looked at some models for drug uptake, we look at research being done into alternative drug delivery methods. This also is a huge area which is being studied in universities and industry. Again, mathematical models have been developed for looking at the release of drugs from different situations. There are many similarities to be drawn between the modeling in pharmacokinetics, in drug delivery, and in fermetations that you encounter in the Bioprocess Engineering module.
1.3.2. The Specific Case of Insulin
Finally we tackle the central issue of insulin. We will look at the cutting edge research that is being conducted into novel ways of delivering insulin. We will look at everything from pumps to nasal sprays, from transplants to skin patches. The economic potential for a novel insulin delivery system is huge. The 1993 market for human insulin was 350 million dollars. This is only eleven years after regulatory approval for human insulin to Eli Lilly in 1982. Projected sales for year 2003 are $675 million.