Oral insulin is a reality: it is simply a matter of when. The realisation that insulin injections are going to have to become a part of everyday life can be extremely harrowing for many diabetics.
Injection takes time, interrupts daily schedules and is considered unpleasant by many people.
Children or adolescents who require daily insulin injections may find that the regimen impacts on their daily lifestyle to an even greater degree.
Using insulin therapeutically is not a new practice at all, but delivery methods to make the process more bearable have not gained widespread prominence as of yet.
Obviously, the priority in delivering insulin to a patient is to make sure it reaches the bloodstream intact.
Alternative insulin delivery methods
Many alternative delivery systems, although they work to some extent, leave the insulin broken down by digestive juices, usually too much for it to be of significant use to the body.
Furthermore, the complicated environment within the stomach means that simple tablets would be unpredictable and ineffective.
The solution will come, and may have already, when a pharmaceutical research company creates a tablet in which insulin can be enclosed and yet still pass through the stomach wall.
Nose, mouth and lungs
Three principal target areas are obvious in developing alternative insulin delivery systems:
Nasal delivery issues
Nasal delivery into the upper airway presents severe problems, primarily that the transport system is too convoluted and would require massive, expensive quantities of insulin to reach the target area.
Insulin delivery via the lungs
Insulin into the lungs is a promising area: the insulin can be directly absorbed into the bloodstream through the thin walls of the lung.
Insulin via the mouth
Effective oral insulin is extremely difficult to create due to the thickness of the stomach wall.
Oral insulin research: expensive
This is by no means an impossible hurdle, but it is a very complicated and costly one. Several companies across the globe are solely concerned with the creation of effective oral insulin delivery mechanisms, and many major pharmaceutical companies are at the research and development stage.
It is thought that oral insulin could be developed that would be absorbed through buccal means (through the walls of the cheeks). This method could see insulin reaching the bloodstream intact.
Oral insulin testing on animals
Data obtained through testing oral insulin on animals has yielded some extremely positive results.
In 2003, Diabetes Care released reports of a small study that appeared to find oral insulin as effective as injectable insulin for type 2 diabetics
Drug companies are obviously interested in the potential of oral insulin to net a massive share of the market, and therefore investment in research is substantial and ongoing.
Companies producing oral insulin
The following companies are market leaders in the field of oral insulin:
- Generex biotechnology: Generex biotechnology have had their rapidmist delivery system (an oral insulin spray that is the flagship product of their company) approved for use in Ecuador. The liquid spray is absorbed by the buccal mucosa. They hail this system as pain free and a reality, and aim to infiltrate the European market at a later date. It is expected to begin being sold in Ecuador in early 2006. Generex have an agreement with insulin giant Eli Lilly.
- Coromed: Coromed is a privately funded biotechnology company started in 1994. Their flagship product is called Alveair, and offers a ‘needleless’ alternative for insulin users. The device delivers a regulated blast of insuli, and Coromed champion the fact that it has lower side-effect levels than injectable insulin.
- Nektar: Formed from Inhale Therapeutic Systems Inc, are another company that are promising oral insulin. In collaboration with pharmaceutical corporation Pfizer and the enormous drug company Sanofi-Aventis, Nektar are eagerly attempting to net a share of the oral insulin market. The Nektar Pulmonary delivery system is one facet they have developed. Exubera, a fast-acting dry powder insulin designed for inhalation has been developed and is being reviewed.
- Aradigm Corporation: Aradigm Corporation aims to develop and manufacture innovative drug solutions: they are backed by another insulin market leader called Novo Nordisk.
- Wockhardt: Wockhardt, a giant Indian company that recently acquired UK insulin supplier CP pharmaceuticals, has recently launched a cartridge and pen system into the Indian market that it claims is almost painless.