To: Saul H Rosenthal who wrote (2339 ) 5/10/1998 1:41:00 PM From: Anthony Wong Read Replies (1) | Respond to of 9523
From the Sunday Times, Diabetics to take insulin by inhaler May 10 1998 INNOVATION A device similar to the inhaler used by asthmatics could avoid the pain of daily injections for millions of sufferers, writes Sean Hargrave Medicine DIABETICS could soon be swapping needles for insulin inhalers, similar to those used by asthmatics. If current trials of new drug-delivery technology are successful, the inhalers could save the 370,000 Britons who rely on insulin, the pain and inconvenience of daily injections. Worldwide, about 35m sufferers are estimated to need daily injections of insulin, which must also be carefully stored and kept refrigerated. The impetus behind the new device came from a discovery in the 1980s at Cornell University, New York. Carl Leopold, a researcher, found corn and soya-bean seeds survive dry conditions by storing sugars in a glass state. When rains arrive, the sugar dissolves and energy is released for the seed to grow into a plant. "It is a great example of nature's ingenuity at finding a means to store energy," says Leopold. "I used the process to patent a means of storing molecules in a glass state so they can be kept at room temperature and only be dissolved when they come into contact with water." The discovery is now being used by Inhale Therapeutic Systems in California to design new versions of existing drugs centred on proteins. The molecules are normally so large they can only be injected into the bloodstream but the American company has developed a means of using the Cornell discovery to "spray dry" medicines so they are turned into a powder of fine granules. The most advanced of the 11 projects is insulin. The company targeted diabetics because it says people who endure regular injections are the perfect market for a system that will allow drugs to be inhaled. Inhale Therapeutics is working with Pfizer, the pharmaceuticals giant. The companies say trials carried out on more than 200 diabetics show that the new powder form of insulin has proven to be as effective as an injection. The partners are planning a third stage of trials before approval is sought from America's Food and Drug Administration. If the process is successful, the insulin inhaler could be launched in 2001. The insulin doses would be kept in foil packets and placed inside a compartment in the inhaler. The foil is essential protection for the drug because the powder is so fine the slightest gust of wind would blow it away. When the compartment is closed, the foil covering is punctured. The user then presses a button, just as with an asthma inhaler, to prompt the device to suck in air, compress it and then shoot a jet through the fine powder. The release of compressed air should give the drug enough momentum, as the user inhales, to reach the lower part of the lungs. According to Joyce Strand of Inhale Therapeutics, much of the research undertaken so far has been to find out the optimum size of each granule. "If they're too small, they get inhaled and then blown out again, like smoke," she says. "If they're too big they get dissolved in the mouth and throat before making it to the lungs. We need them to get right in to the lungs because this is a natural gateway for them to get into the blood system and start working. After tests, we found that the best size for the granules is between three and five microns." The lungs have been chosen as the quickest route to the bloodstream. This overcomes the problem faced by companies developing insulin pills and implanted pumps, which have difficulty getting the insulin to cross the stomach wall lining or fatty tissue. The insulin inhaler resembles models used by asthmatics. It is 6in long but it must be extended, like a telescope, to 12in before it can be used. If the trials of the inhaler are successful, it could be launched in Britain in 2001. Other conditions the company is working on include osteoporosis, hepatitis, fertilisation treatments and delivering human growth hormones to stunted children. "There are so many conditions that require regular injections, and research all over the world shows that people are afraid of the needle," says Strand. "We believe we can provide inhalers that do the job just as well, which should stop people seeking medical help on the basis it might result in painful injections."