New Delhi, March 4: Diabetics who have walked around with sore arms from jabbing insulin injections can finally breathe a sigh of relief — literally.
The world’s leading pharmaceutical giants are working on a new drug delivery system for diabetics that will allow them to inhale insulin.
Inhalers have worked well for asthmatics but this is the first time that the pharmaceutical companies are beginning to work on a non-invasive method to administer insulin.
US-based multinational Eli Lilly has started Phase II studies on the inhalable insulin.
Phase II is the testing phase when the efficacy of a drug is tested on human beings.
Insulin has always been injected with the drug going into the system through the bloodstream. Eli Lilly is planning to use the pulmonary route to administer insulin.
Insulin cannot be administered in tablet form because acids in the stomach can destroy the efficacy of the drug. Until now, pharmaceutical companies have worked on a variety of injectables — vials and syringes, and cartridges in a pen format — to take the sting out of repeated insulin usage.
The lungs, on account of their large surface area, are an ideal target for drug delivery and inhaled insulin (pulmonary insulin) represents one of the promising alternatives to injection.
This method delivers insulin to millions of alveoli in the lungs where it can be readily absorbed into the bloodstream. The alveoli are small pouches with a combined surface area as large as half a tennis court.
Within the alveoli, the inhaled insulin is separated from the bloodstream by only a thin single-cell layer and rapidly passes into the blood. The success of pulmonary insulin therapy largely depends on the development of inhalation devices, which are able to deliver the insulin efficiently and reproducibly to the lungs.
“Eli Lilly has put up a plant in the US at a cost of about a billion dollars to make insulin crystals as the inhaler NDDS requires five times the number of crystals than through injections. Only one fifth of the inhaled units has the reach, unlike injectables where it is cent per cent,” says Rajiv Gulati, managing director, of Eli Lilly and Company (India ) Pvt Ltd.
Pfizer has tied up with AvenCtis to outsource the crystals to work on a similar project. According to industry sources, it will take about four years before inhaler insulin is in the market.
Globally, Eli Lilly and Novo Nordisk are the two leading players in the human insulin business followed by Aventis. Novo Nordisk is also working with Aradigm Corporation of the US to develop inhalable insulin.
“Inhaler insulin on which some companies are working has a good potential since a number of patients want to avoid injections,” said Ambrish Mittal, who is a specialist on the subject working as an endocrinologist with Apollo Hospital in Delhi.
However, Mittal adds a few caveats.
“Insulin users take both short-acting and long-acting doses. The inhalers are likely to replace the short-acting insulin, meaning it may not totally eliminate the need of the injections even though it may reduce it substantially,” he said.
Secondly, the inhalers are expected to cost at least four to five times more, given the fact that they require that much more insulin crystals.
In India, the total insulin market is estimated at Rs 300 crore.
Insulin is available in two forms: human insulin and animal insulin, which is usually generated in the pig’s liver. The human insulin market is estimated at Rs 200 crore while animal insulin accounts for the rest. Eli Lilly has stopped making animal insulin, said Gulati.
Eli Lilly plans to market the insulin in the Indian market soon after it is launched globally for the simple reason that India is where the diabetics are. Consider this: as against a global average of 2 per cent of the population of a country being diabetics (as per WHO studies), India has a 3 per cent.
About 3 crore people in the country suffer from diabetes. According to independent studies done by doctors in Calcutta, Chennai and Mumbai, the diabetics in these cities are high as 5 percentage of the population.