In a development that may make treatment for deadly infectious diseases such as TB more efficient, researchers have devised a novel drug delivery system that could help store the drugs required for up to a month in the patient’s stomach for sustained release.

The system, designed by researchers at the Massachusetts Institute of Technology (MIT) in the US, helps address one of the major problems associated with TB treatment. One reason TB is so pervasive is that treatment requires a six-month course of daily antibiotics, which is difficult for about half of all patients to adhere to, especially in rural areas with limited access to medical facilities.

The new device, developed by the researchers led by MIT scientists Robert Langer and Giovanni Traverso, is hoped to make treatment adherence easy and also cut healthcare costs. The findings were announced in Wednesday’s issue of Science Translational Research .

“In many situations, patients need to take multigram dosages of a drug, but up until now, this has been very difficult to do,” Langer said in a statement.

Automated release system

In this new approach, a coiled wire loaded with antibiotics is inserted into the patient’s stomach through the nasal route. Once in the stomach, the device slowly releases antibiotics over one month, eliminating the need for patients to take pills every day.

Once the wire reaches the higher temperatures of the stomach, it forms a coil, which prevents it from passing further through the digestive system. In tests conducted on pigs, it was found that their prototype device could release several different antibiotics at a constant rate for 28 days. Once all of the drugs are delivered, the device is retrieved through the nasogastric (NG) tube using a magnet. “We had to develop a completely new system that could enable an automated release of these medications over the course of about a month,” said Malvika Verma, a doctoral student at MIT and first author of the study.

“This new system can hold a lot more of the drug and it can release it for a longer period of time,” she added.

The research is sponsored by, among others, Bill and Melinda Gates Foundation and the MIT Tata Centre.

Positive responses

Together with Indian doctors treating TB patients in multiple hospitals and Tata Trusts, the researchers also carried out a survey to know the acceptance for such a monthly treatment among 300 TB patients and 100-odd healthcare workers. “We found that most patients would be willing to undergo a nasogastric (NG) tube procedure to have this device deliver drug for one month, and there is infrastructure and expertise in (Indian) TB clinics currently to deploy these systems,” said Verma, who originally hails from Delhi.

“Most patients expressed discomfort with coming to a clinic daily to swallow multiple drugs and were willing to undergo the procedure capable of month-long delivery of TB medication,” she said. “India has an annual burden of nearly 27 lakh tuberculosis-affected patients. Of these, close to 1.4 lakh patients are multi-drug resistant. The drug depot system can be used for delivering medicines effectively to any TB patient and can be customised to their needs,” said Ashwani Khanna, State TB control officer, New Delhi, and one of the co-authors of the paper.

Drug resistance

According to him, an average MDR-TB patient, over a course of a two-year treatment, has to consume 14,000 pills of medication. “India is grappling with a burden of loss to follow up cases, who discontinue taking medicines or intermittently stop for say, two weeks, and start again, develop resistance to drugs, which is to say that drugs stop working in them,” said Khanna.

Sunil Khaparde, former deputy director general, Ministry of Health and another co-author of the paper, said that currently the research is at a very preliminary stage and is being studied in animal models.

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