Robotic Pills Could Simplify Administration of Biologic Drugs

JULY 20, 2015
Allison Gilchrist, Associate Editor
A robotic pill may be the first oral agent to successfully traverse the acidic digestive environment to deliver biologic drugs that, to date, could only be delivered via injection. The pill would facilitate convenient administration of complex biotech drugs routinely used to treat chronic conditions such as diabetes, rheumatoid arthritis, multiple sclerosis, and hepatitis. It could replace the traditional, more invasive methods of administering the drugs.

US-based start-up Rani Therapeutics, which developed the pill, has secured support from Swedish pharmaceutical giant Novartis, and both companies are set to begin collaborating on a feasibility study that is expected to last between 18 and 24 months. The study will determine which of Novartis’ biologic drugs can be administered in the bloodstream using Rani’s platform.

A primary focus of the feasibility study will be the pill’s ability to administer insulin for patients with diabetes. If successful, this would affect a large market of patients, providers, and manufacturers. According to the 2014 Centers for Disease Control and Prevention fact sheet on diabetes, 29.1 million people in the United States have the disease, and many of those people are dependent on insulin.

The pill uniquely uses the natural process of the digestive system to function. Acid in the intestine corrodes the outermost layer of the polymill pill casing, which exposes a small valve that separates the citric acid and sodium bicarbonate contained inside. Once the valve becomes exposed, the chemicals mix together to form carbon dioxide, which then acts as an energy source to inflate the balloon-like structure inside the capsule that is covered with microneedles made of sugar and preloaded with the drug. The needles make subcutaneous injections in the intestinal wall before detaching and slowly dissolving.

“We understand the magnitude of the problem we are pursuing, and we are confident that our approach has the potential to radically change the way biologics are administered to patients,” Rani CEO Mir Imran said in a press release.

If successful, Rani’s robotic pill would be the latest example of ingestible technology increasing convenience and supporting adherence for patients managing chronic diseases. The smart pill ingestible technology approved by the FDA in 2014 is a sensor that communicates to caretakers and providers whether a patient has taken his or her doses.

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