Pharmaceutical researchers have spent decades trying to figure out how to deliver injectable drugs by means other than injections — pills being the most attractive option. So far, all attempts to replace injectables have been unsuccessful.
But now a Silicon Valley startup may have a solution, giving hope to doctors and patients dealing with chronic conditions. And the solution involves a self-inflating balloon, a dissolvable needle, and an indigestible capsule.
Silicon Valley-based Rani Therapeutics recently received a new round of funding to continue development of the RaniPill, an innovative drug delivery system that could replace injectable medications.
For patients with chronic conditions such as diabetes, some forms of arthritis, Crohn’s disease, hemophilia, and others that require regular injections, the Rani Pill could be a welcome relief.
A significant shortcoming of injectables is the risk of noncompliance, as shots can be painful and inconvenient. A swallowable pill would improve the likelihood of a drug being taken as prescribed.
“The RaniPill will improve patient outcomes,” Mir Imran, the CEO of Rani Therapeutics, told Healthline. “Compliance rates for injectables are fairly poor. The vast majority of patients do not take their injections at the right time every day.”
“Due to their convenience, pills have a higher compliance rate than getting injections,” Imran added. “For diabetics, taking pills will slow down the progression of their disease. This is true for nearly all chronic diseases.”
Imran noted there are 150 million people in the United States with chronic diseases. His company is taking the 40 to 60 million who require regular injections.
“If we can improve compliance rates by 10 to 20 percent, that would have a significant impact,” Imran said.
How the new pill would work
In the past, scientists have attempted to replace injectables with pills by chemical means —trying to replicate an injectable drug with a similar but different chemical mix.
These attempts — at least 150, according to Imran — failed due to the pills’ lack of success.
“A drug’s composition changes when it passes through the stomach,” Imran said. “It can break down.”
The RaniPill, on the other hand, contains the same molecules as the injectable drug it replaces, and it doesn’t break down in the stomach.
Instead, the capsule possesses a special coating that allows the pill to pass through the stomach without dissolving, so it reaches the small intestine intact.
What happens next is a Rube Goldberg-esque feat of engineering.
The environment of the small intestine — less acidic than the stomach’s — causes the pill’s coating to begin dissolving. Fluid then enters the capsule, triggering a tiny, hot dog-shaped plastic bag within to self-inflate.
As it expands, the plastic balloon aligns itself perpendicular to the intestinal wall and pushes in a short drug-filled needle made of sugar, delivering the injection.
Then the needle dissolves, and the plastic is excreted.
To the patient, taking a RaniPill is the equivalent of swallowing a fish oil-sized capsule. To the contained drug, the RaniPill is an injection.
Important tests ahead
Currently, Rani is partnering with just three pharmaceutical companies to develop RaniPills for specific conditions. Will the firm add partners and drug types as it expands capacity?
“We’re a tiny company, so we have resource limitations,” Imran said. “We can only do a couple drugs at a time. We have to pace ourselves to run clinical trials responsibly.”
Given that the drugs Rani is converting into pills have already been tested and approved as injectables, the approval process for RaniPill versions of the same medications should be expedited.
“We’re not inventing the drug,” Imran said. “We’re taking approved drugs and putting them into our pills. We’re just changing the route of administration.”
He said the approval process should take three years. The company hopes to have the pill on the market within 10 years.