Most biological drugs, including insulin, can’t be taken orally, because enzymes and proteins cause the drugs to break down too quickly in the digestive system. For decades, the pharma industry has been searching for a method to convert injectables into pills, thus saving patients from pain and encouraging patient adherence.
Rani Therapeutics of San Jose, California has announced the first-in-human trial of the RaniPill, a ‘robotic pill’ designed to replace injections of biologics. A recent article in Exome explained that Rani Therapeutics has performed over 100 studies in animals delivering drugs such as insulin and Humira. Most recently, as announced by the company, the pill has been tested successfully in an early stage trial.
This exciting innovation combines chemistry, engineering, and materials science. It also involves complex knowledge of physiology, anatomy, and biochemistry to convert injectable drugs into pills.
About the RaniPill
The RaniPill performs an injection inside the body and into the intestine. The design of the pill begins with an enteric coating which protects it from stomach acid. As the pill is transported into the intestine, the coating dissolves due to the higher pH level. This, in turn, causes a chemical reaction that inflates a balloon. At that point, the pressure inside the balloon pushes a dissolvable microneedle containing the drug into the intestinal wall.
About the Study
With the approval of the Investigational Review Board, the human trial took place at a Clinical Research Organization in Texas. Two groups with a total of ten participants were selected. One group fasted before taking the pill and the second group ate before taking the pill.
The team that conducted the study was able to concentrate on the pills’ safety and tolerability because the RaniPill did not contain drugs. The team used x-rays to track the pill at 30-minute intervals.
Results of the Study
There were no reports by patients of any sensations when the pills inflated and they were passed without incident. The RaniPill was well tolerated by patients without adverse events. There was no difference in intestinal deployment within the two groups.
The next study will involve another human trial with a drug-filled resorbable needle.
MIT’s Insulin Capsule
The Massachusetts Institute of Technology (MIT) developed a similar capsule that injects insulin into the stomach.
The capsule is the size of a blueberry. It holds a tint needle, and once it’s swallowed, it injects insulin into the stomach.
The shaft of the needle, built from a biodegradable material, does not enter the stomach wall. Its tip is almost 100 percent compressed, freeze-dried insulin. The needle is attached to a tiny compressed spring that is held in place by a disk of sugar. The needle, spring, and disk are all contained within the capsule.
When swallowed, water in the stomach dissolves the sugar disk. This releases the spring, and the needle is injected into the wall of the stomach.
The stomach doesn’t have pain receptors. Therefore it is unlikely that patients will feel the injection. As of now, MIT’s capsule has been successfully administered to animals.
About Rani Therapeutics
Rani’s chairman and CEO Mir Imran said the company is now preparing to test the RaniPill capsule with octreotide, a drug for the treatment of acromegaly. The drug was chosen for the trial as it is available from a qualified supplier and it is off patent.
There are four other biologic drugs meeting the same criteria as octreotide that, contingent on additional financing, the company plans to test.
Rani’s game plan takes into consideration the fact that the 10 top-selling drugs in the U.S. are biologics. Therefore it follows that this type of technology will create interest among investors.