Both Rani Therapeutics and researchers at Massachusetts Institute of Technology (MIT) have separately developed orally administered capsules, the RaniPill and the self-orienting micro-applicator (SOMA), to replace the injections often required for biologics and insulin.
Drug delivery of insulin has long been subcutaneous, often meaning that diabetic patients are required to inject themselves multiple times a day or rely on a pump. Additionally, patients requiring repeated dosing of biologics have also had to rely on injections.
The drug delivery devices developed have the potential to remove the barrier that needle injection represents and would make the benefits of biological medicines more accessible for patients.
Mechanism of action
Both innovative pills have a specific mechanism of actions to enter the gastrointestinal tract and inject at specific points for optimal absorption.
Mir Imran, CEO of Rani Therapeutics, told us, “We started with the premise that injecting the drug into the intestinal wall would be ideal because there are no sharp-pain receptors in the intestine, rendering the injection painless. In addition, the intestinal wall is highly vascularized, which means that the drug, once delivered, will be quickly absorbed.”
The enteric coating of Rani’s RaniPill protects the capsule from the acidic environment of the stomach and instead dissolves in the intestine, which causes a pressure change and inflates the pill. The microneedles are then released into the vascular wall, providing a dosage with the same bioavailability of a subcutaneous injection.
“Once the needle is delivered, all that is left is a deflated polymer, having the consistency of a bell pepper skin or tomato skin, which the patient passes out,” said Imran.
The RaniPill can enable the delivery of biologics at any molecular weight, regardless of the drug’s structure or properties, making it viable for therapeutic antibodies, as well as small peptides and proteins.
A brave new world of drug delivery
Similarly, MIT’s pill, SOMA, uses a micro-injector made of dried compressed insulin, which is powered by a tiny spring attached to a sugar disk to administer the insulin into the wall of the stomach.
While the stomach wall is not as vascular as the intestinal wall and uptake is not as immediate, MIT researchers said that due to the muscular nature of the stomach, there is no danger in puncturing the stomach with a micro-needle.
Getting the capsule to the right placement in the stomach presents a challenge, the SOMA can self-right itself in the stomach to ensure the needle is injected into the stomach epithelium, or stomach lining.
While the RaniPill has moved into in-human safety and tolerability studies, the SOMA capsule is still in early stages and is waiting for preclinical studies to examine the effects of daily micro-injections in the stomach. MIT researchers stated that they hope to enter the drug delivery device into human testing within the next three years.
