how rani therapeutics’ robotic pill could change subcutaneous injection treatment

A Novel Pill for Drug Delivery: Replacing Injections
A groundbreaking new pill, designed for self-administration, is poised to potentially supersede traditional subcutaneous injection treatments.
The concept behind this innovative, internally-actuated pill originated from an eight-year research endeavor at InCube Labs. This life sciences laboratory is directed by Mir Imran, Chairman and CEO of Rani Therapeutics, who holds degrees in both electrical and biomedical engineering from Rutgers University.
The Genesis of the Robotic Pill
Imran, a recognized leader in life sciences innovation, has previously established over 20 medical device companies and played a key role in the development of the first implantable cardiac defibrillator.
The driving force behind Rani Therapeutics’ work was a desire to mitigate the discomfort associated with subcutaneous injections and simultaneously enhance treatment effectiveness. “Our initial hypothesis was straightforward,” Imran explained. “We asked ourselves, could we engineer a pill containing a biological drug that, upon ingestion, transforms within the intestine to deliver a painless injection?”
How the Pill Functions
Rani Therapeutics’ technology leverages the natural characteristics of the gastrointestinal tract. The pill incorporates an injection mechanism encased in a pH-sensitive coating.
This coating dissolves as the capsule transitions from the stomach to the small intestine, ensuring precise timing and location for drug delivery.
Once in the small intestine, the components react, generating carbon dioxide. This gas inflates a miniature balloon, creating a pressure differential that facilitates the injection of drug-loaded needles into the intestinal wall. “This carefully orchestrated sequence of events culminates in the delivery of the needle,” Imran stated.
Safety and Biocompatibility
Despite its mechanical nature, the pill is devoid of metal or springs, minimizing the risk of an inflammatory reaction. The needles and other components are constructed from injectable-grade polymers, materials already utilized in other medical devices.
Injection into the upper small intestine presents a low risk of infection due to the presence of stomach acid and bile, which inhibit bacterial growth.
Addressing Pain and Enhancing Efficacy
A primary goal for Imran was to eliminate the pain associated with subcutaneous injections. “It would be counterproductive to substitute one painful injection with another,” he noted. Fortunately, the intestines possess fewer pain receptors than the skin.
Furthermore, delivering the injection directly into the highly vascularized small intestine enhances treatment efficiency compared to subcutaneous injection, which deposits the drug into fatty tissue.
Future Applications and Clinical Trials
Imran’s team intends to explore the pill’s use in treating conditions such as acromegaly, diabetes, and osteoporosis.
Clinical trials for their acromegaly treatment, Octreotide, demonstrated both safety and sustained bioavailability in January 2020.
They plan to conduct further clinical trials for other indications, prioritizing acromegaly due to its established treatment but “very painful injection,” according to Imran.
Funding and Development
Rani Therapeutics secured $69 million in funding at the close of last year to support continued development and testing of their platform. “This funding will sustain our operations for the next several years,” Imran said. “Our focus is on creating a technology that is both robust and easily manufactured.”
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