Medical Design Briefs - August 2023 - 18

Ingestible Robotics
Robotic Pill Safely Delivers Injectable Osteoporosis Drug
The pill releases a self-inflating balloon with a microsyringe.
A
proven and effective medication for osteoporosis, which
is currently only available as an injection, can be administered
orally using a novel " robotic pill, " according to a
study presented at ENDO 2023, the Endocrine Society's annual
meeting in Chicago, IL.
" We believe this study provides the first clinical evidence of
safe and successful delivery of the osteoporosis drug teriparatide
through an oral robotic pill, " says Arvinder Dhalla, PhD,
who leads clinical development at Rani Therapeutics, the San
Jose, CA-based company that developed the technology and
funded the study. " Data from this study are very encouraging
and should give hope to those suffering from chronic conditions
that require painful injections, like osteoporosis, that an
oral alternative could be on the way. "
When a person swallows the robotic pill, it moves through
the stomach intact. In the intestine the pill releases a selfinflating
balloon with a microsyringe, which injects a drugfilled
microneedle and delivers the medication.
" The intestines do not have pain response to needles, so the
injection is painless, " Dhalla says. The needle rapidly dissolves,
and the medication is absorbed while the delivery mechanism
deflates and is safely passed out of the body.
" The robotic pill, which is essentially a swallowable autoinjector
in the form of a pill, is designed to deliver the drug
safely and efficiently as a painless intestinal injection, " she
says.
The Phase I study of 39 healthy women evaluated the safety,
tolerability, and movement through the body of the robotic pill
known as RT-102, containing a dose of the drug teriparatide
(PTH 1-34). Teriparatide is a synthetic form of the natural human
parathyroid hormone. It has been in clinical use for decades
as an injectable medication (under the brand name Forteo®
)
for rebuilding brittle bones of osteoporosis patients. It is
taken as a daily injection for up to two years.
Study participants were divided into three groups. Two groups
received either a lower or higher dose delivered with the robotic
pill, and the third group received a standard injection of teriparatide.
Fluoroscopic imaging was used to track the robotic pill
through and out the body. Drug concentrations were measured
in blood samples collected over six hours. The study found the
bioavailability (the ability of the drug to be absorbed and used
by the body) of the drug delivered by the robotic pill was comparable
to or better than the drug given via the injection.
" This breakthrough technology of converting injections into
oral pills is a significant step forward towards ending the burden
of painful injections for millions of patients suffering from
chronic diseases, " Dhalla says.
For more information, visit www.endocrine.org.
Watch the video to see how the robotic pill technology works.
18
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Medical Design Briefs - August 2023

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