RaniPill: robotic pill that replaces injections

At least once in your life, you have probably had an injection. According to the World Health Organization, more than 15 billion injections are given each year in developing countries and countries with economies in transition. Of these, 90% are therapeutic, 5% are for immunization, and 5% are for contraceptive and other purposes. 

Unsafe injections lead to patients being infected with hepatitis B/C or HIV. Some studies claim that in 2000, more than 500,000 people died due to unsafe injections. 

As children, many of us were terrified of syringes and shots. Doctors seemed like the meanest and scariest people on the planet, since the procedure often causes unpleasant sensations. Today, however, robotic pills are being developed that would allow medication to be taken in pill form instead of by injection. 

Turning injections into pills

In 2012, the company Rani Therapeutics was founded and has already raised more than $200 million in funding from investors such as AstraZeneca, Shire, Novartis and even Google.

Rani Therapeutics will improve the lives of millions of patients with chronic diseases by replacing painful injections with a simple, painless robotic pill. It will replace injections of large drug molecules, including peptides, proteins and antibodies. 

The pharmaceutical industry has for decades tried to turn injectable drugs into pills. In its preclinical studies, the company demonstrated delivery of several molecules equivalent to a subcutaneous injection, using a robotic pill to deliver the drug into the intestine. 

The company says: "The RaniPill capsule has a special coating that protects it from the acidic environment of the stomach. When it reaches the intestine and the pH level rises, the coating dissolves and a chemical reaction occurs, inflating a balloon. Pressure in this balloon pushes a soluble microneedle carrying the drug into the intestinal wall. The drug is absorbed immediately thanks to the highly vascularized intestinal wall. Since the intestine has no sharp pain receptors, the injection is painless." 

Simply put, the capsule transforms, straightens out, and injects the drug into the intestinal wall. Before these capsules appeared, many attempts were made at oral delivery of biologics, but most of them were unsuccessful. 

RaniPill does not use metal, springs or other elements that the body cannot easily absorb and assimilate. More than 100 preclinical studies by the company, including testing of more than 1,000 capsules in animals and human testing, showed that in large animals and humans, capsule remnants pass through the body within 1-4 days.

This drug delivery mechanism will solve a problem that has been worked on for decades, namely turning injectable drugs into pills. The company calls the idea the "holy grail of drug delivery."

The Rani concept was developed by Mir Imran, a medical inventor and entrepreneur who founded more than 20 companies in the biological sciences.

Human trials of robotic pills

As with any new medical device, it must first be shown to work well and not harm people. When Rani Therapeutics announced its first successful human trial, it was noted that the main focus was on the effect of food on the robotic pills. 

The study showed similar deployment time in the intestine for both fasting and fed subjects. This suggests that food does not affect the effectiveness of the RaniPill capsule. 

Potential molecules for RaniPill: 

1. Octreotide: can reduce excess growth hormone levels to treat acromegaly (a condition characterized by enlargement of the face, hands and feet), and also treat diarrhea associated with certain types of tumors. Rani could eliminate injections for such patients and replace them with a daily pill. 
2. TNF-alpha inhibitors: used to treat a number of inflammatory disorders and autoimmune conditions, including psoriasis, rheumatoid arthritis and Crohn's disease. The capsule could transform therapy by replacing painful injections given once every two weeks with a daily pill. 
3. Parathyroid hormone (PTH): several drugs exist for treating and preventing osteoporosis, but PTH is the most effective. 
4. Human growth hormone: a peptide hormone that stimulates the growth, reproduction and regeneration of cells, and is used to treat growth disorders and growth deficiency. Rani could transform therapy by replacing painful weekly or daily injections with daily pills. 
5. GLP-1 (glucagon-like peptides): a class of drugs used to treat type 2 diabetes and obesity. Currently, patients must give themselves daily or weekly injections, which Rani could replace with daily pills. 
6. Basal insulin: used in diabetes treatment to regulate glucose levels between meals. RaniPill could change the lives of millions of diabetes patients by radically reducing the number and frequency of injections. 

The company has already tested several molecules on its platform, including in-house programs and partner molecules. RaniPill delivers biologics with high bioavailability, similar to a subcutaneous injection, in the range of 40% to 78% and with high dosing accuracy.