Patients prefer to take drugs orally always over injections. And sometimes we can't take drugs that are made up of large protein as pills since they break down easily in the stomach before they get absorbed. Also, we know that drug bioavailability after oral administration is affected by several factors including physicochemical properties of the drug (like solubility, lipophilicity, pKa value, molecular size, and so on), physiological properties (gastrointestinal pH, gastric emptying time., etc). People with diabetes who need to take a shot of insulin two to four times a day might also face some difficulties.
So, here is one solution to all these problems is novel drug capsule coated with tiny needles developed by researchers at MIT and Massachusetts General Hospital (MGH). In animal studies, they found that this capsule delivered insulin more effectively than the injection under the skin. And there were no side effects as it passes through the digestive tract.
Researchers also assumed that this microneedle capsule can be used to deliver antibodies that are used to treat a disease like Cancer, Autoimmune diseases like arthritis. These are known as biologics which also includes vaccine, hormones, and fusion proteins.
How does this microneedle pill work?
Administrated in the stomach - In the stomach, there is a vigorous moment of muscle, and there might be chances of insulin exposure to other drugs or food. To overcome this problem scientists made an injectable device known as SOMA (Self–Orienting Millimeter Scale Applicator) which works on the principle of the self-orienting leopard tortoise (species that can flip easily themselves when on its back).
SOMA is pea-sized it acts as a reservoir for microneedles, the injection of the drug is controlled by a spring which is held by a sugar disc. In presence of a sugar disc, stomach humidity triggers micro-injection which leads to the injection of a sufficient amount of drug. The biodegradable capsule contains SOMA. When it reaches the stomach the outer covering will be degraded due to stomach acids and the SOMA will settle down on the wall of the stomach, after that the microneedle which contains the powder form of the drug will inject into the wall of the stomach and it will degrade after that since it is also made up of biodegradable material. In the case of SOMA if it is made of biodegradable material then will easily degrade but if not then it will be excreted through the feces.
Administrated in the intestine - Capsules injected into the intestine are made up of pH-sensitive material so that the drug reaches the target part. Stomach acids don't affect the capsule because the outer covering is made up of protein which is only degraded by the intestinal enzymes.
These are two types of microneedles used for intestinal administration
1. Hollow microneedle - it can be used for both stomach as well as intestinal administration.
2. Solid microneedle - It is particularly used for intestinal administration.
To find out more about the safety of this microneedle capsule drug, researchers tested them on pigs with insulin as a drug. They found that the retention time of the capsule was more than a week. They didn't find any tissue damage during the process. Researchers also found that these microneedles injected insulin into the wall of the small intestine, stomach, and colon, and due to this the blood glucose level dropped in animals. It was found that as compared to the administration of the same amount of insulin from a subcutaneous way the insulin administered from microneedle shows larger and faster glucose reduction in blood.
This is really an interesting tech very similar to nanocapsules and VLPs.
Dr. Mansee Thakur, Professor & Director at MGM Institute of Health Sciences, Navi Mumbai
The advantage of using microneedles is that they are painless and can replace injections. easily eliminated through faces. There are disadvantages also one example is it can not be prescribed to people who show difficulty in swallowing.
One of the companies known as "Rani Therapeutics" developed a new device called "RaniPill" for the delivery of biologics. When a patient swallows a pill, it passes through the stomach it reaches the intestine (a highly vascular organ) outer biodegradable covering degrades after inserting the microneedle into the wall of the intestine, and the microneedle which is made up of bioabsorbable material also dissolves. The company was also successful in the development of a new version of "RaniPill" called "RaniPill High Capacity". A device with an 18 mg dose of adalimumab was administered during the preclinical trial. There was the successful delivery of adalimumab using "Ranipill HC" in all cases and in preclinical trials high bioavailability of the drug was found.
Rani Therapeutics CEO Talat Imran said,
"RaniPill HC is a great achievement for our platform technology. It is providing great opportunities for upcoming drug discoveries & partnerships."
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