Health treatments come in many shapes and forms but undoubtedly, the preferred way to deliver treatment into our body is the oral route. Nothing is easier than popping a pill or chugging your medicine and waiting for them to work their magic.
The pharmaceutical industry has long since identified the potential and is developing ingestible therapeutic devices – the next generation of oral drugs. Ingestible therapeutic devices are swallowable devices that can either carry drugs through the GI (gastrointestinal) tract or be used for imaging and sensing to collect data about the gut’s condition. Epitomee medical is taking the field of ingestible therapeutic devices up a notch. Instead of designing a different solution for every need, Epitomee has developed a super smart capsule that can be used to deliver (almost) anything through the oral route and the GI tract.
Challenges of oral drug delivery
Oral drug delivery is a well-established system, it is noninvasive, convenient, and cost effective. For these reasons, oral drug delivery is preferred by patients and their physicians and has become the most common route for both systemic drug delivery and for localized treatment of GI tract.
So, what’s the problem? Whatever you swallow will inevitably go down your GI tract, right? True, but with therapeutics, things are a bit more challenging. The whole purpose of the digestive system is to break down food before it gets absorbed. The stomach itself is a powerful shredder filled with acidic juices that break down food physically and chemically. Any ingestible therapeutics would need to survive the journey through the stomach and make it to the small intestine. The small intestine is a hostile environment for peptides and proteins as it is full of digestive enzymes. Those enzymes damage or destroy the biologic drug molecules before they can be absorbed. In addition, the small intestine is covered in a mucus layer which inhibits both attachment and drug permeability into the GI tissue.
To increase the efficacy of oral therapeutics, we need to overcome these physiological barriers. The ideal delivery system would protect the drug from the harsh gastric environment, increase its penetration through the intestinal wall and also enable us to control where, when and for how long the drug is active. Achieving these drug delivery capabilities would not only improve current treatments but also open a whole new repertoire of oral therapies.
Oral biologics at the forefront of biopharmaceutical advance
The ease of use of oral drugs makes this route optimal for self-administration and home care. It also makes it easier for patients to adhere to their therapy which is a key factor in achieving better clinical outcomes. We are now experiencing a biotechnological golden age in which bio-pharmaceutical companies are constantly developing new drugs for various therapies. Biologics, therapeutics that are produced through a biological process, are currently one of the most promising avenues in conditions such as cancer, metabolic disease, aging and inflammatory disorders. The earliest example for approved biologics is Insulin which was approved for use 40 years ago but since then, the biologic industry has been relatively nascent mainly due to low medical efficacy and population access.
Now, all this is changing. The increasing burden of chronic illness, and the realization of the huge potential of biologics drugs have pushed big pharmaceutical companies to invest in these products. North America currently dominates half the market which has increased by 70% in the last five years and should reach $421.8 billion by 2025. Biologics contribute to more than one-third of all the new drugs approved but as they are very fragile compounds, finding a suitable delivery system remains the bottleneck for effective biologics therapy.
Epitomee’s Ingestible Therapeutic Device
Epitomee medical has come up with a solution that ticks all the boxes with a self-administered, safe, and efficient swallowable capsule. This capsule is made from two hydrogel layers, a layer of thin strip patches containing the active pharmaceutical ingredient (API) and a hydrogel scaffold that is triggered by the pH levels of the intestine. Once activated, the scaffold expands and pushes the strip patches onto the intestinal wall where they release the API. After the patches are closely adhered to the intestinal wall with the mucoadhesive matrix, the scaffold disintegrates so that there is no obstruction to the flow of digested food. The design of the Epitomee capsule harnesses the changing pH levels throughout the GI tract to target API delivery. The capsule is activated only at a pH level that is specific to the small intestine.
Remember the problematic mucosal layer mentioned before? Not a problem anymore. The patches are mucoadhesive so that they are not just in contact with the intestinal wall, they essentially stick to it. This adherence increases contact surface area but also protects the API by preventing exposure to the harsh environment of the intestine. The mucoadhesive patches themselves are protected by an additional backing layer. They are protected because they are important for increasing the efficiency of API delivery but also because the composition of the patches determines the rate in which the API is released. Once all the API is released, the strip patches are disintegrated and are flushed out naturally – maximal performance and minimal invasiveness.
The Epitomee therapeutics delivery platform enjoys the benefits of the oral delivery system but also allows maximal absorption of the API in a targeted and controlled manner. This type of delivery system can finally release the bottleneck for successful biologics therapy.
Toward the future of oral biologics delivery
One of the most important medical and pharmaceutical needs is improving delivery of therapeutics. Epitomee has established a strong platform that overcomes the main challenges of oral drug delivery while keeping its benefits. Our ingestible therapeutic device is ideal for delivery of biologics such as antibodies, hormones, and small molecules. The increase in bioavailability of the drug with this system can be comparable to that of delivery by injections but the treatment is so much safer so that instead of patients coming in every week to receive treatment at the clinic, they could be sent home with a packet of pills.
In a future where biologics are delivered with the Epitomee capsule, chronic illness and cancer are treated at home, side effects are reduced, and patient’s outcomes are substantially improved. This system can be easily modified to fit the specific needs of different drugs; ones that are currently approved and those that are waiting in the pipeline for the perfect delivery system. So now, we are open for partnerships with industry leaders and continue to advance therapies for common chronic diseases. Our goal is to distribute simple, minimally invasive, and more effective treatment options to patients to save lives and improve their quality.