Gelteq: A Breakthrough Ingestible Gel Drug & Nutrient Delivery System

Nathan Givoni, Co-Founder & CEO of Gelteq

The evolution of drug delivery methods has been slow over many centuries and has stalled with the invention of edible gels, introduced in 1986. While technology has rapidly advanced in many other areas over the past few decades, we have seen minimal advancements in drug delivery and crucial issues such as dosage increases, targeted delivery, and control of viscosity have remained unsolved. Additionally, millions of adults and children have dysphagia, or difficulty swallowing pills, causing challenges and stress when medications are needed. Gelteq is aiming to fill a crucial void with its unique formulation that directly addresses this issue along with numerous others that traditional drug delivery has, including the taste unpalatable ingredients and issues with dosage control. The company is focused on advancing and commercializing its delivery solutions within five core verticals: pharmaceuticals, over-the-counter medications, nutraceuticals, veterinary pharmaceuticals, and sports nutrition.

Drug Development & Delivery recently interviewed Nathan Givoni, Co-Founder and CEO of Gelteq, to discuss challenges with traditional drug delivery and the company’s innovative ingestible gel platform designed for drug and nutrient delivery.

Q: How did the business idea start?

A: Gelteq was formed through the shared determination between myself and my co-founder Simon Szewach, who is also Executive Chairman of the Board, to find alternatives for medication and nutrient delivery that do not require patients or consumers to take large pills or measure out specific powders to get the care they need.

We each watched patients and members of our families struggle with issues like dysphagia, diabetes, hypertension, and other indications that require exact medication, and knew that there had to be a better way. From our initial meeting and discussion, we’ve worked on and refined Gelteq’s core technology to create a gel-based oral delivery platform that is much more accessible and easier to swallow than traditional pills or powders.

Gelteq’s story is far from linear, heading down a few directions and false starts before ultimately focusing on our current trajectory. The perseverance of our team has been inspirational, and we are all committed to this platform as a better alternative for drug and nutrient delivery.

Q: Is the gel technology a new delivery method developed by Gelteq? What are the advantages and challenges of formulation development?

A: Yes, Gelteq’s gel platform is a new drug and nutrient delivery method created through a patented process, and we have several other patents pending as well. There are many advantages to the platform beyond just being more accessible for those who can’t take pills, such as being both chemically and physically stable while being capable of including active pharmaceutical ingredients (APIs). The platform is also fully customizable, targeted, and flexible to the client’s needs and wants, as we can tailor our gels to solve specific problems or achieve a specific outcome. It is also a much more pleasant experience that destigmatizes medication consumption with a more food-based presentation versus traditional medication delivery methods.

There are a few areas that we are still focused on advancing. We are working through determining solutions for ingredients that are more difficult to contain in the gel matrix. We have many different patented and patent-pending methods/formulations/solutions that we can apply to solve the problem of difficult ingredients and achieve a stable end product, but each new API can present a new challenge. Ingredient solubility is also a challenge and lastly, flavoring.

We like to work directly with clients on each of these challenges so we can tailor solutions to their needs and desires. Overall, the benefits to their customers and the increased accessibility are worth the challenges we overcome through our process.

Q: What is Dysphagia? What are the causes and symptoms? What are the possible treatments?

A: Dysphagia is the medical term for someone who has difficulty swallowing. It can range from mild discomfort to an inability to swallow at all, with other symptoms including chest pain, coughing or choking, pain while swallowing, pressure in the chest or neck, and more. There are many different causes including nervous system or brain disorders, muscle disorders, or physical throat blockages. This is an indication that can affect anyone, and impacts millions around the world, according to the National Foundation of Swallowing Disorders. Treatments include medications, changes in eating habits, surgical procedures, and texture modifications, among others. Gelteq’s solutions provide a customizable drug delivery platform with dysphagia-friendly textures that are convenient and easy-to-consume while avoiding the risk of choking, making it easier for those with dysphagia to take medication – which can include lifesaving pharmaceuticals.

Q: What are the capabilities of the gel? How does the technology work for different compounds and their solubility and digestion?

A: Gelteq’s proprietary gel platform has the capability to hold and deliver large doses without losing any taste profile or accessibility, issues that have traditionally been the case with pill or liquid medications. This ensures a better dosing experience for the patient and ultimately promotes better ongoing therapeutic adherence for patients who may otherwise struggle with their medication. The gel is also capable of combining water-soluble, solid components, and lipid-soluble excipients into one formulation that can be tailored for rapid digestion or delayed release profiles using different gel matrices through the platform.

Q: What medical conditions are you currently working on, and what are your plans for these products?

A: Our team has already worked on medications with a wide array of capabilities, such as diabetes, pain management, allergy, hypertension, and acid reflux. We have plans to take products through the regulatory pathways in the US with the FDA and with the requisite European bodies. Our initial preclinical work is already done with several APIs, and we expect clinical trials to begin shortly.

As a company, Gelteq is open to working with partners at any stage of the development cycle who are interested in turning their products into a more accessible and pleasant gel-based medication.

Q: What is the process when a customer comes to Gelteq wanting to develop their product into a gel?

A: Our team employs a detailed process when it comes to developing products with our partners. First, we listen to their product concept and the problems they are hoping to solve with our platform. Then, we go through a rigorous R&D testing program of the ingredients involved to ensure capability and provide the partner with an outline of the costs and feasibility. The next step is prototype development and testing with things like flavoring, batch capabilities, stability of the formulations, and more. For pharmaceutical products, there will then be the preclinical/clinical programs for approval. Next will be the required regulatory documentation and then Good Manufacturing Practice (GMP) for mass production.

Q: What are the types of partnerships and collaborations  Gelteq seeks?

A: Gelteq is focused on product development and incorporating our technology into more markets across the globe. We are always open to partnerships, whether it be as a licensee partnership or collaborations to make new products. These can either be new drug applications or via bioequivalent pathways. An ideal partner for our company would be one with an API in a sector which they believe would be well-suited for our gel technology, such as oncology or geriatric medications, or a partner with a well-established sales pipeline looking for a new product to integrate into its pipeline.

Q: Can you please discuss your development status to date? What are the next critical steps for Gelteq? Are there any plans for clinical trials?

A: As a company, we continue to focus on the pharmaceutical development of several APIs with our gel platform, which includes achieving regulatory approvals post-clinical trials. We have also begun working with veterinarian medications and are excited by the preclinical results we’ve seen so far that our technology can open doors for animals in the same way it can for humans.

We have also developed an extensive library of vitamin and health related supplements for licensing. We have several APIs in our current development pipeline, which are in the preclinical stage, and several more that we expect to begin clinical trials in the next few months. Our team has already submitted or is currently in the process of submitting multiple 505(b)(2) applications to the FDA or similar pathways in other regions.

Our goal is to continue to expand with partners worldwide, and to positively impact people and animals who are taking products using the Gelteq platform.