Defying Dysphagia Via Gel-Based Delivery With Gelteq's Nathan Givoni

Patients suffering from dysphagia, or difficulty swallowing, have historically faced limited options for how they receive medications and what kinds can be effectively delivered to them. In this episode of Sit and Deliver, host Tom von Gunden speaks with Gelteq CEO Nathan Givoni about advances in gel-based oral delivery that would allow patients to overcome the challenges dysphagia presents.

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Episode Transcript

Tom von Gunden, Chief Editor, Drug Delivery Leader:

Welcome to another episode of Sit and Deliver. My name is Tom von Gunden, Chief Editor of Drug Delivery Leader and your host for the series. Today our topic is gel-based drug delivery. For that conversation, I am joined by Nathan Givoni, CEO of drug delivery system company Gelteq.

Welcome, Nathan.

Nathan Givoni, CEO, Gelteq:

Thanks very much, Tom. Thanks for having me here. It's a pleasure to join and talk to your audience.

Let’s dive in. A condition in the patient population that you folks think about are people who suffer from dysphagia, or the challenge of or inability to swallow, which the gel-based approach is meant to address. Can you talk a little bit about that population, what that condition is like, and how that informs the way you think about gel-based delivery?

For the population that suffers from dysphasia, it is quite a debilitating condition where you can't dswallow something normally like other people. It’s something that can affect people mechanically if the actual muscles are potentially weaker, or if there's a medical issue that has contributed to it. There are over 600 million adults and over 200 million children that suffer from it. While it may not seem like a large issue, it is quite common. It’s often seen more in senior adults as the muscles get weaker, or in children as their muscles develop. It is something that can also be a factor when people are having cancer treatment, or they might have a stroke or some other sort of medical episode or also have contributing issues like some form of disability that prevents them from being able to swallow. The impact on their life and the impact on how they take their medications is really significant. If you can't physically swallow a pill or a capsule, you need to have something that you can swallow safely and not aspirate. We’re focused on making sure we can give something to an audience that is less targeted, but something that makes a meaningful difference in their lives.

In thinking about those patients, what would be some of the most urgent therapeutic areas or patient needs in that population that would benefit from an improvement in how drugs and therapies are delivered to them?

It’s a great point because, obviously, you can target many different areas. Given the audience, we look at the ones that are more common in those groups of people. We look at things like cardiovascular medications, diabetes medications, and pain medications because they're commonly taken, especially in the older demographic. For children, it may be a pain medication, but could also be things like allergy medications. One other area that is probably more susceptible to issues is mental health in terms of compliance. Taking a medication when you've got some sort of mental health issue can also be a challenge. There might be multiple medications as well. So being able to normalize that medication and have it in a food-like presentation can make it a lot better from an adherence and compliance point of view.

It would be helpful if you could tell us about any of the previous or traditional approaches that may have been used to try to deliver these drugs to these populations, and if you looked at any of them before moving toward a gel-based delivery.

It would always be a lot easier to take something that's already on a shelf and use that as a technology. We certainly looked at different ones. Obviously, injectables don't require any oral ingestion or cause issues with swallowing. We did look at that, but with the patient demographic, injections for children or for seniors are more risky. People also don't really love to take a needle or have to use that regularly if they don't have to. Weight loss medications are now transitioning towards pills and trying to go away from injections where they can. We didn't feel that [injection] was the right pathway for us.

We looked at patches, which are not oral, but there are limitations on the topical nature of them, the payload that can go in, and the type of API [active pharmaceutical ingredient].

The ones that we spent more time with were the sublingual wafers. The challenge we had with those is that there are certain drugs that don't work well when releasing in the mouth. There is also the taste. If you're breaking them down, they sit on your taste buds and may be bitter, nasty-tasting medications. You might take it once, but you're never taking it daily. We couldn't use that for the wide-reaching options that we focus on. That was knocked out, and we had to come up with something that was a bit new, that wasn't really looked at before to target this demographic.

When you did move into gel-based delivery mechanisms that can be swallowed despite dysphagia and other potential challenges, tell us a little bit about the mechanism of action. How does it work?

We've got a way to address the different dysphagia swallowing levels. There are actually different levels of thickness that patients require to avoid aspirating. People are generally put on those levels based on doctor or speech pathologist recommendations. We had to address the fact that we needed to have texture flexibility. We create these rigid bonds to make the gel texture, which creates the matrix for the gel that we hold the APIs in. By doing that, we don't allow them to interact with each other, and we get this stability. By creating a more water-based volume, we can mix in a lot of oil-based drugs as well, and we're able to keep them stable together. As it slides down the throat, this makes it easier to swallow and prevents it from getting stuck. The drugs themselves aren't getting exposed to the tongue or taste buds. It becomes a nice tasting product that they can take and a safe one to swallow.

We can also play with the different aspects for the release profile as well. If it needs to be released higher up or lower down in the gut, that allows us to address the efficacy of the drug. We focus on compliance in the mouth and the swallowability, and then efficacy as we move down. Both of them are covered based on the structure of the gel matrix that we create. Whilst it sounds nice and simple, it has taken a long time to get to that point and have the flexibility that we can work across pretty much any class of drug.

That all sounds very promising and beneficial to the patients who need an alternative approach. Thank you for sharing your perspective, Nathan. I would like to thank our audience for joining us, and we hope to see you here again for another episode of Sit and Deliver. See you next time.