Cyclodextrin Encapsulation: Advancing Powder Stabilization & Delivery

TL;DR

This discussion delves into advanced powder processing techniques, particularly focusing on cyclodextrin encapsulation as a superior alternative to traditional lyophilization for stabilizing sensitive compounds like peptides. While electron microscopy offers visual analysis, the core of material characterization relies on sophisticated lab analysis, especially for peptide integrity. cyclodextrin, unlike some polymers often misconstrued as microplastics, provide a robust ‘submarine shell’ around individual peptide molecules. This microencapsulation shields them from degradation during ingestion and transit through the digestive system, significantly enhancing bioavailability and shelf life. Our patented capabilities extend beyond mere encapsulation; we’ve perfected methods to precisely unwrap cyclodextrin-encapsulated molecules, presenting them for optimal absorption. This approach offers distinct advantages over lyophilization, which is often limited to small-batch, reconstituted vials. For larger-scale applications, such as drink mixes, our cyclodextrin-based powder, exemplified by highly soluble sodium caprate, demonstrate immediate and clear dispersion in water, underscoring the efficacy of dynamic atomization and precise powder processing in California for delivering stable, high-performance ingredients.

Cyclodextrin: A Superior Alternative to Lyoprotectants

Ulli: That’s interesting. And so one thing that I think came up with this in our questions, specifically how stabilization can be affected via cyclodextrin inclusions. But how does cyclodextrin inclusion play a role in stability in comparison to other methods like lyoprotectants?

Hendrik: I’d like to take a stab at this here because so when you look up what lyoprotectants really are and what they are made of, so they are used to protect the peptides during particularly during lyophilization, which is the same as freeze drying. You read things like there are polyols and polymers, and I’m like, I don’t want that in a product that I take. I really don’t., I know there’s a huge debate on microplastics right now and the accumulation of microplastics in the body. And I’m sure not every polymer is a microplastic, but it just it’s nothing that feels particularly conducive to be part of a substance that I would voluntarily take as a consumer, be it as an injectable or be it, in the oral form.

Hendrik: And so side reduction inclusion plays a big role for the stabilization, but it plays an even bigger role in protecting the peptide on its way to its target destination.

Right? So think about it as a little, a little submarine shell that goes around every single peptide protecting it from degradation while swallowing in the esophagus, stomach acid, all sorts of things that can happen to it on the way into your, if taken orally, it on its way into your large or small intestine. And so I think that is that is the bigger role that the cyclodextrin play here because we talked about it earlier.

Microencapsulation for Enhanced Bioavailability and Stability

Hendrik: They can increase bioavailability of a substance by four to five times. And so it’s really the best of both worlds. It’s a it’s a starch derivative, So it’s not plastic or it is it’s it’s cyclodextrin are prebiotics. And so in a strange way because they’re carbohydrate derived. Right? So in a strange way, it offers so many advantages over lyoprotectins., we’ve been talking about them for a really long time, but I’m sure, Will, you have to add something probably.

William: Oh, I think that was a pretty good explanation. Yeah. That, in general, the lyoprotectants are just less stable, which is which is the general theme here. And when you have the extraordinary stability that the cyclodextrin deliveries can provide, and then you have the opportunity to enhance that with our unique patented capabilities to unwrap the cyclodextrin and pull the molecules out one by one by the billions and present them in the body for absorption. Why would anyone pass that up?, that’s a unique opportunity. Again, going back to an earlier theme, people choose different delivery approaches.

William: They choose different drying approaches. They choose different things for different reasons, but usually they come back to an intersection of a certain price point and a use case.

And we just happen to be at one end of a spectrum that’s really suited for premium ingredients, premium applications, and optimum delivery because we can do things that are, I would say, atypical is an understatement. And so when things really need to be optimized, the cyclodextrin delivery that is perfected with our intellectual property and the things around it, they almost always make the most sense.

Ulli: That’s a really interesting explanation from specifically from going back to the original thing that you said, Uli, in going back to really looking up what they are and the fact that more closely related to that of a polymer, whereas a cyclodextrin is more closely related to something much more similar, it seems like, to almost not Food. A food, but so to speak, something that looks much more similar to what we would experience from other food products. And it’s just interesting to me that is a common usage in the industry where you’re directly serving people who are so acutely and precisely trying to get a product in their body that is so, so, so specifically made for optimal health that you would end up I don’t wanna say sacrificing, but Compromising, though.

Ulli: I do think it compromises., you throw a polymer in the equation.

It’s like, what? Yeah. At that point, when you’re dealing with something that is so so specific, it’s like, if you have something that’s supposed to be the absolute top of its performance, top of its class, and then you have a really Yeah. Key aspect of it that just doesn’t seem doesn’t seem fitting. But it does seem like something that almost feels like something that people just might not even normally look up or know or care about, which is why I really like the way I answer the question here. Moving on to the next and final question here.

Ulli: For a biotech company that’s currently using freeze drying for their biologic product, what would the case look like for switching to dynamic atomization? And when would it maybe not make sense if there is a case that it wouldn’t? Freeze drying can make sense. It’s it’s a fairly, I would say, simple approach, but it’s it’s not it’s not necessarily cost effective in a lot of cases. If you’re doing it in house, the equipment can be expensive, but it’s it’s costly.

Advanced Powder Processing for Oral Delivery Systems

William: The equipment is costly, and the equipment is slow. The processing through that equipment is slow. By comparison, our proprietary technology is roughly one fifth the cost and five times the throughput, and the quality of the powder is the same. We get a freeze dry quality powder, but we can do things in the creation of that powder in the drawing that are far more versatile. Freeze drying just extracts the water out of the material. And therefore, you’re left with a powder form, but a powder that has no protection. With our technology, the dynamic atomization technology, you can do a range of things in the customization, the creation of the particles that give you a protected and coated powder. We focus on the cyclodextrin inclusion because we’ve perfected the ability of that cyclodextrin inclusion to wrap the individual molecules and dry them, remove the moisture around that molecule, eliminate the water activity, and then deliver that individual molecule and unwrap it, giving it tremendous shelf life.

William: The freeze dried powder has the benefit of adding shelf life. That is one of the benefits of the freeze dried powder, but the extension of the shelf life with freeze drying is not great. I would say it’s midterm, whereas the extension of shelf life with the cyclodextrin inclusion is long term to ultra long term. A company has to determine what’s their goal, how much shelf life extension do they need. And then the second thing is what do they wanna do with those powders? If they want to deploy those powders in multiple applications, they have to determine if they wanna use those powders in applications where those powders need to be protected for a while. For example, the benefits of the cyclodextrin inclusion allow you to deploy those powders in the gastrointestinal tract, whereas a lifalized powder would never survive in the gastrointestinal tract.

William: You could never get it into and past the stomach. It will dissolve and be destroyed. If you wanted to dissolve in the mouth or under the tongue or you wanna put it in a solution and have it dissolve immediately, it can do that.

But it’s it’s limited to a very small number of applications, whereas a powder with the cyclodextrin inclusion can do dozens or scores of applications. And so the question is, how does it really need to be used? And so the economics around those things have to be evaluated based upon, the scale of production, how far down the channel you’re going, what the applications are. But the technology allows for very substantial throughput, and if there’s any scale at all, then the dynamic atomization technology, cyclodextrin inclusions, and so on can be very competitive financially.

William: Many cases, much more practical financially as well as more versatile. Lyophilization tends to be a good bet if you just want very small micro batches of things put in small vials the way they have historically done peptides to date if you’re going to reconstitute them. And you can keep them in a cold chain where they’re stable enough materials that they can survive ambient temperatures for a while, so you don’t have the cost of the cold chain. But you need a relatively stable product to enhance your business case. If you have a relatively stable product that helps your business case, then it may not be a bad solution. I do have one final question that is really honestly out of curiosity for, myself with a lot of the questions that have been answered. Within versatility of I think you even just touched on it, but lyophilized or freeze dried product can be reconstituted, but it can’t really be used in terms of if you want that to be, digested in the gut.

William: Maybe immediately orally, but it’ll never make its way down to the digestive tract. I understand that dynamic atomization, specifically the cyclodextrin inclusion that you guys do, can make it so that it can be used in a handful of different ways. Can that product from you also be utilized to reconstitute later for different purposes? Or is it or is it now only being able to be used internally or?

Hendrik: Digest? You mean is it forever powder and stays forever powder?

Ulli: Yeah.

Does or does it have to essentially be, made into a powder or a solution or something that gets consumed directly orally by somebody or can it be reconstituted as well?

Hendrik: Sure. It can be reconstituted as well.

Ulli: Okay. That’s interesting.

Hendrik: It can be, it can be powder in a glass vial that’s reconstituted for injectables, IV bags.

Ulli: Alright. No. That was my last question because I was

Hendrik: Hold on. Hold on. Will has an addition.

William: Will, I was just gonna say we have we have great examples of that now. Our powders go in sleeves to make drink mixes and so on, and we have great examples of one of our patented products, the sodium cap rate, which is so highly soluble. You take it directly off the production line, take a spoon of it, throw it on top of a glass of water glass, a beaker filled with water, and it simply disperses in the water and the water immediately turns clear. It absorbs the powder and it’s we can engineer the particles in the powder for dispersion and solubility specifically to facilitate that.

Ulli: Wow. No. I asked that question because I was trying to find something that could have been mark a against that side of it, but I couldn’t. I was like, well, maybe there’s one thing that could be bad about it, and it doesn’t seem like there is after that.

William: Yeah. Well, again, people choose their technologies for all sorts of reasons. And in the peptide space, it’s just a category that suits the technologies we’re talking about very well.

Ulli: No. It seems like it. Well, that is every question that I have for today and even a couple more that came up. Thank you guys so much for hopping on and doing this with us today. And I think we’ll we’ll probably come back with more questions soon.

Hendrik: Sounds great.

Ulli: Thanks, Steven.

Hendrik: Alright. Thank you very much.