A ‘Cocrystal’ Could Change The Way We Take CBD

Episode 62 November 17, 2020 00:43:21
A ‘Cocrystal’ Could Change The Way We Take CBD
The Ministry of Hemp Podcast
A ‘Cocrystal’ Could Change The Way We Take CBD

Nov 17 2020 | 00:43:21

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Show Notes

A new techology called a “cocrystal” could improve our ability to absorb CBD oil.

Welcome to episode 62 of the Ministry of Hemp Podcast. In this episode, Matt talks Dr. Andrew Yates, scientific consultant, and Professor Saorise Sullivan, scientific advisor and consultant. They developed a “cocrystal” that will improve the bio-availability of CBD. The two authored a paper about the cocrystal that is being used in the treatment of PTSD in clinical trials in Europe. The conversation touches on how CBD has trouble being absorbed in the human body, why the cocrystal they developed works, and how it could change the way we take CBD.

A brief introduction to the concept of bioavailability

Matt also mentions his discussion with Dr. Matthew Halpert about a CBD study on aging dogs with arthritis, which used a similar bioavailability booster.

About Saoirse Elizabeth O’Sullivan and Andrew Yates

Professor Saoirse Elizabeth O’Sullivan (@ScienceSaoirse) received her doctorate from Trinity College Dublin in 2001 and moved to the University of Nottingham in 2002 as a Research fellow where she began researching cannabinoid pharmacology through basic and clinical research.  She was made Lecturer in 2007, Associate Professor in 2011 and Full Professor in 2019.  She has over 40 peer-reviewed articles and 3 books chapters on the topic of cannabinoid pharmacology.  In 2016, she was named the International Cannabinoid Research Society Young Investigator of the Year. In 2017, Saoirse set up an independent consulting company called CanPharmaConsulting Ltd, and through this, acts as scientific advisor to companies like Artelo Biosciences, CBDScience Group, Therapix Biosciences and Dragonfly Biosciences.

Dr. Andy Yates has more than 20 years’ experience in the pharmaceutical industry including 10 years as an executive at AstraZeneca. Andy Yates is a UK registered pharmacist who received his PhD in cannabinoid medicinal chemistry from the University of Nottingham. Recently he has acted as an independent consultant and scientific advisor for the Biotech, Life-Sciences, Wellbeing and not-for-profit sectors; predominantly within the expanding cannabinoid field. Andy holds an academic position at the University of Keele.

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Two photos are superimposed on a green crystal background: Andy Yates and Saoirse O'Sullivan, who joined the Ministry of Hemp podcast to discuss research into a CBD cocrystal which improves bioavailability.Andy Yates (left) and Saoirse O’Sullivan (right) joined the Ministry of Hemp podcast to discuss research into a CBD cocrystal which improves bioavailability.

CBD cocrystals: Complete episode transcript

Below you’ll find the complete transcript of episode 62 of the Ministry of Hemp podcast, “A ‘Cocrystal’ Could Change The Way We Take CBD”:

Ep 62 Transcript:

Matt Baum:
I’m Matt Baum. And this is The Ministry of Hemp Podcast brought to you by ministryofhemp.com, America’s leading advocate for hemp and hemp education. Welcome to episode 62 in Ministry of Hemp Podcast and in the little over a year that I’ve been doing this show, I’ve learned a lot about you guys, the listeners. Not just from talking to you when you call our phone line at (402) 819-6417, which you can call, leave a message with your questions at any time. We love to answer your questions on the show.
I’ve also learned a lot about you guys from the comments that are left on the podcast posts on our website, ministryofhemp.com. Based on your calls and your comments, it seems like there are a lot of you that are interested in wellness and then there are others of you that are interested in medicine, medicine as in, I have a condition, will this help. And wellness being, hey, I know I feel better when I do this after I work out or this helps me sleep, neither of which are bad, but on the medicine side, things can get really scary for some people when we start talking about pharmaceuticals and pharmaceutical companies.

I’m not going to get into the debate of whether or not they are giant evil corporations controlled by lizard people who want to drug us through the gills so we can’t pay attention to what’s going on anymore, although 2020 did kind of feel like that. But I will say there is something to be said for the rigorous amount of testing and study that goes into producing a drug for human consumption.

Today on the show, I’m going to talk to two scientists. They’re both out of England and they’re both scientific advisors for a company called Artelo. They recently wrote a paper about increasing the bioavailability of CBD. Now we know that there is evidence that CBD has certain effects on the human body and the brain, it helps with anxiety. It can help with pain and inflammation, but one of the major problems with CBD is it’s very hard for your body to process it, to actually pull it in and take it out of whatever it’s in and introduce it into your bloodstream, where it needs to get.

And that’s why a lot of different companies infuse it into tinctures and oils and pills and whatnot. Well, what they are working on is called a cocrystal, which is fairly popular in pharmaceutical, from what I understand from our conversation. But this cocrystal basically bonds with the CBD molecule and makes it far more bioavailable than it’s ever been before. This was an amazing conversation. And you’re going to hear in the very beginning, I had no idea what I was talking about going into it. I was trying to sound smart and they very quickly correct me. And then we have a really good conversation.

Now we’re not going to get into crazy heavy science here, I promise, but what they are talking about could really change this business and just blow it wide open. Today on the show, I’m speaking with professor Saoirse Elizabeth O’Sullivan and Dr. Andy Yates. Like I said, the two work together with Artelo to create something really incredible. And the more incredible part is it’s not far off, it could be coming soon. Here’s my conversation with professor Saoirse Elizabeth O’Sullivan and Dr. Andrew Yates.

What is a CBD cocrystal?

So we are going to talk about a drug that you guys are developing, and it’s one of the first patents and correct me if I’m wrong here, but from what I understand, it’s one of the first pharmaceutical patents that has been issued using CBD or hemp.

Saoirse Elizabeth O’Sullivan:
So I wouldn’t say that it’s necessarily the first patent because other people have patents. For example, GW pharmaceuticals have patents on their version of CBD that they use in epilepsy. It’s just probably the first composition of musher patent, is that right Andy? In terms of a new molecular structure or a new way of presenting CBD in this cocrystal format. So it’s not a use patent, it’s a composition of musher patent. There’s probably other kind of structural variants on CBD where people have kind of played around with the molecular structure and there’ll be patterns on those also. But in terms of kind of pure CBD, this would be a first.

Matt Baum:
Okay. So let’s talk about that for a second. We’re talking about the molecular structure and you guys have come up with a new, you use the word crystalline structure basically.

Saoirse Elizabeth O’Sullivan:
Yes.

Matt Baum:
So what is the structure that we start with when we’re looking at, and tell me if I’m using the words right, a CBD molecule.

Saoirse Elizabeth O’Sullivan:
Molecule. Yes. No, that’s right. So [inaudible 00:05:12] how it’s built out of its different elements is the molecular structure. And so CBD is CBD when you put together those elements in the right order, in the right orientation, you come up with the molecule that is CBD.

Matt Baum:
Okay. And you guys have affected it in a way that you can make it more potent, more useful.

Saoirse Elizabeth O’Sullivan:
And so what Artelo have done is they’ve formed a cocrystal. So this is where you take a molecule of CBD and you bring it together with another compound, which in our case is a molecule that’s used in Chinese medicine. So they’ve brought them together in what’s called a cocrystal. And so that changes the physical properties of the molecule because CBD has some physical properties that don’t make it very easily usable as a medicine. So we need to try and improve its solubility and its absorption.
And one way that pharmaceutical companies go by fast is to make something as a cocrystal and attach it onto something else. And that can change the physical properties of this molecule that you’re interested in, in order to make it more druggable and easier to give to person and basically better and more consistent exposure to that drug within the patient.

Matt Baum:
So the idea that we have [crosstalk 00:06:35]. Go ahead, I’m sorry.

Andy Yates:
I was going to say if I may come in. We’ve taken everything that we love, if you wish, about CBD, [inaudible 00:06:41] exactly the same, but taken away some of the bits that we don’t love about CBD, which is its crystallinity, its melting point, potential stability and it’s bioavailability and we’ve added something else into it as an integral part of the crystal structure. And we hope that that will improve the way that we can use CBD as a medicine.

Matt Baum:
So basically the CBD molecule is kind of a jerk, and we know it does good stuff, but this jerk doesn’t want to play with your system very well.

Saoirse Elizabeth O’Sullivan:
Exactly.

Matt Baum:
And you have created something, a friend that is saying, “Hey, take it easy jerk. Let’s get along.”

Saoirse Elizabeth O’Sullivan:
And they’re holding to this hand as they work through the body.

Matt Baum:
Yeah. Settle CBD down, walks him into the body and says, all right, see, you feel better now, right? And he goes, okay. I was nervous, it was nothing, my bad.

Andy Yates:
That’s a great analogy. Very well characterized.

Saoirse Elizabeth O’Sullivan:
Yeah. That’s pretty much it.

Traditional Chinese Medicine, TMP and the CBD cocrystal

Matt Baum:
I’m for hire if you need a PR department. So just let me know. I’m really good at boiling this stuff down if nothing else. I’ll be truly, honestly, I tried to prepare for this and I went back through like all my college chemistry [inaudible 00:07:47], oh God, it’s gone, it’s just gone. And I’m like, I’m going to sound like the biggest steady hits. So thank you for bearing with me on this one.

So the cocrystal you’ve created, you said it’s from Chinese medicine. Now I am a skeptic by nature, and so when I hear a term like Chinese medicine, my first knee-jerk reaction is, oh boy, that sounds a little out there and whatnot. But-

Saoirse Elizabeth O’Sullivan:
And it’s funny because that’s the reaction some people have about cannabis-based medicine.

Matt Baum:
I did when I got into this.

Saoirse Elizabeth O’Sullivan:
And the molecule that we’ve used in the cocrystal is something where we know the molecule really well. It’s something that’s really widely used in Chinese medicine and has kind of widespread clinical use, lots of clinical trials, it’s the particular active ingredient of this plant. It’s very similar story to CBD and the cannabis plant as this molecule, which is called Tetramethylpiperidine or TMP.

Matt Baum:
We’ll go with TMP for the rest of the interview.

Saoirse Elizabeth O’Sullivan:
Yeah. It’s very analogist between the plants and the active molecules.

Matt Baum:
Okay. So it’s part of Chinese medicine in the sense that it’s part of several plants, I guess, that are used in Chinese medicine. So it happens to be there.

Saoirse Elizabeth O’Sullivan:
Yeah.

Matt Baum:
And I guess my question was, what worried me was like you said, there’s been lots of clinical studies that show that this works as a binder. What other kinds of stuff does this TMP molecule bind to? What else does it help with?

Saoirse Elizabeth O’Sullivan:
Sorry, it’s not that it is used in Chinese medicine as a binder, it’s used as itself, as the molecule, as a drug in Chinese medicine.

Matt Baum:
I guess it happens to be there.

Saoirse Elizabeth O’Sullivan:
Yeah. And to be honest, that’s not why it was chosen. There was a chemistry screening process where lots of different potential co-formers were assessed because not all, you have the analogy of the two guys walking through the body hand in hand, not all molecules want to be friends. And there was only a few of them in the chemistry screening that was done. There was only a few that actually wanted to hold hands with CBD.
And it just happened that TMP was one of them. The fact that TMP has its own clinical profile is wonderful. And in best case scenario might add some advantage onto the artillery CBD cocrystal, but actually that’s not why it’s there. It’s there really just to be holding the hand of the CBD. And if it adds to CBD then wonderful, but it was kind of happenstance that it was one of the ones that came along that did want to hold hands with CBD.

Matt Baum:
Andy, you were going to say.

Andy Yates:
And also of interest to your listeners, not only does it have a usage in traditional Chinese medicine, but it also has a use in food flavoring.

Matt Baum:
Oh good.

Andy Yates:
So it’s bringing a coffee mocha vibe to CBD. The tones of a TMP are used often in coffee and mocha flavored free products.

Matt Baum:
Really?

Andy Yates:
Yeah.

Matt Baum:
So when you go get like a McFlurry or something, which is, we all agree is not coffee, but has the vaguest hint of coffee flavor, there could be TMP involved.

Saoirse Elizabeth O’Sullivan:
There could be TMP in there. Yeah.

Andy Yates:
It could indeed.

Using CBD to treat PTSD

Matt Baum:
Interesting. So this drug that Artelo is developing is going to be tested for PTSD and-

Saoirse Elizabeth O’Sullivan:
Yeah. It’s a variety of different areas that Artelo are interested in, but PTSD is definitely one of the, probably the first areas of interest. There’s other conditions in which CBD is useful, like inflammatory bowel disease and stroke. And so they’re also kind of on the horizon, but PTSD is probably the first indication that Artelo would try and pursue through clinical research.

Matt Baum:
Okay. So why PTSD? How did we happen upon that? Is it because of the anti-anxiety factors of CBD? And I guess my next question is, is it worth going after CBD to treat this, so much so that you created a cocrystal to help the body accept it better, whereas there are already other treatments for PTSD that are out there? Is this one, do you believe from what you’ve seen in your research, do you believe this is worth it and will be a better treatment?

Saoirse Elizabeth O’Sullivan:
So both of those things are true. So it’s because CBD is very good at reducing anxiety and there’s quite a good evidence-based from scientific and clinical literature to show that. And there’s an awful lot of research going on in this area. So we are not the only people who think that CBD is a good [inaudible 00:12:37] agent.
There’s lots of research going on there, but in order to develop a licensed medicine, we need something that is going to be really good. Good bioavailability, getting good absorption, good stability, all the things you want from a good drug and have patentability, because if you’re going to develop a medicine it’s quite a costly process.

Matt Baum:
Of course.

Saoirse Elizabeth O’Sullivan:
So we need a good CBD, a reliable CBD that we can give in specific doses and that we can prove in an area which is probably considered to be an area of unmet need. So there are medications available for PTSD, but they’re not without their side effects and some of them can have limited efficacy. So I think that people who work in this area would say, there’s definitely a need for a new medicine in PTSD and CBD is really emerging as something that is of interest in lots of different anxiety disorders, it’s not just PTSD but-

Matt Baum:
Yeah. Absolutely.

Saoirse Elizabeth O’Sullivan:
… things like central anxiety disorder, generalized anxiety disorder, social phobia, there’s lots of research going on that points to controlled, randomized controlled data the points to CBD being effective in these areas.

Improving CBD bioavailability with a cocrystal

Andy Yates:
And two additional adds to that, one of the other big parts of PTSD is ability to sleep. And CBD well is unknown aid to sleeping and we think that would obviously help the syndrome itself. And the other aspect is that if you are not going down that route of, as you said, coupling it with a friend to help into the body, the other way of doing it, as I’m sure you’ve seen from shops that sell CBD is to dissolve it in oil.

Matt Baum:
This is my next question. I’m glad you’re going there.

Andy Yates:
You have to hold it under your tongue. And I think what we’ve done with this sort of friendly crystal is that you could start to think about form relate in this now in a capsule or a pill, which I think most people would agree is a much more convenient way to take CBD for the majority of the people. I’m not saying that’s for everyone or the companies like GW have been developing medicines for children, so they’re quite happy to put CBD in an oil or an alcoholic based solution.
So we’ve really got an advantage there with our cocrystal, when it comes to thinking that we’ve designed or we’ve pre-programmed into the solid form, some good characteristics that will make it easily or more easily atunable to a tablet form.

Matt Baum:
So Andrew, let me ask you based on what you were saying, bioavailability, I’m glad you went there because that was my exact next question. This cocrystal is designed to help the body accept CBD better. If I’m not using that, if I just say, have a tincture, a high quality CBD tincture like you said, and I’m putting it under my tongue, what would you say is the amount of CBD that I’m going to, just percentage wise, rough percentage wise versus what I would get from CBD with this cocrystal.

Andy Yates:
I would love to be able to give you a flavor of that. We’re actually doing that work right now to understand it. And I think it would be disingenuous of me to say where those levels could be.

Matt Baum:
You scientists.

Saoirse Elizabeth O’Sullivan:
We can say in general that the fact that, and if you’re using a sublingual oil, just of any type of CBD, we’re not talking about our CBD, but probably the bioavailability is maybe 20% to 25% under the tongue, whereas if you’re just taking a cocktail or a tablet orally, it’s probably less than 10%. So just in general terms [crosstalk 00:16:30]

Matt Baum:
I was holding my bottle like, how much am I getting when I pour this in my eyeballs.

Andy Yates:
I’m sorry. I thought you were asking what the difference would be between our cocrystal and what you can get.

Matt Baum:
No. I guess just more broadly. It seems like there’s a lot of research going into this that we have found, like you said, CBD does not want to be absorbed by our body very well. So we put it in carrier liquids, we put it in powder forms. We nano encapsulated stuff.

Saoirse Elizabeth O’Sullivan:
We inhale it.

Matt Baum:
We inhale it. Yeah.

Saoirse Elizabeth O’Sullivan:
That’s what we’ve always done because actually inhalation is still the best methods, delivery methods in terms of getting as much of the drug into your system as possible. It may not stay around for very long, but there’s a reason why people have always inhaled.

Matt Baum:
Sure.

Saoirse Elizabeth O’Sullivan:
But people like to take drugs orally, people like to take tablets, as Andrew said. And if we know that with the tablet only 10% of that drug is going to get into the system, then clearly what pharmaceutical companies want to do is make a tablet that has better bioavailability because that drug is being wasted. 90% of that drug is being excreted. So it’s not good, it’s not good for the economy, it’s not good for the environment.

Matt Baum:
Yes, it’s not good for anybody.

Saoirse Elizabeth O’Sullivan:
It’s not good for the patients.

Andy Yates:
And it’s also around the variability as well. We know as Saoirse said that taking a tablet when you’ve got an empty many will be different for your bioavailability for when you take a tablet and you’ve eaten a meal, typically if the meal is fatty.

Matt Baum:
Of course.

Andy Yates:
These things can really affect. If one day it’s a 10% bioavailability and the next it’s a 25% bioavailability, you can expect that you’re going to get lower and higher efficacy and safety side effects.

Matt Baum:
Sure.

Andy Yates:
So if we can bring a crystal to the market, which does things just more reproducibly, both within the same patient and between patients so that every person in the clinical trial, every person using the drug, you take the pill, you get 20%, that’s a much better place than where we are now, where it’s a bit of a sort of coin toss of whether you’re going to get a low or a high dose today.

Matt Baum:
Right. So just the fact that you can establish what we all got X, that’s a starting point that we have not had-

Andy Yates:
Absolutely.

Will cocrystals change the CBD market?

Matt Baum:
… up to this point yet, because of all the different ways that it’s being taken, the different ways it’s being delivered, to the different potencies and whatnot. Now this sure sounds like when this research comes out and it’s accepted, it sure sounds like it’s kind of going to blow the entire CBD market up pretty badly, in the sense that a lot of people that are making claims, which is good. I think it’s a good thing, but a lot of people that are making claims like this is the best way to do it, or we have the highest quality or all of a sudden the bioavailability is going to come into play. And now that you can prove, well, this cocrystal increases bioavailability, this is kind of where everybody has to go next, right?

Andy Yates:
So I think for me, it’s yeah, it is. I think you’ve hit the nail on the head. If this delivers everything we think it can deliver, promise what you think it can promise, then it is a game changer for CBD in many respects, because suddenly it’s the go-to form. And we’re talking here whether it’s be the wellbeing market, the one that we, over-the-counter, but particularly in the pharmaceutical field, it’s the go-to form that you would be putting your money, your energy into so that the patients are getting that reliable, consistent dosing and stay higher dosing.
For the pharmaceutical industry, as one of the connotation. And sometimes profits and intellectual property is a bit of a dirty word. But in order for any pharmaceutical company to spend the tens/hundreds of millions of dollars to turn a drug into a PTSD therapy or a PTSD therapy or another therapy area, it has to know that it’s able to recover and make some money for it’s shareholders who put their money in at risk.

Matt Baum:
Of course.

Andy Yates:
And what we found so far, and if you look at a company like GW, is that it stayed away from areas which it doesn’t have this, what they call orphan drug protection behind it. So all of these conditions that their trial in, their drug in tends to be in small groups of patients that they wouldn’t normally have a therapy designed for them, but people like the FDA and the European equivalents give us special dispensation for people who develop medicines in orphan drugs. And one of them is they call it data exclusivity. So if you spend money, develop a drug in an orphan indication, you get rewarded by the regulators with a longer period of time before people can start piggybacking on your data.

Matt Baum:
That’s amazing.

Andy Yates:
That’s great.

Matt Baum:
So if you do that here, you just get fired and then you get made fun of in the news. And maybe you get shot. I don’t know, it’s America. So things are crazy right now.

Andy Yates:
That’s right. It’s really great. But what it does do is it limits where people will spend their money developing CBD right now.

Matt Baum:
Sure.

Andy Yates:
And I think with a cocrystal, you take the handcuffs off and you allow people like Artelo, or it may be others that want to come in and work with Artelo and borrow or pay us to borrow our technology. Suddenly you can start developing in diseases that aren’t orphan drug and know that your investment is protected through the patent that you brought up right at the very beginning of the show.

Matt Baum:
Right. It’s kind of an early game, but it’s a game you have to play if you’re going to bring this to market. And if this will do what you think it’s going to do… It’s pretty amazing because like you said, there can’t be a whole lot of money in PTSD treatment. It’s not like something we see TV commercials. Do you have PTSD? Maybe you can talk to your doctor about [Narco flex 00:22:39] or whatever. So I think the fact that you, it makes me feel a little better that you guys are developing a drug for something like PTSD to show that it works there. And then from there it opens up.

The immense potential of CBD drugs

Saoirse Elizabeth O’Sullivan:
And then you go on. Yeah. As Andy is saying, the beauty here is with that IP behind you, you have the potential to go into much bigger patient populations. But ultimately this is going to be good to patients because Epidiolex is only available for these very rare forms of epilepsy, but every kid with epilepsy wants it, but that’s not what it has it’s license for, because they’ve down that route, whereas if we can produce something which is going to hit a much bigger patient population, then that’s obviously going to be really good.
And yeah, you start with PTSD, but then you might go into generalized anxiety, then you might go into other mental health conditions or a sleep, if you get a good signal with sleep, you might go into insomnia. You’ve just got to start somewhere and somewhere where you’ve got good hope that it’s going to be successful as well.
And actually PTSD is on the rise. And especially in the post COVID era, there’s going to be an awful lot more PTSD. And that’s something that we are quite mindful of. There’s going to be an awful lot of people who suffer with mental health conditions because of the pandemic and the impact that it’s had on them socially and financially. It’s huge. And the estimates of the rates of PTSD are that they’re going to really significantly increase. And especially in frontline workers, people who’ve been exposed to the disease.

Matt Baum:
Most definitely.

Saoirse Elizabeth O’Sullivan:
So we can see that in the short term, this is going to be a really important [Marcus 00:24:19] to be proving the cocrystal in.

Matt Baum:
So let’s talk about sleep for a second, because you brought that up earlier about how it’s excellent in treating PTSD or any trauma, sleep is definitely one of the biggest issues. Now, this molecule, pardon me, this molecule that you have created, this cocrystal, binds really well as CBD. We’re seeing a lot of companies in the industry saying that CBN, a different cannabinoid, is very useful in sleep. Will this cocrystal behave the same with something like CBN, or is that a whole different jerk of a molecule that needs an entirely different buddy or something?

Saoirse Elizabeth O’Sullivan:
The CBN is a completely different molecule. And actually it’s funny because it often has a reputation for being sleep enhancing, but it actually doesn’t have as much evidence as CBD does for sleep disorders.

Matt Baum:
Really?

Saoirse Elizabeth O’Sullivan:
No, CBD definitely has far better evidence. There’s very little clinical use of CBN, if any that I can think of, I can’t think of any clinical trial.

Matt Baum:
Yeah. It’s very new. And the same with CBG, is another one.

Saoirse Elizabeth O’Sullivan:
With CBN, yes. So this is definitely an anecdote rather than something which has an evidence base. Whereas at least with CBD, we do have an evidence-based. There is randomized control data either where sleep has been looked at as the primary endpoint. So specifically in people who have sleep disorders, but more often what you see in a clinical trial is that the CBD is being used for something else but sleep is coming back consistently as being one of the other symptoms that’s positively affected by CBD. So it’s one of the secondary findings of a trial.
So we have quite a lot of information with CBD in areas like autism, Parkinson’s, Crohn’s disease, or there’s types of conditions where people are reporting that they’re sleeping better when they’re taking CBD. And actually being sleepy is also one of the side effects of CBD. So we have that as a signal as well. So I think CBN has the rep, but probably CBD has a better evidence base.

Matt Baum:
Got you. So it’s one of those things where, and I realized I may be asking you out of your field here because you’ve been focusing on one thing, but it does seem like the claims are being made again. And with a health claim like sleep, it’s not like you’re saying, hey you blind guy, you’ll be able to see again. That would be a health claim that can’t make, but something like sleep, I take a CBD with CBN in it to help with sleep. And chances are, from what it sounds like you’re saying, it’s the CBD that’s putting me to bed.

Saoirse Elizabeth O’Sullivan:
Until somebody does the trial and convinces me otherwise, all I can go on is the data that I have seen and I haven’t seen data with CBN. So it might be excellent, but nobody has tested it yet. So yeah, it could be that people find us goods, there could be anecdotes of it. And that’s a great place to start if you want to design a study, but we just don’t have that kind of empirical evidence [crosstalk 00:27:32] about CBN.

Matt Baum:
Sure.

Saoirse Elizabeth O’Sullivan:
And it may be that the combination is excellent. If you were designing something which was purely a sleep aid, then maybe a combination of CBN and CBD is and great.

Matt Baum:
But we got to do the work first.

Saoirse Elizabeth O’Sullivan:
Yeah. We’re just not at that level of kind of granularity, I think in cannabis-based medicines of knowing exactly which combinations of compounds to put together. But the probability is that CBN is probably just like CBD in that in most of these compounds from the plant are very fussy lipophilic. And so they all have these problems that they’re not very well absorbed. So it may be that CBN needs a friend as well.

Matt Baum:
Just a different friend. We’ll find out.

Saoirse Elizabeth O’Sullivan:
Yeah. Who knows what the friend will be.

The future of cocrystals and CBD

Matt Baum:
How far away are we? So I assume if you’re talking to a podcast or in Omaha, Nebraska, right now, you guys feel pretty positive that this is coming through and it’s going to happen. How far out are we from this cocrystal exploding onto the scene?

Saoirse Elizabeth O’Sullivan:
Andy you’re better at these, understanding the length of pipelines.

Andy Yates:
I think in something like PTSD, which has already got a good evidence-base in it, which is one of the reasons we chose to develop in that area. We’re looking roughly at being able to generate clinical data. So the sort of data where Saoirse said before, where we have compelling evidence that our cocrystal does something in PTSD.
I would say looking at sort of a two to three year time horizon for where we are now, before you’d be seeing that data come out. Beyond that, to get something which would be available to go to your doctor, your physician for, you’re probably looking at another two to three years on top of that. That’s the realistic sort of timeframe that you’re looking out for a true drug developer to do this,
That being said, Artelo bio-sciences aren’t exploring this, but potentially people might want to come and talk to us about using this cocrystal in the wellbeing market. And if that’s the case, then obviously without putting claims behind it, but potentially having knowledge that this is better absorbed or more consistently absorbed by the body. This could be available on the shelves within a year if it wanted to be used in that sort of way.

Matt Baum:
So I’m not asking you to bust any deals here, but have you been approached by anyone? Because I guess I was of the mindset that, and I don’t know how this works, but I was of the mindset that once you to go down this pharmaceutical path, we do not sway from it, we’re not allowed to. I thought maybe there was a direct line. I didn’t know that you could be approached by a private company and say, we want that.

Andy Yates:
Yeah. Exactly. We’ve been approached by a lot of companies to talk about our portfolio because it’s sort of out there in the sense of all of our compounds target the endo cannabinoid system, that’s a sort of fairly hot topic and very relevant topic. So we speak to a lot of people all the time about our innovations. Obviously I couldn’t say if we’re speaking about this specifically with any partner, but what I think is of interest is that particularly in Europe. And the US has some interesting views and rules on this, but in Europe it’s clear that you could develop this in a wellbeing product and you could develop it as a pharmaceutical.
You may not wish to do that for commercial reasons, but there’s nothing stopping you from the laws and the regulations from doing that. And I don’t see why you couldn’t do that in the US particularly because it’s not approved as a medical product. And as so she said at the beginning, you have to see this molecule with its friend, the way that it’s cocrystallized, right. It’s a sort of unique sort of chemical entity. It’s got unique composition of matter. So until it is a medicine, if you wish, the analogy is it’s not a medicine, it can be put into some products to… So watch this space.

Saoirse Elizabeth O’Sullivan:
It just like kind of straight CBD is available over the counter or through Epidiolex. So it already exists in these geo world worlds.

Matt Baum:
So it’s not a matter of they could put it in a purple pill and give it a crazy name and patent it and now no one can use that crystal but of them. This is the kind of thing where yes, it could be very available and very soon.

Andy Yates:
Yeah, absolutely. It could be. If somebody wants to come and speak to us about using this in a wellbeing product, does it say that’s not Artelo’s remit. But if people want, because the thing is, with some drugs, as you probably know, they can be developed in different therapy areas and obviously we would hope to do that with the cocrystal. But sometimes it’s probably not commonly known for necessarily listeners of the show, but the pharmaceutical companies can sometimes do these types of deals. And it sort of sells the rights for the drug, the Parkinson’s disease to company A, and it sells the drugs for the treatment of pain conditions to company B. It’s called split in indications, but we’re not invoking to do that, but potentially you could see something where somebody wants to have this as a wellness product. And Artelo don’t wish to develop in that space. So yeah.

Matt Baum:
Let me ask you, are other people working on this too, because not too long ago, I spoke to a vet that was out of, I think it was Murray state, I can’t remember, left me now. But they were working on a study with aging dogs and arthritis and how CBD affected the inflammation and whatnot in the dogs. And one of the things he mentioned was, I can’t say he used the word crystal, but an element that they were working with that was increasing the bioavailability majorly. And he said, I can’t say the name, I can’t talk about it, it’s very exciting and it’s coming in. It’s huge. Was it you guys? Is it you?

Saoirse Elizabeth O’Sullivan:
Well, Andy and I can both comment on this is that it’s widely known that CBD isn’t great by itself. And so lots of people are looking at ways to improve bioavailability. They tend to use different strategies. So there’s multiple strategies in the pharmaceutical world of how you can make a drug better. And so most companies so far have focused on things like using different types of solubilizers or maybe making emulsions or non-emulsions and that those were using… So solubility enhances is probably more common. And so through that way, can they improve the bioavailability of CBD?
And so there are some, there’s not an awful lot of data out there. A lot of people have kind of claimed that their CBD has enhanced bioavailability. There are some that have shown that, have demonstrated this through proper kind of pharmacokinetic profiles. So there are people out there who have developed ways of improving the bioavailability of CBD. But just not through the cocrystal strategy. Andy and I also recently wrote a paper called, Towards Better Delivery of CBD.

Matt Baum:
Cool.

Saoirse Elizabeth O’Sullivan:
You could point people to that because it’s a really good summary of everything that people are doing in the pharmaceutical world, not just Artelo but other companies as well. And so we basically summarize the strategies of lots of different companies who are trying to make CBD better. And so it would be a really good thing to link to [crosstalk 00:35:14]

Matt Baum:
Yeah. Please shoot me that link. That sounds awesome. That sounds totally awesome.

Saoirse Elizabeth O’Sullivan:
Obviously we did that on Artelo time. So there is a, not a conflict of interest because we did it in a very independent way of just looking at what was out there. But our summary is that we think that the cocrystal, because this is a really, this is a typical strategy of pharmaceutical companies to do the cocrystals. And so we think it is applying that kind of pharmaceutical knowledge that Artelo have onto a common problem in drugs. Cannabis isn’t unique or cannabinoids aren’t unique in having physical issues. And so there are lots of different ways that people can approach this. And I think Artelo have done a very smart job of making CBD better.

Matt Baum:
This really sounds like it’s going to change everything. Not to mention the fact that once we can get something like a cocrystal that like you said, can prove that it’s delivering X, a value of some kind. I think that’ll go a long way with the American FDA setting up rules as well, because we can establish something and say, all right, this is exactly what it’s putting in your body. And right now, maybe you’re drinking olive oil. You know what I mean?

Saoirse Elizabeth O’Sullivan:
We actually did a study last year, and then I work for another organization in the UK called The Center for Medicinal Cannabis. And we actually took 30 over-the-counter, CBD products and we did find that one of them with a fairly hefty price tag was just olive oil, there were no cannabinoids in there.
So there was a lot of issues in the over-the-counter CBD markets. And Andy’s working really hard in the UK trying to solve those issues and have some regulation in the industry. Even when you have a good product, the best that it can be is still probably not as good as a consumer would want from a product. And the basis, something we didn’t really mention is that in a lot of the medicinal uses of CBD, you do need quite a lot of the molecule within your body for it to have the pharmacological effects that you need. And for that kind of dosing, it’s very difficult to achieve that with sublingual oils.

Matt Baum:
Oh yeah, definitely.

Saoirse Elizabeth O’Sullivan:
It’s very difficult to get hundreds of milligrams of cannabidiol into your body using an oil. It just doesn’t. It’s not a very effective way of drug delivery. It doesn’t taste good, you’re never quite sure exactly how much, you’re guessing because you’re using a dropper trying to figure it out by yourself. Tablets are consistent, you know if you take a paracetamol it’s 500 milligrams of paracetamol to go with. Wherever you go, that’s how it comes.
We need to get to a very pharmaceutical way of delivering basic cannabinoids. If we want them to really be the best that they can be, we’ve got to have that approach to them. And tinctures and oils and foods for me are not necessarily the best way of if you want it for medicinal reasons. Now I’m not talking about what are the reasons you might be taking them. But if you were trying to cure an ailment, you need to know what dose you’re getting.

Matt Baum:
Sure. If you’re targeting an anxiety, for example, then we need to target the anxiety and we need to make sure everything we are shooting at it is getting to the anxiety.

Saoirse Elizabeth O’Sullivan:
Yes. And that’s why you need a product that you can have reliability and consistency and have good stability and absorption, and all the other things that over-the-counter medications should have.

Matt Baum:
Right. And you can write that right on the side of the bottle and say, this is exactly what it does and we know that. That’s important. I think you guys are doing the work of the CBD angels right now honestly, thank you.

Final thoughts from Matt

I want to thank Dr. Andy and Professor Saoirse so much for coming on this show, putting up with my uninformed BS and gently correcting me. And to also just for boiling a very heady, intense pharmacological discussion into something that we can all understand. And I cannot stress how important what they’re working on is. If this cocrystal can do what they say it can do, it literally changes everything. We’re talking about better dosages, real dosages, putting less CVD into your dose, which brings the price of CBD down.

I will have links to the paper they wrote in the show notes and I will also have a link to the episode I mentioned where I interviewed Dr. Matthew Halbert about aging dogs and arthritis, and how CBD is helping them.
Speaking of show notes here at the Ministry of Hemp, we believe that a more accessible world is a better world for everyone. So you can find a complete written transcript for this show in those show notes that I was just talking about.

That is about it for this episode. Thank you again for listening, for downloading, for interacting. And if you have questions about what you heard, I’m going to repeat myself, but call us at (402) 819-6417 and leave your hemp and CBD related questions. Now, those are questions about how it works, not telling me that you want to buy some, because people do that a lot. And that’s great. And we’ve got all kinds of trusted brands that you can find right here on ministryofhemp.com. Speaking of ministryofhemp.com, get over there and check out our new review of the level two. It’s an infusion machine that allows you to make things like infused hemp butter and oil, which is fun. We also have just in time for the holidays, our best 11 CBD skincare and hemp beauty products to help you create a hempy skincare routine.

And if that’s not enough for you, follow us on all of our social media, Twitter, Instagram, Facebook, just search Ministry of Hemp. You’ll find us. We’re always putting up all of quality information. And if you appreciate this quality, hemp education, then please go to Patrion/ministry of hemp, and become a ministry of hemp insider. It is the best way to help us out, keep the show going and keep us putting out high quality researched information on hemp and hemp products.

Also, it gets you access to all kinds of early articles and podcast extras. Like this week, I am talking with Dr. Andy about his side gig working with the UK health system to make sure that CBD and other wellness companies are held to a very high standard when it comes to what is actually in the bottle. I’m sure could use someone like that here in the United States.

Luckily, you got us to help you with that. Like I mentioned, we have a trusted brand section at ministryofhemp.com and we have our own seal which says, we researched it, we checked out the lab testing and we know these people are for real. Next time on the show, we’re going to talk about hemp straws and a company that is making them the right way and why hemp plastic might not be as cool as we think it is. And guess what? I’m guilty of that, but hey, I’m here to learn and I’m glad that you guys are here to learn with me.

Now it’s starting to get cold outside and COVID numbers are starting to spike again, so please take care of yourselves out there, wash your hands, wear a mask. If you’re feeling anxious, up your CVD dosage a little bit. I know I have, and it’s really helped. Don’t forget to take care of yourself, take care of others and make good decisions, will you? This is Matt Baum with the Ministry of Hemp signing off.

CBD cocrystals could improve bioavailability and change how we take CBD. Photo: Green crystals such as emeralds, clustered together naturally. A dark green hemp leaf is superimposed on the image.
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Episode Transcript

Speaker 0 00:00:00 I'm Matt balm. And this is the ministry of hemp podcast brought to you by ministry of hemp.com. America's leading advocate for hemp and hemp education. Speaker 1 00:00:08 <inaudible> Speaker 2 00:00:17 Welcome to episode 62 in ministry of hemp podcast and in the little over a year that I've been doing this show. I've learned a lot about you guys. So listeners not just from talking to you when you call our full mine at (402) 819-6417, which you can call, leave a message with your questions. At any time. We love to answer your questions on the show. I've also learned a lot about you guys from the comments that are left on the podcast posts on our website, ministry of hemp.com based on your calls and your comments. It seems like there are a lot of you that are interested in wellness. And then there are others of you that are interested in medicine medicine. As in, I have a condition, will this help and wellness being, Hey, I know I feel better when I do this after I work out or this helps me sleep, neither of which are bad, but on the medicine side, things can get really scary for some people. When we start talking about pharmaceuticals and pharmaceutical companies, Speaker 2 00:01:23 I'm not going to get into the debate of whether or not they are giant evil corporations controlled by lizard. People who want to drug Gus through the gills. So he can't pay attention to what's going on anymore. Although 2020 did kind of feel like that. But I will say there is something to be said for the rigorous amount of testing and study that goes into producing a drug for human consumption today on the show, I'm going to talk to two scientists. They're both out of England and they're both scientific advisors for a company called <inaudible>. They recently wrote a paper about increasing the bioavailability of CBD. Now we know that there is evidence that CBD has certain effects on the human body and the brain that helps with anxiety. It can help with pain and inflammation, but one of the major problems with CBD is it's very hard for your body to process it, to actually pull it in and take it out of whatever it's in and introduce it into your bloodstream, where it needs to get. And that's why a lot of different companies infuse it into tinctures and oils and pills and whatnot. What they are working on is called a co crystal, which is fairly popular in pharmaceutical, from what I understand from our conversation, but this co crystal basically bonds with the CBD molecule and makes it far more bioavailable than it's ever been before. This was an amazing conversation. And you're going to hear in the very beginning, I had no idea what I was talking about Speaker 3 00:03:00 Going into it. I was trying to sound smart and they very quickly correct me. And then we have a really good conversation. Now we're not going to get into crazy heavy science here. I promise, but what they are talking about could really change this business and just blow it wide open today on the show, I'm speaking with professor sear, HSA Elizabeth O. Sullivan and dr. Andy Yates, like I said, the two work together with our Tello to create something really incredible. And the more incredible part is it's not far off, it could be coming soon. Here's my conversation with professor sear show Elizabeth Sullivan and dr. Andrew Yates. So we are going to talk about a drug that you guys are developing, and it's one of the first patents and correct me if I'm wrong here. But from what I understand, it's one of the first pharmaceutical patents that has been issued using CBD or hemp. Speaker 4 00:03:58 So I, I wouldn't say that it's necessarily the first patent because other people have patents. For example, GW pharmaceuticals have patents on their version of CBD that they use in epilepsy. Um, it's just probably the first composition of musher patent. Is that right? And in terms of a new molecular structure or a new way of presenting CBD in this Coke or format. So it's not a, it's not a use patent, it's a compensation of Marcia. Um, there's probably other kind of structural variants on CBD where people have kind of played around with the molecular structure and there'll be patterns on those also. Um, but in terms of kind of pure CBD, this would be, um, a first. Speaker 3 00:04:49 Okay. So let's talk about that for a second. I mean, we're talking about the molecular structure and you guys have come up with a new, you use the word crystalline structure basically. So what is the structure that we start with when we're looking at? I didn't tell me if I'm using the words, right. A CBD molecule molecule. Yes. Okay. No, that's right. Yeah. Yeah. Okay. Speaker 4 00:05:12 How it's built out of its different elements. Yeah. Is the molecular is the molecular structure. Um, and so CBD is CBD when you put together those, um, elements in the right order, in the right orientation, you come up with the molecule that is CBD. Speaker 3 00:05:29 Okay. And you guys have affected it in a way that you can make it more potent, more or less. Speaker 4 00:05:35 And so what, what, um, our Tello have done is they've formed a co crystal. So this is where you take, um, a molecule of CBD and you bring it together with another compound, which in our case is, um, uh, a molecule that's used in Chinese medicine. So they've brought them together in what's called a co crystal. And so that changes the physical properties of the molecule because CBD has some physical properties that don't make it very easily usable as a medicine. So we need to try and improve its solubility and its absorption. And one way that pharmaceutical companies go by fast is to make something as eco crystal and attach it onto something else. And that can change the physical properties of the molecule that you're interested in, in, in order to make it more druggable and easier to give, to press in and basically better and more consistent exposure to drugs within the patient. Speaker 5 00:06:33 Yeah. Go ahead. And just say, if I may come in, we've taken everything that we love. If you wish about CBD, Cat-Back exactly the same, but taking away some of the bits that we don't love about CBD, which is its crystallinity its melting point, potential stability and inspire availability. And we've added something else into it as an integral part of the crystal structure. Um, we hope that that will improve the way that we can use CBD as a medicine. Speaker 3 00:07:00 So basically the CBD molecule is kind of a jerk and we know it does good stuff, but this jerk doesn't want to play with your system very well. And you have created something that a friend that is saying, Hey, take it easy jerk. Let's get along. Speaker 4 00:07:17 And they held holding to this hand as they work through the body, Speaker 3 00:07:21 Walks him into the body and says, all right, see you feel better now. Right? And he goes, okay. I was nervous. It was nothing my bad. Speaker 5 00:07:30 So that's a great analogy. Very well, very well I'm for hire, if you need a PR department, right. Speaker 3 00:07:37 Let me know. I'm really good at boiling this stuff down. If nothing else, I I'll be truly, honestly, I tried to prepare for this. And I went back through like all my like college chemistry that texts like, Oh God, it's gone. It's just gone. I'm like, I'm going to sound like the biggest daddy yet. So thank you for bearing with me on this one. So the co course that you've created, you said it's from Chinese medicine. Now I am a skeptic by nature. And so when I hear a term like Chinese medicine, my first knee-jerk reaction is, Ooh, you know, like, Oh boy, that sounds a little out there and whatnot. Speaker 4 00:08:12 And it's funny because that's the reaction some people have about cannabis space medicine and the molecule that we've, you know, that we've, um, used in the co crest alyssum thing where we, we, we know the molecule really well. It's something that's really widely used in Chinese medicine and has kind of widespread clinical use lots of clinical trials. Um, the it's the particular active ingredient of this plant. It's very similar story to CBD and the cannabis plant as, as this molecule, which is called <inaudible> or TMT. And it's very, yeah, it's very analogist between the plants and these molecules Speaker 3 00:09:00 Of T of Chinese medicine in the sense that it is in, it's a part of the plant part of several plants, I guess, that are used in Chinese medicine. So it happens to be there. And I guess my question was what worried me was, like you said, there's been lots of clinical studies that show that this works as a binder. What other kinds of stuff does this TMP molecule bind to? Like, what else does it help with? Speaker 4 00:09:23 So, sorry, it's not that it, um, is used in Chinese medicine as a binder it's used as itself as the molecule, as a drug in Chinese medicine. Speaker 3 00:09:32 Oh, okay. I guess it happens to be there. Yeah. Speaker 4 00:09:36 Yeah. So, and, and to be honest, that's not why it was chosen. I mean, there was a, there was an, a chemistry screening process where lots of different potential co formers were assessed because not all, you know, you, you have the analogy of the two guys walking through the body hand in hand, not all molecules want to be friends. And there was only a few of them in the, in the chemistry screening that was done. There was only a few that actually wanted to hold hands with CBD. And it just happened that that PMP was one of them. The fact that PMP has its own own clinical profile is, is wonderful. And, uh, you know, in best case scenario might add some advantage onto the artillery CBD co crystal, but actually that's not why it's there. It's there really just to be holding the hand of CBD. And if it, if it adds to CBD then wonderful, but it was, it was kind of happenstance that it was one of the ones that, that came along that did want to hold hands for students Speaker 5 00:10:34 And also of interest to your listeners. Not only does it have a usage in traditional Chinese medicine, but it also has a, uh, use in food flavoring. It's bringing spring air coffee, Maka vibe to CBD. The tones of a TMP are used often in coffee and Maka flavored really food products. Yeah. Speaker 3 00:11:02 And you go get like a McFlurry or something, which is where we all agree is not coffee, but has the Vegas hint of coffee flavor, there could be TMP Speaker 4 00:11:10 That could be TNP in there. Yeah. Speaker 3 00:11:13 Interesting. So this drug that you are Tello is developing is going to be tested for PTSD. Speaker 4 00:11:22 Yeah. There's a variety of different, um, areas that our teller are interested in, but PTSD is definitely one of the, um, probably the first areas of interest there's other conditions in which CBD is useful, like inflammatory bowel disease and stroke. And so they're also kind of on the horizon, but PTSD is probably the first indication thus that, um, our teller would try and pursue to clinical research. Speaker 3 00:11:47 Okay. So why PTSD? How did we happen upon that? Is it because of the anti-anxiety factors of CBD? Speaker 5 00:11:54 And I guess my next question is, is it worth going after CBD to treat this so much so that you created a Coke crystal to help the body accept it better? Whereas there are already other treatments for PTSD that are out there is this one, do you believe from what you've seen in your research, do you believe this is worth it and will be a better treatment? Speaker 4 00:12:17 So both of those things are true. So, um, it's because CBD is very good at reducing anxiety and there's quite a good evidence-based from scientific and clinical literature to show that, and there's an awful lot of research going on in this area. So we are not the only people who think that CBD is a good unscientific agent. There's lots of research going on there, but in order to develop a licensed medicine, we need something that is going to be really good. Um, good bioavailability, getting good absorption and good stability or all the things you want from a good drug and have patentability because if you're going to develop a medicine, um, it's quite a costly process. So we, we need a good CBD, a reliable CBD that we can give in, in specific doses. Um, and that we can prove in an area which is probably considered to be an area of unmet need. So there are medications available for PTSD, but they're not without their side effects, right? Some of them can have limited efficacy. So I think that people who work in this area would say, there's definitely a need for a new medicine and PTSD and CBD is really emerging as something that is of interest in lots of different anxiety disorders. It's not just PTSD, but things, central anxiety disorder, generalized anxiety disorder, social phobia, there's lots of research going on that points to an controlled randomized controlled data that points to CBD being effective in these areas. Speaker 5 00:13:48 And to add two additional adds to that, the one of the other, um, big, um, parts of PTSD is, um, ability to sleep. Yeah. And CBD will, will is, is a known, um, aid to sleep in. And we think that would obviously help help the syndrome itself. Um, and the other aspect is that if, if you are not going down that route of, as you said, Copeland, get with a friend to help NS and the body, the other way of doing it, as I'm sure you've seen from shops that sell CBD is to dissolve it in oil. This is my next question. You have to hold it on your tongue. And I think what we've done with this sort of friendly crystal is that you can start to think about form relates in this now in a capsule or a pill, which I think most people would agree is a much more convenient way to take CBD for the majority of the people. Um, I'm not saying that for everyone or that companies like GW have, um, been developing medicines for children, so quite happy to put CBD in a, an oil or an alcoholic based solution. Um, so we've really got an advantage there with our co crystal, when it comes to thinking that we've we've designed or we've, pre-programmed into the solid form, some good characteristics that will make it easily or more easily, um, actionable to, to, to a tablet form. Speaker 3 00:15:14 So, Andrew, let me ask you, based on what you were saying on bioavailability, I'm glad you went there because that was my exact next question. This Coke crystal is designed to help the body except CBD better. If I'm not using that, if I just say, have a tincture, a high quality CBD tincture, like you said, and I'm putting it under my tongue, what, what would you say is the amount of CBD that I'm going to just percentage wise, what rough percentage wise versus what I would get from CBD with this Coke crystal, Speaker 5 00:15:44 I would love to be able to give you a flavor of that. We're actually doing that work right now to understand it. And I think it would be disingenuous of me to say where, where those levels could be viewed, Speaker 3 00:15:56 Uh, tests. I think Speaker 4 00:16:00 I would say in general that the fact that, and if you're using an, an, uh, a sublingual oil, just any type of CBD, we're not talking about our CBD, but probably the bioavailability is maybe 20 to 25% under the tongue. Whereas if you're just taking a capsule or a tablet orally, it's probably, you know, less than 10%. Yeah. So just in general Speaker 3 00:16:30 Was like, hold up my bottle. Like, how much am I getting when I pour this in my eyeballs? You know, Speaker 5 00:16:35 I thought you were asking what the difference would be between our co crystal and what you can get. Speaker 3 00:16:40 No, no, I, I guess I just, just more broadly, it seems like there's a lot of research going into this that is, we have found, like you said, CBD does not want to be absorbed by our body very well. So we put it in carrier liquids, we put it in powder forms. We nano encapsulated stuff. We inhale it. Speaker 4 00:17:00 That's what we've always done because actually inhalation is still the best methods delivery methods in terms of getting as much of the drug into your system as possible. It may not stay around for very long, but there's a reason why people have always inhaled. Sure. But people like to taste drugs already. People like to take tablets, as Angie said. And if we know that with the tablet, only 10% of that drug is going to get into the system. And then clearly what pharmaceutical company was wanting to do is make a tablet that is much, has better bioavailability. All of that drug is being wasted. You know, you're not 90% of that drug is being excretion. So it's not good. It's not good for the economy. It's not good for the environment. Speaker 3 00:17:42 That's not good for anybody. Yeah. Speaker 5 00:17:47 And it's also around, um, the variability as well. Um, you know, we, we know, as Sirchie said, um, that, you know, take in a tablet when you've got an empty Tomine will be different for your bioavailability for when you take a tablet and you've eaten a meal, typically it's a meals fatty, right? Um, these things can really affect, you know, if, if one day it's a 10% bioavailability and the next it's a 25% bioavailability, you can expect that you're going to get lower and higher efficacy and safety side effects. So if we can, if we can bring a crystal to the market, which does things just more reproducibly, both within the same patient and between patients so that, you know, every person in the clinical trial, every person using the drug, you take the pill, you get 20%, that's a much better place than where we are now, where it's a bit of a sort of coin toss of whether you're going to get a low or a high dose today. Speaker 3 00:18:49 So just the fact that you can establish what we all got X that's a starting point that we have not had up to this point yet, because of all the different ways that it's being taken, the different ways it's being delivered, the different potencies and whatnot. Speaker 5 00:19:03 Yep. This sure. Sounds like when this research comes out and it's accepted it sure. Sounds like it's going to blow Speaker 3 00:19:11 The entire CBD market up pretty Speaker 5 00:19:13 Badly in the sense that a lot of people Speaker 3 00:19:17 That are making claims, which is good. I think it's a good thing. But a lot of people that are making claims like this is the best way to do it, or we have the highest quality or Speaker 5 00:19:25 All of a sudden the bioavailability Speaker 3 00:19:27 Is going to come into play. And now that Speaker 5 00:19:29 You can prove, well, this cold Speaker 3 00:19:32 Crystal increases bioavailability, this is kind of where everybody has to go next. Speaker 5 00:19:37 Right. So I think for me, it's yeah, it is. Um, you know, I think you've, you've hit the nail on the head. If this delivers everything, we think it can deliver promise what we think it can promise than it is a game changer for CBD in many respects, because certainly it's the go-to form we're talking here, whether it's be the wellbeing market, the one that we over the counter, but particularly in the pharmaceutical field, it's the go-to form that you would be putting your money, your energy into so that the patients are getting that reliable, consistent dosing stay high at OSA for the pharmaceutical industry. It has one of the connotation and sometimes, you know, profits and intellectual property is a sort of a bit of a dirty word. But in order for any pharmaceutical company to spend the tens stroke, hundreds of millions of dollars to turn a drug into a PTSD therapy or a PTSD therapy or a, uh, another, um, the therapy area, it has to know that it's got, is able to recover and make some money for it. Speaker 5 00:20:45 Shower, put the money in a risk of course, and what we found so far. And if you look at a company like GW, is that it stayed away from areas which it doesn't have this, what they call orphan drug protection behind it. So all of these conditions that their trial in their drug in tends to be in small groups of patients, um, that the wouldn't normally have a therapy designed for them, but people like the FDA and the European equivalents give us special dispensation for people who develop medicines in orphan drugs. And one of them is they call it data exclusivity. So if you spend money, develop a drug in an orphan indication, you get rewarded by the regulators with a longer period of time before people can start piggybacking on your data. Speaker 3 00:21:33 That's great. So if you do that here, you just get fired and then you get made fun of in the news. And so, and maybe you get shot. I don't know, it's America. So things are crazy right now. Speaker 5 00:21:45 It's really great. But what it does do is it limits where people will spend their money developing CBD right now. And I think with a co crystal, you take the handcuffs off and you allow people I call tallow, or it may be others that want to come in and work with our teller and sort of borrow our, or pay us to borrow our technology. Suddenly you can start developing in diseases that aren't orphan drug though, that you're, um, you know, that your investment is protected through the pattern that you brought up right. At the very beginning of the, of the show, Speaker 3 00:22:16 Right? It's, it's kind of an early game, but it's a game you have to play. If you're going to bring this to market. And if this will do what we, what you think it's going to do, I mean, it's pretty amazing. Cause like you said, there can't be a whole lot of money in PTSD treatment. It's not like something we see TV commercials, right? Do you have PTSD? Maybe you can talk to your doctor about, you know, narco flex or whatever, you know? So I think the fact that you, it makes me feel a little better that you guys are developing a drug for something like PTSD to show that it works there and then from there, Speaker 4 00:22:52 And then you go on. Yeah, yeah. I mean, and that's as Andy, you're saying the beauty is with, with that IP behind you, you have the potential to go into much bigger patient populations. Right. But ultimately this is going to be good to patients because you know, at the dialects is only available for these very rare forms of epilepsy, but everybody, every kid with epilepsy wants it, but that's not what it has its license for because they've gone, then that reach. Whereas, you know, if we can produce something which is going to hit a much bigger patient population, then that's obviously going to be really good and yeah, you start with PTSD, but then you might go into generalized anxiety. Then you might go into other mental health conditions are asleep. You know, if you've got a good signal with sleep, you might mention Somnia. Speaker 4 00:23:34 You've just got to start somewhere and somewhere where you've got a good hope that it's going to be successful as well. And actually, you know, PTSD is on the rise. And especially in, in the post COVID era, there's going to be an awful lot more PTSD. And that's something that we are quite mindful of. There's going to be an awful lot of people who suffer with mental health conditions because of the pandemic and the impact that it's had on them socially and financially. It's huge. Um, and, and the estimates of the rates of PTSD are, are, are, are that they're going to really significantly increase. And especially in frontline workers, people who've been exposed to. So, you know, we can see that in the short term, this is going to be, you know, a really important Marcus, um, to be proving <inaudible>. Speaker 3 00:24:23 So let me, let's talk about sleep for a second because you brought that up earlier about how it's excellent. I mean, in treating PTSD or any trauma sleep is definitely one of the biggest issues. Now, this molecule, pardon me, this molecule that you have created this co crystal binds really well with CBD. We're seeing a lot of companies in the industry saying that CBN, a different cannabinoid is very useful and sleep. Will this Coke crystal behave the same with something like CBN, or is that a whole different jerk of a molecule that needs you can entirely different buddy or something. Speaker 4 00:24:59 So CBN is a completely different molecule. Um, and actually it's, it's funny because it often has a reputation for being steeped in hunting, but it actually doesn't have as much evidence as CBD does for sleep disorders. CBD definitely has far better evidence and back, you know, there's very little clinical use of CBN. If any, that I can think of, I can't think of any clinical trials. Speaker 3 00:25:22 It's very new for <inaudible>. Speaker 4 00:25:26 This is definitely an anecdote, uh, rather than something which has an evidence-based. Whereas at least with CBD, we do have an evidence-based. There is, um, randomized control data either where CBD, where I sleep has been looked at as the primary endpoint. So specifically in people who have sleep disorders, but action, more often what you see in a, in a clinical trial is that the CBD is being used for something else, but sleep is, is coming back consistently as being one of the other symptoms of positively affected by CBD so that the secondary findings of a trial. So we have quite a lot of information with CBD and in areas like autism Parkinson's Crohn's disease, that other types of conditions where people are reporting that they're sleeping better when they're taking CBD and actually being sleepy as also one of the side effects of CBD. So it has that as a signal as well. So, um, I think CBN has the rep, but probably CBD has a better evidence. Speaker 3 00:26:29 Gotcha. So it's one of those things where, and I realized, I may be asking you out of your field here because you've been focusing on one thing, but it does seem like the claims are being made again and with a health claim, like sleep, uh, know, it's not like you're Speaker 5 00:26:44 Saying we're going to hit you blind guy. You'll be able to see again, that's an, that would be a health claim that can't make, but something like sleep. Like I take a CBD with CBN in it for to help us sleep. And chances are from what it sounds like you're saying it's the CBD that's putting me to bed. Speaker 4 00:27:02 Um, I would say I would, I am until somebody does the trial and convinces me otherwise, all I can go off on is the data that I have seen. And I haven't seen data with CBN, so it might be excellent. Right. But you know, nobody has tested it yet. So, um, yeah, it, it could be that people find us good. There could be anecdotes of it. And that's a great place to start if you're, if you want to design a study, but we just don't have that kind of empirical evidence. So, and it may be that the combination is accent. You know, if you were designing something which was purely a sleep aid, then maybe a combination of CBN and CBD is great. But I think, yeah, we're just not at that level of kind of granularity, I think, in, in cannabis based medicines of knowing exactly which combinations of campaigns to put together. But the probability is a CBN is probably just like CBD and that most of these campaigns from the plant are very fancy lipophilic. And so they all have these problems that they're not very well absorbed. So it may be that CBN needs a friend as well, Speaker 5 00:28:11 Just a different friend we'll find out Speaker 4 00:28:14 Who knows what the friend will be, how far away are we at? Speaker 5 00:28:18 So, I mean, I assume if you're talking to a podcast or in Omaha, Nebraska, right now, you guys feel pretty positive that this is coming through and it's going to happen. How far out are we from this cold crystal exploding onto the scene Speaker 4 00:28:33 And do what you're better at these pipelines? Speaker 5 00:28:38 I think in something like PTSD, which has already got a good evidence-base in it, which is one of the reasons we chose to, um, chose to develop in that area. We're looking at roughly it's, um, being able to generate clinical data. So the sort of data where we're, so she's had before, where we have, you know, compelling evidence that our code crystal does something in PTSD. I would say looking at sort of a, um, a two to three year time horizon for where we are now, before you'd be seeing that data come out beyond that, to get something which you know, would be available to go to your G your doctor, your physician for, um, you probably looking at another two to three years on top of that, that's the realistic sort of timeframe that you're looking out for a true drug developer, um, to do this, that being said, um, you know, we, this year, we, we, our telos bio sciences, aren't exploring this, but potentially, you know, people might want to come and talk to us about using this co crystal in the wellbeing market. And if that's the case, then obviously without putting claims behind it, but potentially having knowledge that this is better absorbed or more consistently absorbed by the body. Um, this could be available on the shelves, you know, within a year, if, if it wanted to be, um, used in that sort of way, Speaker 3 00:30:02 Bust any deals here. But have you been approached by anyone? Because I guess I was of the mindset that, and I don't know how this works, but I was of the mindset that wants you to go down this pharmaceutical path. We do not sway from it. Like we're not allowed to, I, like I thought maybe there was a direct line. I didn't know that you could be approached by like a private company and say, we want that. Speaker 5 00:30:24 Yeah, exactly. I mean, we we've been approached by a lot of companies to talk about our portfolio because, you know, it's sort of out there in the sense of all, all of our compounds target, the endo cannabinoid system, that's the sort of fairly hot topic, very relevant topics. So we speak to a lot of people all the time about our innovations. I mean, obviously I couldn't say if we're speaking about this specifically with Emmy partner, but what I think is of interest is that particularly in your opinion, the us has some interesting views and rules on this, but in your it's clear that you could develop this in a wellbeing product and you could develop it as a pharmaceutical. Um, you may not wish to do that for commercial reasons, but there's nothing stopping you from the laws and the regulations from doing that. And I don't see why you couldn't do that in the U S particularly because it's not approved medical products. Um, and so she said at the beginning, you have to see this molecule with its friend, the way that it's co crystallized, it's a sort of unique sort of chemical entity. It's, it's got unique composition of matter. So until it's, until it is a Madison, if you wish the analogy is it's not a medicine, it can be put into some products to so, you know, watch this space Speaker 4 00:31:42 Just like pure. It just like kind of straight CBD is available over the counter or through epidata annex. So it already exists in the real world, right? Speaker 3 00:31:52 So it's not a matter of like, they could put it in a purple pill and give it a crazy name and patent it. And now no one can use that. Chris, a little bit of them. This is the kind of thing where yes, it could be very available and very soon. Speaker 5 00:32:04 Yeah, absolutely. It could be, if it, if somebody wants to come and speak to us about using this in a wellbeing product, does it say that's not our tellers remit, but if people want, because the thing is, I mean, with, with some drugs, as you probably know, they can be, they can be developed in different therapy areas. And obviously we would hope to do that with the co crystal, but sometimes it's probably not commonly known for necessarily listeners of the show, but pharmaceutical companies can sometimes do these types of deals. And it sort of cells the cells, the rights for the drug Parkinson's disease to company a and sells the drugs for the treatment of pain conditions to company B it's called split in indications right now. We're not, we're not invoking to do that, but potentially you could see something where somebody wants to have this as a wellness product. And, uh, I'll tell, I don't wish to develop it in that space. So yeah. Speaker 3 00:32:57 Let me, let me ask you are other people working on this too, because not too long ago, I spoke to a vet that was out of, I think it was Murray state. I can't remember for the life of me now, but they were working on a study with aging dogs and arthritis and how CBD affected the inflammation and whatnot in the dogs. And one of the things he mentioned was, I can't say he used the word crystal, but an element that they were working with that was increasing the bioavailability majorly. And he said, I can't say the name. I can't talk about it. It's very exciting. And it's coming in. It's huge. Was it you guys, is it, is it you? Speaker 4 00:33:40 Well, Andy and I can both comment on this is that, um, it, it's, it's widely known that CBD isn't great by itself. And so lots of people are looking at ways to improve bioavailability. They tend to use different strategies. So there's multiple strategies in the pharmaceutical world of how to make a drug better. Um, and so most companies so far have focused on things like using different types of solubilizers or maybe making emulsions or none of emotions, um, and, and that, you know, or using, yeah, so using solubility enhances is probably more common. And, and, and so through that way, can they improve the vibe bioavailability of CBD? And so there are some, th there's not an awful lot of data out there. A lot of people kind of claim that their, their CBD has enhanced bioavailability. There are some, some that have shown that have demonstrated this through true proper kind of pharmacy pharmacokinetic profiles. Speaker 4 00:34:39 So there are people out there who have developed ways of improving the bioavailability of CBD. Um, but, but just not through Ark, the co crystal strategy. And then I also recently wrote a paper called towards better delivery of CBD. You could point people to that because it's a really good summary of everything that people are doing in the pharmaceutical world, not just our teller, but other companies as well. And so we basically summarized the strategies of lots of different companies who are trying to make CBD better. Right. So it, it, it would be a really good thing to link to shoot me that link. Yeah. Yeah. Speaker 3 00:35:17 That sounds totally, Speaker 4 00:35:20 Obviously we did that on our tallow time. So there is a, you know, not a conflict of interest because we, we did it in a very independent way of just looking at what was out there. Um, but you know, our summary is that we think that the Coke crystal, because this is a really, this is a typical strategy of pharmaceutical to do the Coke wrestles. And so we think it is applying that kind of pharmaceutical knowledge that our tallow have on to a common problem in drugs, you know, cannabis isn't unique or cannabinoids aren't unique and having, um, physical issues. And so there are lots of different ways that people can approach this. And I think our talent have done a very smart job of, of making CBD better. Speaker 3 00:36:02 I mean, this really sounds like it's going to change everything. Like not to mention the fact that once we can get something like a Coke crystal, that like you said, can prove that it's delivering X a value of some kind. I think that'll go a long way with the American FDA setting up rules as well, because we can establish something and say, all right, this is exactly what it's putting in your body. And right now, maybe you're drinking olive oil. You know what I mean? It's, Speaker 4 00:36:31 I mean, we actually did a study last year, and then I worked for another organization in the UK called the center for medicinal cannabis. And we actually took 30 over the counter a CBD products. And we did find that one of them with a fairly hefty price tag was just olive oil. There were no cannabinoids in there. So, you know, the, the, there was a lot of, um, issues in the over-the-counter CBD Marcus. And, you know, and Andy's working really hard in the UK trying to, um, solve those issues and, and have some regulation in the industry. Um, you know, even, even when you have a good product, the best that it can be is still probably not as good as a consumer would want from a product. Right. And the basis. I mean, something we didn't really mention is that in a lot of the medicinal uses of CBD, you do need quite a lot of the molecule within your body for it to have the pharmacological effects that, and for that kind of dosing that, you know, it's very difficult to achieve that with sublingual oils. Speaker 4 00:37:35 It's very difficult to get hundreds of milligrams of cannabidiol into your body using an oil. It just doesn't, it's not, it's not a very effective way of drug delivery. It doesn't taste good. You're never quite sure exactly how much you're getting, because you're using a dropper trying to figure it out by yourself. You know, tablets tell us a consistent, you know, if you take a pair of small, it's 500 milligrams apart, wherever you go, that's how it comes. You know, we need to get to a very, um, you know, pharmacy school way of delivering twice cannabinoids. If, if we want them to, to really be the best that they can be, right. We've got to have that approach to them and pinchers and oils and foods from me are not necessarily the best way of if you want it from additional reasons. Now I'm not talking about what are the reasons you might be taking them. But if you were trying to cure an ailment, you need to know what those you're getting. Sure. Speaker 3 00:38:30 If you're targeting and anxiety, for example, then we need to target the anxiety. We need to make sure Speaker 2 00:38:36 Everything we are shooting at it is getting to the anxiety. Speaker 4 00:38:40 Yes. Um, so, and that's why you need a, uh, you know, a product that you can have reliability and consistency and have good stability and absorption, and all the other things that, you know, over the counter medications should have. Speaker 2 00:38:54 Right. And you can write that right on the side of the bottle and say, this is exactly what it does. And we know that that's important. I think you guys are doing the work of the CBD angels right now. Honestly, thank you. Speaker 2 00:39:12 I want to thank dr. Andy and professor. <inaudible> so much for coming on this show, putting up with my own informed BS and gently correcting me. And to also just for boiling a very heavy, intense pharmacological discussion into something that we can all understand. And I cannot stress how important what they're working on is if this coal crystal can do what they say it can do. It literally changes everything we're talking about better dosages, real dosages use putting less CVD into your dose, which brings the price of CBD down. I will have links to the paper they wrote in the show notes. And I will also have a link to the episode. I mentioned where I interviewed dr. Matthew Halbert about aging dogs and arthritis, and how CBD is helping them. Speaking of show notes here at the ministry of hemp, we believe that a more accessible world is a better world for everyone. So you can find a complete written transcript for this show in those show notes that I was just talking about. Speaker 1 00:40:25 <inaudible> Speaker 2 00:40:32 That is about it for this episode. Thank you again for listening, for downloading, for interacting. And if you have questions about what you heard, I'm going to repeat myself, but call us at (402) 819-6417 and leave your hemp and CBD related questions. Now, those are questions about how it works, not telling me that you want to buy some, because people do that a lot. And that's great. And we've got all kinds of trusted brands that you can find right here on ministry of hemp.com. Speaking of ministry of hemp.com, get over there and check out our new review of the level two. It's an infusion machine that allows you to make things like infused hemp, butter and oil, which is fun. We also have just in time for the holidays, our best 11 CBD skincare and hemp beauty products to help you create a MP skincare routine. Speaker 2 00:41:24 And if that's not enough for you follow us on all of our social media, Twitter, Instagram, Facebook, just search ministry of hemp. You'll find us. We're always putting up all kinds of quality information. And if you appreciate this quality hemp education, then please go to Patrion, backslash ministry of hemp and become a ministry of hemp insider. It is the best way to help us out. Keep the show going and keep us putting out high quality researched information on hemp and hemp products. Also, it gets you access to all kinds of like early articles and podcast extras. Like this week. I am talking with dr. Andy about his side gig working with the UK health system to make sure that CBD and other wellness companies are held to a very high standard when it comes to what is actually in the bottle. I'm sure could use someone like that here in the United States. Speaker 2 00:42:21 Luckily, you got us to help you with that. Like I mentioned, we have a trusted brand section ministry of hemp.com and we have our own seal, which says we researched it. We checked out the lab testing and we know these people are for real next time on the show, we are going to talk about hemp straws and a company that is making them the right way and why hemp plastic might not be as cool as we think it is. And guess what? I'm guilty of that, but Hey, I'm here to learn and I'm glad that you guys are here to learn with me. Now it's starting to get cold outside and COVID numbers are starting to spike again. So please take care of yourselves out there, wash your hands, wear a mask. If you're feeling anxious up your CVD dosage a little bit. I know I have, and it's really helped. Don't forget to take care of yourself, take care of others and make good decisions. Will you? This is Matt balm with the ministry of hemp signing off.

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