Diana: Well, I did pharmacy straight out of school, because I wanted to work in healthcare. And I loved it. I was a pharmacist in hospital and industry, actually, and community pharmacy for about 10 years. And I was happily working in my local community pharmacy when I had a fellow come in with a script for blood pressure, and cholesterol, and acid-lowering drugs. And he went off to get his lunch. You know, normal day in the life of a pharmacist. And he came back with his lunch. And his scripts were ready, and he had in his hand a pie, a sausage roll, and a Coke. And I just thought, wow, this doesn’t add up. You know, on the one hand, he’s getting all this medicine free from the government. On the other hand, he’s just filling himself up with foods that are gonna really damage his health. So, I went home that day and enrolled in the nutrition and, well, and that ended up in the naturopathy course. I feel like maybe, for me, I’d always been interested in the whole food, kind of, the, like, food as medicine. I grew up on a farm, and, you know, it was a, like, a open spaces, real food, idyllic sort of life for a child. And I feel like what we eat, well, I know for sure, what we eat has an impact on our health, and so that sort of dragged me into naturopathy, I guess.

Andrew: Yeah. I think we need to add for our international listeners that growing up on a farm in Australia is whole food, wide-open spaces, brown snakes, spiders the size of dinner plates and everything else is out to kill you. Drop bears.

Diana: Exactly. Mouse plague.

Andrew: So, take us through… Actually, first take us through that change in paradigm shift that you had to make, from that orthodox medicine, where you’re talking about really tightly-defined, you know, drugs switch on or off, they block or they upregulate. There’s very strict things. And then you have to move into a world in, with nutrition, where we’re talking about nourishing, supporting, the more nuanced narrative, if you like. Was that a big jump for you to think about?

Diana: I don’t really think it was, because I always knew deep down that, you know, prevention is better than cure. And so, it makes much more sense, you know, and I guess I was always just aligned with that naturopathic principle, of nature as healer. So, you know, that the body has the innate ability to heal. And even though, yeah, I was sort of trained to use drugs, I felt, for my own treatment, my own health and my family’s health, I always looked at a healthy diet, exercise, meditation, all those things that I had applied to my life. So, it was really just, I guess, merging those two, the professional and the personal, and then it, I didn’t have the skills, professionally, to be able to help people. And so that’s why I went back to do the formal training. But I think…

Andrew: Gotcha.

Diana: …yeah, I always, I did, I always sort of had that sense. The leap, I think, was drugs just generally hit off on one receptor, whereas herbs and nutrients are both involved in so many different complex pathways. And so, let’s say nutrients, obviously, like magnesium and zinc, and all the vitamins, they’re involved in so many different things. And also, herbs, like, I couldn’t quite get my head around how one herb could have so many different actions. As a pharmacist, at first I thought that was nonsense until I realized that one herb has lots of compounds in it. So, you know, it’s sort of, and once I realized that, and did the pharmacology of the plants, then I realized that it makes perfect sense, and that I don’t really think that they’re…that it’s not such a big leap for me. They are, actually, sort of part of that same continuum, I guess, for healing, and helping people get better.

Andrew: Yeah. Because you didn’t, I don’t mean this glibly, “just do herbal medicine.” You did pharmacognosy, didn’t you?

Diana: That’s part of the herbal medicine course. Yeah. That’s, everybody does pharmacognosy.

Andrew: Right, right.

Diana: We did pharmacognosy as part of pharmacy. That was a small, like, I don’t know, one or two lectures, probably, back in, you know, last century sometime.

Andrew: Oh, I see.

Diana: Yeah, yeah. But I don’t know that that’s, I’m pretty sure it’s not part of the pharmacy course now.

Andrew: Yeah, right. Gotcha.

Diana: It’s, that lecture is no longer there.

Andrew: Gotcha.

Diana: But we, yeah, all herbalists do, all, you know, and naturopaths, do pharmacognosy as part of the training. And it just lit me up, though. Like, if, are you allowed to say that? I’m not sure. I found it very interesting…

Andrew: Yeah.

Diana: …the, just the way the compounds have chemicals in them, but hit off receptors, and have actions in the human body. And they’re plants, and as humans, we’ve evolved alongside them, as well as alongside the foods. And that makes sense that they should be able to help us get better.

Andrew: I’m, look, I’m so with you, particularly when we mentioned herbs, that I would feel, with my knowledge now, I would feel so frustrated being shackled by only nutrients, and not herbs, because herbs are just so beautiful to work with. I just, ahh.

Diana: Yeah. Yes. Yeah, yeah. Yeah, exactly. Yeah.

Andrew: Anyway… But…

Diana: And, equally, to be shackled by just having drugs, you know, I just couldn’t go back to work in a pharmacy now, where I was just treating symptoms. And so, that’s, I guess that’s part of it, too. It’s the paradigm shift is, in the pharmaceutical medicine world, it’s all about treating symptoms. Whereas in the naturopathic world, it’s about that underlying cause, and the nature as healer. And, yeah, that you can’t unlearn that either. So, yeah, that’s…

Andrew: Yep. Yeah. No, that’s right.

Diana: …I like to combine the two.

Andrew: All right. So, let’s dive into extemporaneous dispensing. Firstly, a definition. Extemporaneous compounding. What are we talking about here?

Diana: Well, you have to have the Latin, if you want the definition, sorry. But it does… And, you know, lots of people just sort of use the word. They don’t really know what it means. But “extempore” is the Latin for “of the time.” And it really…and “compounding” just means mixing. So, we’re mixing something at a particular time, for a particular person. So, they, actually, in English, we mostly use word “extemporaneous” for a speech. It’s not in my vocabulary much, but, for where somebody is making a speech, and they’re doing it off the cuff, or at the time. So, that’s what an extemporaneous speech would be. And it’s [inaudible 00:08:04] extemporaneous compounding is making something at the time, for an individual person.

Andrew: And the common thing is that extemporaneous dispensing is done all day, every day, by medical herbalists. And yet, when it comes to nutrients, it’s this real funny disconnect about, “Oh, no. Like, how do I open a bottle of something, of powder, and combine it with that powder?” It’s this weird reticence, that I don’t fully understand.

Diana: Yes. Yeah. Well, I think herbal manufacturing, or herbal extemporaneous compounding, is part of the herbal tradition. Herbalists have always practiced like that. Herbalists have always been taught like that. I think nutraceutical medicine is probably, well, it’s definitely newer. I think, you know, traditionally, herbalists probably used herbal medicine, and food as medicine, but they didn’t really have this other, that we now have, which is nutritional medicine. And that’s, you know, where you’re isolating the nutritional ingredients in nutritional compounds, and finding, and with testing, you know, we can now find where somebody’s got a deficiency, or where we understand the underlying role of the nutrients in metabolism, so we can see how a nutrient might help. And so, nutraceutical compounding has come into the armamentarium of a naturopath, but through the products that are ready-made, you know. But, so, all the companies that make these products for us, that’s how we’re accessing what I would call nutritional medicine. Whereas, the herbal medicine, they are available that way as well, but, you know, through all the ready-made products with herbs in them, as you would know. But they’re also available, of course, in the traditional way.

And so, this is another way of prescribing those nutritional medicines, where you would use a very similar principle to what you’re doing for an individual, for a patient with a individual prescription for herbal medicine. And actually, the rules are the same. It’s just, because we’re trained in herbal medicine manufacturing, we don’t have to think about what the rules are. But what I, I would like to go through what the rules are, because they’re…

Andrew: Please do.

Diana: …that it’s accessible to naturopaths and nutritionists, and it’s accessible because the rules are there in place, to cover them for extemporaneously combining herbs together for a patient. And so, the underlying, the laws are set up by the TGA, that say naturopaths, nutritionists, homeopaths, pharmacists, I think that’s it, have an exemption to the TGA ruling. And, you know, you would, you know that concept, the TGA exemption certificate. And we always think about that in terms of being able to access the practitioner-only products, but it actually also enables us to, if we’ve got that exemption certificate, it exempts us from the rules of otherwise manufacturing a product that the TGA sets for anybody who’s making TGA-registered or TGA-listed products, and the exemption is, we don’t have to fit those rules, because we’re extemporaneously compounding it. Does that make sense?

Andrew: But we do still have guidelines to sit within, correct?

Diana: Correct. Yeah. And so, we sit within the… Well, it’s an Australian regulatory, and I will read this, Australian regulatory guideline for complementary medicines. And if you just google that, you’ll find a big document. And within that, there’s a section about what the exemptions are for compounding. And it includes naturopaths and nutritionists.

Andrew: Gotcha. okay.

Diana: But, it’s also important to combine that with your understanding of the SUSMP, which is the Standards for the Uniform Scheduling of Medicines and Poisons. And, the, so, or the “poison schedule,” it’s known as as well. But the, so, again, if you just google SUSMP, then you can see… Like, say, for example… [inaudible 00:12:25] I looked up for somebody the other day. Oh, boric acid, I looked up for someone recently. Iodine. There are, you know, zinc is in there. Or, there are quite a few nutrients in there. Vitamin D’s in there. They’re all… There are rules about how, like, which schedule of medicines these, which schedule these medicines fit into. So, for example, zinc is unscheduled, up to 25 milligrams per dose. And it’s schedule… The rules, that, I can’t remember which schedule it is, but you have to have, on the, between 25 and 50 milligrams per dose, you have to have some writing…

Andrew: Yeah, have a warning.

Diana: …some writing on the label that says “zinc in overdose is dangerous,” and so, you know, shouldn’t be taken…it, “no more than one tablet per day should be taken of this product,” let’s say. I can’t remember the exact wording of it [crosstalk 00:13:22]

Andrew: Yeah, yeah. No, no, I totally getcha. And that’s really interesting when we’re dealing with multiple nutrients. Like, I’d never really given much thought to, we had the obligatory warnings, and certainly, those warnings which we weren’t happy about, you know, CoQ10 with warfarin, and certain things like that. TGA is very down on vitamin B6, pyridoxine, at the moment. And I see the warnings decreased from 50 milligrams in 2022 to 20 milligrams in 2023. There’s another story about what’s true, but anyway. But, I’ve never given much thought to just a safety warning rather than a danger warning, if you like. You know? So, the SUSMP…

Diana: Yeah, it’s still…but I’ve… Yeah. Yeah. And, so if you’re compounding, you need to have access to the SUSMP. It’s online. It’s very easy to find…

Andrew: Yeah.

Diana: …and it’s chunky. It’s very, it’s long. Like, every known chemical poison or otherwise is in there. And, but if it’s not in there, that means it’s not scheduled.

Andrew: Gotcha. okay.

Diana: So, but, you know, you have to be careful. But, and another example is vitamin D. You’re not allowed to compound… Well, you’re not allowed to prescribe vitamin D over 1000 international units per day, unless it’s…otherwise it’s Schedule 4, in Australia.

Andrew: Yeah, per dose.

Diana: Yeah, per day. Yeah.

Andrew: I think that’s per dose. Yeah, yeah. Yeah, you can certainly, you can increase the dosage you’re giving to somebody per day. Like, and you can use 2000, 3000 IU per day, but each unit dose has to be no more than 1000 IU, or it’s Schedule 3. Like, there’s a 7000 S3.

Diana: Oh, I see. Yes, but even that is only, it’s labeled as that’s a weekly dose. So, that is true, yeah, what you’re saying.

Andrew: Right.

Diana: But it also is true to say that you can’t label something to take, that 7000 international unit dose can’t say “take one per day.” It has to say “take one per week.” Because it’s the daily dose.

Andrew: Really? Okay.

Andrew: So, forgive me. So, are you telling me that a practitioner cannot advocate a dose greater than 1000 IU per day for any patient?

Diana: Yeah. Yeah.

Andrew: Really?

Diana: I mean, I know that, doesn’t… Oh, no. Yep. That, according strictly to the SUSMP, yep. Yeah, you can’t…

Andrew: That’s ludicrous.

Diana: You can tell the patient to do it, but you can’t put it on the label. So, you shouldn’t really tell patients to do it.

Andrew: Yeah, right. I see what you mean. Directions. Yes, yes, yes. But I think that’s where they say, “or as directed by your healthcare practitioner.” Isn’t that on the labeling?

Diana: Yeah. Yeah. Correct. That’s right. Yeah. Yes.

Andrew: Yeah, yeah. I just thought, where does stoss therapy sit, then?

Diana: Yeah, I mean, lots of people bend that rule.

Andrew: Yeah, yeah. Ah, that’s very interesting. Okay. So, take us through, though. Why are only some nutrients available in extemporaneous form?

Diana: So, it, I guess there’s two ways of looking at that question. Why are only some nutrients available, or why are some nutrients only available in extemporaneous form? So, it, why are some nutrients… And it all comes down to the TGA regulations, and that’s to do with the, like, the AUST L and the AUST R. So, if you’ve got… I don’t know whether it’s worth going over those, whether…

Andrew: Yep.

Diana: Yeah. So, the TGA, the Therapeutic Goods Administration, has the Australian Register of Therapeutic Goods, the ARTG. And on that, products are listed as either…products are on that list as either listed medicines or registered medicines. So, listed are the, those tend to be the supplements. They’re the lower, considered to be lower-risk, whereas the…and they’re, actually, they’re only assessed for quality and safety, whereas the registered products are considered to be higher-risk, and they’re assessed for quality, safety and efficacy. So, that’s the registered. They’re the drugs. The pharmaceutical drugs are all in that category. And the things that can be patented tend to be in that category, because it’s a lot of work to get a product registered, and then anybody else could just register theirs once you’ve done, like, you’ve done a lot of the work for somebody else. And so, when it’s not patented, manufacturers tend not to do that.

So, that’s the two categories AUST L or AUST R, and they’re registered on the TGA. The products that are not listed on the TGA, but a company wants to manufacture that because there’s a need, a market need for it, then they would be the products that are not on the TGA, but are available as extemporaneous compounding only. And so, they’re registered in that way, on the market. They’re not registered on the TGA. They’re sold on the market in that way because then there’s no product that’s listed or registered on the TGA, and so you’re allowed to compound it. Yeah. So, that, I mean it’s because, so, I guess there are two ways of, two things that are important, in that the products that are available as compounding products are not available in ready-made products. So, the companies create these extemporaneous products so that practitioners have access to those products even though there’s no TGA file for it. And equally, they, if a product is on the TGA, we’re not allowed to compound it.

So, you can’t, like, magnesium glycinate is a good example of that. It used to be that there was no ready-made magnesium glycinate on the market in Australia. So we used to compound it quite a lot for people, either as powder or as capsules. And PEA is another example. So, before it was available, we were able to compound it, but now it’s available on the TGA. The pharmacy guidelines say we’re not allowed to compound it now. And it would be the same. It would apply to a naturopath. And so, all equally. So, like, let’s say there’s a product on the market that’s got zinc, magnesium, B6, and, I don’t know, theanine, let’s say. Let’s say you like that formula. If there’s something on the market that’s exactly that, technically, you’re not really supposed to compound it, because there’s a ready-made product that’s considered to be safer.

Andrew: Right. Yeah. Oh, I see what you mean. That’s really interesting. I’m just thinking about herbal medicines. It’s like, there’s a disconnect there. Because we can  do them extemporaneous and we can do them pre-formulated. That’s interesting, isn’t it?

Diana: Yeah, but they’re not exactly the same.

Andrew: No, no.

Diana: Yes, but you could argue that they’re not the same, and that’s why you can extemporaneously compound them, because they’re different. And I guess this sort of brings us to the, you know, “what are the benefits of compounding?” question that people always ask as well. And one of them is, the same benefit that the patient gets out of having their own formula of herbs, they get that benefit, of having their own formula of nutraceuticals. So, it’s unique to them, it fits their exact symptom picture. It doesn’t have any additives that they don’t need. You know, that, all those benefits of naturopathy is used to, gaining from having a personally blended, bespoke herbal medicine, then that applies equally to the nutraceutical medicines.

Andrew: Yeah. I think, you know, like, how many times have we, I, you know, had a patient presentation, and you think in your head, “I’d really like that, but with this?”

Diana: Yeah, correct. Yeah.

Andrew: And then you try and find that in a pre-made formula, and it’s like, “which one?”

Diana: Yeah, exactly.

Andrew: So, how many formulas do you then have? And it’s like, da, da, da.

Diana: Yeah. That’s right. And so, yes.

Andrew: So, compounding could actually reduce your stockholding, reduce your number of products that you’ve got to have on the shelf. Yeah. So, you could actually have a bespoke thing for more patients. Okay.

Diana: Yeah.

Andrew: So, the next step, just things like equipment, just a brief thing on equipment. How sensitive do we have to… Is this the right question? What quality of equipment do we have to have? You know, can we just get away with some scales that we bought on Amazon, or do you really have to be, you know, calibrated, and, you know, what’s the ISO? ISO-level calibration?

Diana: Yeah, that’s right. Yeah. Well, yes, exactly. So, I don’t know the ISO number, but yes, there is one for calibrating scales. So, I guess, it, that comes down to the doses that you’re prescribing for your patient. So, you know, on a set of scales, you’ve got three or two or one decimal places after the, zeros after the decimal place?

Andrew: Yep.

Diana: So, if there are three, that means it measure, you can read down to 1 milligram, right? Because if we’re talking grams, and you’ve got… 0.1 would be 100 grams, .01 would be 10. Sorry. 0.1 would be 100 milligrams, .1 grams.

Andrew: Yep.

Diana: .01 would be 10 milligrams, .001 would be 1 milligram. And so, the rules, in pharmacy at least, and I think it’s worth sticking to that, are that you can compound, you can weigh something accurately if it’s fifty times the minimum number that you can read.

Andrew: Gotcha. Gotcha.

Diana: Yeah. So, if you’re on your kitchen scales, and it measures down to 1 gram, then that means that you can measure down, accurately, down to 50 grams, which is fine if you’re baking a cake. No problem. But if you want to make sure that you’re getting an accurate dose for a patient, you need to have a better set of scales than that.

Andrew: Yeah.

Diana: I mean, ideally, you would get them calibrated regularly. You know, just like a blood pressure monitor, ideally, you would send that off for calibration once a year. We send ours back to the manufacturer annually, for a calibration. And I just think it’s probably good… We send our scales off for calibration every year.

Andrew: Gotcha.

Diana: And I think it’s good practice. Yeah.

Andrew: Gotcha.

Diana: So, you would just have to, when you’re buying a set of scales, make sure that you’ve got enough decimal places on it to measure accurately the quantity that you want. And also, ask the manufacturer if they can calibrate it for you as part of a regular service. You know, they clean them, and pull them apart, make sure everything’s working properly. So, but, that, you’d have to check that with the manufacturer of the scales that you buy.

Andrew: Yeah. Yeah, yeah, yeah. Yeah. That’s a good point. So, just moving on, what sort of nutrients are available on the Australian market, then? Obviously, there’s going to be differences between the U.S. market and Australia. So, what sort of things can we use? What sort of sort of nutrients do we have at our availability, to be able to use for patients in Australia?

Diana: Well, the ones that are available from the manufacturers that we have access to would be, I mean, the obvious ones are, inositol, calcium-D-glucarate. NAC is another one. Magnesium threonate. They’re all the ones that, made by Designs for Health. But then there are lots more that are made by the other companies. You know, there’s zinc picolinate. There are lots of them. But all the other as well.

Andrew: But, so, can you make a decent dispensary from the availability of, through various companies? Can you make a decent dispensary out of those products that are available in Australia, or do you have to go to somewhere like, you know, PCCA or the other pharmaceutical wholesalers to get certain nutrients?

Diana: It’s a limited range that’s available from the supplement manufacturers.

Andrew: Got it.

Diana: Yeah. Because they’ve got products that are ready-made. And so, you know, they’re not, the ingredients that they’ve got, other ones that are not in the ready-made formulations. Whereas, so, if you’re wanting to make something that’s unique to your patient, and they can get away with having only one product, you’re gonna wanna have all the other ingredients as well. Yeah.

Andrew: Got it. Yeah.

Diana: So, I guess it depends on how, like, one thing that a lot of naturopaths ask me about is, “Can I take a ready-made product and add something else to it?” And you can. Yes, you certainly can do that.

Andrew: Yeah, of course. Yeah.

Diana: Yeah. Yeah. So, you could add a compounding ingredient to a ready-made product. And that’s, you know… The only reason… Or you can use the compounding ingredients that are available just by themselves. You know, they’re labeled as “for extemporaneous compounding only” because the companies are not allowed to label them, because they’re not TGA-listed products.

Andrew: Yeah. Yeah.

Diana: But that’s not to say that you can’t… A naturopath and nutritionist can still prescribe those. But what they have to do is that they’re not labelled at all. And so they have to make sure that what they write on the label meets the labeling guidelines. And that’s in that same document, but I can, you know, like, there’s a, it’s a simple list. I can run through it, if you like, what has to be on there. Like, it’s, you know, the patient’s name, the dose, all that sort of stuff.

Andrew: Yeah. Yeah, please, no. Run through it.

Diana: Okay. So, my first point, if you, just, with making a label, you have to remember that there’s nothing written on the packet for the patient. So, everything that, the only information that patient getting is from the prescriber. So, you just have to keep that, I think that’s important to keep top of mind. And the rules are you have to have the name of the patient, the name of the prescriber, the form, which means, like, the capsules or powder or cream, the quantity, as in the number of doses, the ingredients in each dose, like the name of the ingredients, the strength of the ingredients. You have to have clear directions for the patients. You have to have storage conditions, the date of dispensing, the date of expiry, a unique identifying number. So, we, you know, have a prescriber, a dispensing number. You have to have the name, address, and phone number of the person compounding it. And you have to, it has to say “keep out of reach of children,” and that has to be written in red.

Andrew: Right. Ah. Okay.

Diana: Yeah, legally.

Andrew: You know what? You brought up something really interesting there about the number of doses. And this is something where practitioners can track, if you like, compliance, but also, by doing so, you can make it less confusing for patients. What I mean by here is, let’s say some pre-formulated product comes in a bottle of 60 tablets or capsules, and you’ve said to take two per day. That’s one month’s-odd supply. Now you’ve got a massive bottle of magnesium threonate, you know, which, if you take it at the dose that you’ve recommended would probably last you six months or something. Not the least of which, that’s a bigger purchase for the patient, but the other one is, it starts to get confusing when the patients are sort of having one month supply of this and five months supply of that, and [inaudible 00:29:02]. Whereas if you dispensed, even if that single magnesium threonate into a one-month supply, “There, you’ve got your pre-formulated one-month supply, your compound of one-month supply, and you’ve got one month’s supply. I’ll see you in one month.” So, not just making it easy…

Diana: Yeah, correct. And your liquid herbs. Yeah.

Andrew: Yeah, yeah. Not just making it easy for the patient, but also making it more affordable for the patient as well.

Diana: Yeah. Yeah. That is true. And that’s, so, that’s why I was saying, like, the practitioner can prescribe just the simple, you know, it’s like a herbal medicine simple. You’re just prescribing… It’s labeled for extemporaneous compounding, but that doesn’t mean that you have to compound it, as in mix it with something else. You can just prescribe it as it is, but you do have to meet those labeling requirements.

Andrew: Yeah, yeah. Okay. So, what’s the practical next step for compounding?

Diana: But then you, I would say…

Andrew: Oh, sorry. You go.

Diana: Well, yeah. [crosstalk 00:29:57] that was. Yeah. No, no, no. I would say, if you want to have something that’s unique to that patient and that fills all their needs, you can do that with compounding. But you would have to add in all the micronutrients as well. And so, when you’re adding in the micronutrients, that makes the dispensary unwieldy, really. And that’s when it would be worthwhile talking a compounding pharmacy, just to get access to all the smaller, the less, the ingredients where you’re gonna use less of them. So, you might wanna use inositol, is a great example, where the, you know, the dose would be 1 to, well, up to 18 grams, in some clinical trials. But if you’re using 1 gram of something, times 30 doses, or times 60 doses, then, you know, you’re gonna get through your 100-gram jar pretty quickly. Whereas if you’re prescribing, you know, 150 micrograms of iodine that you wanted to add to a formula for somebody, then you’re gonna, it’s gonna take you a long time to get through your minimum purchase of that. And realistically, it’s gonna be, I mean, do naturopaths and nutritionists have access to those ingredients that are TGA-approved in Australia? I mean, not that I have found. I’m not…because I’ve just used the pharmaceutical supply wholesalers.

And the other thing I think to consider is, like, from a pharmacy point of view, there are three levels of compounding. So, there’s simple, complex, and sterile. Simple compounding would be like this sort of thing, with the calcium-D-glucarate plus inositol, let’s say, if you wanted to make that formula. Or just plain old magnesium threonate, where you’re taking, you’re just decanting it out of the jar, like you suggested, and put it into a smaller jar.

So, that’s simple compounding. You need, we started talking about the equipment that you need, and we didn’t finish that, but I’ll finish this idea first. So, that’s simple compounding. Complex compounding is where the doses are smaller, and that’s where you wanna make sure that your homogeneity of your ingredient mix is really good, probably better than you can get in a mortar and pestle. But, you know, you can get good homogeneity in a mortar and pestle, but the smaller the dose, and the smaller the therapeutic window, which, I think that’s, you know, where the difference between the minimum effective dose and the maximum dangerous, or, you know, the upper safe level dose, the narrower that window, the smaller the dose, the more problematic the side effects, then you start to worry about, am I getting the right dose to the right patient at the right time? Whereas if you’re talking magnesium threonate, where the dose is sort of 500 to 2000 milligrams, is, would be, like, an average dose range for magnesium threonate, then it’s less of a concern if, accidentally, they get, you know, 450 milligrams instead of 500. We’re not too worried about that. Whereas if they accidentally get 300 micrograms of iodine per day, again, I mean, it’s not…or maybe 300 micrograms of selenium per day, let’s say, you know, you, that’s more of a problem, and it’s harder to get that exactly right at that tiny, tiny end of the dose range.

Andrew: Yeah. So, can I ask, then, if you’re dealing with… I actually think your example of iodine is a perfect one. So, let’s say you want 150 micrograms per day of iodine. Certainly well within the upper limits, right? But let’s say you now want to make a mixture, and you want to provide a months’ worth of iodine within that mixture. Then you’ve gotta think about settling, and, as you said, the homogeneity of it. So, if you’re taking into account settling, would you therefore, instead of using a powder, to control each potential mishap, let’s say, would you therefore go, “Nah, I’m not happy about you taking powder. I’d prefer that you have a capsule, and I’ll make you up a capsule-dosed…”

Diana: Correct.

Andrew: …compounding

Diana: Exactly. That’s right, yes. And so that’s what we would then call complex compounding, because it’s, I mean, it’s not hard to make capsules. It’s just, there’s quite a bit of set-up, and the equipment required and all that sort of stuff. And it’s labor-intensive. It’s not, don’t be thinking that you’re just gonna smash up capsules if you’re gonna get it right. It’s, yeah, it’s time-consuming. If you wanna get the dose in each capsule right, you’ve gotta…there’s a whole formula, with adding an inert filler, which, we can use vitamin C, or probiotics, or magnesium glycinate is often, they’re often things that we would use as fillers. Or it’s just, like, a cellulose, a very inert, plant-based fiber. So, anyway, that’s what we call complex compounding. And then there’s sterile compounding. And that’s where you need a sterile unit, where, you know, you’re double-scrubbing and, like, the air flow is important, and it’s a whole setup, of a sterile unit. And in a sterile unit, then you would, that’s the next level of compounding, where you do, like, injections, and eye drops, things that have to be sterile. But, complex compounding is not as elaborate as sterile. And simple, so, simple, complex, sterile, like, they’re this sort of continuum of difficulty and importance in getting it exactly…the margin of error increase…the importance in getting that margin of error absolutely right increases.

Andrew: Yeah. Yeah, got it. And what about delivery types? Like, we always just assume, with extemporaneous compounding, that we’re gonna be taking it orally, even if it’s in a different dosage form, like capsules or powder. But what about other forms? Like, for instance, I was podcasting with Lisa Moane, who deals with extremely fussy eaters, and she says sometimes, because there’s even a texture issue, because the muscles of their mouth are poorly developed, they can’t chew properly, and so she’ll go to a cream. And it blew my mind. I thought, “Oh, my goodness. How small-minded have I been?” So, what about absorption kinetics and things like this? Like, how… That’s a whole ‘nother ball game, isn’t it?

Diana: It is. It’s worth just trying it, if a patient or particular child won’t absorb it…won’t, sorry, won’t tolerate it. The stat, you would start at a standard equivalency of pretty much one-to-one, but you tend to get better absorption across the skin, and particularly across the mucosal membrane, the absorption is better than through the gut, because it doesn’t have to do that first-pass effect through the liver. So, you’re getting, it’s going straight into the bloodstream, across the skin, or across the, especially across the transmucosal membrane. So, like, we make these little sublingual troches, we call them, and they, you can use those in the mouth, or in the vagina. Or a pessary in the vagina, of course, as well.

Andrew: Right.

Diana: And you get really good absorption. Or suppository in the rectum, because you get better absorption that way for many drugs, and nutrients, if they won’t take them orally.

Andrew: Okay. So, here’s a question. Previous, let’s say, I don’t know, five years ago, we were able to, we had available to us in Australia, these probiotics in a pessary form, designed for intravaginal delivery, for the treatment of bacterial vaginosis and candidiasis, things like that. And then, what happened is there was a law change, whereby any supposed internal, apparently the vagina is internal, so, any internal delivery had to be sterile, so therefore you had to sterilize the probiotics, i.e., you’ve now got dead probiotics. Which basically kiboshed that whole therapeutic avenue. Can we therefore mix probiotics and put them into a pessary form, still, legally, in Australia?

Diana: I actually don’t know that. I…

Andrew: Ooh. Homework.

Diana: …thank you.

Andrew: I’m gonna look that up.

Diana: Yeah, I don’t know the answer to that question. Can you… I mean, we can make them. The question is, is it legal? But also, we tend to…capsules are used trans-vaginally as well…

Andrew: Yeah.

Diana: …for probiotics. And that’s off-label. And, I mean, I see practitioners doing that.

Andrew: Right.

Diana: But it would… Yeah, that’s a good question, about whether that would, because then that is for internal use, and should that be sterilized, and therefore not gonna be effective? But women use capsules trans, in the trans, in the vaginal space, all the time, for probiotics.

Andrew: Yeah, yeah. Okay. So, next question, forgive me for taking liberty with this one, but, so, would you prefer to choose a certain type of capsule, like, for instance a vegan capsule, a, you know, a totally plant-based capsule, rather than a gel cap? Any preference there? Like, have you got any knowledge there?

Diana: For vaginal use, do you mean? Or do you mean for oral use?

Andrew: Yeah, yeah.

Diana: Oral?

Andrew: Vaginal.

Diana: Ah, vaginal.

Andrew: Vaginal.

Diana: I would tend towards a veggie cap, actually, for vaginal use, because you’re gonna get…the breakdown is easier, with a veggie cap. They’re not as solid as a gelatin capsule.

Andrew: Yeah.

Diana: So you’re probably gonna get a better, better…

Andrew: I would think it would sit with the vaginal microbiota a lot more readily.

Diana: Yeah, yeah. And you would get a better breakdown as well…

Andrew: Cool.

Diana: …I would imagine, than doing, using gelatin.

Andrew: Now, Diana, this is such an interesting topic. There’s so many avenues we can go. Where can we find out more about this?

Diana: I’ve done a webinar, which is on our website, at naturalscript.com.au. And so, that explains how to do, how to create a compounded prescription using our platform, and then we would make it for you. And I’ve also got a webinar coming up with Designs for Health, which is, we’ll focus on their ingredients of course, but I’ll mention all the other ones as well, that are how to formulate those, the equipment that you need. I’ll go over the labeling requirements and all that sort of thing, and, yeah, there’ll be more information about it there. So, it depends on, if you wanna do it yourself, there’s probably more information in the Designs for Health webinar, but if… And lots of practitioners, they want a compound, they wanna create the compounds for their patients, but they don’t necessarily wanna actually do the work themselves, because of the equipment required, the calculations of the dosages, all that sort of thing. Or perhaps they want to include ingredients that they don’t have access to, and for that, it, we can do that for them. That’s that webinar on natural scripts that explains how to use our platform to create those scripts.

Andrew: Yeah. So, just one more time, what’s your website again?

Diana: That’s naturalscript.com.au. And that’s a platform for…

Andrew: Natural scripts, plural?

Diana: No, no. Just one. No, just, no S at the end.

Andrew: Natural script.

Diana: Yeah, natural script.

Andrew: Yeah. Gotcha.

Diana: And that’s a platform for naturopaths, nutritionists, and other healthcare professionals too, to upload scripts for their patients. So, we do all the ready-made products, but our main focus is bespoke, compounded, extemporaneously-prepared medicines. So, you know, you might wanna add, you can do a nutraceutical formulation. You can do a liquid herbal formulation, and then you might wanna add a ready-made one, any of the ready-made products. We’ve got those as well.

Andrew: Yeah, sure. Beautiful. I look forward to learning a lot more in this webinar…

Diana: Thank you.

Andrew: …and certainly on the information on your website. Thank you so much for taking us through extemp compounding today, Diana. It’s been great.

Diana: Okay. Thanks, Andrew.

Andrew: Cheers. And thank you, everyone, for joining us today. Remember, you can catch up on all the show notes. We’ll put as much information as we can up on the website, on the Designs for Health website. And of course, you can catch up on all the other podcasts there as well. I’m Andrew Whitfield-Cook. This is “Wellness by Designs.”