Advanced Drying: Enhancing Bioavailability & Flavor Retention

TL;DR

Optimizing powder characteristics is crucial for product efficacy and consumer appeal, particularly in nutraceutical and pharmaceuticals. Key challenges include overcoming the low absorption rates of poorly soluble powder and ensuring effective flavor retention. The success of these aspects hinges on selecting the most appropriate drying and encapsulation technologies. Advanced drying technologies, such as those employing dynamic atomization, provide precise control over particle size, shape, and moisture content, which are critical for achieving desired product specifications. For instance, technologies that can create uniform particle sizes and narrow distributions are essential for consistent performance. Furthermore, effective encapsulation, as seen with cyclodextrin, not only protects sensitive molecules but also significantly extends shelf life and locks in vital nutrients and flavors. Contract powder processing partners must be FDA registered and CGMP certified, adhering to regulations like 21 CFR 117, with robust quality systems including HARPC-validated processes, risk-based supply chain programs, and meticulous record-keeping. The ability to precisely control process parameters like inlet/outlet temperatures, atomization energy, and drying time is paramount for producing high-potency, in-specification finished products, as demonstrated by the successful commercialization of liposomal ascorbic acid using dynamic atomization technology.

Overcoming Solubility and Flavor Retention Challenges

Will: Awesome. Let’s dive right in. This set of questions is specifically within the category of specialty applications and industry-specific solutions. We’ll get right into the right about 10 questions that we have for the day. The first question being, what spray drying techniques work best for creating instant beverage powders with superior solubility and flavor retention?

Hendrik: Let me start by saying that low or poor solubility is probably the biggest and most common problem that we encounter when developing beverage formulations and powders for customers. More than 40% of new products and formulations in the pharma and nutrient industries are practically insoluble. It is a basic requirement that any drug to be effectively absorbed must be present in the form of solution at the site of absorption. More on that later. It brings me to a basic requirement that any drug, sorry, it brings me to another point. The extensive use of the term solubility has led to solubility being expressed in various manners with various definitions.

I will not go into that right now, but the true or actual challenge almost always lies in the poor bioavailability of these products.

Hendrik: It could also be a major challenge if product developers for new products with solubility, bioavailability, or flavor retention objectives do not have access to the best particle engineering or solubilization technologies. There are four considerations for beverage powder development projects with solubility and flavor retention objectives. One, high solubility at the point of absorption is an absolute requirement to ensure maximum bioavailability. Second point, solubility is a critical parameter to achieve the desired concentration and optimum dosage levels for drug and supplements. Third consideration poorly soluble powder has low absorption qualities and will always lead to inadequate bioavailability and then the fourth point flavor retention or masking is directly related to the most appropriate drying and encapsulation technology and the success of the flavor profile depends on this so what drying technologies works best and there are many different technologies out there.

Precision Particle Engineering with Dynamic Atomization

Hendrik: Drain technologies capable of incorporating different formulation technologies that achieve the following four requirements should be the focus. First, highly specialized and controlled atomization technology to ensure consistent and evenly distributed particle size. Particle size directly affects density, moisture content, morphology, and solubility. Second, it must be capable of handling different solubilization, enhancement, and flavor retention techniques, such as nano emulsions and inclusion technologies, for example, psychodexin inclusions that provides optimum solubility and flavor retention. Third point that I want to make, the best technology should be capable of highly advanced particle engineering techniques that provides particle morphology that specifically supports solubility and flavor retention. Again, particle size, density, and shape is directly related to aqueous solubility. Finally, the best drying technology will be the one that has no mechanical shear, no low thermal stress, or heat scorching that will negatively influence flavor or flavor retention.

Hendrik: Preferably no high shear nozzles that could influence the integrity of particles. Excellent control over droplet size formation, control over humidity inside the process, and highly dependable reproducibility and consistent high quality. APD not only have a unique drying technology that we call DAT, dynamic atomization technology, that complies to all these requirements, but we are also experts in psychodexin inclusion reactions.

And they successfully developed and reacted more than 40 of these formulations that specifically focuses on flavor retention, odor masking, solubility, and bioavailability objectives.

Will: I would add to that the cyclodextrin inclusion technology is particularly useful in this situation for a number of reasons. However, there are some significant challenges for using cyclodextrin inclusions. The number one challenge is drawing the interior of the cavity of the cyclodextrin when you’re putting molecules in that cavity. The dynamic atomization technology that Hendrick describes is the one and only method that can do that effectively. The reason for that is it dramatically reduces the water activity on the inside of that cavity.

Will: As we say internally, putting a molecule inside that cavity in the process is like putting a wet foot in a wet sock. And the dynamic atomization technology is the only way to dry both. And so in addition to being the effective drying methodology, it also provides extensive shelf life for those powders. When you can use the cyclodextrin technology and then dry it effectively.

Ulli: From previous conversations about cyclodextrin, again, from like an outsider’s perspective looking in, the effective drying of the inside and the outside that encapsulates the actual molecule, that is something that would effectively help with, because it’s staying so dry, it’s staying so protected, that’s going to help with not only the shelf life, but that’s going to help lock in the flavors, lock in some of those aspects of what we were talking about?

Or is that something that purely mostly is going to help with the solubility side? Or is it both?

Will: It’s going to be both. And in particular, it’s going to lock in the nutrient value of what you’re trying to deliver, which when you’re talking about some of the most important trends in Nutra food and beverage, delivering nutrient value to the consumer or even the patient in products that are geared toward those markets where doctors are serving patients or nutritionists are thinking about the buyer’s needs the value of the of the that makes a bunch of sense i think we can i think that’s a great wrap-up of that question. Let’s move on to the next question, which is, how can spray drying technology improve the processing efficiency and product quality of specifically mineral concentrates?

Navigating Regulatory Compliance in Powder Processing

Hendrik: That’s a very interesting question. With regards to processing efficiency for minerals, the technology should be able to handle high viscosities and high density slurries and sometimes even mildly abrasive powders at high throughput without compromising on powder specifications. It should also be able to rapidly remove the water at high concentration feeds. To achieve this, very effective but very gentle atomization is required to form even and fine droplets that can be dried instantly, offering high efficiency and produce the required moisture content and other particle specifications. Additionally, repeatability and scalability with consistent high yields are critical. Powders that are mostly very dense with very small particle sizes also requires the processing ability to handle a very narrow particle size distribution without creating too much dust. The second part of the question was related to powder quality.

Hendrik: I would say that advanced drying technologies with the ability to create uniform particle sizes and shapes, narrow particle size distribution, mid-density requirements, and then very important, the ability to achieve the required moisture content must be the customer focus. Repeatability and consistency are also very important if you want to develop mineral concentrates. APD has more than 20 years of experience with developing and successfully commercializing mineral products with our in-house R&D team and our unique DAT technology Again, our DAT technology is unique in the sense that we have absolute control over droplet size creation at different feed solids concentrations and viscosities Atomization is even controllable with multiple nozzle iterations for easy adjustment of spray patterns and atomization energy for the creation of specific particles and particle morphology.

Will: Wow, okay. Is there anything else to add from anyone else on the team on that one? I feel like that was a pretty all-encapsuling answer. We’ll move on to the next question, which is, what are the specific regulatory requirements for spray drying nutraceutical and dietary supplement powders?

Hendrik: Spray drying of nutraceutical and dietary supplement ingredients fall under the FDA’s Good Manufacturing Practices Regulation, GMP in short. It requires strict adherence to applicable 21 CFR 117 standards and requirements. Contract manufacturers must be FDA registered CGMP certified and compliant to 21 CFR 117 as dietary supplements and nutraceutical ingredients are regulated as food products Quality requirements include HARP validated process and risk management By the way, HARP-C, for those who doesn’t know, is the hazard analysis and risk-based preventative process controls that forms part of the standard GMP elements such as food safety and food defense.

Hendrik: And then other requirements include a risk-based supply chain program, batch production records, strict cleaning and sanitation practices and control, and other aspects such as record keeping, traceability, etc.

Third-party standards and certifications are not required, but essential, such as GFSI, which is the Global Food Safety Initiative, BRC, NSF, SQF, and then also sometimes general ISO standards.

Will: That is an in-depth set of needs, but it makes a lot of sense when you’re talking about something like nutraceuticals or things that people are using to help. Moving on to the next question, how do I optimize spray drying parameters to preserve the bioactivity of sensitive vitamins and probiotics?

Hendrik: Yeah, and another very interesting but also very important question. There are various processing conditions in spray drying that could influence the quality of sensitive products. Products. Some of these are already mentioned, but mainly they are high feed pressures and atomization pressures, exposure to high temperatures, and extended time exposure to the rain temperatures. Mechanical shear and then also certain conditions such as light, pH of the product, and oxygen could also influence sensitive materials negatively. The drain technology of choice should minimize or mitigate these high pressure and high temperature factors to be able to produce a high quality powder that includes sensitive compounds. It should also have the most up-to-date control system that allows for very clear-cut, defined, and easy to dial in process and drying parameters. These process parameters include precise control over inlet temperatures and Outlay temperature settings, the amount of atomization or kinetic energy applied to disperse a liquid feed and create optimum droplet size, and then the time that it takes to dry the droplets into equal or even powder particles.

Hendrik: APD’s DAD technology has no high feed or atomization pressures, no mechanical shear, very rapid drying with no heat scorching, and no extended drying time in a drain chamber. There is no residence time or extended drying time. We have a state-of-the-art control system that allows for easy dialing in or adjustment of each of these parameters mentioned. And although we have developed or dried multiple sensitive ingredient products in the past, such as flavors, proteins, yeast-based products, and vitamins, for example, we recently successfully commercialized a liposomal ascorbic acid product with our dynamic atomization technology, and we produced a high-potency and in-specification vitamin-based product.

Will: Yeah, I would add here that your question, Stephen, was about vitamins and probiotics, but the application of this technology is much broader, and it’s important for the audience to understand that.

This drying technology and the platform technologies that we can deploy and have deployed both through APD on behalf of Tesseract Life Sciences includes almost all flavonoids, lipophilics, terpenes, quite a few amino acids, even a number of peptides, which is increasingly powerful in the industry and very much a trend right now. In fact, we’ve done over 400 compounds and that number is growing quite quickly. Yeah, I would add here that your question, Stephen, was about vitamins and probiotics, but the application of this technology is much broader, and it’s important for the audience to understand that.

Will: This drying technology and the platform technologies that we can deploy and have deployed both through APD on behalf of Tesseract Life Sciences includes almost all flavonoids, lipophilics, terpenes, quite a few amino acids, even a number of peptides, which is increasingly powerful in the industry and very much a trend right now. In fact, we’ve done over 400 compounds and that number is growing quite quickly. We’re finding not only more and more compounds that we can work with, it’s just a matter of time because we’ve been working on this for a while, but we’ve just been time limited. But we’re finding new and innovative ways to work within the universe of things that we’ve already touched, stacking multiple molecules in one cyclodextrin, doing other unique things with our drying platform with molecules in general.

Will: In essence, we’ve pioneered quite a number of things that people didn’t know were possible before with small molecules. And so even those that are above the 750 molar weight, which is where it gets a lot harder to work within the cyclodextran universe, we have some very innovative ways of using this technology. It’s a broad field for us and an exciting landscape for our clients.