Getting Granular: Supply Chain Issues May Prompt Supplement ‘Finishing’ In-House

 Getting Granular: Supply Chain Issues May Prompt Supplement ‘Finishing’ In-House
Alex Trombley 
Syntegon


COVID-19 has been a blessing and a curse to many industries. There is no doubt that the current and future outlook for nutraceutical companies manufacturing capsules and tablets will continue to flourish, but what challenges still face this burgeoning market? Globally there is a tendency for manufacturers of finished dose nutraceuticals to rely on excipient providers and other Third Party organizations to granulate various components of their formulations. This over-reliance on outside parties to produce granulated products has placed a stranglehold on many nutraceutical companies. The same pandemic that brought growth to the industry through a renewed emphasis on preventative health has revealed weak supply chain points and a renewed interest in “in-sourcing” as much as possible. 

But what is granulation and how can a company with limited experience in the space bring such capabilities in-house? Wet granulation is a process used to bind diff erent powders together with the addition of a liquid solution or adhesive to produce granules or agglomerates. This can be performed in a high-shear mixer with solution sprayed atop a blending bed of powder or in a fluidized bed. Both options offer benefits and limitations, so flexibility to do both is critical when considering a diverse or growing product portfolio. 

Why do we granulate? We do so to offer: improved powder flow characteristics, improved compressibility, reduced segregation and fines, control blend uniformity of granulated powder for use in tablet or capsule dosage forms, and control dissolution profile of tablets. Ultimately, we create a more robust product that can be tableted or encapsulated easily and we remove problems associated with raw material variability by processing it to our desired standards in-house. By having a stable, granulated product, the potential for higher output on tableting and encapsulation equipment can be drastically improved. With a brief understanding of the benefits of wet granulation, how will this benefit nutraceutical companies looking to manufacture their own granulated product?

When nutraceutical companies can offer a supplement where they have granulated and packaged the final product in-house, they have two distinct competitive advantages in their respective markets. The first advantage is raw product cost. Paying for product that has already been granulated can be extremely expensive. Having your own granulation equipment will pay for itself quickly due to the cost benefits of purchasing powders, not granulated product. The second distinct advantage is product quality. Granulating products in-house offers a higher level of product control, and increases the quality of your final product. Granules can be tailored to your specific process with large, round granules for a poorly flowing product being compressed into tablets or denser granules for a high-dose product going into a capsule. 

When a company decides that it does indeed want to bring granulation into their facilities, there are a couple key milestones. First, they must select a technology and find the right equipment vendor to provide such a processing solution. This foundational decision will greatly impact all subsequent granulation work. It is critical that nutraceutical companies understand the capabilities of the equipment they purchase. 

Second, companies need to build some level of technical competence and expertise internally to support the process. Wet granulation is a well-understood unit operation with established regime maps, large data sets, and heuristics honed over decades of work in the pharmaceutical and food industries. You may already have a portion of your team with such experience, but if not, your equipment provider can offer the next line of support in fostering such technical capabilities internally. Once equipment is selected and inhouse expertise is developed, then a company can truly reap the benefits of granulation. 

To select an equipment vendor and design, there are several factors to consider. Are any of your products unstable under thermal stress? Or in the presence of moisture? How critical is it to achieve a narrow particle size distribution? Does granule density matter for your application? Answering these questions will inform buyers if they should pursue fluid granulation, high shear granulation or some other system. Fluid bed granulation provides faster processing and less material handling time, while high shear granulation excels at processing difficult and poorly flowing materials. Since most nutraceutical companies have diverse product portfolios and their products can generally handle the temporary presence of water and heat, high shear granulation followed by fluid bed drying is one logical conclusion. 

Not all high shear granulators are created equal, however. It’s true that one can granulate powder in a food processor, but the true innovation often comes as additional levels of control are applied to uniformity of mixing and shear stresses imparted to the material. This control becomes even more important as batch sizes grow. Traditional oral solid dosage high shear impellers consist of three equilateral blades creating high amounts of shear between the bottom face of the impeller and the lower portion of the bowl, while imparting relatively little shear to the upper portion of material. This profile in shear rates can result in insufficient mixing. 

Any home cook who uses a food processor knows the struggles of insufficient mixing and the need to scrape down the sides of the bowl. Since stopping the process to scrape the bowl becomes economically unviable pretty quickly at large scales, higher impeller speeds are needed. At these high impeller speeds and energy inputs, it is easy to overwork the material and over-granulate. Recent advancements made by some in the industry offer tighter tolerances between the product container and impeller, as well as novel new impeller designs to mix the entire bed of powder with lower energy inputs. These new features allow for higher yields and most importantly, better control over granule quality. 

Once you’ve got a granulation line, you must learn how to use it. There is ample theoretical material online and in today’s newly virtual setting, training can happen anywhere and at any time. To build internal technical competence quickly, equipment vendors themselves can also be great sources of information. Doing trials with your product and specific equipment experts can take a process from an idea to proof of concept quickly. Even after installation, consulting with OEM process experts can let you tap into years of experience without having to suffer through individual “trial and error” lessons. Bringing granulation in-house can initially be intimidating, but doing so successfully can result in both technical pride and competitive advantage.


Alex Trombley is Syntegon’s North American Process Specialist and Business Development Manager for Hüttlin products. To learn more about Syntegon’s granulation solutions visit our website.


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