Are more nutraceutical makers turning to pharmaceutical-grade equipment?

March 19, 2020
Volume: 
23
Issue: 
2

In some respects, the pharmaceutical and nutraceutical industries share common ground. Take delivery systems, for instance. Both the drug and supplement industries produce ample amounts of pills—tablets, capsules, softgels, etc. There’s something else these industries share, too: the desire to produce the best-quality products possible, all while increasing manufacturing efficiency and lowering costs.

Equipment advances play a large role in making these goals possible. To this end, could nutraceutical manufacturers find inspiration in the benefits offered by some of today’s pharmaceutical-grade equipment? Many equipment providers say yes.

 

Common Ground

Pills are common to both the pharma and nutrition industries. And while more advanced delivery features are certainly more frequent in the pharma industry, some of these designs have caught the attention of nutritional companies.

For instance, “Immediate-release, delayed-release, [and] sustained-release delivery technologies are commonly used within pharma, and these are now being employed by nutritional manufacturers to provide more unique products, improve efficacy, and differentiate their product from the competition,” says John Carey, international business head of developed markets for ACG Engineering (Piscataway, NJ), part of ACG Group, a supplier of capsule and tablet manufacturing solutions for the pharmaceutical industry. Advanced delivery forms include those that enable incompatible ingredients to be combined in the same tablet or capsule, including “capsule-in-capsule, pellets/beads with powder/liquid, and numerous other permutations and combinations,” he notes. Two-piece hard capsules filled with liquid is a particularly growing trend in the nutraceutical industry, he says.

Bilayer tablets are another increasingly popular format among both nutraceutical and drug makers. “The use of bilayer tablet formats, to combine different products, is clearly emerging as a favored technology that is easily understood and accepted by consumers,” says Frederick Murray, president of tablet press technology provider KORSCH America Inc. (South Easton, MA).

The same equipment can be used to produce these pills for both nutraceuticals and drugs. “In general, the tablet and capsule delivery platforms used in nutritional and pharmaceutical products are basically identical, making transition to these [pharma-grade] technologies fairly straightforward,” says Carey.

He points out, however, that there are some differences between nutraceutical and drug product formulas that require special consideration. “The one major difference between nutraceutical and pharmaceutical oral solid dosages is the percentage of actives and the number of actives in a dose. Pharmaceutical APIs tend to be relatively small in the overall composition of a dose, whereas a nutraceutical dose comprises a larger number of varied natural ingredients. This also means that traditional additives and fillers that were added to support the easy flow and mixing of pharmaceutical products are not viable for nutraceutical manufacturers, and hence, many equipment companies offer a ‘Nutra Kit’ that mitigates this challenge whilst running on the equipment.” The cleaner labels sought by nutraceutical customers can further exacerbate this challenge, Carey says, noting that there “may be some modifications that need to be made to the standard pharmaceutical equipment to withstand processing more abrasive natural products and especially to help with clean-label claims.”

On a whole, however, nutraceutical companies can use pharma-grade equipment—if nutraceutical companies choose to do so. There are some good reasons to consider it, according to many of the equipment suppliers interviewed for this story.

Pharma equipment can sometimes offer advantages over nutraceutical equipment, says Stan Matthews, sales manager, processing division, for MG America (Fairfield, NJ), the U.S. subsidiary of MG2 (Italy) and a supplier of processing and packaging equipment. Says Matthews: “Pharma-grade equipment is much more advanced in specialized delivery forms.”

With pharma-grade equipment, you get “a higher degree of control over the uniformity of the dosage, thus providing a final product with an increased quality,” adds ACG’s Carey. For instance, pharma-grade fluid-bed granulation equipment can make it easier to handle nutritional products that otherwise aren’t easily compressible or to produce specialty pellets for delayed- or sustained-release products, he says.

“Pharma-grade equipment is designed and manufactured with highly accurate dosing systems, resulting in better-quality products that reduce rejects, diminish waste, and offer significantly upgraded products overall,” says Matthews. He adds: “Today’s nutraceutical formulations are more complex; this is where pharma-grade equipment provides a major manufacturing advantage.”

Tablet manufacturing is a good example of where pharma-equipment stands out, says KORSCH’s Murray. “The basic process of tablet compression—fill, compress, eject—is common among all tablet presses, but there are very stark differences in machine design, quality, and reliability when you compare high-end pharma equipment and low-budget nutraceutical machines.”

For instance, he says, “Tablet compression equipment—including high-speed, fast-change, single-sided machines, and high-volume, double-sided machines—are both being utilized” in the pharma world. “The fast-change capability is critical to maintain an acceptable operating efficiency where there are small batch sizes and a vast portfolio of different products”—things nutraceutical firms deal with often. These efficiencies, and subsequently better margins, are goals of all businesses, including nutraceutical makers.

“There is anecdotal information that the nutraceutical industry could benefit from using traditional pharmaceutical equipment for their manufacturing operations to meet current Good Manufacturing Practices (cGMP) guidelines,” says Darryl Peterson, key account manager for Antares Vision North America (Moorestown, NJ), a provider of visual inspection systems, track-and-trace solutions, and smart data management.

He continues: “There are similarities in both industries around proving cleanliness, and limiting microbial growth as well as following strict quality standards and keeping meticulous batch records. The pharma industry has a long history of identifying these sources of contamination that the nutraceutical industry could take note of. For example, supplying equipment that has stainless-steel contact surfaces with welds ground smooth, polished with 2B type (or greater) finishes, helps to eliminate hard-to-clean surfaces. In addition, supplying in-process steam-sterilizable systems rated to handle pressure and high temperature to kill microbial growth, or CIP (clean-in-place nozzles), aid in assuring aseptic operations and can, if done properly, promote sterility. All drains should promote full draining of cleaning liquids and water to the lowest point of the chamber with a drain so that water can be removed entirely. Having equipment that is designed and engineered for maximum cleanability, like in the pharma industry, provides advantages to the nutraceutical industry for repeatable operations with little downtime between cleaning procedures due to employing validated cleaning operations used for many years in the pharma industry.”

He further notes that many pharma systems come equipped with advanced control systems, including software packages, as well as high-speed cameras used to inspect pills. In general, he says, “Pharma-grade equipment has several advantages over typical food-grade equipment in cleaner construction materials, automated controls, and precise inspection tolerances. Pharma-grade equipment is made to handle complex manufacturing demands at high speeds.”