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Probiotic Reach

As the list of the health benefits probiotics offer expands, suppliers and manufacturers must take a number of factors into account to ensure that the finished product is stable and effective.

According to the firm BCC Research, the global market of probiotic ingredients, supplements and foods nearly reached $27.1 billion in 2013 and will grow at a compound annual growth rate of 6.2 percent over the next five years to reach $36.7 billion in 2018. “The demand for products fortified with probiotics is definitely increasing and consumer awareness of probiotics continues to grow,” said Michael Bush, senior vice president of Ohio-based Ganeden Biotech. “It is estimated that 80 percent of consumers know what probiotics are and associate them with a health benefits.” 

So, what are the reasons that the category continues to expand? It is hard to pinpoint a single event that is causing the growth, noted Larry E. Robinson, PhD, vice president of scientific affairs for Embria Health Sciences, LLC in Iowa. “Certainly, there has been a lot of interest in the research surrounding the Human Microbiome Project (HMP),” he said. “Since this is such a huge scientific endeavor, there will be media stories coming out periodically underscoring the importance of our microbiome as it relates to overall health and immune health in particular.” 

Bush added that at least part of the reason probiotics are becoming more popular is because consumers are now paying more attention to nutrition labels and are becoming more health conscious.

Probiotic Benefits 

Probiotics are best know for helping to regulate the digestive system, but in recent years, it has also become widely accepted that they also aid in regulating immune health, as approximately 70 percent of the immune system is located in the digestive tract. And according to George Paraskevakos, business development director for Lallemand Health Solutions in Canada, probiotics act on three lines of intestinal defense:

1. They influence the intestinal flora composition and behavior.

2. They modify the mucus layer and reinforce intestinal mucosa integrity.

3. They modulate the intestinal immune system directly or indirectly through intestinal flora.

And while probiotics can be incredibly helpful for both digestive and immune health, research has shown that the benefits reach so much further. “Today, applications of probiotics go beyond gut health, with documented benefits in areas such as immunity, stress, women’s health, etc.,” Paraskevakos said.

“Scientists are just now scratching the surface on the benefits of probiotics; research showing the benefits from probiotics is amazing,” agreed Bush. “In addition to digestive and immune health, science is showing a multitude of additional ways that probiotics can be beneficial. Depending on the probiotic strain, we are seeing that they support basic digestion, immune health, inflammatory responses, skincare and some science even suggests that probiotics support the metabolism, which can help fight obesity.” Ganeden Biotech’s most popular probiotic, GanedenBC30 (Bacillus coagulans GBI-30, 6086) is a patented, spore-forming organism that is unlike most other probiotic strains used in food and beverages. GanedenBC30 is highly stable and can remain viable through processing, shelf life and the low pH of stomach acid. GanedenBC30 is extremely safe and has been given United States Food and Drug Administration (FDA) GRAS (generally recognized as safe) status, according to the company.

Ganeden’s newest probiotic ingredient, Bonicel is a supernatant produced from GanedenBC30. “Bonicel is the first science-backed, probiotic- derived personal care ingredient; it has been shown in four clinical studies to increase skin hydration and elasticity and reduce the appearance of fine lines, wrinkles, roughness, pore size and redness,” Bush explained. “Bonicel is produced through a proprietary fermentation process and contains the optimal combination of naturally derived metabolites. It is formulation friendly for anti-aging creams, gels, masks, serums, body lotions, cosmetics and hair care products.” 

Embria offers Epicore, and while not a probiotic, it does support gut health by as shown by its prebiotic-like effects. “EpiCor isn’t a probiotic, but it does act like a prebiotic in validated gut health models that look at the entire digestive system,” explained Robinson. “In these sophisticated models, published research shows that EpiCor increases the beneficial gut bacteria lactobacillus and bifidobacteria versus placebo, in as little as a 500 mg dose over time. The fact that an ingredient can demonstrate prebiotic-like effects with such a small dose is truly novel.”

While the public has begun to embrace that probiotics are good for the body, many are still struggling to fully understand the fact that there are many probiotics strains that can benefit the body in different ways. According to Lallemand’s Paraskevakos, several mechanisms of action have been documented, depending on the strain considered:

• Production of pathogen inhibitory substances (e.g. lactic acid; certain probiotics produce bacteriocins, or various anti-microbial substances such as: H2O2, acetic acid, propionic acid, etc.).

• Inhibition of pathogen attachment to the epithelium surface (the gut, but also the mouth or vagina); through competition for adhesion, or by stimulating mucus production

• Finally, through modulation of the immune system (systemic effect)—regulation of interleukins and other cytokines

• Certain specific metabolic activities —breakdown of microbial toxins, breakdown of lactose, etc. 

At the 2014 SupplySide West, Lallemand Health Solutions launched its new portfolio of custom-made probiotic solutions for women’s overall health. The portfolio consists of a unique range of probiotic strains and formulation know-how to design specific solutions with three major areas: feminine health, everyday women’s health and age-specific women’s health, the company stated. In addition, Lallemand also introduced a wide range of strains and adapted dosage forms of probiotics for oral health.

Delivery & Stability 

Probiotics can be dispensed in just about every delivery method one could think of. However, there can be issues when it comes to stability. And because probiotics are live bacteria, and that can make manufacturing a finished product with probiotics more challenging. “Probiotics are alive: survival is key to ensure their optimal activity and modes of action,” said Paraskevakos. “Formulation know-how makes the difference to ensure this survival (for example ingredient compatibility; protective technology when necessary, etc.). Further down the line, proper packaging is also important to keep the product stable over time.” 

This process needs to be a collaborative effort between suppliers and manufacturers to ensure that everyone is on the same page. “In conversations with manufacturers and marketers at the leading consumer health care companies—almost all of which Capsugel serves—we learned of the specific challenges associated with the manufacture of probiotic supplements,” said Missy Lowery, senior manager, marketing for South Carolina-based Capsugel, Americas Region. “They needed capsules with lower moisture as well as a way to provide some protection from stomach acid so that the probiotics would be released further along in the digestive tract, preferably the intestines, where they work best. In response, we created some new capsule technologies to address these and other challenges. In a way, it has been a collaborative effort.” 

Capsugel offers Vcaps vegetarian capsule, Vcaps Plus, as well as Drcaps. Drcaps provide for flexible and targeted delivery of moisture-sensitive products, including probiotics, according to the company.

“The pressure and heat from the tableting process is harsh and can compromise the stability of probiotics. This is less of a concern with encapsulation in general. But the low-moisture content of Vcaps and Vcaps Plus— which is made of hydroxypropyl methycellulose (HPMC)—provides a distinct advantage over a standard gelatin capsule. Probiotics are sensitive to moisture,” explained Lowery. “Normal HPMC has 4 to 6 percent moisture content at 50 percent relative humidity compared to 12 to 14 percent for gelatin. What this means is that Vcaps can better protect the probiotics from activating in the package and/or before reaching the intestines, where they are most effective for digestive health.”

Finally, standards need met to guarantee that the product does what it is supposed to do when it lands in the hands of the consumer. “In order to ensure ‘alive and kicking’ probiotics with the highest quality standards, it is important to have full control of the whole manufacturing process, with GMP (good manufacturing practice) facilities and strict quality controls all along the process, from the petri dish to the finished formulation,” Paraskevakos concluded.

FORMOREINFORMATION:

Capsugel, Americas Region, (888) 783-6361 

Embria Health Sciences, LLC, (877) 362-7421 

Ganeden Biotech, (866) 777-0825 

Lallemand Health Solutions, (450) 433-9139