The use of probiotics in supplements and foods is increasing. Probiotics are live microorganisms that provide health benefits when consumed in adequate amounts. They help maintain a balance of beneficial bacteria in the gut. However, manufacturers must address challenges to ensure probiotics survive processing and storage. Probiotics are sensitive to moisture, heat, air and light. Strict controls and short transit times are needed. Products should be labeled with colony-forming units and stored and shipped under refrigeration to maintain viability until consumed.
1. [Digestive Health] Vol. 17 No. 5 May 2012
www.naturalproductsinsider.com Page 1
By Michael Shahani
The use of probiotics in food supplements and as food additives is on the rise. But manufacturers of
supplements and functional foods need to keep specific challenges in mind as they incorporate these
strains of bacteria into their products. Before addressing those challenges in more detail, it may be
worth reviewing some different definitions of probiotic bacteria, why we need them, some
assumptions and what to look for when selecting strains.
As originally used in 1965, the term “probiotics” referred to the “growth-promoting factors” produced
by one microorganism that stimulated growth of another (i.e., the opposite of antibiotics). This
definition went through several permutations and, by 1989, probiotics were defined as a “live
microbial feed supplement that beneficially affects the host animal by improving its intestinal balance.”
The current definition, adopted by the World Health Organization (part of the United Nations’ Food
and Agriculture Organization), defines probiotics as “live microorganisms that, when administered in
adequate amount, confer a health benefit on the host.” This latest derivation is important because it
recognizes both the relevance of a live and sufficient dose, as well as the many reports that indicate
probiotics may have health benefits that extend beyond the gastrointestinal (GI) tract.
A healthy intestine is one that maintains a critical balance between various groups of these bacteria
such as lactobacilli, streptococci, clostridia, coliform and bacteriodes. Any suboptimal or unhealthy
conditions such as stress, onset of disease, ingestion of antibiotics and/or medicines, and improper
food and rest, and harmful environmental conditions may endanger this fine balance in the intestinal
flora, resulting in the reduction of the friendly or beneficial bacteria such as lactobacilli and
bifidobacteria in the gut. In addition, most of the food in our modern diet is devoid of the healthy
bacteria found in many traditional foods we no longer eat, such as yogurt, buttermilk, fresh cheeses,
sauerkraut and other fermented vegetables, and even fermented meat products.
Although numerous health claims have been made in support of probiotics, it has been difficult to
establish many of these claims, and the concept itself remains controversial. Strains are often poorly
defined and inconsistently prepared, and it is difficult to ascribe specific effects to specific strains.
Even the notion that probiotic bacteria actually colonize the intestinal tract appears to be
questionable, since several studies indicate that some probiotic strains are not long maintained in the
intestinal tract.
Nonetheless, evidence does provide support for many claims, including reducing the severity and
duration of diarrheal diseases and for alleviating symptoms associated with lactose intolerance.
Evidence suggests production of short-chain fatty acids (SCFAs) by certain probiotic bacteria may
alter cholesterol synthesis, and bile acid and/or cholesterol adsorption by probiotic bacteria may lower
blood cholesterol. Other studies testing the hypothesis that probiotic bacteria can reduce cancer risks
have been inconclusive.
Most of the microbial preparations added to foods or consumed as food supplements consist of
species of bifidobacteria, lactobacilli and streptococci. Probiotic bacteria should resist low pH and
Formulating Probiotic Foods and Supplements
2. [Digestive Health] Vol. 17 No. 5 May 2012
www.naturalproductsinsider.com Page 2
survive gastric acidity, they should tolerate bile salts at concentrations present in the intestinal tract,
they should have antagonistic or inhibitory activity against intestinal pathogens, they should adhere or
otherwise interact with intestinal epithelial cells, and they should provide clinically proven benefits.
Manufacturing with probiotic raw materials presents a unique set of problems. It is important to realize
bacteria in freeze-dried probiotic raw materials are dormant and can be killed if not handled correctly,
rendering the them useless. With the exception of a few extremely stable strains such as Bacillus
coagulans, which by their nature are hardy, the stability of lactobacilli and bifidobacteria are
negatively impacted by four factors: moisture, heat, air and light. Minimizing or eliminating these
factors is essential for the survival of the bacteria in manufacturing, packaging, transportation and
storage so that the probiotic products reach the consumer in a viable condition.
Packaging (encapsulation, bottling, etc.) should be done in a low-humidity and temperature-controlled
environment. All manufacturers of probiotic raw materials suggest storing the materials under
refrigeration before packaging. Raw materials should be allowed to reach the ambient temperature
gradually before being packaged; extreme temperature fluctuations are to be avoided. It is also
important that any other ingredients or excipients blended with the probiotics are low in moisture
content. Dry formulations are best; probiotics in a liquid state are notoriously unstable unless kept
constantly refrigerated or frozen. Tableting can also kill the live bacteria due to excessive pressure or
heat, or due to any liquid used in granulation.
Shipping probiotic products presents other challenges. It is essential to keep transit times as short as
possible, and to keep products cool or under refrigeration. Most manufacturers of probiotic raw
materials ship overnight, often with dry ice. While it is possible to find many probiotic products on
retail shelves, it is perhaps better if consumers order probiotic products directly from a manufacturer,
avoiding the possibility that a product has been sitting on an unrefrigerated store shelf for an
extended period of time. If buying products in a store, consumers should look for probiotics kept in a
refrigerated case in the store. Consumers need to be educated to properly care for their products
once they get them home. Leaving probiotic products at room temperature for a few days or even a
few weeks (while traveling, for instance) is probably not enough to harm the products significantly, but
it is almost always better to keep probiotics in the refrigerator at home if possible.
Manufacturers of probiotic supplements should label their products correctly. While no
Recommended Daily Intake (RDI) exists for probiotic supplements, it is important consumers know
how much of each probiotic bacteria they are receiving in a supplement. The label should give the
number of colony forming units (CFU) per serving or dosage, giving the number of milligrams is
irrelevant information, and is meaningless from a standpoint of how much of a probiotic a consumer is
getting. The bacteria should be properly identified by genus and species and all other ingredients
should be listed on the label as well.
When adding probiotics to food products, manufacturers must address two distinct issues. First, it is
important to ascertain that the probiotics will actually survive in food product; the problems of
temperature and moisture are especially critical when adding probiotics to food. And second, it is
necessary for the consumer to perceive that the food product containing probiotics is, in fact, a
product that would be improved by adding probiotics. For example, refrigerated dairy and fruit
beverages, or frozen desserts are good candidates for this kind of supplementation.
3. [Digestive Health] Vol. 17 No. 5 May 2012
www.naturalproductsinsider.com Page 3
Probiotics is still a fast-growing segment of the supplement industry, and responsible manufacturers
of both raw materials and finished products that formulate and label their products correctly, provide
customer education, and are responsive to regulatory and industry changes will do especially well.
Michael Shahani, director of operations, Nebraska Cultures Inc., oversees all aspects of manufacturing, new product
development, customer service and marketing, as well as coordinates all scientific resources and activities for the
company. Shahani is also an executive committee member of the International Probiotics Association board of directors.
![[Digestive Health] Vol. 17 No. 5 May 2012
www.naturalproductsinsider.com Page 1
By Michael Shahani
The use of probiotics in food supplements and as food additives is on the rise. But manufacturers of
supplements and functional foods need to keep specific challenges in mind as they incorporate these
strains of bacteria into their products. Before addressing those challenges in more detail, it may be
worth reviewing some different definitions of probiotic bacteria, why we need them, some
assumptions and what to look for when selecting strains.
As originally used in 1965, the term “probiotics” referred to the “growth-promoting factors” produced
by one microorganism that stimulated growth of another (i.e., the opposite of antibiotics). This
definition went through several permutations and, by 1989, probiotics were defined as a “live
microbial feed supplement that beneficially affects the host animal by improving its intestinal balance.”
The current definition, adopted by the World Health Organization (part of the United Nations’ Food
and Agriculture Organization), defines probiotics as “live microorganisms that, when administered in
adequate amount, confer a health benefit on the host.” This latest derivation is important because it
recognizes both the relevance of a live and sufficient dose, as well as the many reports that indicate
probiotics may have health benefits that extend beyond the gastrointestinal (GI) tract.
A healthy intestine is one that maintains a critical balance between various groups of these bacteria
such as lactobacilli, streptococci, clostridia, coliform and bacteriodes. Any suboptimal or unhealthy
conditions such as stress, onset of disease, ingestion of antibiotics and/or medicines, and improper
food and rest, and harmful environmental conditions may endanger this fine balance in the intestinal
flora, resulting in the reduction of the friendly or beneficial bacteria such as lactobacilli and
bifidobacteria in the gut. In addition, most of the food in our modern diet is devoid of the healthy
bacteria found in many traditional foods we no longer eat, such as yogurt, buttermilk, fresh cheeses,
sauerkraut and other fermented vegetables, and even fermented meat products.
Although numerous health claims have been made in support of probiotics, it has been difficult to
establish many of these claims, and the concept itself remains controversial. Strains are often poorly
defined and inconsistently prepared, and it is difficult to ascribe specific effects to specific strains.
Even the notion that probiotic bacteria actually colonize the intestinal tract appears to be
questionable, since several studies indicate that some probiotic strains are not long maintained in the
intestinal tract.
Nonetheless, evidence does provide support for many claims, including reducing the severity and
duration of diarrheal diseases and for alleviating symptoms associated with lactose intolerance.
Evidence suggests production of short-chain fatty acids (SCFAs) by certain probiotic bacteria may
alter cholesterol synthesis, and bile acid and/or cholesterol adsorption by probiotic bacteria may lower
blood cholesterol. Other studies testing the hypothesis that probiotic bacteria can reduce cancer risks
have been inconclusive.
Most of the microbial preparations added to foods or consumed as food supplements consist of
species of bifidobacteria, lactobacilli and streptococci. Probiotic bacteria should resist low pH and
Formulating Probiotic Foods and Supplements](https://image.slidesharecdn.com/21edfae4-636d-428b-8b52-08a22cc80f70-160606013638/85/Mike-s-article-for-Virgo-1-320.jpg)
![[Digestive Health] Vol. 17 No. 5 May 2012
www.naturalproductsinsider.com Page 2
survive gastric acidity, they should tolerate bile salts at concentrations present in the intestinal tract,
they should have antagonistic or inhibitory activity against intestinal pathogens, they should adhere or
otherwise interact with intestinal epithelial cells, and they should provide clinically proven benefits.
Manufacturing with probiotic raw materials presents a unique set of problems. It is important to realize
bacteria in freeze-dried probiotic raw materials are dormant and can be killed if not handled correctly,
rendering the them useless. With the exception of a few extremely stable strains such as Bacillus
coagulans, which by their nature are hardy, the stability of lactobacilli and bifidobacteria are
negatively impacted by four factors: moisture, heat, air and light. Minimizing or eliminating these
factors is essential for the survival of the bacteria in manufacturing, packaging, transportation and
storage so that the probiotic products reach the consumer in a viable condition.
Packaging (encapsulation, bottling, etc.) should be done in a low-humidity and temperature-controlled
environment. All manufacturers of probiotic raw materials suggest storing the materials under
refrigeration before packaging. Raw materials should be allowed to reach the ambient temperature
gradually before being packaged; extreme temperature fluctuations are to be avoided. It is also
important that any other ingredients or excipients blended with the probiotics are low in moisture
content. Dry formulations are best; probiotics in a liquid state are notoriously unstable unless kept
constantly refrigerated or frozen. Tableting can also kill the live bacteria due to excessive pressure or
heat, or due to any liquid used in granulation.
Shipping probiotic products presents other challenges. It is essential to keep transit times as short as
possible, and to keep products cool or under refrigeration. Most manufacturers of probiotic raw
materials ship overnight, often with dry ice. While it is possible to find many probiotic products on
retail shelves, it is perhaps better if consumers order probiotic products directly from a manufacturer,
avoiding the possibility that a product has been sitting on an unrefrigerated store shelf for an
extended period of time. If buying products in a store, consumers should look for probiotics kept in a
refrigerated case in the store. Consumers need to be educated to properly care for their products
once they get them home. Leaving probiotic products at room temperature for a few days or even a
few weeks (while traveling, for instance) is probably not enough to harm the products significantly, but
it is almost always better to keep probiotics in the refrigerator at home if possible.
Manufacturers of probiotic supplements should label their products correctly. While no
Recommended Daily Intake (RDI) exists for probiotic supplements, it is important consumers know
how much of each probiotic bacteria they are receiving in a supplement. The label should give the
number of colony forming units (CFU) per serving or dosage, giving the number of milligrams is
irrelevant information, and is meaningless from a standpoint of how much of a probiotic a consumer is
getting. The bacteria should be properly identified by genus and species and all other ingredients
should be listed on the label as well.
When adding probiotics to food products, manufacturers must address two distinct issues. First, it is
important to ascertain that the probiotics will actually survive in food product; the problems of
temperature and moisture are especially critical when adding probiotics to food. And second, it is
necessary for the consumer to perceive that the food product containing probiotics is, in fact, a
product that would be improved by adding probiotics. For example, refrigerated dairy and fruit
beverages, or frozen desserts are good candidates for this kind of supplementation.](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)