In order to encourage the responsible production and marketing of probiotics, the Council for Responsible Nutrition (CRN) and the International Probiotics Association (IPA) in 2017 developed scientifically-based best practices for the labeling, storage and testing of stability of food supplements containing probiotics. These best practices continue to be used today and have been recently updated.
As described in the Best Practices document, stability testing performed to verify the expiration date on the label of a probiotic product should be performed under the same temperature conditions as the recommended storage conditions on the product label. finished product, and under conditions representative of the finished product. in the final packaging offered for sale. Testing should also be performed under real-time conditions, and the use of accelerated or other testing in a program to support product release should be scientifically justified and documented.
Sensitive to changes in temperature and humidity, some probiotics are stable at room temperature, but many of these living organisms require refrigeration. The extent to which an individual product is affected by temperature and humidity depends on the probiotic strains present in the product, formulation matrix and dosage form, manufacturing and packaging conditions, packaging of the product, product and other factors. When it comes to packaging, the type of packaging material (e.g. glass bottle vs. plastic) and lid (e.g. screw cap vs. hinged lid) will result in different rates of probiotic degradation, as each Packaging type offers different levels of protection against moisture, which is a key factor in the stability and viability of probiotics.
Other packaging options include blister cards, especially foil / foil blister cards, as each blister acts as its own sealed container. Different types of capsules can be subjected to increased water activity caused by the constant opening and closing of a bottle. Manufacturers should always provide storage and handling instructions to their retail contacts to ensure that products are stored under proper conditions throughout their life cycle, including at the warehouse, during shipping and on store shelves.
This article is an excerpt from a longer article. To read it in its entirety, consult the “Probiotics: Macro Trends in Microorganisms“Digital magazine.
Andrea Wong, Ph.D., is senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN), a leading trade association for the dietary supplement and functional foods industry.