Consumers increasingly demand food supplements with high quality, safety and efficacy. Although the value they receive depends on the amount of active ingredient present in the product, most regulatory environments don’t require stability studies on the main ingredients. Alarmingly, many manufacturers believe that including a certain amount of an active substance at production will unquestionably result in this same amount being available for the consumer at the end of shelf life, which is far from the case. Ingredient cross-interactions can occur in nutraceuticals and must be considered when developing a product. With pharmaceutical companies introducing their standards to the nutraceutical market and consumers demanding complete transparency, companies risk a lot by not investing into stability studies.
When mentioning stability, many stakeholders of the nutraceuticals industry think of physicochemical and microbiological stability. These basic standards must be met. To be able to claim a product is stable, one must prove that all active ingredients stated on the label are present in those quantities throughout the shelf-life.
Pharmaceutical companies are aware of this issue, as stability studies are mandatory for drugs to reach consumers. As they enter the nutraceutical market, they often bring the standards they uphold in their industry and for their brand. We see pharmaceutical companies increasingly outsourcing nutraceuticals development, and they report having a hard time finding anyone in this industry who performs stability testing. In PharmaLinea’s experience as an outsourcing partner, such commitment to consumers builds brand trust and long-term successful sales. The product’s efficacy ensures strong rebuying rates, and this can only be achieved through stability of active ingredients.
For now, unfortunately, only a few regulatory authorities worldwide require proof of ingredient stability for launch. Companies not conducting stability tests are limited and cannot enter such markets, which is an inevitable loss of opportunity. Business risk is also present in the remaining, more permissive markets. Increasing consumer involvement is accompanied by consumer tests and poor reviews can ultimately trigger media reports and product recalls, which can tarnish brand perception and cause financial damage. A company can never save enough resources compromising quality to be able to afford it.
A growing number of companies are aware that finished product stability is a major quality concern, and still not conducting these studies. They are generally not able to make the investment because compensating the costs with a price increase would make them uncompetitive in their market. The best option for them is to outsource development and production to a partner with the appropriate expertise, who works on a global scale. Certain companies take a different approach and, instead of addressing the problem at its root, compensate with large overages. In practice this means that, when buying a product at the beginning of its shelf life, consumers can get two to three times more of the active substance than stated on the label, which can greatly exceed their intentions.
During product development, several characteristics and measures should be taken into consideration to minimize the risks of interactions.
As substances will inevitably react if they are able to interact, stability depends on the product form. Dry forms such as tablets or pills are most stable, yet they provide no guarantee. Liquid forms present a much more suitable environment for chemical reactions. Achieving stability in liquid forms is difficult and requires years of expertise. As liquids, gummies and other user-friendly forms are gaining in popularity, the concern is much greater.
With the rise of complex products—different blends of vitamins, minerals, proteins and botanical extracts—stability should be a major focus for manufacturers. The more ingredients incorporated, the more reactions can happen. In addition, stability issues do not come only from active substances interacting: molecules can react with excipients, solvents or simply air. The most problematic ingredients to use are vitamins and minerals, because of their high reactivity, herbal extracts because of their complexity—some plant extracts can contain several dozen different molecules—and probiotics, since they are living organisms and therefore remain sensitive to their environment. Iron is relatively stable alone, but tends to interact with other nutrients, inactivating them and thus making the solution nutritionally less valuable for the end-user. Vitamin C is one of the most reactive compounds and can degrade easily. Folate and lutein are also extremely unstable substances, sensitive to air oxidation, heat, light and acidity.
Solutions exist to overcome these challenges. The industry has been innovating on this matter and several options are available to stabilize active ingredients. Microencapsulation, chelation, emulsion and nanoemulsion are just a few. These solutions are at the level of ingredients, but solutions at the level of development, production process and technology can be even more important. Finding which strategy to use for each specific case is a process of trial and error, ultimately requiring a substantial investment of time and funds.
While consumers are becoming knowledgeable on proof of efficacy, and they screen products for transparency and quality, they will demand product stability too. The process of their education on the matter is being sped up by the activity of the pharmaceutical industry. Product stability may become a trend as big as transparency and clean label, because it fits the same criteria: better quality for the end-user. With the rise of digitalization and gagdets, consumers could soon have their own quick testers, get data on their apps and share product reviews publicly.
It is also possible that an independent, universally recognized stability brand will appear and eventually, regulation will change. For the moment, raising stability standards is not only industry’s responsibility, but t is also an opportunity for differentiation on the market, and one of the key pathways to future success.
Blaž Gorjup is chairman and founder of PharmaLinea Ltd.