Dear Sender,

Biotin is fairly stable to air, heat, and light as well as acid, and at neutral pH. It is slightly unstable in alkali.  D-Biotin is very slightly soluble in water (approx. 0.02 g per 100 ml) and in ethanol, and practically insoluble in organic solvents. However, our experience indicates that the presence of alkali significantly improves the overall water solubility.

As it pertains to the application mentioned in the question, there used to be a method in the 1960s and 1970s of incorporating dry water-soluble forms and fat-soluble vitamins into an aqueous preparation. This required the use of an emulsifying agent to produce a homogeneous and physically stable formulation. However, methods for this application are no longer available, and to the best of our knowledge, this process is currently not in use in the industry today.

An alternative approach would involve adding the biotin (as is) directly into the oil blend using the right mixing and excipients to prevent settling.  The success of this approach would also depend on the level of biotin and the overall percentage of all solids (by weight) being added to the blend or final formulation.

In the end, whether you attempt to solubilize the biotin in water and combine with the oil-soluble product by preparing an emulsion, or incorporate the biotin (as is) directly into the oily blend, significant formulation and development are absolutely necessary to achieve the right blend for your final product.  This sounds like a very interesting product application!  DSM Nutritional Products has the product knowledge, formulation, and blending expertise to assist in such applications.  Please contact us directly to find out more about our products and services in this area.

Dear Sender,

A very appropriate question to ask given the heightened awareness of food and product safety concerns amongst consumers these days!

At the nutrient or functional-ingredient level, many of the ingredients utilized for dietary supplementation have established quality standards such as an identification assay and appearance, heavy metal content, microbiological purity, minimum potency, and sieve size—just to name a few.  These standards or monographs can be found in various compendia such as United States Pharmacopeia (USP), the European Pharmacopeia (Ph. Eur.), or the Food Chemical Codex (FCC). This information should be present in the supplier’s Product Data Sheet for the particular nutrient or functional ingredient in question.  These product characteristic standards assist the supplement manufacturer to ensure that the ingredient meets a certain level of quality.

Another important method of discerning whether or not a nutrient or functional-ingredient supplier adheres to “good” standards is by conducting a thorough review of the supplier’s manufacturing practices.  In the United States, dietary supplement ingredient manufacturers need to minimally adhere to Current Good Manufacturing Practices (CGMPs) in the manufacturing, packing, or holding of human food (21 CFR Part 110).  These CGMPs provide standards in the area of personnel, facilities, equipment, production and processes for the food industry.  Another criterion to also evaluate is whether the supplier’s operations are ISO certified.

Lastly, a dietary supplement manufacturer would need to ensure that the nutrient or functional-ingredient manufacturer is adhering to these standards.  This is normally done through various types of quality audits either from internal personnel from your organization or a certified third-party audit provider.

When applying the above criteria to your evaluation of whether a nutrient or functional ingredient supplier adheres to “good” quality standards, you will find that the top-quality ingredient suppliers to the supplement industry apply the above criteria on a consistent basis to the manufacturing and distribution of their products, whether the ingredient has an established monograph from one of the various compendia or has GRAS (Generally Regarded as Safe) status.

Dear Sender,

Your question is an important yet challenging one to address since there are many important nutrients and nutraceuticals to consider as nutritional supplements.  However, not all supplements are supported by the same level of credible scientific evidence.  Hopefully, my perspective below sheds the proper light on the subject matter.

First, it is important to properly define the purpose for taking a nutritional supplement.  Nutritional supplements serve two purposes; one, to supplement a person’s diet with essential or key nutrients or nutraceuticals that are difficult to find in a normal diet, and two, when science suggests that the recommended intake level should be higher than what is available through a normal diet.

In order to determine if a nutritional supplement has any real value, a number of different aspects must be thoroughly evaluated.  The first aspect to address is to fully understand the function the supplement supports in nutrition.  Specifically, what health condition does the supplement support, and what function does it play in that role?  For example, adequate levels of CoQ10 help to support heart health by its role in helping to maintain healthy blood pressure and heart rhythm.  Although CoQ10 is not a nutrient, since the body makes it, its level in the body declines with age and may need to be supplemented.

Once the function of the nutritional supplement is understood, the next important aspect to evaluate is whether the currently available scientific evidence fully supports the function or claim.   Is the available science supporting the claim valid?  What is the strength of the science supporting the function or claim?  Is the scientific evidence supporting the function or claim from a credible source?  There are a number of sources that can provide the answers to these questions.  PubMed.gov (www.ncbi.nlm.nih.gov/pubmed), which is supported by the U.S. National Library of Medicine and National Institutes of Health, is an excellent source of scientific citations supporting numerous health studies for those persons with more of a science background.  This approach does require one to understand and carefully evaluate the quality of the studies to determine if the claims are justified.  However, for those individuals looking for an interpretation of the available science on the function of a particular nutritional supplement, the Linus Pauling Institute (www.lpi.oregonstate.edu), Life…supplemented (www.lifesupplemented.org), and WebMD (www.webmd.com) are all excellence sources of credible information.

So, in the end, the answer is yes, many nutritional supplements do have value as long as the function or claim is supported by credible and efficacious science.  It is important to note that not all supplements are supported by the same level of scientific evidence, and that the nutrient under consideration needs to be thoroughly evaluated for its true value as a nutritional supplement.