June 26, 2006
Key Steps in Nutritional Formulation
by Robin Koon
The first thing a formulator considers when undertaking a new product is the product concept: What is the purpose of the product and what is it to be used for? There are many different types of ingredientsvitamins, minerals, herbal, amino acids, enzymes and other specialty compoundsused in formulations singly or in combinations. Similarly abundant in options are design choices. Products often target a range of health goals, including anti-aging, antioxidants, weight loss and general wellness, in addition to supporting specific conditions such as prostate issues, cardiac problems, cholesterol management and memory loss.
When the active ingredients have been chosen or determined, the next step is to consider the regulatory and labeling issues involved. First off, is the product or ingredient legal for sale as a supplement? New dietary ingredients (NDIs), for example, must be approved by the Food and Drug Administration (FDA) prior to sale.
As far as labeling, dietary supplement labels generally follow similar laws to those used for food, but the Dietary Supplement Health and Education Act (DSHEA) does have specific requirements. The product is required to carry a Supplement Facts panel, which is similar to the Nutrition Facts panel most processed foods carry. DSHEA also limits the use of claims or comments on the label or in promotional material; these include structure/function claims, health claims, high potency claims and organic. Botanicals (herbals) should identify which part of plant is being usedaerial, leaf, root, etc. As of January 2006, product labels must also declare inclusion of any of the top eight major food allergens: milk, eggs, fish, crustacean shellfish, peanuts, tree nuts, wheat and soy.
Beyond the regulatory parameters, when reviewing and choosing the active ingredients to be used in the product, there are several consumer-end issues that need to be considered and addressed:
. Are the active ingredients safe to consume, and is the overall potency and amount of each active ingredient safe to ingest? In addressing these questions, formulators must consider not just a single dose, but the entire total daily dose. Additionally, the formulator should consider whether there would be any issues if the product is taken for longer than directed.
. Are there any known unwanted side effects to any of the active ingredients? This is especially important relative to the dose being ingested. For example, a formulator might have to determine the specific amount of an ingredient such as licorice root that may cause unwanted diarrhea.
. Are there any known interactions with either the other ingredients being used or with any common food or drug? For example, Ginkgo biloba, a vasodilator, should not be taken concurrently with any prescription blood thinners.
. Some compounds are available in several different forms, some of which may react with other ingredients in the formulation. For example, the mineral magnesium is available as an amino acid chelate, ascorbate, aspartate, bisglycinate, carbonate, chloride, citrate, gluconate, glycinate, histidinate, lactate, malate, orotate, oxide, sulfate and taurate. The potency and bioavailability of magnesium is different in each of these forms.
After the above issues are settled, a formulator must then determine which dosage form is best suited for the product, taking into consideration such forms as tablets, two-piece hard shell capsules, soft gel capsules or liquid. Cost-effectiveness and/or economics often determines which delivery vehicle is chosen. And the marketing department or the client may have a request for a specific dosage form due to differentiation purposes. Also, compliance may be an issue, as could the number of doses it takes to reach the ultimate daily dosage requirements. In the end, some dosage forms may use fewer doses than others.
After questions on dosage comes stability (degradation) of the active ingredients, especially relative to the dosage form being considered. For example, fat soluble ingredients are best for soft gels. Using them in tablets or capsules usually requires obtaining a spraydried or beadlet version of the ingredient. However, there may be issues with potency and long-term stability when using such ingredients.
After the dosage form is determined, the formulator would decide which excipients are needed to complete the final product. The excipient options are usually determined by the requirements of the active ingredients and the dosage form. Tablets may need binders, fillers, hardeners, flow agents, lubricants, disintegrants, flavoring and coating agents; hard-shell capsules may need bulking agents, flow agents and lubricants; soft gels may need a lipid carrier, emulsifiers, surfactants, suspending or viscosity modifying agents; and liquids may need a carrier liquid, emulsifiers, flavoring, sweeteners, coloring and, possibly, a preservative.
Robin Koon is senior vice president, sales & marketing, at Best Formulations.
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