Fortification: Getting It Right

As more people throughout the world continue to educate themselves on the long-term benefits of a healthy diet, the opportunity for manufacturers to develop fortified, good-for-you products will dramatically increase. The on-the-go lifestyle of today's consumer unfortunately does not leave a lot of time for a well-balanced diet that incorporates the necessary servings of vegetables; fruits; meats, fish, and poultry; dairy; and grains. This is where fortification plays a vital role in delivering the vast array of nutrients that would normally be derived from each food group. With the technology available today, numerous types of foods and beverages offer fortification opportunities. The key is to successfully deliver a nutrient premix blend without negatively affecting consumer expectations of taste, texture, mouth feel, and appearance.

Blending, testing, and processing techniques can make the difference between producing a reliable, high-quality, homogeneous, shelf-stable nutrient premix and an inferior one that may lead to poor consumer confidence, potential regulatory issues, or recall situations. Particle size, the type of blending equipment and ingredients used during processing, and potential ingredient interactions are all important considerations.

The challenge in blending ingredients with different particle sizes is that bulk density and variable particle sizes can lead to segregation. Therefore, minor nutrients should be diluted with another carrier to get the two different materials to blend well and make a homogeneous product. In the nutraceutical and functional food industries, combination products are the norm. The most common nutrients are vitamins, minerals, amino acids, nucleotides, and other functional food ingredients offered in a single serving of powdered products for tablets or capsules. The average premix formulation contains at least 10–14 active nutrients and 3–6 functional food ingredients or carriers. Some formulations can contain more than 50 active nutrients and carriers.

To comprehend the challenges of producing a homogeneous, correctly proportioned blend of these active ingredients, imagine trying to create a uniform blend of 1 spoonful of granular sugar, 3 spoonfuls of flour, and 5 spoonfuls of rice. Then add to that one-half teaspoon of salt and a quarter spoonful of color. Presuming success in combining these ingredients into a homogeneous blend, the next challenge is compressing small amounts of the blend into a serving of a nutritional product. Each serving must contain each ingredient in the same proportion as the blend. In fact, making a uniform blend is one of the most critical and complicated steps in manufacturing premixes that contain multiple nutrients. While there are many possible reasons for these deficiencies, inadequate blending is often the source of variations or absence of nutrients.

ACTION-SYNERGIZED COEXTRACTED INGREDIENTS CAN BE AN ADVANTAGE TO TRADITIONAL PREMIXES

PREMIX BLENDS FORMULATED for a variety of applications are being offered as helpful alternatives to using separate ingredients in the nutraceutical, beverage, and contract manufacturing markets. Using premixes avoids the need to have different suppliers for each of the ingredients, thereby saving time and effort. It also allows one to have confidence that the quality and supply is being guaranteed by one manufacturer.

The action-synergized extraction process allows multiple botanicals, fruits, and vegetables to be extracted together at the same time. Using the partial solubility of the nonpolar and polar parts of a molecule, known as amphiphilicity, phytochemical entities of varying solubilities help each other to extract into the final product. Due to this chemical property, phytocompounds that have a lower degree of water solubility are able to be extracted with water. In a cycled process under controlled time, temperature, and pressure, a full-spectrum profile is possible, which ensures a much greater availability of total plant phytochemicals than if the narrow range of plant compounds were extracted using a specific hydrocarbon solvent.

Because water is actually thought of as "the universal solvent," it makes sense that when used with just the right manufacturing tools, it can function as well, if not better, than conventional solvents. Using water, manufacturers can extract many of these botanicals at the same time, rather than taking the costlier step of making separate extracts that later have to be mixed together.

Because concerns about quality and safety abound in the industry, the use of a single extract that covers all ingredients reduces the risk of formulation problems and having to track down or test all ingredients to figure out which one might be the problem.

As many supplement companies know, new CGMP regulations from FDA slated to be enforced later this year require extensive quality testing, including identity testing by TLC (thin-layered chromatography) or HPTLC (a high-performance type of thin-layered chromatography). Companies should give additional support by providing HPTLC identity test methods when buyers purchase custom coextracted ingredients.

Brien Quirk is research and development director for Draco Natural Products (San Jose, CA).

Emerging Ingredient Trends
Because of their purported health benefits, superfruits (e.g. açai, goji, mangosteen, noni, pomegranate, sea-buckthorn, dragon fruit, Indian gooseberry, and yumberry) continue to gain notice as popular ingredients that target an array of health conditions and fulfill the growing consumer taste for exotic flavors. While clinical research on this category is still in its infancy, these fruits and their benefit claims, which range from promoting heart health to antiaging and increased immunity, have been culturally upheld by the various ethnic groups who include them in their diets.

In addition to superfruits, other ingredient trends to keep an eye on are the following:

• Omega-3s from flax, microalgae, chia, and krill.

• GABA (gamma aminobutric acid) for antistress and mental-focus applications.

• Resistant starch for increased satiety, fat burning, and insulin sensitivity.

• Simple fruits such as tart cherries as a source of melatonin, and grapes for their polyphenol compounds.

• Botanicals such as hibiscus for antihypertension, rhubarb for antianxiety applications, and choke berries for blood sugar management.

Using any of the above-mentioned ingredients in a premix requires taking several factors into account during the product development stage. Challenges associated with multiple-nutrient premixes include the type of finished product as well as the desired taste, flavor, and color of the finished product; solubility; bioavailability; pH level; safety and toxicity; interactions among various ingredients; and stability of the individual ingredients. Factors that can affect stability, for instance, include temperature, pH, oxygen, light, and moisture, to name a few. And an example of a potential interaction is the formulation of a product that contains thiamine, as well as a superfruit and its possible sulfur dioxide content. Thiamine plays an important role in helping the body metabolize carbohydrates and fat to produce energy, and it also helps maintain proper functioning of the heart and the nervous and digestive systems. Combining this nutrient with a superfruit can possibly result in immediate degradation of thiamine due to the fruit's carryover of sulfur dioxide. The level of sulfur dioxide should be determined prior to fortification, and appropriate overages should be added to compensate for losses.

To minimize interactions, a manufacturer can separate vitamins and minerals into two individual premixes, encapsulate certain vitamins or minerals, or use a particular form of a specific ingredient. For example, iodine's ingredient form may be potassium iodide, magnesium's may be magnesium phosphate, zinc's may be zinc oxide, copper's may be copper gluconate, and calcium's could possibly be tricalcium phosphate, depending on what other ingredients are in the premix.

Most experts on formulation agree that there is no science to blending powders that are part of the finished product and that will work for every product. However, blending powders is very different from blending liquids. While overblending is almost impossible, powder-to-powder blends can be “unmixed” when particles segregate. There are two common blending processes employed in the nutraceutical industry to achieve a homogeneous product: dry blending and wet granulation. Dry blending is the most common method used to manufacture premixes. The physical properties of powders are a critical aspect of dry blending. Before blending starts, first consider the properties of the ingredient powders, including particle size, shape, density, and flowability.

Enhanced waters, meal-replacement bars, functional beverages, and fortified biscuits will continue to grow in popularity. To successfully introduce new products to the marketplace, a manufacturer needs to lay a solid foundation at the very beginning of the development process. That should include partnering with an experienced nutritional premix formulator to minimize the challenges associated with not just bringing a product to market, but also ensuring that the product lives up to its label claims, delivers repeat purchase, and protects the brand value or brand relevance.

Ram Chaudhari, PhD, is senior executive vice president and chief scientific officer of Fortitech Inc. (Schenectady, NY).