FORMULATION FOCUS

There is great need for bone support products in the United States, as it has been estimated more than 90 percent of women, 60 percent of men and 66 percent of children have calcium deficiencies. Calcium supplements have been the bestselling mineral product and the third highest-selling product in the dietary supplement industry. In formulating dietary supplements, calcium is still the major nutrient needed to maintain bone health and prevent osteoporosis. When calcium is depleted, bone density declines and bones become more brittle.

However, there are several other minerals and vitamins that are important to consider in formulating bone products, including magnesium, zinc, manganese, boron, vitamin K and vitamin D. One common bone health formulation combines calcium and magnesium with vitamin D; however, supplementing with calcium could result in consumers exceeding normal doses of vitamin D since they may be taking other dietary supplements such as a multi that contain D.

Consumers may purchase a bone support product based on price, a doctors recommendation, the number of pills, pill size or bioavailability. Product options include stand-alone calcium pills, multiple minerals, multiple vitamin/mineral products, and enhanced nutraceutical formulations. Other nutrients added to calcium formulas are beneficial since supplementation with only pure calcium can cause a mineral imbalance caused by the leaching of potassium, magnesium and some other minerals from bones.

Formulators should also be aware that some consumers complain about calcium, as well as some other mineral supplements, causing bloating, gas and constipation. It may be beneficial to include label directions recommending calcium be taken with food to reduce gastrointestinal problems.

Formulation Challenges

Calcium can be difficult to work with, since it is hard to fit the necessary quantity into a single capsule. The average consumer may purchase a less-expensive calcium product because of need, but may not have knowledge of bioavailability or quality. They also may frown upon the size or number of capsules they would have to take on a daily basis.

In pill form, the elemental amount of calcium ranges from 9 percent to 45 percent, making it difficult to make small tablets or capsules. To meet 100 percent of calciums daily value (DV), a product would need 1,000 mg/d. Calcium forms available with their elemental amount of calcium are calcium gluconate (9 percent), calcium citrate (21 percent), calcium citrate malate (24 percent), hydroxyapatite (33.7 percent), calcium phosphate (17 percent), calcium chloride (36 percent), calcium lactate (14 percent) and bisglycinocalcium (18 percent). One possibility to maximize bioavailability is to use a different delivery system.

There are consumers who prefer ingesting calcium in pill form; but, with such prevalence of calcium deficiency in the U.S. population and studies showing pills are not necessarily a first-line choice for many Americans, different calcium-rich products are necessary. In formulating food products, evaluate calcium forms, bioavailability, stability, taste, mouthfeel and solubility. Calcium can be added to foods such as soymilk, orange juice, biscuits, breads and cereal. There is even a patent available to fortify carbonated or noncarbonated drinks that have a low pH with calcium and vitamin D. In addition, product formulators need to consider the population, and related subpopulations, purchasing the product. For example, women are the most frequent supplement purchasers, even for products designed for men and children. It is important to investigate all those in a specific market to formulate for and understand their issues.

Consider bone health products formulations for vegetarians or other consumers who restrict dairy products. Research has shown vegetarians, particularly vegans, consume particular vitamins and minerals at suboptimal levels. Depending on their specific bentvegetarians may only avoid meat or may not ingest dairy or eggscalcium intake is usually low. A soy protein powder with bone-supporting nutrients may be one option for this population.

Soy protein has been demonstrated to support bone health, whereas the isoflavones alone do not have convincing research to support those type of health claims. Among the considerations when formulating a soy protein for bone health are flavor, viscosity, mouthfeel, stability and solubility. Calcium can be added to fortify foods such as soymilk and other soy products.

On a related note, soy-derived ingredients such as ipriflavone and isoflavones may play a role in bone health formulations. There is substantial research on ipriflavone, an isoflavone derivative, which has been used to support bone health and prevent osteoporosis; the branded ipriflavone product Ostivone has a daily effective dose of 600 mg combined with 1,000 mg of calcium. Other nutrients could also be included, depending on the price point and target market. Isoflavones from soy or red clover are appealing and are possibilities to include for support, but presently the research on isoflavones for bone support is limited, so claims are not recommended. New research may show differently in the future.

There is a great need to reduce calcium deficiency and improve bone health. Product formulators have various options besides pill form to produce calcium-fortified products that both taste good and are bioavailable. 

Judi Quilici-Timmcke, MS, is the president of Q-Tech Services Inc. (www.judiq.com) and works as a product formulator in the dietary supplement industry. She was previously vice president of product development and research for Weider Nutrition Specialty Market and for Rexall. She has a masters degree in dietetics/exercise physiology.