Optimal Delivery Systems for Dietary Supplement Products

by Ned Becker

Selecting the most efficacious and consistent delivery system for a dietary supplement product is one of the most crucial decisions a business can make when launching a new product. The list of delivery system options continues to grow as companies try to find new alternatives to win over consumers for their products. From beverages to bars, and from softgels to traditional two-piece capsules, consumers have an ever increasing number of options from which to choose.

The key factors in determining the optimal delivery system for a dietary supplement product revolves around two principal issues: the formula and the consumer.

The first question that must be answered is what are the critical nutrients or active ingredients the product is trying to deliver to the consumer and for what specific health benefits. When answering this question, it is important to have an indepth understanding of each ingredient and what is the most bioavailable form in which to achieve the desired health benefit. In addition to considering bioavailability, however, a company must also ensure the form will be readily available with a consistent supply source and will be cost effective for the target market.

Ingredients come in many shapes and sizes, so it is imperative to know what the options are when determining the optimal product delivery system. Are the ingredients oil-based or water soluble, and are they chemically appropriate for delivering the proposed health benefits? When combined, the ingredients must be analyzed for disintegration and dissolution to evaluate whether the active ingredients are reaching the critical location within the body and if the body is readily absorbing these nutrients.

Since each ingredient has different physical properties, and the combined formula may also have interactions, a formulation concept must be explored one step at a time. Among the commonly used delivery systems are:

• Capsules: dry powder ingredients blended and encapsulated into a hard-shell capsule;
• Tablets: dry powder ingredients blended and compressed into a solid tablet, with or without a coating applied;
• Softgels: typically oil-based liquid ingredients blended and processed into a gelatin formed capsule shape;
• Powder mix: dry powder ingredients blended with flavors and then mixed with liquids by the customer for a final beverage form;
• Liquids: dry powder or water-soluble liquids blended with flavors and water or alcohol to generate either a ready-to-drink (RTD) or liquid concentrate;
• Chewables: either in a compressed tablet form or a “gummy” type profile; and . Foods: key ingredients are formulated into the baked or processed product, such as a bar or cookie.

The other key factor in determining the optimal delivery system is the target consumer. Certain consumers may have a definite preference on product form, or they may have dietary restrictions that would hinder the type of delivery form that can be considered.

The age of the consumer target, such as children or the elderly, heavily impacts selection of a delivery form. Children typically cannot swallow a solid dose type of product, but must have either a chewable or liquid form for improved compliance. Elderly consumers may prefer breaking open a hard-shell capsule product and sprinkling it onto their food, instead of trying to swallow it whole.

An analysis of what a consumer is willing to pay is another key determinant in selecting the final delivery system. Certain delivery formats may be price prohibitive for the target market, which is clearly a death sentence for what may be the most effective product available.

There are many issues to consider when selecting the optimal delivery system for a dietary supplement product. It is critical that a company align itself with a knowledgeable manufacturing partner or utilize an in-house expert who understands the different processing requirements. In this industry, the end consumers and their requirements, needs and desires are the deciding factors.

Liquid-Filled, Hard-Gelatin Capsules Re-Enter the Marketplace
by Tamara Smith

One usually does not think of “hot” trends when thinking of the nutritional delivery systems market, but one that is gaining momentum is the practice of filling two-piece capsules with liquids.

This trend isn’t new, as the ability to fill a two-piece hard shell capsule with a liquid substance has been around for more than 150 years. Its advantages have only recently been rediscovered, making it a popular alternative for the nutritional market.

The ability to fill two-piece capsules with liquid or semi-solid ingredients opens up a whole new range of possibilities for supplement manufacturers and has spawned a viable alternative to soft-gelatin capsule technology. By using a two-piece capsule shell, ingredients that:

• have low melting points
• are unstable when exposed to oxygen or moisture, and/or
• require bioavailability enhancement can now be formulated as liquid-filled two-piece capsules.

Liquid-filled formulations in hard capsules are not merely replicates of those filled into soft capsules because a much wider range of excipients can be used. The sealing temperature in the rotary die process for soft capsules is 37°C and thus, formulations must be in liquid-state below 35°C for this to work. On the contrary, hard capsules can be filled with hot liquids enabling excipients with higher melting points to be used. This benefit can help the formulator overcome the challenges presented by poorly soluble actives. Recent research indicates liquid-filled capsules can also provide improved bioavailability over tablets and a simple way to produce sustained release formulations.

Vitamins, in particular, have benefited from the reemergence of the liquid-filled capsules. Oily products, such as vitamins E and A, can be filled and sealed in this manner without adding thickening agents. This allows the maximum concentration of the substance in the minimum capsule size, while also reducing the risk of product instability.

Several manufacturing issues can be addressed through the use of liquid-filled twopiece capsules versus soft-gelatins, such as:

No organic solvents are used in the manufacture of empty two-piece capsules, thereby producing a healthy and environmentally-friendly product.

Originators buy empty two-piece capsules and often perform the development work in-house, thus safeguarding their ideas and expertise.

Production can easily be geared to demand because automatic filling machines are available for batch sizes from bench-top to full-scale production.

Although the technology for filling twopiece capsules with liquids on automatic machines has been around since the mid 1980s, more and more capsule manufacturers are now appreciating the benefits that liquid filled two-piece capsules bring to their operations. This simple formulation technique based on readily available excipients solves most formulation challenges. Automatic filling machines are available for all major manufacturers, enabling in-house production that can be easily geared to demand, thus offering a cost effective alternative for liquid-filled products.

Share this article: Email, Slashdot, Digg, Del.icio.us, Yahoo!MyWeb, Windows Live Favorites, Furl
Add this article feed to: RSS, My Yahoo, Newsgator, Bloglines