Supplementing diets with omega-3 fatty acids docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and alpha-linolenic acid (ALA) benefits consumers in many ways, including promoting normal blood pressure and lowering triglyceride levels. In addition, DHA has been shown to promote eye and brain health. These omega-3 oils come primarily from marine organisms, including fish liver, Antarctic krill, and green-lipped clams. Oils like ALA, which are converted to EPA and DHA in the body, can also be obtained from plant sources. Alternative non-animal sources of omega-3s also include microalgae, which often contain EPA or DHA as either glycolipids or phospholipids. Biotechnological genetic modification techniques are also used to make EPA from yeast.

The source of omega-3 fatty acids is important to health conscious consumers, as are products that offer superior quality and quantifiable benefits. Today’s consumers are looking for more convenient and convenient supplements, and omega-3 supplement delivery systems continue to improve.

Fish oils have traditionally been served as liquids, with consumers taking one spoonful daily. Many consumers have been put off by the fishy taste and odor of the liquids, as well as their tendency to cause acid reflux and a persistent, unpleasant aftertaste. The reason for this often described rancid taste is the natural oxidation of the omega-3 oil molecules. With a liquid formulation, this effect was almost impossible to prevent, as serving the product on a spoon exposes the contents of the bottle to oxygen as soon as the seal is broken for the first time. The purity of the product can also affect the rate of product deterioration as the presence of trace metals or enzymes in the oil accelerates oxidation.

Numerous alternative dosage forms exist today to overcome these delivery system problems. One of the most successful are capsules. For the consumer, this dosage form is more convenient and less cumbersome to handle, and for formulation scientists, encapsulation offers the significant benefit of protecting the oil from the effects of atmospheric oxidation and maintaining product quality. The shelf life of products is also greatly increased.

The oxidation of omega-3 oils is irreversible. In addition to the unpleasant physical properties, oxidation can also affect the nutritional quality of a product and compromise safety through the formation of by-products such as aldehydes, ketones, acids and other complex molecules. In addition to oxidation, omega-3 oils are prone to degradation caused by heat and light. Therefore, careful handling is critical throughout the entire softgel manufacturing process.

Manufacture of the optimal omega-3 capsule

As with any process, it is important to start with the highest quality raw material. The next step is to look for a compatible antioxidant molecule that the omega-3 oil can be formulated together with to minimize oxidation. There are a number of options for complementary antioxidants, including tocopherols, which are naturally found in some sources of omega-3 oils or citric and ascorbic acids, as well as a number of spice extracts. Due to the variations and different needs of different types of oil, there is no one-size-fits-all solution. A mixture of antioxidants is often preferable to a single source.

Next, it is crucial to find the right manufacturing process. The modern form-fill-seal process that is used to manufacture most capsules today was invented by RP Scherer over 80 years ago. This process begins with the production of two flat yellow ribbons, which can be made from animal gelatine, fish or vegetarian. Vegetarian materials are becoming increasingly popular in Southeast Asian markets, including those that use the algae-derived hydrocolloid carrageenan combined with starch.

The manufacturing process brings the gel bands together between two rotating capsule-shaped punches to form a capsule which is then filled using a nozzle that contains the liquid oil that has been pre-formulated with other ingredients such as the antioxidants. The softgel is then sealed. At this point the airtight environment that protects the omega-3 oil is created.

Throughout production it is important to maintain a closed system for material transfer so that the products remain protected by an inert gas blanket such as nitrogen, including within the storage drums in which the raw materials are delivered.

The capsules are then subjected to primary packaging, usually in bottles or in blister packs, preferably in an inert atmosphere to maintain integrity and minimize the risk of oxidation.

Innovative omega-3 dosage forms

Within the highly competitive market for dietary supplements, there is a strong demand for new innovations in the marketing of products. Capsule encapsulation has revolutionized the omega-3 market away from liquid formulations. Additionally, advances in technology such as microemulsion filling technology can improve user compliance by further eliminating fish oil flavor and anti-reflux properties, helping to address some of the key challenges in today’s omega-3 products. Controlled release technologies and a modified delivery profile offer significant benefits to consumers. For example, an acid stable enteric coating would allow capsules to pass through the acidic conditions of the stomach and then dissolve under the more alkaline conditions of the small intestine, reducing reflux and minimizing the potential for unpleasant, fishy aftertaste.

By leveraging advanced delivery technologies, formulators and manufacturers ensure that consumers have access to convenient, high-quality omega-3 dietary supplements. From liquids and capsules to vegetarian capsules and beyond, the constant challenge is to ensure that innovations can continue to meet changing market demands.

Catalent Consumer Health employs writers. Humera Ahmad is the director of product development at APAC. Claudia Valla is a product development consultant; and Rosa Bertolami is Senior Scientist Advisor.

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