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Omega-3 market spirals.
When creating an omega-3 supplement product, careful
consideration must be given to both the ingredients used and
the dosage form in which it is formulated. The most common
omega-3 oils found in supplements are docosahexaenoic acid
(DHA), eicosapenataenoic acid (EPA), and the shorter chain alphalinolenic
Oil composition varies according to the source. Historically, fish
oils such as cod liver oil were given as a supplement, long before
the benefits of the EPA and DHA omega-3 ingredients they contain
had been scientifically studied. Products derived from oily fish
such as sardines, mackerel and herrings have the highest omega-3
content, with the omega-3 present in the form of triglycerides.
More recently, krill has been identified as a source of omega-
3s, with the advantage that the EPA and DHA components are
bound to phospholipids, which is thought to make them more
biocompatible, as they do not need to be processed by the liver
into a form that can be used by the cells. An additional advantage
is the presence of the antioxidant astaxanthin, which can help
preserve the oil’s nutritional content.
Omega-3s can also be derived from vegetable sources;
however, this is predominantly alpha-linolenic acid (ALA), which
has to be converted to EPA and DHA in the body – EPA and DHA
are the forms for which health claims have been approved. The
most common is flax seed oil, which comprises more than half
ALA. Microalgae oil, meanwhile, contains high levels of DHA, and
an optimum balance of EPA. This form is growing in popularity as
an alternative to fish, as concerns are increasingly being raised
over fish stock sustainability.
There is a wide variation in the quality of the oils, and it is
important that these raw materials are carefully tested to determine
the EPA and DHA levels they contain. This would typically be
done by comparing gas chromatograms to reference standards.
Additional tests include measuring the acid value, plus peroxide
and anisidine levels, and checks for contaminants such as dioxins,
polychlorinated biphenyls (PCBs) and heavy metals, including
lead, cadmium and mercury.
Delivery formats for omega-3 supplements
The traditional spoonful of deodorised fish oil is still common in
some markets such as Norway, where there is a strong tradition of
The market for omega-3 products has spiralled in recent years. According to a report
published by Transparency Market Research in September, global demand for omega-3
products was estimated to be worth US$1.6 billion in 2010, and expected to exceed US$4
billion by 2018. This represents a compound annual growth rate of 15%, and while North
America remains the largest market, with more than a third of consumer sales, Asia-Pacific
is anticipated to grow most rapidly in the near future, outstripping the North American
market by 2018.
Omega-3 market spirals
By Terri Albert Director of Research, Development & Innovation.
its use in the prevention of, for example, colds and flu, but there
are drawbacks. Because of the propensity of omega-3s to oxidise,
they may need to be refrigerated to prevent them going rancid,
and the constant opening and closing of the bottle can accelerate
the oxidation process. As a result, omega-3s are now more
commonly taken in alternative dosage forms.
By far the most successful of these is the softgel capsule.
They are convenient to take and stable, and are generally
straightforward to manufacture in bulk, with the shell protecting
the oil from the oxygen in the atmosphere and reducing oxidation
levels on storage. More recently, enteric coated softgels have
emerged, which can deliver the oil into the lower intestine and
reduce the amount of reflux. This second reason is less important
nowadays, with the modern breed of refined and deodorised
oils reducing the incidence of that unpleasant fishy aftertaste
Other possibilities include solid doses, which are commonly
chewable tablets for children. However, the highest possible
payload of coated oils into powders is about 50%, and thus the
EPA/DHA levels are quite low. In addition, the high compression
involved in tableting can cause the coating of the oil to crack,
allowing the oil to be oxidised and the tablets to go rancid.
The resulting fishy smell and taste makes them unpalatable,
particularly for the children at whom they are aimed.
Gummies are an alternative, but the oil payload is even lower.
The high levels of sweeteners mean the flavour is much better, but
they tend to be perceived as healthier confectionery rather than
a delivery form for a dietary supplement. The popularity of this
format is growing substantially, however.
The advantages of softgels
That tendency to oxidise makes softgels the ideal format for
omega-3 supplements, as they are hermetically sealed, thus
providing an extremely effective method for protecting the oil from
the oxygen in the atmosphere. It is common practice to add a
small amount of the antioxidant d-alpha-tocopherol – a form of
vitamin E – as an additional deterrent to oxidation.
Key to preserving the non-oxidised forms of the oil is to start
with a high-quality oil. Handling and exposure should be kept to a
minimum to prevent contact with the air, and encapsulation under
a nitrogen blanket can also prevent oxidation. Storing in closed
vessels and gravity feeding into the encapsulation area will assist
in minimising exposure to air. Even so, prior to encapsulation, the
oil will undergo a deaeration process to remove any air that has
been introduced into the oil.
The choice of plasticiser and shell thickness play an important
role in the performance of the softgel. Ideally, a permeability of
below 5ml of oxygen per metre squared per day at 20°C and a
relative humidity of 30%. This is essential for maintaining the
product’s quality during its shelf-life. Ribbon thickness is also
important. Some manufacturers use a thinner ribbon to cut costs,
but if it is made too thin oxygen may permeate through the shell,
The composition of the shell itself is determined by a number
of factors. In the light of the bovine spongiform encephalopathy
(BSE) scare, only certain parts of an animal, notably the hide, can
be used to make bovine gelatin. No parts of an animal’s central
nervous system are permitted in some regions, with the origin
of the gelatin being commonly regulated. Porcine gelatin is an
alternative, but is not suitable for consumers requiring a kosher or
halal diet. Fish gelatin is available, but the supply is limited and it is
There are also completely non-animal derived alternatives. For
example, shells can be made from seaweed-derived carrageenan,
or potato starches. These shells may have some limitations in
combination with particular active materials, but in general are
very compatible with omega-3s. Catalent’s version comprises
iota-carrageenan and corn-derived hydroxypropyl starch, which
retains the key attributes of soft gelatin capsules, including ease
of swallowing. These forms have been sold in south-east Asian
for more than a decade. Handling, storage, transportation and
packaging requirements are similar to those for traditional gelatin
capsules, with a shelf-life of at least three years.
There are other ways in which softgel formulations can be
altered to give different properties. Reflux and taste issues can
be minimised via an emulsified dispersion system, which can
also speed up absorption. Typically, the oil will be emulsified
with polysorbate or lecithin, with particle sizes below 100μm.
These colloidal particles increase dispersion in the gut, and allow
improved uptake and better bioavailability. The softgels can also
be pierced, and the contents will disperse readily into food or
Chewable softgels are particularly useful for children and those
who have difficulty in swallowing. These have gained popularity
because of the growing trend to supplement children’s omega-3
intake, after research indicated that it might have benefits in brain
development and behavioural improvement. These comprise
a chewable shell of gelatin and starches derived from sources
such as potato or corn, with the starch ‘weakening’ the shell.
The capsules comprise a mixture of the omega oils, compatible
flavour agents that are predominately oils, and time varying
carriers, notably silicon dioxide, depending on the required texture
of the fill. As the capsule is chewed, the shell begins to dissolve,
releasing the taste-masking flavour technology. However, the
weaker nature of the ribbon creates manufacturing challenges
in balancing its robustness and flexibility throughout the
encapsulation process. The final capsules also need to be carefully
packed to ensure they remain stable on shipping and storage.
Another recent development at Catalent is the GraphiCaps™
inline printing option. This in-line dual-sided ribbon printing
technology allows for coverage of the whole, or a part, of the
capsule . Originally developed for pharmaceutical identification,
the technology enables graphics to be added to either regular
or chewable softgels using food grade ink, which can enhance
the brand identity of the product, make them more appealing to
children, for example, or create more easily identifiable dosing
regimes for the elderly.
Softgels remain the ideal delivery format for omega-3
polyunsaturated fatty acids. The continued growth of consumer
interest in the health benefits of omega-3s, combined with
technical developments that improve the delivery profiles and
provide greater convenience and palatability, is sure to see the
market for these products expand further in coming years.
Terri Albert is Catalent Pharma Solutions’ Director of
Research, Development and Innovation, based in Melbourne,
Australia. She began her career in 1996 as Strategic Sales
Manager for Australia and New
Zealand with Catalent’s former
incarnation, Cardinal Health.
From 2001, she then spent 11
years as Catalent’s Director of
Innovation and New Business
before moving into her current
role in 2012.
Ms. Albert has a Master’s
degree in Marketing from