Functional
Attributes Of OmniActive’s Vegetarian Beadlets Designed
Right for The Delivery System:
Delivery of carotenoids in a dry delivery form has been considered
to be a challenging task since long. Crux of the problem is
the instability of the carotenoid such as Lutein in presence
of oxygen, light and heat. Lutein/ Zeaxanthin needs to be
protected from these by co-formulating it with other antioxidants
and stabilizers such as natural mixed tocopherols and other
proprietary ingredients.
Traditionally, carotenoids are stabilized by presenting them
in the oil suspension form. But in this form one can deliver
only as soft gelatin capsule. In this form, the active ingredient
is encapsulated in a thickly walled gelatin capsule. There
are several limitations of delivering in the form of soft
gelatin capsules as compared to tablets. Tablets are considered
to be more common and versatile form of delivery with better
bioavailability as compared to soft gelatin capsules.
During past 35 years, numerous attempts were made to produce
tablet-grade Lutein. The product that finally saw the light
of the day was a free-flowing beadlets made by a complicated
process known as ‘spray-congealing’. In this process,
the Lutein is solubilized in an organic solvent and then microemulsified
with aqueous solution of gelatin containing sugar. The microemulsion
is then subjected to spray congealing process whereby the
emulsion is converted in to beadlets. The beadlets are rendered
non-sticky by rolling them in through a bed of starch. There
are several drawbacks of this technology
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Lutein which is embedded
inside the gelatin matrix is protected, whereas lutein
present at the surface of the beadlet is vulnerable
to harmful effects of oxygen and light. |
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When compressed to form a tablet,
the lutein gets squeezed out of the gelatin matrix and
is released in to un-friendly tablet matrix thereby
rendering it unstable. |
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Upon ingestion, the release of lutein in to the intestine
is governed by the solubility of thick gelatin matrix
in gastrointestinal fluid. Due to slow solubility of gelatin,
the bioavailbility of lutein is adversely affected. |
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Gelatin being highly hygroscopic,
strict control of humidity and temperature is mandatory
during tabletting operation. |
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Gelatin being animal protein, there
are associated risks in its usage, such as mad-cow disease. |
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Since to form gel one needs more
than 40% gelatin, there is limitation on the quantity
of lutein that can be loaded. It is extremely difficult
to make beadlets of more than 5% lutein. |
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To
overcome these limitations, OmniActives has developed
a novel beadletting technology. The beadlets made by
special fluidbed technology have following advantages- |
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They are made of 100% vegetarian ingredients. |
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Lutein and other carotenoids are
stabilized by a combination of polymer coatings that
ensure protection not only from oxygen but also from
moisture. |
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Particle size range is small enough
to enable tabletting without harming the protective
coatings. |
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When compressed in to the tablets,the
protective coatings remain intact, the lutein does not
get squeezed out of the beadlets. |
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Upon ingestion, the beadlets readily
disintegrate and release lutein for absorption. The
bioavailability of lutein from these beadlets is certainly
higher than the gelatin beadlets. |
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Since the technology is not based
on matrix embedding, there is more ‘space’
available for incorporating more lutein or any other
carotenoid. Beadlets containing 25% lutein thus can
easily be prepared. |
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The beadlets are not hygroscopic and do not require
controlled humidity during tabletting. |
