DR Capsules from Capsugel Overview Presentation

Capsugel, a division of Pfizer
• Global Business
• 2600 Colleagues
• Over 180 billion capsules sold worldwide
– market share leader
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Peapack, N.J. (HQ)
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Greenwood, S.C.
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Mexico City, Mexico
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Bornem, Belgium
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Ploërmel, France
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Colmar, France
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New Delhi, India
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Bangkok, Thailand
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Jakarta, Indonesia
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Suzhou, China
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Sagamihara, Japan
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Short introduction to Capsugel
2
Who is Capsugel?
Leading provider of innovative dosage forms and
solutions to healthcare customers around the world
Products
Short introduction to Capsugel
Services
3
Equipment
Two axes of development
Liquids
• Capsugel has evolved along two major
development axes:
– New materials (alternatives to
gelatin – Vcaps, Pullulan)
– Liquid filled hard gelatin (Licaps)
and soft gelatin (SGcaps) capsules
2000
1998
1996
Short introduction to Capsugel
2004
4
New materials
Understanding opportunities in today’s vegetarianaware marketplace – 26% of the population
Vegetarian aware consumers take more
supplements than the general
population: an average of 3.1 per day
versus 2.4
63% report that they prefer to buy
supplements that have a specific health
claim
This group has a high interest in preventing
and treating specific conditions with
supplements
54% are brand loyal to the supplements
they use and regularly purchase those
same brands
Ratings of effectiveness, safety, and
believability are important considerations
in choosing supplement brands
Not all supplements available today meet their needs…
Some supplements need protection from
acid as they pass through the stomach
on the way to the intestinal tract.
Some supplements are coated with
chemicals, solvents and other unnatural
ingredients in order to protect them for
targeted release
Some supplements cause reflux or have a
bad aftertaste making it difficult to take
over time
How can a vegetarian consumer get
protection and targeted release but stay
in a plant-based product?
What are some of the products that need protection?
Probiotics
Some strains need protection from
premature activation in the acidic
environment which can destroy the bugs
Amylase enzymes
The enzyme needs protection from
denaturing in the stomach, which would
render it unfit for hydrolyzing glucose
Valerian Root
Valerian root has a pungent odor which
can be released in stomach – causing a
bad aftertaste
Garlic
Garlic also has a pungent taste and odor
which can be released in the stomach
causing a bad aftertaste
Adenosine Triphosphate
ATP, the energy currency of cells, can be
broken down in the stomach by
phosphatase enzymes
Probiotics market is growing fast –
but underdeveloped in supplement use
In 2009, P&G entered FDM and changed the game…
• Dynamic category jumps 24%* to $527 mio
• Align pulls away from Culturelle at the top
•All others grew strongly as well pulled along
by the attention
*up 54% in FDM
Growth is expected to continue with new studies
expanding the category into immunity and oral health
Align
What polymer do most probiotics use and how are they
different?
• Most probiotics traditionally
use HGC, Vcaps® capsules or
Vcaps® Plus capsules
• Enteric, by definition, does
not disintegrate in the first 2
hours in pH 1.2 and then
fully disintegrates in pH 6.8
• DRcaps™ capsules show no
disintegration in the first 30
minutes and less than 10%
disintegration in the first 2
hours in pH 1.2
Representative dissolution curves.
So what’s the promise?
• To Health & Nutrition companies who market acid-sensitive
products, looking for a vegetarian means of providing some
protection for their product to maintain the potency their
customers expect—now there is a vegetarian capsule that
provides up to 30 minutes of protection against stomach acid.
– Same great low moisture capsule but without the need
to add chemical or other coated protection
– Reduces the potential of disintegration and bad
aftertaste.
• To the Contract Manufacturers of those products…
– For products that need some acid-protection,
this reduces manufacturing time, cost and steps needed as well
as the product waste typical in after-encapsulation coating
processes.
What is a DRcaps™ capsule?
Description: Capsule designed to delay
disintegration of a hard HPMC capsules in pH
1.2 with a qualitative composition that is
similar to Capsugel Vcaps® capsules.
They are formulated with:
• HPMC (Hypromellose - Hydroxypropyl
Methylcellulose)
• Gelling agent (Gellan gum)
• Water
DRcaps™ capsule properties:
These capsules present the same characteristics as
Capsugel Vcaps® capsules:
• Dimensions and aspect
• Resistant to capsule cross-linking
• Excellent Machinability
• Well suited for moisture-sensitive ingredients
• Compatible with all major excipients
They differ from Vcaps capsules by their delay in
release as an innovative application optimized for
lower GI tract release
Properties: Acid-resistant release
Probiotics remain stable in DRcaps™ capsules
Probiotics filled in
standard gelatin were
destroyed in the gastric
fluid.
Probiotics in DRcaps
capsules passed the
gastric fluid and were still
active in the intestinal
fluid.
Consumers prefer capsules
* Sensory performance panel, 2010
• Consumers prefer capsules
because they consider them
easier to swallow and gentle on
their stomach.
• Consumers want clean label
performance.
• Most consumers did not
perceive an aftertaste with
DRcaps™ capsules when more
than two-thirds perceived an
aftertaste with the same
ingredients in tablet form.*
• Vegetarian-aware consumers
prefer their supplements from
vegetarian sources.
New opportunities for the retailer
• Now there is the “promise
of performance” for sensitive
ingredients.
• „New & Improved‟ package
claim for retail excitement
• Now there is a vegetarian
solution that better fits what
their customer is looking for.
• Now there is an opportunity
to create a family of
“protected products.”
New opportunities for manufacturing operations
•
•
•
•
New products
Speed to market
While saving $ on operations
No new capitol/outsourcing
Enteric Process
Blending
CFM
Coating
•
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Transport
Warehouse
Yield Loss
Safety risks
Logistical
Control
• Time+$$$
Bottling
Shipping
Eliminate
What hurts a probiotic?
Heat
Moisture
Stability