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Short introduction to Capsugel 2
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)
Greenwood, S.C.
Mexico City, Mexico
Bornem, Belgium
Ploërmel, France
Colmar, France
New Delhi, India
Bangkok, Thailand
Jakarta, Indonesia
Suzhou, China
Sagamihara, Japan
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Short introduction to Capsugel 3
Who is Capsugel?
Products Services Equipment
Leading provider of innovative dosage forms and
solutions to healthcare customers around the world
Short introduction to Capsugel 4
Two axes of development
• Capsugel has evolved along two major development axes:
– New materials (alternatives togelatin – Vcaps, Pullulan)
– Liquid filled hard gelatin (Licaps)and soft gelatin (SGcaps) capsules
New materials
Liquids
1998
2000
1996 2004
Understanding opportunities in today’s vegetarian-aware marketplace – 26% of the population
Vegetarian aware consumers take moresupplements 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, andbelievability 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
• 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. * Sensory performance panel, 2010
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
Blending CFM Coating
• Transport
• Warehouse
• Yield Loss
• Safety risks
• Logistical Control
• Time+$$$
Bottling Shipping
Enteric Process
Eliminate
What hurts a probiotic?
Stability
Heat Moisture