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enTRinsic Drug

Delivery Technology
Capsugel Dosage Form Solutions developed enTRinsic drug delivery
technology to provide oral delivery with full enteric protection and
rapid release in the upper gastrointestinal (GI) tract without the use
of coatings. Tailored capsules utilized with enTRinsic technology
are manufactured using pharmaceutical grades of cellulosic enteric
derivatives (100%). This novel and proprietary technology has proven in
vitro and in vivo performance, and is finding application in several areas:
Enabling the oral delivery of sensitive molecules, such as nucleotides and peptides, vaccines and live
biotherapeutic products (LBPs).
A product development tool enabling rapid prototype development and accelerated in vivo testing.
A novel enteric dosage form for market differentiation and/or intellectual property.

Sensitive Molecule Applications

Product Development Tool

Some products are difficult or impossible to delivery orally


due to the need for enteric protection, but the inability to
withstand either the high temperatures associated with
coating application and/or sensitivity to the coating solution or
suspension. enTRinsic technology can therefore be enabling
for oral delivery providing full enteric protection without
coating, and applicable to a range of sensitive molecules:

enTRinsic technology can be utilized to greatly simplify and


accelerate prototype development and rapid in vivo testing of
products requiring enteric protection and/or targeted release
to the upper GI tract:

Nucleotides

Eliminate coating system preparation and application


steps.
Rapid screening and optimization of enteric performance.
Remove dependency of enteric functionality with process
variability.

Peptides
Vaccines
Live Biotherapeutic Products

Obviate need for process development of the enteric


coating step, process scale-up and validation.

Enteric capsule technology has been shown to rapidly release


at pH 5.5 allowing optimal absorption in the upper GI tract.

Independent analysis estimates time savings afforded by


enTRinsic technology of 9 months or more through Phase III.

enTRinsic Drug Delivery Technology - Specifications


Product description:
Two piece intrinsically enteric hard capsule

Regulatory Status:

Contains commercial polymers used in


coating for more than 20 years
Manufactured with pharmaceutical grade of
cellulosic enteric derivatives
Complies with relevant European,
Japanese and US Pharmacopeia
Size # 0 standard (additional sizes
monographs
upon request)
White opaque standard (specific colors
upon request)
Dry ingredient formulations only

Water content: less than 7%


Storage (empty enTRinsic technology capsules: 15 25C & 35 65%RH, in moisture
tight packaging
Shelf life/stability (6 months storage in HDPE
bottles)
No change in dimensions (diameter, length)
(storage @ 40C/75%RH 6 months)
No change in the enteric properties (storage
@ 30C/65%RH 6 months)

Billions of Commercial Units Produced Annually


Capsugels Dosage Form Solutions solves customers
most pressing product development challenges, including
bioavailability enhancement, modified release, abuse
deterrence, biotherapeutic processing, and inhalation
formulation. We have manufacturing sites approved by global
regulatory agencies in the U.S., Europe and Asia producing

billions of liquid-fill hard capsules and soft gels annually for


the pharmaceutical and health & nutrition market segments.
Drug product intermediates are produced at commercial scale
at our Bend, OR (USA) facility using spray-dry dispersion and
other proprietary technologies.

Integrated Product Development

Active Pharma/
Nutritional Ingredient
Target Product Profile
Commercial Goals

Product

Design

Develop

Technology Breadth
Formulation Capabilities
Rapid Advancement Process C
 linical Manufacture
Tech Selection Methodology
Scale-up

Capsugel Dosage Form Solutions utilizes an integrated product


development approach ensuring that our clients can rely on
one partner from design to commercial scale production of
innovative drug product intermediates and finished dosage
forms. High quality science and engineering is core to our
offering at every stage of the product development cycle and
has enabled the successful advancement of hundreds of

Technology Platforms
Capsugel Dosage Form Solutions utilizes
a premier breadth of technologies, used
alone or in combination, to address key
formulation challenges and meet target
product profiles. Specialized development
and manufacturing capability is in place to
handle highly potent, controlled substance,
hormonal and oncology compounds.

Manufacture
Facilities & Equipment
Global Footprint
Quality & S
 upply Chain

Claims & IP
R
 obust &
Well Understood

compounds. Specialized rapid advancement & technology


selection methodologies allow our product development teams
to advance compounds to clinic in 4-6 months. Co-located
product development and manufacturing sites further ensure
accelerated speed-to-market as well as reduced product
development risk and cost.

Bioavailability Enhancement
Spray-dried dispersions Hot-melt extrusion Lipid/liquid-based formulations
Nano-crystal technology Salt forms Particle size reduction/micronization

Modified & Targeted Release


Multiparticulate approaches Matrix & osmotic technology Intrinsically enteric capsule
technology Colonic delivery Pulsatile release/dual release & fixed dose combinations

Specialized Applications
Lipid multiparticulate technology Inhalation formulations Abuse deterrent technology
Taste-masking High potency APIs

For more information on our enTRinsic Drug Delivery Technology contact


us at DFSinquiry@capsugel.com, visit capsugel.com, or reach a Capsugel
representative directly at:
Europe, Middle East & Africa: +44 (0) 150 644 8080 | North America: +1 (541) 382-4100

Capsugel will use reasonable efforts to include accurate and up-to-date information on this brochure but makes no warranties or representations of any kind as to its accuracy or completeness. The entire contents of this brochure are subject to
copyright protection. Copyright 2015 Capsugel Belgium NV. All rights reserved. GMCN 201510005