Enteric Capsule Release

GELITA® EC• First of its kind• Production with one gelatine
product in one process• Creates value-added market
opportunitiesGELITA® EC
Expanding GELITA’s Portfolioof Capsule Release Possibilities
GELITA offers a comprehensive portfolio of gelatines that provides a broad release profile
in soft capsules. Besides variety of versatile and tailor-made standard gelatines, there areGELITA® RXL and GELITA® RXL Advanced for improved capsule shelf-life and stability. These
special gelatines provide reliable release and reduced cross-linking properties, even under
extreme storage conditions. This GELITA capsule gelatine portfolio is complemented byGELITA® RXL R² for revolutionary fill release. The soft capsules produced with GELITA® RXL R²offer faster release of the fill and offer the added advantage of the reduced cross-linking
properties of the RXL technology.
And, now – on the opposite end of the release profile spectrum, GELITA offers GELITA® EC;
a gelatine product for the one-step production of truly enteric capsules.

Release Profile of theGELITA® Portfolio
Revolutionary Release

Release profile

Fast release and reduced cross-linking

Reliable Release
Reduced cross-linking

Standard Release
Improved shelf-life and stability

Enteric ReleaseOne-step-production of truly enteric capsules[2]

GELITA® EC
The perfect (dis)solution[3]

Dissolution results

0100

Consumers have been ingesting nutrients in soft capsulesfor decades due to their easy of swallowing and convenience.
However, one nagging issue has been plaguing consumers foras long as they’ve been ingesting fish oil and other omega-3
fatty acids: fishy burps and aftertastes. This un­desirable
effect has even demotivated the otherwise health conscious
consumers to avoid taking fish oil supplements altogether.
Until now. GELITA® EC – the first commercially available
gelatine product of its kind – allows for the one-step
production of enteric capsules that open in the intestine(instead of the stomach, as with traditional gelatine capsules).

Added Value withGELITA® EC
Most enteric delivery systems are produced by applying an
acid-insoluble coating to freshly produced soft capsules. Thisintensive two-step process adds time and money to the costof each enteric capsule. Additionally, this coating produces
an opaque shell – which is less desired by consumers.
With GELITA® EC, capsules producers now have the ability
to create enteric capsules using existing equipment in a
one-step process – avoiding additional time and costs –while creating brilliantly clear capsules.

[4]

min%%

No capsules
released the fillin simulated
gastric acid

Satisfying Consumer
Demand<10All capsules
showedno release

Average time forcapsules to open
after pH adjustment

Proven EntericReleaseGELITA® EC allows manufacturers to produce enteric capsulesthat adhere to USP (US Pharmacopeia) and the Ph.Eur. (European Pharmacopeia) dissolution parameters.
These parameters include:• Capsules will not release more than 10% of the fill during
two hours in 37°C simulated gastric fluid• Capsules will be fully dissolved by 45 min in simulated
intestinal fluid
Dissolution results with 20 oblong enteric fish oil capsules
produced with GELITA® EC.
• 0 % of capsules released the fill in simulated gastric acid(representing the stomach)• 100% of the capsules showed NO RELEASE (no “leakers”)• <10 min = average time for capsules to open after pH
adjustment to represent intestinal fluids

Figure 1: Gelatine Shell Dissolution – GELITA® EC soft gelatine capsules compared to standardgelatine capsules
100

Dissolution (%)

80

GELITA® EC capsules, fresh
GELITA® EC capsules, 40 °C,
75% r. h. 6 months
Standard bovine bone capsules, freshStandard bovine bone capsules, 40 °C,
75% r. h. 6 months

6040200030

60

90

120

150
Time (minutes)

Table 1: Results of fill release for soft gelatine capsules made from GELITA® EC

No. Capsulesreleased thefill in acid

No. Capsules
passed acidstage

Average time forcapsules to open after
pH adjustment [min]

Fresh

0/6

6/6

1.67

45.040°C, 75% r. h.
closed 3 months

0/6

6/6

1.65

47.540°C, 75% r. h.
closed 6 months

0/6

6/6

2.28

47.6

Storage
Conditions

As figure 1 shows, the fresh gelatine capsules made fromstandard gelatine show a shell dissolution of 100% within
30 minutes. However, fresh capsules produced from GELITA® EC
provide a delayed dissolution of the shell. After 2 hours at
pH 1.2 in simulated gastric fluid, only 45% of the gelatine
shell was dissolved (table 1). After adjusting the pH from
1.2 to 6.8 the GELITA® EC capsules start to dissolve. Within
30 min the soft gelatine capsules are completely gone intribasic sodium phosphate solution.

% Average gelatindissolved after 2hin acid

After 6 month accelerated aging at 40 °C, 75% r. h. (closed)
capsules from standard gelatine show some delay in shell
dissolution. The GELITA® EC capsules provide similar dissolution
kinetics as fresh capsules. Neither a delay in capsules
dissolution nor an increased dissolution is visible and theoil release is similar after storage. These results provethat GELITA® EC provides true enteric behavior also underaccelerated ICH aging conditions.

[5]Folder_GELITA ® EC_eng (6p)_04-2018_srg

One Product. One Step.
GELITA® EC Add Value toConsumers and Industry
Benefits of GELITA® EC• Promotes consumer convenience by eliminating
fishy burps often associated with fish oils
• Offers true enteric performance• Reduces additional time and processing steps
associated with traditional enteric coating processes• Provides an enteric solution with one
product and one process• Although currently available in bovinebone types, GELITA is developing solutions
from other raw material sources.

PatentPending

Product characterization• Product appears faintly yellow to amber
granules or powder and is provided
readily soluble in warm water.
• Produced in accordance with
FDA regulations, HACCP,
ISO9001: 2015 and FSSC22000.
• Product is suitable for products for
Health & Nutrition, Over-the-counter (OTC)
and pharmaceutical applications.

GELITA® EC
RAW MATERIALNAME OF GELATINEBLOOM [g]VISCOSITY 6.67 %/60 °C [mPas]

Bovine BoneGELITA® EC
130 Bloom Bovine Bone Gelatine Product

115 – 145

6.0 – 12.0

Gelita excludes any warranty and/or liability for any and all claims arising from or in relation with statements made in thisbrochure and/or the positioning of GELITA® EC, including but not limited to claims based on misleading advertising and/or breachof relevant German and EU legislation. The positioning as well as the packaging, labelling and advertising of the client’s productswith GELITA® EC falls solely within the responsibility of the client.

GELITA AG · Uferstr. 7 · 69412 Eberbach · Germany · www.gelita.com