IN THIS ISSUE - Drug Development & Delivery

Drug Development & Delivery July/August 2012 Vol 12 No 6
12
GSK Successfully Uses Capsugel’s Licaps
Capsugel recently announced that its Licaps liquid-filled
hard capsules have been successfully used by major
healthcare company, GlaxoSmithKline (GSK), for the most
established brand in the German urological market, GRANU
FINK.
After initially launching the product in a soft gelatin
capsule form, GSK’s Consumer Healthcare Division decided to
investigate other dosage form options to try and improve the
product’s quality and reduce its production-to-market lead time.
GRANU FINK’s active ingredients, pumpkin seeds extracts,
and pumpkin oil, were challenging to encapsulate because of
the large particle size and required a long maturing period
when encapsulated in traditional softgels. After testing a switch
to Capsugel’s Licaps technology, GSK found the product to be
leak-free and have now reduced their product lead times by an
amazing 12 weeks.
"After comparing two different automated capsule sealing
techniques, the Licaps capsules had intact seals during the
complete period of stability testing, and we could not detect
any leakage,” said Dr. Stephan Wurtz, Head of Production at
GSK in Herrenberg. “Capsule integrity is a key parameter used
to predict product shelf-life and especially helps with
preventing too many product returns, and this is why we
ultimately chose the Licaps liquid-filled hard capsules as our
dosage form."
Since Licaps capsules entered the market nearly 10 years
ago, Capsugel has made multiple technological advances,
including an enhanced mechanical seal with a seal zone six
times greater than a banded capsule. And while they are able to
effectively mask taste and odor, Licaps capsules also offer
many branding options that may improve loyalty when
compared with other dosage forms. According to Capsugel’s
research, consumers perceive Licaps capsules to be highquality,
modern, and natural looking in a dosage form that is
memorable, easy to recognize, and easy to swallow. GSK also
conducted their own consumer survey to test the visual and
handling acceptance of the Licaps dosage form among regular
users of GRANU FINK femina, and 73% of consumers were
positive about the new Licaps liquid-filled hard capsule format.
And Licaps liquid-filled hard capsules provide a solution
for a variety of challenging compounds. It can improve
bioavailability for poorly soluble compounds while providing
effective formulation options for low-melting point compounds
and safe formulation of low-dose/high potency actives. Licaps
manufacturing also offers an established and robust process
with the flexibility to allow for production in-house or by
Capsugel. With a straightforward manufacturing transfer,
including the installation of Liquid Encapsulation Microspray
Sealing (LEMS) technology, Licaps capsules can even use the
same line as powder-filled capsules and are sealed and dried in
a matter of minutes, making manufacturing a cost-effective and
environmentally friendly process.
"The Licaps system has integrated well with our Bosch
capsule filling equipment, and because of the expert technical
assistance we had from Capsugel's installation and formulation
teams, we put in place a number of new validated production
processes with five fully trained operators in a very short
time,” added Dr. Wurtz. “During one shift using the Licaps
system, up to 350,000 Licaps capsules can be filled. We now
have full in-house control of the manufacture of our drug and
supplement lines, which gives us a number of benefits."