June 6, 2012
Innovative Liquid-filled Hard Capsules with a High Integrity Seal Provide the Solution for Challenging Formulas
BORNEM, BELGIUM, June 6, 2012: Capsugel, the world's leading provider of dosage form solutions to the healthcare industry, is pleased to announce 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.
Dr. Stephan Wurtz, Head of Production at GSK in Herrenberg explained, "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. 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 high-quality, 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.
Dr. Wurtz added, "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. 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."
Keith Hutchison, Senior Vice President of R&D at Capsugel concluded, "We are delighted that a company such as GSK was willing to embrace and test Licaps capsules so extensively with their new pharmaceutical and nutraceutical product lines. Their work leads the way for other pharma and healthcare companies seeking rapid scale up and production of high integrity liquid-filled hard capsules."
GSK’s GRANU FINK® range of products is used to strengthen the function of the bladder and help treat prostrate disorders and now includes GRANU FINK® femina, GRANU FINK Prosta and GRANU FINK® Blase.