GSK Using Novel Drug Delivery System For Rapid Manufacture of Capsules with a High Integrity Seal
Wed, 05/13/2009 - 10:00am
Capsugel, a provider of dosage form solutions to the pharmaceutical and related healthcare industries, has integrated its Licaps® Drug Delivery System of Licaps® capsules and Liquid Encapsulation Microspray Sealing (LEMS®) equipment at GlaxoSmithKline's (GSK) Herrenberg, Germany facility to produce new capsule lines with a proven secure seal.
Production scientists at GSK's Consumer Healthcare center in Herrenberg, Germany are filling Capsugel's Licaps® two-piece gelatin capsules with liquid formulations containing pumpkin seed; pumpkin seed oil or herbal extracts such as saw palmetto or hop extract. The filled capsules are then sealed using Capsugel's LEMS® automated capsule sealing system and the finished capsules are marketed by GSK as pharmaceuticals to treat several types of urological conditions or as nutraceuticals.
Dr. Stephan Wurtz, Head of Production at GSK in Herrenberg explained: "These capsule products are new lines for GSK, so we decided to determine the optimal production method by comparing two different automated capsule sealing techniques. The capsules produced by the Licaps® Drug Delivery System 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 decided to continue using the Licaps® Drug Delivery System for our capsule filling."
Dr. Wurtz added: "The Licaps® Drug Delivery System has integrated well with our Bosch capsule filling equipment and because of the expert technical assistance we have had from Capsugel's installation and formulation teams, we have in a very short time put in place a number of new validated production processes with five fully Licaps® Drug Delivery System at GSK/2trained operators, who can perform them. During one shift using the Licaps® Drug Delivery 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, Vice President R&D at Capsugel concluded: "We are delighted such an innovative company like GSK was willing to embrace and test the Licaps® Drug Delivery System so extensively with their new pharmaceutical and nutraceuticals product lines. Their work leads the way for other pharma and healthcare companies seeking rapid scale up and production of high integrity oil filled capsules and shows that assessing a Licaps® Drug Delivery System is a well-informed strategic decision."