New Findings Advance Industry Understanding of Standardizing in vitro Tests for Lipid-Based Formulations

August 14, 2012

Scientific Presentation of Study Findings by Lipid Formulation Classification System Consortium at Capsugel’s Product Development Center in France

BORNEM, BELGIUM, August 14, 2012: With the push to bring new drugs to market faster, the healthcare industry has made significant advances in utilizing lipid-based drug delivery systems to expedite their development. While lipid-based formulations have proven to be capable of improving bioavailability, while also reducing food effect and intra and inter patient variability, many formulation challenges remain. With a very high proportionof the industry’s development pipeline consisting of molecules with poor bioavailability, advances in lipid-based formulation technologies are essential to the future of drug development.

To reduce the hurdles to lipid-based product development, the Lipid Formulation Classification System Consortium (LFCS), a non-profit organization comprised of researchers from academia and industry, has been created to conduct research into lipid-based drug delivery systems for the oral administration of poorly soluble drugs with the end goal of developing guidelines that support the development of promising drug candidates. Capsugel is a founding industry member of the Consortium. The findings are the first of a series of research updates that will be published by the Consortium over the next several months.

These new findings recently published online in the Journal of Pharmaceutical Sciences were presented for the first time by two key members of the Consortium: Professor Colin Pouton of Monash University in Melbourne and Dr. Ross Blundell, Sanofi R&D. “Given the increase in poorly soluble compounds under investigation that have the potential for real patient and consumer benefit, there is a need to standardize in vitro methods for evaluating lipid-based formulations,” Professor Pouton, working group leader of the Lipid Formulation Classification System Consortium, shared with attendees. “Our initial findings confirm that using the digestion model is the preferable method for differentiating between formulations.”

Dr. Ross Blundell emphasized during his talk the importance of the LFCS findings for the pharmaceutical industry by stating, “It is difficult to see that an industrial partner working alone could have achieved the same breadth of data in the same time frame as the Consortium. The findings will enable lipid-based formulations to be screened both accurately and rapidly and to move projects more swiftly through the development process.” 

In their research paper, the LFCS Consortium team describes the test performance of eight different types of lipid-based formulation models and found good differentiation of formulation performance was possible. Digestion experiments were performed in vitro using a pH-stat device and the compound danazol as the model for a poorly water-soluble drug. Lipid-based formulation digestion and drug solubilization patterns on digestion were examined and experiments were conducted at two sites for consistency to ensure results could be reproduced.  

“Researchers at Capsugel have developed lipid-based technologies that are proven to address many of the challenges presented by poorly soluble compounds. We have two world class centers based in France and the U.S. specializing in the development of lipid-formulations,” said Dr. Hassan Benameur, Senior Director of Pharmaceutical Sciences at Capsugel and elected chairman of the Lipid Formulation Classification System Consortium. “Findings from the Consortium are important steps toward advancing standardization methods and helping to facilitate future dialogue between industry and regulatory authorities.”

For more information about the LFCS Consortium and its activities, visit

Capsugel is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, liquid-filled, and vegetarian capsules, to innovative R&D product development services, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production. For more information about Capsugel, visit