Welcome to the LFCS Consortium


Unlike most oral drug delivery systems, lipid-based drug delivery systems (LBDDS) have the potential to increase the oral bioavailability of poorly water-soluble drugs via several different mechanisms that include:

(i)     Bypassing the dissolution step by delivering the drug in a pre-dissolved form and avoidance of re-precipitation from this pre-dissolved state

(ii)   Increasing drug solubilization in the intestinal milieu directly through formulation components formed upon digestion of formulation excipients and indirectly by recruiting natural solubilizers (e.g. bile salts and phospholipid)

(iii) Increasing intestinal drug permeability through inhibition of P-gp and other efflux transporters

(iv)  Decreasing first-pass metabolism of the drug through recruitment of intestinal lymphatic processes.

 

All of the above processes have the potential to enhance bioavailability in the fasted state to decrease the high risk of a food-effect and establish the desired reproducible pharmacokinetic profile of orally administered drugs. Furthermore, lipids are physiologically well tolerated and absorbed. As a result, an increasing number of academic and industrial formulation groups concentrate their efforts in this field of research and development, and an increasing number of lipid formulated products have reached the market in recent years.

Within a challenging pharmaceutical development environment, the sharing of knowledge and expertise, and combination of research efforts is an effective way to advance science and address common technical problems. The Lipid Formulation Classification System (LFCS) Consortium aims to use collective resources to solve generic problems that help development of novel and optimized therapies for healthcare professionals and the patients they serve.

The LFCS Consortium is a non-profit organization that sponsors and conducts research on lipid based drug delivery systems (LBDDS) for the oral administration of poorly water-soluble drugs.

 

Inspired by Professor Colin Pouton’s Lipid Formulation Classification System (first published in 2000 and in modified form in 2006; see Table 1 below), with the joint leadership of Capsugel, the LFCS Consortium has been established as a small, yet growing scientific community of industrial and academic professionals with a unique focus and expertise covering all scientific and technical aspects that relate to LBDDS, from formulation and in vitro characterization, to enhancement of in vivo bioavailability of poorly soluble compounds

The primary objective of the LFCS Consortium is to develop guidelines that rationalize and accelerate the development of promising drug candidates, specifically through:

(i)         The identification of LBDDS key performance criteria

(ii)         The validation and publication of universal Standard Operating Procedures to assess performance

(iii)         Initiating an appropriate dialogue with pharmaceutical regulatory bodies (EMEA, FDA) to establish approved guidelines for evaluating the performance of LBDDS.

Today, industrial partners of the LFCS Consortium sponsor research programs conducted by multinational University members under the leadership and direction of the LFCS Consortium Scientific Advisory Committee. The primary research aims are to develop standardized in vitro methods to assess the performance of LBDDS during dispersion and digestion and to use these methods to identify the key factors that determine LBDDS performance.


LFCS Classification Diagram
Table1: The Lipid Formulation Classification System

Today, industrial partners at Full and Associate Membership levels sponsor research programs conducted by multinational University members under the leadership and direction of the LFCS Consortium Scientific Advisory Committee. The research aims to develop in vitro methods to assess the performance of LBDDS during dispersion and digestion.

Consortium members include Full Members, Associate Members and Universities: