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  Lipid-Based Drug Delivery Systems Focus Group

Purpose and Description
There is growing interest and investment in the use of lipid-based systems in drug discovery and product development to effectively overcome physical and biological barriers related to poor aqueous solubility and stability, membrane permeability, drug efflux and bioavailability. The rapid growth in this area is primarily due to the diversity and versatility of pharmaceutical grade lipid excipients and drug formulations and their compatibility with liquid, semi-solid and solid dosage forms. An array of lipid systems is available to pharmaceutical formulators such as, emulsions, micellar solutions, liposomes, lipid nanoparticles, self-emulsifying lipid formulations, solid dispersions, dry emulsions, solid-liquid compacts and drug-lipid conjugates. This along with ongoing advances in manufacturing technologies has resulted in the rapid introduction of lipid-based drug formulations into the marketplace with a number of drug products on the market and several in clinical development. Parenteral formulations on the market include emulsions, micellar solutions and liposomes. In the case of oral administration, the marketed products are primarily in the form of oral lipid solutions with and without co-solvents and/or filled into hard or soft gelatine capsule. As we better understand the manufacturing and in vivo processing and site-specific targeting of lipidic formulations and bridge product quality with in vivo performance, expanded product development use and market can be expected.

It is the mission of the LBDDS FG to continue advancing the science and pharmaceutical applications of lipid-based systems in a multidisciplinary approach. The specific areas of involvement include:

  • small molecule and macromolecule (peptide/protein, vaccine, and nucleic acid/gene) delivery
  • lipidic prodrugs and self-assembled lipid systems in drug discovery and development
  • drug solubilization and site-specific passive and active targeting aspects of lipids
  • biopharmaceutical aspects and drug absorption mechanisms
  • physicochemical determinants of the utility of lipidic excipients and their impact on product performance for immediate and sustained drug release
  • in vitro and in vivo methodologies for the evaluation of lipid-based formulations and potential IVIVC
  • processing and manufacturing aspects of lipidic formulations
  • regulatory considerations of lipid excipients
  • emerging lipid-based drug delivery technologies

Any AAPS member with interest in lipid-based systems is welcome to join the focus group and actively participate in fulfilling its mission and objectives.


AAPS WORKSHOP REPORT

AAPS Workshop on Effective Utilization of Lipid-Based Systems to Enhance the Delivery of Poorly Soluble Drugs: Physicochemical, Biopharmaceutical and Product Development Considerations, March 5-6, 2007 (PDF)


Meeting Minutes


JOIN THE LIPID-BASED DRUG DELIVERY SYSTEMS FOCUS GROUP

To join the Lipid-Based Drug Delivery Systems Focus Group, click here.

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  Leadership

Chair
Paul M. Bummer, Ph.D.
University of Kentucky
Lexington, KY UNITED STATES



Chair-Elect
Anette Mullertz, Ph.D
Bioneer:FARMA, Faculty of Pharmaceutical Sciences, University of Copenhagen
Copenhagen Ĝ, Denmark



Past Chair
Panayiotis P. Constantinides, Ph.D.
Biopharmaceutical and Drug Delivery Consulting, LLC
Gurnee, IL UNITED STATES



Steering Committee Member
Mei-Ling Chen, Ph.D
Office of Pharmaceutical Science, Food and Drug Administration
Potomac, MD United States



Steering Committee Member
Asis Jain
Roquette America
, UNITED STATES



Steering Committee Member
Jasmine Musakhanian, M.Sc.
Gattefossé U.S.A.
Baie D'Urfe, PQ Canada



Steering Committee Member
Christopher J.H. Porter, Ph.D.
Monash University
Parkville, Victoria AUSTRALIA



Student Rep
Mohamed M. Ismail Nounou
University of Houston School of Pharmacy
Houston, TX




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