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Lipid-Based Drug Delivery Systems Focus Group |
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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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Chair-Elect Anette Mullertz, Ph.D Bioneer:FARMA, Faculty of Pharmaceutical Sciences, University of Copenhagen Copenhagen Ĝ, Denmark |
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 |
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