Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 93, Issue 5, Pages 1100-1109Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.20009
Keywords
biodegradable polymers; macromolecular drug delivery; microspheres; microparticles; protein delivery; stabilization
Funding
- NCI NIH HHS [CA-52857-12] Funding Source: Medline
- NIBIB NIH HHS [EB-000244-24] Funding Source: Medline
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Interleukin 2 (IL-2) is a pleotropic growth factor essential to immune system function. Current methods of administration are limited by the necessity of hospitalization as well as dose-limiting toxicities and side effects. There is also the issue of low therapeutic concentrations at the desired site of action; for instance, in the case of solid tumor treatment. Here we describe the design of controlled-release vehicles for the local administration of IL-2 based on single (SE) and double emulsion (DE) poly(lactic-co-glycolic acid) (PLGA) systems and a newly developed class of spray-dried lipid-protein-sugar systems composed of L-alpha-dipalmitoylphosphatidylcholine (DPPC) and 0.2% Eudragit E 100. All three systems demonstrated the release of therapeutic drug quantities. Totals of 2.0, 0.5, and 2.8 mug of IL-2 (per mg of solid) were encapsulated in the SE, DE, and spray-dried formulations, respectively. The SE and DE released of 30 and 15% of the encapsulated protein, respectively, with delivery of biologically active IL-2 during the first 5 to 10 days. The lipid-protein-sugar-based system demonstrated extended sustained release of biologically active IL-2 for a period of 4 months. These systems provide a potential framework for long-term loco-regional immunotherapeutic treatment regimens. (C) 2004 Wiley-Liss, Inc. and the American Pharmacists Association.
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