Elan Pharma International Limited

Klan Pharma International Ltd.

Greta A Gottardy

Elaine Liversidge

Linden Wei

Nanoparticulate compositions comprising an insoluble organic drug and at least one polyethylene glycol-derivatized lipid adsorbed on the surface of the drug are described. The polyethylene glycol-derivatized lipid can be a PEG-phospholipid, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, PEG-vitamin E, or a mixture thereof The compositions have an effective average particle size of less than about 1 micron. The invention also describes methods of making and using such compositions.

Use of peg-derivatized lipids as surface stabilizers for nanoparticulate compositions

The present invention is directed to methods for preventing crystal growth and particle aggregation in nanoparticulate compositions. The methods comprise reducing a nanoparticulate composition to an optimal effective average particle size. The resultant nanoparticulate compositions exhibit prolonged particle size stability and minimal crystal growth, even following exposure to elevated temperatures.

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Lansdale, PA, United States of America

Greta A Gottardy