Methods for preventing crystal growth and particle aggregation in nanoparticulate compositions
AssigneeKlan Pharma International Ltd.
InventorsElaine Liversidge, Greta A. Gottardy, Linden Wei
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Abstract
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.
Claims31
A nanoparticutate formulation that exhibits minimal particle aggregation or crystal growth following exposure to elevated temperatures, wherein the composition comprises:
- (a) a water-insoluble crystalline drug;
- and
- (b) one or more surface stabilizers adsorbed to the surface of the drug, wherein at least 50% of the drug particles in the composition have a weight average particle size of from about 150 nm to about 350 nm,
- wherein the nanoparticulate composition has been exposed to elevated temperatures for heat sterilization.
A method for preventing crystal growth and particle aggregation in a nanoparticulate composition during heating or storage, said method comprising:
- (a) forming a nanoparticulate composition of a poorly soluble crystalline drug having one or more non-crosslinked surface stabilizers adhered to the surface of the drug, wherein at least 50% of the drug particles in the composition have a weight average particle size of from about 150 nm to about 350 nm;
- and
- (b) exposing the nanoparticulate composition to elevated temperatures for heat sterilization,
- wherein the nanoparticulate composition exhibits minimal particle size growth and/or aggregation during storage following exposure to the elevated temperatures.
A method of administering a nanoparticulate composition to a mammal in need, wherein the nanoparticulate composition exhibits minimal particle size or crystal growth following exposure to elevated temperatures, and wherein the composition comprises:
- (a) a water-insoluble crystalline drug;
- and
- (b) one or more surface stabilizers adsorbed to the surface of the drug, wherein at least 50% of the drug particles in the composition have a weight average particle size of from about 150 nm to about 350 nm
- said method comprising administering to a mammal in need a therapeutically effective amount of the nanoparticulate composition.
Dependencies are inferred from the claim text.