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US 2007/0178051 A1Published application
Sterilized nanoparticulate glucocorticosteroid formulations
AssigneeElan Pharma International Limited
InventorsJohn Pruitt, Raj Kewalramani, David Slifer, Jack Shaw, Stephen Ruddy
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Abstract
The invention is directed sterile to compositions of glucocorticosteroids useful in the prophylaxis and chronic treatment of asthma and other allergic and inflammatory conditions in adults and pediatric patients.
Claims41
A sterile composition comprising:
- (a) particles of at least one glucocorticosteroid, wherein the particles have an effective average particle size of less than about 2000 nm;
- (b) at least one nonionic surface stabilizer;
- and
- (c) at least one amphiphilic lipid.
1 more element
A method of making a sterile composition comprising:
- (a) particles of at least one glucocorticosteroid, wherein the particles have an effective average particle size of less than about 2000 nm;
- (b) at least one nonionic surface stabilizer;
- and
- (c) at least one amphiphilic lipid,
- wherein the method comprises:
- (i) contacting particles of a glucocorticosteroid with at least one nonionic surface stabilizer for a time and under conditions to reduce the effective average particle size of the particles to less than about 2000 nm;
- (ii) adding at least one amphiphilic lipid to the glucocorticosteroid composition, either before, during, or after particle size reduction;
- and
- (iii) steam heating the composition to a temperature of from about 115° C. to about 135° C.
6 more elements
A method of treating a subject in need comprising administering to the subject a therapeutically effective amount of a sterile composition comprising:
- (a) particles of at least one glucocorticosteroid, wherein the particles have an effective average particle size of less than about 2000 nm;
- (b) at least one nonionic surface stabilizer;
- and
- (c) at least one amphiphilic lipid.
1 more element
A sterile composition comprising:
- (a) particles of at least one glucocorticosteroid, wherein the particles have an effective average particle size of less than about 2000 nm;
- (b) at least one nonionic surface stabilizer;
- (c) at least one amphiphilic lipid;
- and
- (d) ethylenediaminetetraacetic acid, a sodium salt of ethylenediaminetetraacetic acid, a calcium salt of ethylenediaminetetraacetic acid, or a combination thereof,
- wherein the ethylenediaminetetraacetic acid or salt thereof is present in a amount sufficient to prevent or reduce heat-induced chemical degradation of one or more components in the composition.
3 more elements
Dependencies are inferred from the claim text.