Itraconazole compositions and dosage forms, and methods of using the same
AssigneeMayne Pharma International Pty Ltd.
InventorsStuart James MUDGE, David Hayes, Stefan Lukas
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Abstract
The disclosure relates to, among other things, pharmaceutical compositions, such as solid oral dosage forms, comprising itraconazole, methods of making the compositions, and methods of using the same for treating disorders including, but not limited to, fungal infections.
Claims30
An oral pharmaceutical composition comprising about 65 mg of itraconazole, wherein the composition exhibits an AUC0-t which is 80% to 125% of about 650 h*ng/ml to about 1200 h*ng/ml following administration of the composition to a subject under fed conditions.
An oral pharmaceutical composition comprising about 65 mg of itraconazole, wherein the composition exhibits an AUC0-t which is 80% to 125% of about 450 h*ng/ml to about 900 h*ng/ml following administration of the composition to a subject under fasting conditions.
An oral pharmaceutical composition comprising itraconazole, wherein the composition exhibits an AUC0-t which is 80% to 125% of about 10.0 h*ng/ml to about 18.0 h*ng/ml per milligram of itraconazole following administration of the composition to a subject under fed conditions.
An oral pharmaceutical composition comprising itraconazole, wherein the composition exhibits an AUC0-t which is 80% to 125% of about 7.5 h*ng/ml to about 13.6 h*ng/ml per milligram of itraconazole following administration of the composition to a subject under fasting conditions.
Dependencies are inferred from the claim text.