Claims for Patent: 10,463,740

Summary for Patent: 10,463,740

Title:	Itraconazole compositions and dosage forms, and methods of using the same
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.
Inventor(s):	Mudge; Stuart James (Northcote, AU), Hayes; David (Rostrevor, AU), Lukas; Stefan (Manningham, AU)
Assignee:	MAYNE PHARMA INTERNATIONAL PTY. LTD. (Salisbury South, AU)
Application Number:	16/198,645
Patent Claims:	1. An oral pharmaceutical composition comprising about 50 mg to about 100 mg of itraconazole and one or more pharmaceutically acceptable polymers in a matrix system, wherein the composition exhibits an AUC.sub.0-t that is 80% to 125% of about 440 h*ng/ml to about 1200 h*ng/ml following administration of the composition to a subject under fed conditions. 2. The oral pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable polymer is a non-gelling polymer. 3. The oral pharmaceutical composition of claim 1, wherein the oral pharmaceutical composition is a solid dosage form. 4. The oral pharmaceutical composition of claim 3, wherein the composition comprises about 50 mg to about 75 mg itraconazole. 5. The oral pharmaceutical composition of claim 3, wherein the composition comprises about 50 mg to about 70 mg of itraconazole in each unit dosage form. 6. The oral pharmaceutical composition of claim 1, wherein the composition exhibits an AUC.sub.0-t which is 80% to 125% of about 650 h*ng/ml to about 1200 h*ng/ml following administration of the composition to the subject under fed conditions. 7. The oral pharmaceutical composition of claim 1, wherein the composition exhibits an AUC.sub.0-t which is 80% to 125% of about 350 h*ng/ml to about 900 h*ng/ml following administration of the composition to the subject under fasting conditions. 8. The oral pharmaceutical composition of claim 1, wherein the composition exhibits a ratio in the range from about 0.70 to about 1.43 for AUC.sub.0-t between the oral pharmaceutical composition and a composition containing about 100 mg of itraconazole, sugar spheres, hydroxypropyl methyl cellulose, and polyethylene glycol in a capsule shell, with a 90% confidence interval. 9. The oral pharmaceutical composition of claim 1, wherein the composition exhibits a C.sub.max which is 80% to 125% of about 65 ng/ml to about 100 ng/ml following administration of the composition to the subject under fed conditions. 10. The oral pharmaceutical composition of claim 1, and the composition under fed conditions is therapeutically similar to a composition containing about 100 mg of itraconazole, sugar spheres, hydroxypropyl methyl cellulose, and polyethylene glycol in a capsule shell, under fed conditions. 11. The oral pharmaceutical composition of claim 1, wherein the composition under fasting conditions is therapeutically similar to a composition containing about 100 mg of itraconazole, sugar spheres, hydroxypropyl methyl cellulose, and polyethylene glycol in a capsule shell, under fed conditions. 12. The oral pharmaceutical composition of claim 1, wherein the composition exhibits reduced intra-subject variability for the AUC.sub.0-t, C.sub.max, or T.sub.max as compared to a composition containing about 100 mg of itraconazole, sugar spheres, hydroxypropyl methyl cellulose, and polyethylene glycol in a capsule shell. 13. A method of treating a disease or condition in a subject, comprising administering to the subject an oral pharmaceutical composition of claim 1. 14. The method of claim 13, wherein the disease or condition is fungal infection or cancer. 15. The method of claim 14, wherein the cancer is prostate cancer, skin cancer, or lung cancer. 16. The method of claim 13, wherein the pharmaceutically acceptable polymer is a non-gelling polymer. 17. The method of claim 13, wherein the oral pharmaceutical composition is in solid dosage form. 18. The method of claim 17, wherein the composition comprises less than about 75 mg itraconazole. 19. The method of claim 17, wherein the composition comprises about 50 mg to about 70 mg of itraconazole in each unit dosage form. 20. The method of claim 13, wherein the composition, upon administration under fed conditions, exhibits a relative bioavailability (F.sub.rel) of greater than about 150% relative to a composition containing about 100 mg of itraconazole, sugar spheres, hydroxypropyl methyl cellulose, and polyethylene glycol in a capsule shell, under fed conditions. 21. An oral pharmaceutical composition comprising 50 mg to 100 mg of itraconazole and one or more pharmaceutically acceptable polymers in a matrix system, wherein the composition exhibits an AUC.sub.0-t that is 80% to 125% of about 440 h*ng/ml to about 1200 h*ng/ml following administration of the composition to a subject under fed conditions. 22. The oral pharmaceutical composition of claim 21, wherein the composition comprises 50 mg to 70 mg of itraconazole.