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Claims for Patent: 8,486,456

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Claims for Patent: 8,486,456

Title:Itraconazole compositions with improved bioavailability
Abstract: A solid dispersion product comprising itraconazole and hydroxypropyl methylcellulose, which satisfies the Formula 0.35>.DELTA.H.sub.tr (1) (wherein .DELTA.H.sub.tr represents the endotherm (J/g) accompanying a transition at about 240.degree. C). The solid dispersion product shows an improved bioavailability.
Inventor(s): Berndl; Gunther (Herheim am Berg, DE), Degenhardt; Matthias (Limburgerhof, DE), Maegerlein; Markus (Mannheim, DE), Dispersyn; Gerrit (Pennington, NJ)
Assignee: Abbott GmbH & Co., KG (Wiesbaden, DE)
Application Number:11/997,256
Patent Claims: 1. A solid dispersion product comprising itraconazole and hydroxypropyl methylcellulose, which satisfies the formula 0.35>.DELTA.H.sub.tr wherein .DELTA.H.sub.tr represents the endotherm (J/g) accompanying a transition at an endothermic peak temperature in the range of from 240.degree. C. to 250.degree. C.

2. The solid dispersion product of claim 1, which satisfies the formula 0.20>.DELTA.H.sub.tr wherein .DELTA.H.sub.tr represents the endotherm (J/g) accompanying a transition at an endothermic peak temperature in the range of from 240.degree. C. to 250.degree. C.

3. The solid dispersion product of claim 1, having a weight-average particle size ranging between 50 .mu.m to 600 .mu.m.

4. The solid dispersion product of claim 1, wherein the total content of methoxy and hydroxypropyl groups in the hydroxypropyl methylcellulose is in the range of 23 to 42% by weight.

5. The solid dispersion product of claim 4, wherein the methoxy group content is in the range of 19 to 30 wt % and the hydroxypropyl group content is in the range of 4 to 12% by weight.

6. The solid dispersion product of claim 5, wherein the hydroxypropyl methylcellulose has an apparent viscosity of from 3 to 15 mPas, as determined as a 2 wt. % aqueous solution at 20.degree. C.

7. The solid dispersion product of claim 1, wherein the weight ratio of itraconazole: hydroxypropyl methylcellulose is in the range of 1:1 to 1:17.

8. A pharmaceutical dosage form comprising particles of the solid dispersion product of claim 1, and at least one additive selected from a diluent and a disintegrant.

9. A pharmaceutical dosage form comprising the solid dispersion product of claim 1, the dosage form providing in vivo plasma levels of itraconazole and hydroxy itraconazole characterized by C.sub.max of 400 ng/mL or higher, after oral administration of a single dose of 200 mg itraconazole.

10. A pharmaceutical dosage form comprising a solid dispersion product of itraconazole and hydroxypropyl methylcellulose, the dosage form providing in vivo plasma levels of itraconazole and hydroxy itraconazole characterized by C.sub.max of 400 ng/mL or higher, after oral administration of a single dose of 200 mg itraconazole, and wherein the solid dispersion product satisfies the formula 0.35>.DELTA.H.sub.tr wherein .DELTA.H.sub.tr represents the endotherm (J/g) accompanying a transition at an endothermic peak temperature in the range of from 240.degree. C. to 250.degree. C.

11. A pharmaceutical dosage form comprising a solid dispersion product of claim 1, wherein said pharmaceutical dosage form is for oral administration to a mammal suffering from a fungal infection.

12. A method for treating a fungal infection in a mammal comprising administering to a mammal suffering from a fungal infection a pharmaceutical dosage form for oral administration comprising the solid dispersion product of claim 1.

13. The method of claim 12, wherein the fungal infection is selected from the group consisting of blastomycosis, histoplasmosis, aspergillosis, onychomycosis, tinea pedis, dermatophytosis, malessezia/yeast dermatitis, cryptococcosis, candidiasis, coccidiodomycosis, chromoblastomycosis, fungal menigitis, and oral mucositis.
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