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Claims for Patent: 7,410,957

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Claims for Patent: 7,410,957

Title:Method of treatment using bisphosphonic acid
Abstract:The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.
Inventor(s): Bauss; Frieder (Neuhofen, DE), Pichler; Bernhard (Ketsch, DE), Turley; Stephen (Bottmingen, CH)
Assignee: Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:10/430,007
Patent Claims: 1. A method for treating osteoporosis comprising commencing treatment by orally administering to a subject in need of such treatment, on a single day, a first dose in the form of a tablet, wherein said tablet comprises an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid and continuing said treatment by orally administering, once monthly on a single day, a tablet comprising an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid.

2. The method of claim 1, wherein the pharmaceutically acceptable salt is a sodium salt of ibandronic acid.

3. The method of claim 2 wherein the pharmaceutically acceptable salt is a monosodium, disodium, or trisodium salt of ibandronic acid.

4. The method of claim 3 wherein the pharmaceutically acceptable salt is a monosodium salt of ibandronic acid.

5. The method of claim 4 wherein the pharmaceutically acceptable monosodium salt of ibandronic acid is a monohydrate.

6. A method for treating osteoporosis consisting of orally administering to a subject in need of such treatment, once monthly on a single day, a tablet comprising an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid.

7. The method of claim 6, wherein the pharmaceutically acceptable salt is a sodium salt of ibandronic acid.

8. The method of claim 7 wherein the pharmaceutically acceptable salt is a monosodium, disodium, or trisodium salt of ibandronic acid.

9. The method of claim 8 wherein the pharmaceutically acceptable salt is a monosodium salt of ibandronic acid.

10. The method of claim 9 wherein the pharmaceutically acceptable monosodium salt of ibandronic acid is a monohydrate.

11. The method of claim 2 wherein the tablet comprises at least one member selected from the group consisting of lactose, maize starch, talc, stearic acid, a salt of stearic acid, polyvinylpyrrolidone, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, silicon dioxide, hydroxypropyl methyl cellulose, titanium dioxide, and polyethylene glycol 6000.

12. The method of claim 2 wherein the tablet comprises stearic acid.

13. The method of claim 2 wherein the tablet comprises a salt of stearic acid.

14. The method of claim 2 wherein the tablet comprises silicon dioxide.

15. The method of claim 2 wherein the tablet comprises cross-linked polyvinylpyrrolidone.

16. The method of claim 7 wherein the tablet comprises at least one member selected from the group consisting of lactose, maize starch, talc, stearic acid, a salt of stearic acid, polyvinylpyrrolidone, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, silicon dioxide, hydroxypropyl methyl cellulose, titanium dioxide, and polyethylene glycol 6000.

17. The method of claim 7 wherein the tablet comprises stearic acid.

18. The method of claim 7 wherein the tablet comprises a salt of stearic acid.

19. The method of claim 7 wherein the tablet comprises silicon dioxide.

20. The method of claim 7 wherein the tablet comprises cross-linked polyvinylpyrrolidone.
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