Method of treatment using bisphosphonic acid

• US 20050075319A1
• Filed: 11/29/2004
• Published: 04/07/2005
• Est. Priority Date: 05/10/2002
• Status: Active Grant

• Current Assignee: Bernhard Pichler, Frieder Bauss, Stephen Turley
• Original Assignee: Bernhard Pichler, Frieder Bauss, Stephen Turley
• Inventors: Bauss, Frieder, Pichler, Bernhard, Turley, Stephen
• Granted Patent: US 7,192,938 B2
• Time in Patent Office: Days
• US Class Current: 514/102
• CPC Class Codes: A61K 31/663 Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
• CPC Class Codes: A61K 31/675 having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/06 Antigout agents, e.g. antihyperuricemic or uricosuric agents
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 for osteoporosis

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.

Claims

1. A method for preventing disorders characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficacious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients at a period of one day per month.

2. The method according to claim 1 wherein the disease is osteoporosis.

3. The method according to claim 1 wherein the efficacious daily dose is about 100 mg to about 150 mg of a bisphosphonic acid or a pharmaceutically acceptable salt thereof.

4. The method according to claim 1, wherein the bisphosphonic acid or pharmaceutically acceptable salt thereof is ibandronic acid or a pharmaceutically acceptable salt of ibandronic acid.

5. The method of claim 4 wherein the bisphosphonic acid is ibandronic acid.

6. The method of claim 4 wherein the pharmaceutically acceptable salt is ibandronate sodium.

7. The method according to claim 6, wherein the pharmaceutically acceptable salt is the monosodium salt of ibandronic acid.

8. The method according to claim 6 wherein the pharmaceutically acceptable salt is 3-(N-methyl)-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate.

9. The method according to claim 1, wherein the efficacious daily dose is about 100 mg of a bisphosphonic acid or a pharmaceutically acceptable salt thereof.

10. The method according to claim 1, wherein the efficacious daily dose is about 150 mg of a bisphosphonic acid or a pharmaceutically acceptable salt thereof.

11. A method for preventing disorders characterized by pathologically increased bone resorption comprising oral administration of an effective amount of a bisphosphonic acid or a pharmaceutically acceptable salt thereof, wherein 50 to 250 mg of a bisphosphonic acid or a pharmaceutically acceptable salt thereof is administered at a period of one day per month.

12. The method according to claim 11 wherein the bisphosphonic acid or pharmaceutically acceptable salt is ibandronic acid or a pharmaceutically acceptable salt thereof.

13. The method of claim 12 wherein the bisphosphonic acid is ibandronic acid.

14. The method of claim 12 wherein the pharmaceutically acceptable salt is ibandronate sodium.

15. The method of claim 14 wherein the pharmaceutically acceptable salt is the monosodium salt of ibandronic acid.

16. The method of claim 14 wherein the pharmaceutically acceptable salt is 3-(N-methyl)-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate.