Anhydrous alendronate monosodium salt formulations

• US 5,849,726 A
• Filed: 12/03/1997
• Issued: 12/15/1998
• Est. Priority Date: 06/06/1995
• Status: Expired due to Fees

• Current Assignee: Merck Sharp & Dohme Corporation (Merck & Co., Inc.)
• Original Assignee: Merck & Co., Inc.
• Inventors: Ostovic, Drazen, Thies, J. Eric, Brenner, Gerald S., Oberholtzer, Earl R. Jr.
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US08/973,386
• Time in Patent Office: 377 Days
• Field of Search: 514/108
• US Class Current: 514/108
• 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: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07F 9/3873 containing nitrogen substituent, e.g. N.....H or N-hydrocarbon group which can be substituted by halogen or nitro(so), N.....O, N.....S, N.....C(=X)- (X =O, S), N.....N, N...C(=X)...N (X =O, S)

Abstract

Disclosed is a method for treating and preventing bone loss in patients by administering a formulation of anhydrous alendronate sodium. Also described is a pharmaceutical dosage form of said anhydrous alendronate sodium, being anhydrous 4-amino-1-hydroxy-butylidene-1,1-bisphosphonic acid, monosodium salt, in a pharmaceutically acceptable excipient.

Claims

1. A pharmaceutical composition comprising a pharmaceutically effective amount of anhydrous 4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid monosodium salt in a pharmaceutically acceptable carrier.

2. The pharmaceutical composition of claim 1 wherein said anhydrous 4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid monosodium salt is present in the amount of 0.005 to 1.0 gram per gram of composition.

3. A method for treating and/or preventing bone loss in a subject, comprising administering to said subject in need thereof, the pharmaceutical composition as defined in claim 1.

4. The method of claim 3, wherein said subject is human.

5. The method of claim 3, wherein the bone loss is osteoporosis-related, due to disuse, age-related, related to steroid therapy, rheumatoid-related, related to Paget'"'"'s disease, or related to cancer.

6. The method of claim 3, wherein the treatment is prophylactic.

7. The anhydrous form of 4-amino-1-hydroxybutylidene- 1,1-bisphosphonic acid monosodium salt.