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Parenteral bisphosphonate composition with improved local tolerance

  • US 6,677,320 B2
  • Filed: 01/11/2001
  • Issued: 01/13/2004
  • Est. Priority Date: 01/20/2000
  • Status: Expired due to Term
First Claim
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1. A method for the treatment and prevention of diseases involving bone resorption, osteoporosis, Paget'"'"'s disease, hypercalcemia of malignancy, and metabolic bone disease comprising the step of administering to a patient in need of such treatment and prevention a parenteral composition having a pH of from about 6 to about 8 comprising a pharmaceutically acceptable bivalent cation chelating agent and at least one bisphosphonate selected from the group consisting ofa) N-methyl-4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid, b) 4-(N,N-dimethylamino)-1-hydroxybutylidene-1,1-bis-phosphonic acid, c) 3-amino-1-hydroxypropylidene-1,1-bisphosphonic acid, d) 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-bisphosphonic acid, e) 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-bisphosphonic acid, f) 1-hydroxy-3-(N-methyl-N-pentylamino)propylidene-1,1-bisphosphonic acid, g) 1-hydroxy-2-[3-pyridinyl]ethylidene-1,1-bisphosphonic acid, h) 4-(hyroxymethylene-1,1-bisphosphonic acid)piperidine, i) cycloheptylaminomethylene-1,1-bisposphonic acid, j) 1,1-dichloromethylene-1,1-diphosphonic acid, k) 1-hydroxy-3-(1-pyrrolidinyl)-propylidene-1,1-bisphosphonic acid, l) 1-hydroxyethane-1,1-ciphosphonic acid, m) 6-amino-1-hydroxyhexylidene-1,1-bisphosphonic acid, n) 3-(dimethylamino)-1-hydroxypropylidene-1,1-bisphosphonic acid, o) [2-(2-pyridinyl)ethylidene]-1,1-bisphosphonic acid, p) (4-chlorophenyl)thiorrethane-1,1-diphosponic acid, q) 1-hydroxy-2-(1H-imidazol-1-yl)ethylidene-1,1-bisphosphonic acid, r) [(cycloheptylamino)-methylene]-bisphosphonic acid, and s) 1-hydroxy-2-imidazo-(1,2-a)pyridin-3-ylethylidene]-bisphosphonic acid and pharmaceutically acceptable salts thereof wherein the molar ratio between the bisphosphonate and the chelating agent is from about 1:

  • 0.1 to about 1;

    50.

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