CRYSTALLIZATION METHOD AND BIOAVAILABILITY
Preparation, in-vitro and in vivo characterization of novel forms of (1-hydroxy-2-imidazol-1-yl-1-phosphono-ethyl) phosphonic acid, suitable for pharmaceutical compositions in drug delivery systems for humans.
1 . A molecular complex comprising zoledronic acid and sodium.
2 . A pharmaceutical composition comprising a molecular complex of claim 1 and a pharmaceutically acceptable excipient.
3 . A pharmaceutical composition according to claim 2 , wherein the composition is an oral dosage form.
4 . A molecular complex of claim 1 , wherein the molecular complex is crystalline.
5 . A molecular complex of claim 1 comprising zoledronic acid, sodium zoledronate and water.
6 . A molecular complex of claim 5 , wherein the molecular complex is crystalline.
7 . A pharmaceutical composition comprising a molecular complex of claim 4 and a pharmaceutically acceptable excipient.
8 . A pharmaceutical composition according to claim 7 , wherein the composition is an oral dosage form.
9 . A molecular complex of claim 5 , wherein the sodium zoledronate is monosodium zoledronate.
10 . A pharmaceutical composition comprising a molecular complex of claim 9 and a pharmaceutically acceptable excipient.
11 . A molecular complex of claim 5 , wherein the sodium zoledronate is disodium zoledronate.
12 . A pharmaceutical composition comprising a molecular complex of claim 11 and a pharmaceutically acceptable excipient.
13 . A method for the treatment of disease states associated with osteoporosis, hypercalcemia, cancer induced bone metastasis, Paget's disease or adjuvant or neoadjuvant cancer therapies comprising the step of administering to a patient in need thereof a therapeutically effective amount of the molecular complex according to claim 1 .
14 . A method for the treatment of disease states associated with osteoporosis, hypercalcemia, cancer induced bone metastasis, Paget's disease or adjuvant or neoadjuvant cancer therapies comprising the step of administering to a patient in need thereof a therapeutically effective amount of the molecular complex according to claim 5 .
15 . A method for the treatment of disease states associated with osteoporosis, hypercalcemia, cancer induced bone metastasis, Paget's disease or adjuvant or neoadjuvant cancer therapies comprising the step of administering to a patient in need thereof a therapeutically effective amount of the molecular complex according to claim 9 .
16 . A method for the treatment of disease states associated with osteoporosis, hypercalcemia, cancer induced bone metastasis, Paget's disease or adjuvant or neoadjuvant cancer therapies comprising the step of administering to a patient in need thereof a therapeutically effective amount of the molecular complex according to claim 11 .