Novel crystalline forms

Abstract

Preparation and 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.

We claim: 
     
         1 . A crystalline form of zoledronic acid: DL-lysine, wherein
 said crystalline form is characterized by a powder X-ray diffraction pattern comprising powder X-ray diffraction peaks at about 6.6, 11.0, 14.2, 18.3, 19.7, 22.7 and 27.6±0.2 degrees 2-theta; or   said crystalline form is characterized by a powder X-ray diffraction pattern comprising powder X-ray diffraction peaks at about 7.2, 14.0, 18.3, 19.1, 20.7, 24.6 and 34.4±0.2 degrees 2-theta.   
     
     
         2 . A composition comprising a crystalline form of  claim 1 . 
     
     
         3 . A pharmaceutical composition comprising a crystalline form of  claim 1  and at least one pharmaceutically acceptable carrier. 
     
     
         4 . The pharmaceutical composition of  claim 3  wherein the pharmaceutical composition is a solid oral composition. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the solid oral composition is a tablet or capsule. 
     
     
         6 . The pharmaceutical composition of  claim 3 , wherein the pharmaceutical composition is a unit dose. 
     
     
         7 . A method of treating a disease for which zoledronic acid is indicated. 
     
     
         8 . A treatment method comprising the step of administering to a patient in need a therapeutically effective amount of a pharmaceutical composition of  claim 3 . 
     
     
         9 . The method of  claim 8 , wherein said disease is selected from the group consisting of osteoporosis, hypercalcemia, cancer induced bone metastasis, Paget's disease, adjuvant cancer therapy and neoadjuvant cancer therapy. 
     
     
         10 . A method of treating a disease for which zoledronic acid is indicated, said method comprising the step of administering to a patient in need thereof a therapeutically effective amount of a crystalline form of  claim 1 . 
     
     
         11 . The method of  claim 10 , wherein said disease is selected from the group consisting of osteoporosis, hypercalcemia, cancer induced bone metastasis, Paget's disease, adjuvant cancer therapy and neoadjuvant cancer therapy.