DEVELOPMENT OF SUBCUTANEOUS AND INTRAMUSCULAR FORMULATIONS OF CALCIUMALENDRONATE SALTS

Poorly soluble calcium-alendronate salts were prepared and investigate d as potential candidates for subcutaneous or intramuscular formulatio ns. Three such formulations containing calcium-alendronate salts with different stoichiometries were developed for testing in safety, dispos ition and efficacy studies in animals. All formulations demonstrated a drastic reduction in pain on injection and tissue damaging propensity compared to the soluble salts of ABP. All three were efficacious and showed prolonged absorption from the injection site with the depositio n of a large percentage of the dose into the bone. Complex formation b etween alendronate and calcium was also studied.