risedronate sodium delayed-release

Actonel EC is an enteric-coated, delayed-release oral formulation of risedronate sodium, a nitrogen-containing pyridinyl bisphosphonate. It is designed with a pH-sensitive coating and formulated with the chelating agent EDTA to bypass the stomach and dissolve in the small intestine (at pH > 5.5). This formulation allows the drug to be administered with or without food, overcoming the significant food-interaction and absorption limitations associated with immediate-release bisphosphonates. Risedronate sodium binds to hydroxyapatite in bone and is internalized by osteoclasts, where it inhibits farnesyl pyrophosphate synthase (FPPS) in the mevalonate pathway. This inhibition disrupts protein prenylation, leading to osteoclast inactivation and apoptosis, thereby suppressing bone resorption and increasing bone mineral density. Actonel EC is approved for the treatment of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis. It is also being evaluated in a Phase 3 clinical trial (the SABRE study) by the Westmead Hospital Research and Education Network to determine if once-weekly administration improves bone mineral density and structural bone measures in patients with end-stage kidney disease receiving satellite haemodialysis.

Brand names

Actonel ECAtelviaActonel DR

Other names

risedronate sodium enteric-coatedenteric-coated risedronate sodiumdelayed-release risedronate sodium