ENTERIC SOLID ORAL DOSAGE FORM OF A BISPHOSPHONATE CONTAINING A CHELATING AGENT

Oralni dozni oblik farmaceutske kompozicije koji sadrži:(a) bisfosfonat izabran od risendronata, i njegovih soli, estara, hidrata, hemihidrata, polimorfa i solvata, kao i njihovih kombinacija;(b) od 75 mg do 250 mg dinatrijum-EDTA; i(c) enterični omotač koji omogućava oslobađanje bisfosfonata i EDTA u donjem delu gastrointestinalnog trakta sisara;i gde je molski odnos dinatrijum-EDTA i bisfosfonata najmanje 2:1.Prijava sadrži još 8 zavisnih patentnih zahteva. Oral dosage forms of a bisphosphonate comprised of a safe and effective amount of a pharmaceutical composition comprising a bisphosphonate, a chelating agent, and means for effecting delayed release of the bisphosphonate and the chelating agent in the lower gastrointestinal tract provide delivery of the pharmaceutical composition to the lower gastrointestinal tract of the mammal subject and pharmaceutically effective absorption of the bisphosphonate with or without food or beverages. The present invention substantially alleviates the interaction between bisphosphonates and food or beverages, which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of the bisphosphonate and the chelating agent to the lower GI tract, substantially alleviating the upper GI irritation associated with bisphosphonate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphosphonate therapies.