Inventors:
Anastasia Daifotis - Westfield NJ, US
Andrew Denker - Hoboken NJ, US
Craig Ikeda - Harleysville PA, US
Bogdan Matuszewski - North Wales PA, US
Sid Mazel - Basking Ridge NJ, US
Arturo Porras - Lansdale PA, US
Art Santora - Watchung NJ, US
Randal Seburg - Collegeville PA, US
Limin Zhu - Collegeville PA, US
John Yates - Libertyville IL, US
John Kirsch - Waynesburg PA, US
International Classification:
A61K031/675, A61K031/59, A61K031/663
US Classification:
514089000, 514102000, 514167000
Abstract:
Disclosed are compositions and methods for preventing, inhibiting, reducing and treating conditions and diseases associated with abnormal bone resorption in mammals, including for example osteoporosis. Embodiments of compositions of the invention comprise a pharmaceutically effective amount of alendronate and vitamin Dsuitable for once-weekly dosing. Compositions and methods of the invention provide vitamin D nutrition during bisphosphonate treatment to facilitate normal bone formation and mineralization while minimizing the occurrence of or potential for the complications associated with vitamin D insufficiency, such as hypocalcaemia and osteomalacia. Also disclosed are methods for manufacturing compositions of the present invention, for measuring stability and degradation of those compositions, and for measuring blood plasma levels of vitamin D.