Pharmaceutical formulation with improved stability

Details Pharmaceutical formulation with improved stability Pharmaceutical formulation with improved stability

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 31/66 (2006.01)

Patent

CA 2540488

There is provided an oral formulation which includes an intragranular phase comprising a bisphosphonic acid derivative and at least one carbohydrate alcohol, together with an aqueous binder. There is also provide a process of preparing the same and a therapeutic method employing such a formulation in the treatment of various skeletal diseases, such as systemic bone diseases including osteoporosis, osteoarthritis, Paget's disease, osteomalacia, multiple myeloma, and other forms of cancer, steroid therapy wherein the skeletal system is effected and age-related loss of bone mass, local disorders such as bone fractures and other such related disorders.

L'invention concerne une formulation orale comprenant une phase intragranulaire constituée d'un dérivé d'acide bisphosphonique et d'au moins un alcool de d'hydrate de carbone liés par un liant aqueux. L'invention concerne également un procédé permettant de préparer la formulation orale et une méthode thérapeutique utilisant ladite formulation pour traiter des maladies osseuses variées, telles que des maladies osseuses systémiques notamment l'ostéoporose, l'ostéoarthrite, la maladie de Paget, l'ostéomalacie, le myélome multiple et autres formes de cancer. Une thérapie stéroïde est appliquée lorsque le système osseux est affecté par la perte de masse osseuse due au vieillissement et des troubles locaux tels que les fractures osseuses et d'autres troubles associés.

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