A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/20 (2006.01) A61K 9/14 (2006.01) A61K 9/26 (2006.01) A61K 9/48 (2006.01)
Patent
CA 2406574
Pharmaceutical compositions that have excellent storage stability even though they include an active component that is susceptible to degradation in an acidic environment are disclosed. The stabilized pharmaceutical composition of the invention includes a ring-opened 7-substituted-3,5-dihydroxyheptanoic or a ring-opened 7- substituted-3,5-dihydroxyheptenoic acid, or a pharmaceutically acceptable salt thereof, as an active component and a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof; wherein the stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer of a combination of other stabilizers. The pharmaceutical composition may optionally include one or more pharmaceutically acceptable excipients such as a filler, a disintegrating agent and one or more lubricants such as magnesium stearate to aid compression where a tablet dosage form is desired.
L'invention concerne des compositions pharmaceutiques qui présentent une excellente stabilité en stockage, même si elles renferment un composant actif susceptible de se dégrader dans un milieu acide. La composition pharmaceutique stabilisée comprend un acide 7-substitué-3,5-dihydroxyheptanoïque à cycle ouvert ou acide 7-substitué-3,5-dihydroxyhepténoïque à cycle ouvert, ou un sel de ce dernier pharmaceutiquement acceptable, en tant que composant actif, et une dose efficace stabilisante d'au moins un groupe amido contenant un composé polymère, ou une combinaison de ces derniers. La composition pharmaceutique stabilisée ne contient pas une dose efficace stabilisante d'un autre stabilisant ou une combinaison d'autres stabilisants. La composition pharmaceutique peut éventuellement contenir au moins un excipient pharmaceutiquement acceptable, par exemple une charge, un désintégrant et au moins un lubrifiant, par exemple un stéarate de magnésium qui facilite la compression lorsque l'on souhaite obtenir une forme posologique en comprimé.
Dorossiev Ivo
Fox Michael
Ridout & Maybee Llp
Teva Pharmaceutical Industries Ltd.
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