A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/20 (2006.01)
Patent
CA 2647809
A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion. Various functional excipients can be included in the carrier system to improve process performance and/or improve the chemical or physical properties of the HME composition.
L'invention concerne une composition bioadhésive stabilisée contenant un médicament labile alcalins et son procédé de préparation. Selon un aspect, la composition est une composition extrudée à chaud (HME) comprenant un mélange d'excipients préformé comprenant un composant acide et un matériau formateur de matrice thermoplastique alcalin, par exemple un polymère. Le mélange d'excipients est formé avant le mélange avec un médicament labile alcalin. Le mélange est ensuite extrudé à chaud pour former la composition HME. Ce faisant, le composant acide est capable de neutraliser ou de rendre modérément acide le mélange d'excipients. On a montré que ce procédé particulier réduisait sensiblement la dégradation d'un médicament labile alcalin pendant l'extrusion à chaud. Le mélange d'excipients se ramollit ou fond pendant l'extrusion à chaud. Il peut solubiliser ou non les particules contenant du médicament pendant l'extrusion. Divers excipients fonctionnels peuvent être inclus dans le système véhicule afin d'améliorer les performances du procédé et/ou d'améliorer les propriétés physiques ou chimiques de la composition HME.
Crowley Michael M.
Keen Justin M.
Koleng John J.
Zhang Feng
Auxilium International Holdings Inc.
Auxilium Pharmaceuticals Inc.
Blake Cassels & Graydon Llp
LandOfFree
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