Dispersible phospholipid stabilized microparticles

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/14 (2006.01) A61K 9/19 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2349203

Rapidly dispersing solid dry therapeutic dosage form comprised of a water insoluble compound existing as a nanometer or micrometer particulate solid which is surface stabilized by the presence of at least one phospholipid, the particulate solid being dispersed throughout a bulking matrix. When the dosage form is introduced into an aqueous environment the bulking matrix is substantially completely dissolved within less than 2 minutes thereby releasing the water insoluble particulate solid in an unaggregated and/or unagglomerated state. The matrix is composed of a water insoluble substance or therapeutically useful water insoluble or poorly water soluble compound, a phospholipid and optionally also at least one non-ionic, anionic, cationic or amphipathic surfactant, together with a matrix or bulking agent and if needed a release agent. The volume weighted mean particle size of the water insoluble particle is 5 micrometers or less.

L'invention concerne une forme posologique sèche et solide à dispersion rapide qui comprend un composé insoluble dans l'eau existant sous la forme d'un solide particulaire nanométrique ou micrométrique dont la surface est stabilisée par la présence d'au moins un phospholipide, le solide particulaire étant dispersé à travers une matrice gonflante. Lorsque la forme posologique est introduite dans un environnement aqueux, la matrice gonflante se dissout de façon sensiblement complète en moins de deux minutes en libérant dans l'eau le solide particulaire insoluble dans un état non granulé et/ou non aggloméré. La matrice est composée d'une substance non hydrosoluble ou d'un composé à utilité thérapeutique faiblement hydrosoluble ou non hydrosoluble, d'un phospholipide et éventuellement d'au moins un surfactant non ionique, anionique, cationique ou amphipathique ainsi que d'une matrice ou d'un agent gonflant et, si nécessaire, d'un agent de libération. La taille particulaire pondérée des particules non hydrosolubles est inférieure ou égale à 5 micromètres.

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