A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/22 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/52 (2006.01) A61K 47/30 (2006.01) A61P 9/08 (2006.01)
Patent
CA 2434835
The present invention is directed to a multiparticulate, modified release solid dispersion formulation, comprising a drug substance having a water- solubility of, or below, 8 mg/ml at room temperature; a hydrophobic matrix former which is a water insoluble, non-swelling amphiphilic lipid; and a hydrophilic matrix former which is a meltable, water-soluble excipient; wherein the weight ratio hydrophobic matrix former/hydrophilic matrix former is >= 1; and the particle size is less than 300 µm. Also a unit dosage of the same, as well as process for the preparation thereof and the use of the formulation and unit dosage are claimed.
L'invention concerne une formulation à dispersion solide multiparticulaire à libération modifiée, renfermant une substance médicamenteuse dotée d'une solubilité dans l'eau inférieure ou égale à 8 mg/ml à température ambiante, un formateur de matrice hydrophobe sous forme d'un lipide amphiphile hydro-insoluble non gonflant, un formateur de matrice hydrophile sous forme d'un excipient fusible. Le rapport pondéral formateur de matrice hydrophobe/formateur de matrice hydrophile est >= 1, et la taille particulaire est inférieure à 300 µm. L'invention concerne également une forme de dosage de la formulation, ainsi qu'un procédé de préparation de cette dernière et d'utilisation de la formulation et de la forme de dosage.
Astrazeneca Ab
Fetherstonhaugh & Co.
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