Patent ID: 7081255
Filing Date: 2006-07-25
Classification: A61K,A61P

Abstract:
1. A pharmaceutical dosage form comprising a therapeutically effective amount of particles consisting of a solid dispersion comprising (a) itraconazole, or one of its stereoisomers, or a mixture of two or three or four of its stereoisomers, and (b) one or more pharmaceutically acceptable water-soluble polymers, wherein the particle has a size of less than 600 μm, and wherein the dosage form comprises by weight based on the total weight of the dosage form: 21.65% itraconazole 32.48% HPMC 2910 5 mPs·s 30.57% spray-dried mixture of lactose monohydrate and microcrystalline cellulose in a 75:25 ratio 8.49% crospovidone 2.79% talc 0.93% hydrogenated vegetable oil Type I 0.28% colloidal anhydrous silica 0.24% magnesium stearate, yielding 97.43% tablet core, and 1.47% HPMC 2910 5 mPs·s 0.37% propyleneglycol 0.29% talc 0.44% titanium dioxide, yielding 2.57% film-coat.