Patent ID: 8748489
Filing Date: 2014-06-10
Classification: A61K,A61P

Abstract:
1. A solid pharmaceutical composition consisting of: (a) an effective amount of an intestinal motility regulating agent selected from the group consisting of trimebutine, trimebutine maleate, stereoisomers of trimebutine and metabolites thereof; (b) an effective amount of simethicone; and (c) a pharmaceutically acceptable inert excipient consisting of: (i) 2-10% by weight of a flowability promoting agent selected from the group consisting of: talc, starch, polyethyleneglycol 4000, silicon dioxide, microcrystalline cellulose and mixtures thereof; (ii) 0.25% to about 8% by weight of a lubricant selected of the consisting of talc, magnesium stearate, calcium stearate, stearic acid, sodium steary fumarate, hydrogenated vegetable oils, sodium benzoate, sodium chloride, leucine, polyethyleneglycol 4000, sodium laury sulphate and mixtures thereof; (iii) 5% to about 50% by weight of an extender/diluent selected from the group consisting of dicalcium phosphate, calcium sulphate, lactose monohydrate, kaolin, mannitol, sodium chloride, starch, pulverized sugar, microcrystalline cellulose and its derivatives, polyalcohols or mixtures thereof; (iv) 2% to about 9% by weight of a disintegrant selected from the group consisting of corn starch, potato starch, sodium carboxymethyl starch, pregelatinized starch, sodium croscarmellose, methylcellulose, bentonite, veegurn, ion exchange resins, alginic acid, guar gum, carboxymethylcellulose, sodium lauryl sulphate, starch glycolate, microcrystalline cellulose, polyvinylpyrrolidone, cross-liked polyvinylpyrrolidone and mixtures thereof; (v) 2% to about 8% by weight of a binder selected from the group consisting of starch, gelatin, sucrose, glucose, dextrose, lactose, polyvinylpyrrolidone, acacia gum, sodium alginate, carboxymethylcellulose, methylcellulose, veegum, polyethyleneglycol 4000, polyethyleneglycol 6000, ethylcellulose, waxes, tragacanth gum, to agar-agar, pectin, dextrin, polyvinyl alcohol, carbopol, bentonite, kaolin and mixtures thereof; said solid composition being formed from granules having a particle size in the range between 250 μm and 6000 μm.