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US 10,946,015 B2Granted
Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
AssigneeActelion Pharmaceuticals Ltd.
InventorsCharles Tokunbo Adesuyi, Bruce Hamilton Lithgow, Olivier Lambert, Lovelace Holman
Life of this patent
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Abstract
The invention relates to stable pharmaceutical compositions comprising the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof.
Claims42
A pharmaceutical composition comprising:
- a) the compound of the formula I as drawn below
- or a pharmaceutically acceptable salt, solvate, hydrate or morphological form thereof, in a total amount of 1 to 50% in weight based on the total weight of the pharmaceutical composition,
- b) filler, in an amount of 10 to 95% in weight based on the total weight of the pharmaceutical composition,
- c) disintegrant, in an amount of 1 to 20% in weight based on the total weight of the pharmaceutical composition,
- d) surfactant, in an amount from 0.1 to 1% in weight based on the total weight of the pharmaceutical composition, wherein the surfactant comprises a polysorbate, and
- e) lubricant, in an amount from 0.05 to 10% in weight based on the total weight of the pharmaceutical composition.
3 more elements
A pharmaceutical composition comprising:
- a) the compound of the formula I as drawn below
- or a pharmaceutically acceptable salt, solvate, hydrate or morphological form thereof, in a total amount of 1 to 50% in weight based on the total weight of the pharmaceutical composition,
- b) filler, in an amount of 10 to 95% in weight based on the total weight of the pharmaceutical composition, wherein the filler comprises one or more from lactose, maize starch, pregelatinized starch, dibasic calcium phosphate dihydrate (CaHPO4.2H2O), microcrystalline cellulose, maltodextrin and mannitol,
- c) disintegrant, in an amount of 1 to 20% in weight based on the total weight of the pharmaceutical composition, wherein the disintegrant comprises one or more from croscarmellose sodium, sodium starch glycolate, calcium carboxymethylcellulose, sodium carboxymethylcellulose, cross-linked polyvinylpyrrolidone, polyvinylpyrrolidone, alginic acid, sodium alginate, pregelatinized starch, guar gum, clays and ion exchange resins,
- d) surfactant, in an amount from 0.1 to 1% in weight based on the total weight of the pharmaceutical composition, wherein the surfactant comprises a polysorbate, and
- e) lubricant, in an amount from 0.05 to 10% in weight based on the total weight of the pharmaceutical composition, wherein the lubricant comprises one or more from magnesium stearate, aluminium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, talc, sodium benzoate, a glyceryl mono fatty acid, glyceryl dibehenate, glyceryl palmito-stearic ester, polyethylene glycol, hydrogenated cotton seed oil, castor seed oil and sucrose esters.
3 more elements
Dependencies are inferred from the claim text.