Pharmaceutical compositions of ubrogepant and process for preparation thereof
AssigneeAurobindo Pharma Ltd
InventorsSaravanan KANNUSAMY, Koteswararao GUDE, Nagaprasad VISHNUBHOTLA, Sivakumaran MEENAKSHISUNDERAM
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Abstract
The present invention relates to a stable immediate release tablet compositions of Ubrogepant and one or more pharmaceutically acceptable excipients and a process for preparation thereof.
Claims12
A stable immediate release tablet comprising Ubrogepant and a water insoluble polymer selected from the group consisting of hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate and polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, wherein the tablet is prepared by hot melt extrusion process.
A stable immediate release tablet comprising of:
- (a) about 1-20% by weight of Ubrogepant;
- (b) about 2.5-50% by weight of hydroxypropyl methylcellulose acetate succinate;
- (c) about 1-10% by weight of tocopherol-polyethylene-glycolsuccinate;
- (d) about 0-2.5% by weight of plasticizers selected from polyethylene glycol and triethyl citrate or combinations thereof;
- (e) about 10-50% by weight of mannitol and microcrystalline cellulose;
- (f) about 10-25% by weight of croscarmellose sodium and sodium chloride;
- (g) about of 0.1-1% by weight of colloidal silicone dioxide;
- (h) about of 0.1-2% by weight of sodium stearyl fumarate, wherein the tablet is prepared by hot melt extrusion process.
A stable immediate release tablet comprising Ubrogepant, a water-soluble polymer, a dispersing agent, a disintegration system and other pharmaceutically acceptable excipients, wherein the composition is devoid of solid dispersions or solid solutions or extrudates comprising of Ubrogepant, wherein the water-soluble polymer is polyvinylpyrrolidone vinylacetate copolymers.
Dependencies are inferred from the claim text.