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US 10,478,399 B2Granted
Modified release tablet composition comprising mirabegron
AssigneeSynthon BV
InventorsAgnes Fernandez Pena, Onne Peter Hilbert Backers, Jose Velada Calzada
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Abstract
The present invention relates to a pharmaceutical composition, particularly a modified release tablet composition comprising mirabegron or a pharmaceutically acceptable salt thereof and to a process for preparing such a composition.
Claims19
A modified release tablet composition comprising:
- a) 5 to 25 wt % with respect to the total weight of the uncoated tablet of a therapeutically effective dose of mirabegron or a pharmaceutically acceptable salt thereof;
- and
- b) polyethylene oxide (PEO) having an average molecular weight of approximately 7,000,000 or a viscosity of 7500 to 10000 cps at a 1% aqueous solution at 25° C. and polyethylene glycol (PEG) having an average molecular weight of approximately 6000 to 10000, wherein the weight ratio PEO to PEG ranges from 1:3 to 1:4.5;
- wherein said tablet exhibits an in vitro dissolution profile that meets the following release criteria:
- 15%-35% of mirabegron is released within 1 hour, at least 50% of mirabegron is released within 2 hours, and at least 90% of mirabegron is released within 3 hours, wherein said dissolution profile is measured in 250 ml phosphate buffer (pH 6.8) using USP apparatus 3 at 20 dpm and 37° C.
2 more elements
A modified release tablet composition comprising the following ingredients:
- a) a therapeutically effective dose of mirabegron or a pharmaceutically acceptable salt thereof in an amount of from 5 to 25 wt % with respect to the total weight of the uncoated tablet;
- b) polyethylene oxide (PEO) having an average molecular weight of approximately 7,000,000 or a viscosity of 7500 to 10000 cps at a 1% aqueous solution at 25° C. and polyethylene glycol (PEG) having an average molecular weight of approximately 6000 to 10000, wherein the weight ratio PEO to PEG ranges from 1:3 to 1:4.5;
- c) a binder in an amount of from 1 to 5 wt % with respect to the total weight of the uncoated tablet;
- d) a lubricant in an amount from 0.05% to 5 wt % with respect to the total weight of the uncoated tablet;
- and
- e) optionally microcrystalline cellulose (MCC);
- wherein said tablet exhibits an in vitro dissolution profile that meets the following release criteria:
- 15%-35% of mirabegron is released within 1 hour, at least 50% of mirabegron is released within 2 hours, and at least 90% of mirabegron is released within 3 hours, wherein said dissolution profile is measured in 250 ml phosphate buffer (pH 6.8) using USP apparatus 3 at 20 dpm and 37° C.
5 more elements
Dependencies are inferred from the claim text.