Prasugrel containing quickly released stable oral pharmaceutical compositions
AssigneeEgis Pharmaceuticals PLC
InventorsAndrás FEHÉR, Zsolt Zsigmond, Péter Tonka-Nagy, György Tibor Ujfalussy
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Abstract
Prasugrel containing quickly released stable oral pharmaceutical compositions containing micronized prasugrel base, and starch or a starch derivative, and processes for the preparation thereof, and the use thereof for treating atherothrombotic events of patients suffering from acute coronary syndrome in which patients were subjected to percutaneous coronary intervention.
Claims21
1-19. (canceled)
A pharmaceutical composition comprising:
- an internal phase and an external phase, wherein the internal phase is in the form of granules and the external phase is present around and between the granules of said internal phase, wherein
- the granulated internal phase comprises starch or a starch derivative, and
- the external phase comprises a micronized prasugrel base and at least one further auxiliary agent,
- wherein prasugrel means (5-/2-cyclopropyl-1-(2-fluoro-phenyl)-2-oxoethyl/-4,5,6,7-tetrahydrothieno/3.2-c/-pyridine-2-yl-acetate.
A pharmaceutical composition having an internal phase and an external phase, wherein the internal phase is in the form of granules and the external phase is present around and between the granules of said internal phase, which composition is prepared by a process comprising:
- granulating the internal phase comprising starch or a starch derivative with an aqueous solution of a binder, drying the granules obtained, admixing the dry granules with a micronized prasugrel base which forms the external phase, homogenizing the mixture, and optionally pressing into tablets or filling in capsules,
- wherein prasugrel means (5-/2-cyclopropyl-1-(2-fluoro-phenyl)-2-oxoethyl/-4,5,6,7-tetrahydrothieno/3.2-c/-pyridine-2-yl-acetate.
A pharmaceutical composition comprising:
- an internal phase and an external phase, wherein the internal phase is in the form of granules and the external phase is present around and between the granules of said internal phase, wherein
- a micronized prasugrel base, which has been micronized without any further ingredients is in the external phase and starch or a starch derivative is in the internal phase, and optionally sodium stearyl fumarate or stearic acid, wherein the composition does not contain sodium lauryl sulphate and magnesium stearate, and the composition is free of a prasugrel salt,
- wherein prasugrel means (5-/2-cyclopropyl-1-(2-fluoro-phenyl)-2-oxoethyl/-4,5,6,7-tetrahydrothieno/3.2-c/-pyridine-2-yl-acetate.
Dependencies are inferred from the claim text.