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Rivaroxaban tablet

A technology of rivaroxaban and beta-cyclodextrin, which is applied in the direction of non-active ingredient medical preparations, pill delivery, blood diseases, etc., can solve the problem of failure to provide rivaroxaban tablets, etc., and achieve drug dissolution Rapid, uniform drug dispersion and smooth production process

Active Publication Date: 2017-06-20
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] In the prior art, a rivaroxaban tablet with rapid in vitro dissolution, good stability and simple preparation process has not been provided.

Method used

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Examples

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Comparison scheme
Effect test

Embodiment 1

[0032]

[0033]

[0034] Preparation Process:

[0035] Dissolve rivaroxaban, hydroxypropyl beta-cyclodextrin, and deoxycholic acid in ethyl acetate, then granulate the solution on lactose and crospovidone, dry at 40°C, and sizing on a 20-mesh sieve , Magnesium stearate is added to dry granules, mixed evenly, and compressed into tablets.

Embodiment 2

[0037]

[0038] Preparation workers:

[0039] Dissolve rivaroxaban, hydroxypropyl betacyclodextrin, and deoxycholic acid in ethyl acetate, then granulate the solution on lactose and croscarmellose sodium, dry at 40°C, 20 mesh Sieve the granules, add magnesium stearate to the dry granules, mix them evenly, and compress them.

Embodiment 3

[0041]

[0042] Preparation Process:

[0043] Dissolve rivaroxaban, hydroxypropyl beta-cyclodextrin, and deoxycholic acid in ethyl acetate, then granulate the solution on mannitol and sodium carboxymethyl starch, dry at 40°C, and sieving with 20 mesh , Magnesium stearate is added to dry granules, mixed evenly, and compressed into tablets.

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Abstract

The invention discloses a rivaroxaban tablet. The rivaroxaban tablet is prepared by dissolving rivaroxaban, hydroxypropyl-[beta]-cyclodextrin and deoxycholic acid in ethyl acetate; then, granulating an obtained solution with the addition of a pharmaceutically acceptable carrier; drying obtained granules; and adding a lubricating agent, and conducting mixing and tableting. In comparison with the prior art, the rivaroxaban tablet provided by the invention is simple in preparation process, uniform in drug dispersion, smooth in production process and rapid in drug dissolution.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a rivaroxaban tablet. Background technique [0002] Rivaroxaban is the world’s first oral direct factor Xa inhibitor jointly developed by Bayer Pharmaceuticals and Johnson & Johnson. It was approved for marketing in Canada and the European Union on September 15 and October 1, 2008. The trade name For Xarelto. Rivaroxaban is a low-molecular-weight oral anticoagulant with high selectivity and direct inhibition of factor Xa, which is used to prevent and / or treat various embolic diseases. [0003] The chemical name of rivaroxaban is 5-chloro-nitrogen-((5S)-2-oxo-3-[-4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidine- 5-yl-2-thiophene-carboxamide, the structural formula is as follows: [0004] [0005] Molecular formula: C 19 H 18 ClN 3 O 5 S, molecular weight: 435.89, [0006] Rivaroxaban is soluble in dimethyl sulfoxide and almost insoluble in methanol or water. Rivaroxaban is a p...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/5377A61K47/28A61K47/40A61P7/02
CPCA61K9/2013A61K9/205A61K31/5377
Inventor 张贵民陈小伟荣维燕臧营
Owner SHANDONG NEWTIME PHARMA
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