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Rivaroxaban tablet pharmaceutical composition

A technology of rivaroxaban and composition, applied in the field of medicine, capable of solving problems such as insufficient friability performance

Active Publication Date: 2017-05-17
HANGZHOU ZHUYANGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the present inventors have found that the friability properties of the tablets obtained using the prior art methods are not sufficient, which will seriously affect the ability of the tablets to be further coated with a film coating.

Method used

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  • Rivaroxaban tablet pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Embodiment 1: Preparation of rivaroxaban tablet

[0076] Prescription composition (mg / tablet):

[0077] Chip:

[0078] Rivaroxaban (micronized) 20.0mg

[0079] Microcrystalline Cellulose 35.0mg

[0080] Lactose monohydrate 22.9mg

[0081] Croscarmellose (Ac-Di- FMC) 3.0mg

[0082] Hydroxypropyl methylcellulose (5cp) 3.0mg

[0083] Sodium Lauryl Sulfate 0.5mg

[0084] Magnesium stearate 0.6mg;

[0085] Coating:

[0086] Hydroxypropyl methylcellulose (15cp) 1.5mg

[0087] Polyethylene glycol with a molecular weight of 3350 0.5mg

[0088] Titanium dioxide 0.5 mg;

[0089] Total 87.5mg.

[0090]Preparation method: Dissolve hydroxypropyl methylcellulose and sodium lauryl sulfate in water. Micronized rivaroxaban is suspended in this solution. The suspension thus prepared is sprayed in the fluidized bed granulation stage as a wet granulation liquid onto a mixed powder material in a fluidized state consisting of microcrystalline cellulose, lactose monohydrate ...

Embodiment 2

[0091] Embodiment 2: Preparation of rivaroxaban tablet

[0092] Prescription composition (mg / tablet):

[0093] Chip:

[0094] Rivaroxaban (micronized) 5mg

[0095] Microcrystalline Cellulose 40mg

[0096] Lactose monohydrate 33.9mg

[0097] Croscarmellose (Ac-Di- FMC) 3mg

[0098] Hydroxypropyl methylcellulose (3cp) 2mg

[0099] Sodium Lauryl Sulfate 0.5mg

[0100] Magnesium stearate 0.6mg;

[0101] Coating:

[0102] Hydroxypropyl methylcellulose (15cp) 1.5mg

[0103] Polyethylene glycol with a molecular weight of 400 0.5 mg

[0104] Iron oxide yellow 0.1mg

[0105] Titanium dioxide 0.4mg;

[0106] Total 87.5mg.

[0107] Preparation method: carry out according to the preparation method of embodiment 1.

Embodiment 3

[0108] Embodiment 3: preparation rivaroxaban tablet

[0109] Prescription and preparation method are with reference to embodiment 1, and difference is only that the croscarmellose wherein is replaced with the croscarmellose sodium of equal amount.

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Abstract

The invention belongs to the technical field of medicines, relates to a rivaroxaban troche pharmaceutical composition, and particularly relates to a pharmaceutical composition in form of a troche. The pharmaceutical composition includes rivaroxaban, a diluent, a disintegrant, an adhesive, a wetting agent and a lubricant. Each troche comprises 1-100mg of rivaroxaban. The troche can be further coated, for example, a film coated troche. The troche provided by the invention has the advantages described in specification. The rivaroxaban troche pharmaceutical composition has excellent dissolving-out performance, stability and other preparation performances.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a composition of anticoagulant drugs, in particular to a pharmaceutical composition of FXa inhibitor rivaroxaban, especially a tablet thereof, and to a preparation method of the pharmaceutical composition. Background technique [0002] Rivaroxaban was first described in WO01 / 47919, which has the following structure [0003] [0004] Molecular formula C 19 h 18 ClN 3 o 5 S, molecular weight 435.89, English name rivaroxaban, R&D code BAY5927939, trade name Xarelto, CAS366789-02-8, domestic drug name Xarelto, Chinese chemical name 5-chloro-N-({(5S)-2-oxo Substitute-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophene carboxamide, English chemical name is 5 -Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. Clinically used rivaroxaban is a pure (S)-enantiomer, which is an odorless, non-hygroscopic,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/30A61K31/5377A61K47/38A61P7/02
Inventor 李阅东唐建飞沈如杰姚成娥何海珍马雯霞张群刘秋敏
Owner HANGZHOU ZHUYANGXIN PHARMA
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