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Solid pharmaceutical composition containing rivaroxaban

A technology for rivaroxaban and a composition, applied in the field of medicine, can solve problems such as differences between individuals inside and outside the body, and achieve the effects of avoiding the use of surfactants and improving dissolution performance

Active Publication Date: 2016-01-13
SHANGHAI LINKCHEM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to a large number of surfactants may cause individual differences in vivo and in vitro

Method used

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  • Solid pharmaceutical composition containing rivaroxaban
  • Solid pharmaceutical composition containing rivaroxaban
  • Solid pharmaceutical composition containing rivaroxaban

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 110

[0103] Embodiment 110 mg specification rivaroxaban film-coated tablet preparation (unit: g)

[0104] Raw materials

Dosage

Rivaroxaban

10g

n-pentanol

Appropriate amount

Hypromellose

10g

microcrystalline cellulose

49g

Mannitol

25g

Croscarmellose Sodium

5g

Sodium Stearyl Fumarate

1g

Co-made

1000 pieces

Opadry(R)II

3%-5% weight gain

[0105] Preparation Process:

[0106] 1) Take the rivaroxaban raw material, dissolve it with an appropriate amount of n-amyl alcohol, add hyprolose, and dissolve to obtain a drug-containing solution;

[0107] 2) Take the prescription amount of microcrystalline cellulose, mannitol, and croscarmellose sodium and put them in a fluidized bed, and enter the air to obtain a boiling material;

[0108] 3) Spray the drug-containing solution obtained in step 1) into the boiling material in step 2) in the form of a bottom spray, and remove the...

Embodiment 215

[0112] Embodiment 215mg specification rivaroxaban film-coated tablet preparation (unit: g)

[0113] Raw materials

Dosage

Rivaroxaban

15g

n-pentanol

Appropriate amount

Hypromellose

15g

microcrystalline cellulose

42g

Mannitol

21g

Croscarmellose Sodium

5g

Sodium Stearyl Fumarate

2g

Co-made

1000 pieces

Opadry(R)II

3%-5% weight gain

[0114] Preparation Process:

[0115] 1) Take the rivaroxaban raw material, dissolve it with an appropriate amount of n-amyl alcohol, add hyprolose, and dissolve to obtain a drug-containing solution;

[0116] 2) Take the prescription amount of microcrystalline cellulose, mannitol, and croscarmellose sodium and put them in a fluidized bed, and enter the air to obtain a boiling material;

[0117] 3) Spray the drug-containing solution obtained in step 1) into the boiling material in step 2) in the form of a bottom spray, and remove the ...

Embodiment 320

[0121] Embodiment 320mg specification rivaroxaban film-coated tablet preparation (unit: g)

[0122] Raw materials

Dosage

Rivaroxaban

20g

n-pentanol

Appropriate amount

Hypromellose

20g

microcrystalline cellulose

35g

Mannitol

18g

Croscarmellose Sodium

5g

Sodium Stearyl Fumarate

2g

Co-made

1000 pieces

Opadry(R)II

3%-5% weight gain

[0123] Preparation Process:

[0124] 1) Take the rivaroxaban raw material, dissolve it with an appropriate amount of n-amyl alcohol, add hyprolose, and dissolve to obtain a drug-containing solution;

[0125] 2) Take the prescription amount of microcrystalline cellulose, mannitol, and croscarmellose sodium and put them in a fluidized bed, and enter the air to obtain a boiling material;

[0126] 3) Spray the drug-containing solution obtained in step 1) into the boiling material in step 2) in the form of a bottom spray, and remove the ...

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Abstract

The invention relates to a pharmaceutical composition containing rivaroxaban, in particular to a solid pharmaceutical composition containing rivaroxaban and a preparation method of the solid pharmaceutical composition. The solid pharmaceutical composition containing the rivaroxaban can be further prepared into a film-coated tablet by a specific preparation technology to serve as a specific administration mode. The solid pharmaceutical composition containing the rivaroxaban and the preparation method of the solid pharmaceutical composition have the advantages that by application of the specific preparation technology, using surfactants in a preparation is avoided and dissolution rate of the tablet is increased effectively; by means of using sodium stearyl fumarate in the composition, marked increase of degraded impurities I during long-term storage of the tablet is avoided effectively; through stability accelerating research, the film-coated tablet containing the rivaroxaban, prepared by the prescription and technological steps, is stable and controllable in quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a solid pharmaceutical composition containing rivaroxaban, a preparation method and application thereof. Background technique [0002] Thrombosis is a common vascular disease caused by narrowing of the lumen of blood vessels, blood embolism and occlusion of the circulatory system. Thrombotic complications are the leading cause of death in the industrial world and include acute myocardial infarction, unstable angina, chronic stable angina, transient ischemia, stroke, peripheral vascular disease, deep vein thrombosis, Embolism, disseminated intravascular coagulation, and thrombotic thrombocytopenic purpura. Thrombotic and restenotic complications also commonly occur after invasive procedures such as angioplasty, carotid endarterectomy, coronary artery bypass graft surgery, vascular grafts, stents Placement and knee and hip replacement surgery. [0003] Compared with...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/5377C07D413/14A61K47/16A61P7/02
Inventor 杨玉廷
Owner SHANGHAI LINKCHEM TECH CO LTD
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