Rivaroxaban pharmaceutical composition

A technology of rivaroxaban and its composition, which is applied in the field of medicine, can solve the problems of individual differences in vivo and in vitro, and achieve the effect of avoiding the use of surfactants and improving dissolution performance

Active Publication Date: 2021-04-16
浙江东日药业有限公司
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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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  • Rivaroxaban pharmaceutical composition
  • Rivaroxaban pharmaceutical composition
  • Rivaroxaban pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0105] Example 1 Preparation of rivaroxaban film-coated tablets with a specification of 10 mg (unit: g)

[0106] 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

[0107] Preparation Process:

[0108] 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;

[0109] 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;

[0110] 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 solvent through the action of hot a...

Embodiment 2

[0114] Example 2 Preparation of Rivaroxaban Film-Coated Tablets with Specifications of 15 mg (unit: g)

[0115] 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

[0116] Preparation Process:

[0117] 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;

[0118] 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;

[0119] 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 solvent through the action of hot ai...

Embodiment 3

[0123] Example 3 Preparation of rivaroxaban film-coated tablets with a specification of 20 mg (unit: g)

[0124] 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

[0125] Preparation Process:

[0126] 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;

[0127] 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;

[0128] 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 solvent through the action of hot a...

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PUM

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Abstract

The invention relates to a pharmaceutical composition taking rivaroxaban as a main drug component and a preparation method of the pharmaceutical composition. Specifically, the invention relates to a pharmaceutical composition taking rivaroxaban as the main drug component, and the composition can be further prepared into a film-coated tablet as a specific administration form through a certain preparation process. By applying a method of a specific preparation process, the use of a surfactant in the preparation is avoided, and meanwhile, the dissolution rate of the tablet is effectively improved. And the sodium stearoyl fumarate is used in the composition, so that the significant increase of the degradation impurity I in the long-term storage process of the tablet is effectively avoided. Accelerated stability research finds that the rivaroxaban-containing film-coated tablet prepared by the prescription and the process steps disclosed by the invention is stable and controllable in quality.

Description

[0001] The present invention is a divisional application of a patent with the application number 201510670400.8, the application date: 2015.10.15, and the invention name "a solid pharmaceutical composition containing rivaroxaban". technical field [0002] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition with rivaroxaban as the main ingredient, a preparation method and application thereof. Background technique [0003] 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 resten...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/5377A61K47/14A61K47/38A61K47/26A61K47/32A61P7/02
Inventor 不公告发明人
Owner 浙江东日药业有限公司
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