Rivaroxaban tablet and preparation method thereof

A technology for rivaroxaban and tablets, applied in the field of rivaroxaban tablets and their preparation, can solve problems such as complicated process and achieve the effects of requiring simple equipment, stable release and simple components

Inactive Publication Date: 2021-12-24
SHANGHAI PUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The process is complicated. Firstly, it is necessary to solve the problem of uniform dispersion of micronized raw materials. At the same time, it is necessary to control various parameters in the fluidized bed granulation process. Finally, the dried granules must be sized and mixed to obtain tablets. Particles used

Method used

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  • Rivaroxaban tablet and preparation method thereof
  • Rivaroxaban tablet and preparation method thereof
  • Rivaroxaban tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Prepare the formulation composition of rivaroxaban according to the formula in Table 1:

[0039] Table 1.

[0040] Dosage(kg) Rivaroxaban (d90=13.8μm) 0.5 Mannitol microcrystalline cross-polysilicone co-treatment 6 Magnesium stearate 0.03 total 6.53

[0041] Preparation method: first mix the rivaroxaban raw material with the same amount of co-processed auxiliary materials and magnesium stearate in the material bag, and then transfer the above mixed powder and the remaining co-processed material to the HLS-50 laboratory hopper In the mixer, set the mixing frequency to 8rpm and the mixing time to 20 minutes for physical mixing, measure the content of the intermediate, control the hardness of the tablet to 50-80N, and compress the intermediate granules.

Embodiment 2

[0043] Prepare the formulation composition of rivaroxaban according to the formula in Table 2:

[0044] Table 2.

[0045]

[0046]

[0047] Preparation method: first mix the rivaroxaban raw material with the same amount of co-processed auxiliary materials and magnesium stearate in the material bag, and then transfer the above mixed powder and the remaining co-processed material to the HLS-50 laboratory hopper In the mixer, set the mixing frequency to 12 rpm and the mixing time to 12 minutes for physical mixing, measure the content of the intermediate, control the hardness of the plain tablet to 50-80N, and compress the intermediate granules.

Embodiment 3

[0049] Prepare the formulation composition of rivaroxaban according to the formula in Table 3:

[0050] table 3.

[0051] Dosage(kg) Rivaroxaban (d90=12.6μm) 0.3 Mannitol cross-polymerization copolymer Maishan co-processed substance 500 5.4 Magnesium stearate 0.05 total 5.75

[0052] Preparation method: first mix the rivaroxaban raw material with the same amount of co-processed auxiliary materials and magnesium stearate in the material bag, and then transfer the above mixed powder and the remaining co-processed material to the HLS-50 laboratory hopper In the mixer, set the mixing frequency to 15 rpm and the mixing time to 8 minutes for physical mixing, measure the content of the intermediate, control the hardness of the tablet to 50-80N, and compress the intermediate granules.

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a rivaroxaban tablet and a preparation method thereof. According to the rivaroxaban tablet, a co-treatment substance formed by mannitol and other pharmaceutically acceptable auxiliary materials is mixed with rivaroxaban, and the mixture can be directly tableted to form a tablet, especially in a rivaroxaban micronized raw material; and by adoption of the composition provided by the invention, the problem of uneven dispersion caused by easy agglomeration of the raw material during tabletting of the conventional rivaroxaban micronized raw material can be solved. The process for preparing the tablet from the composition is few in steps, the required equipment is simple, the manpower and fixed asset cost for preparing the rivaroxaban tablet can be greatly reduced, and meanwhile after the composition is tableted, the rivaroxaban content uniformity is better, the release rate is high, and the release degree is more stable.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a rivaroxaban tablet and a preparation method thereof. Background technique [0002] Rivaroxaban (RIV) is the world's first highly selective oral anticoagulant that directly inhibits factor Xa. It has been approved in more than 100 countries around the world. It was launched in China by Bayer in 2014. for The approved indications are for adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE). It is mainly used for antithrombotic anticoagulant therapy clinically. In addition, the drug can also prevent stroke and other diseases in patients with atrial fibrillation. Potential for clinical disease. The structural formula of rivaroxaban is as follows: [0003] [0004] Rivaroxaban is an anticoagulant drug, which has strict requirements on the disintegration time limit and dissolution behavior of the tablet, and also put...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/26A61K31/5377A61P7/02
CPCA61K9/2095A61K9/2018A61K31/5377A61P7/02
Inventor 杨勇赵颖
Owner SHANGHAI PUKANG PHARMA
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