Apixaban tablet and preparation method thereof

An apixaban tablet and butyl technology, which is applied in the field of apixaban tablet and its preparation, can solve the problems of slow dissolution rate and high impurity content, and achieve the effects of rapid dissolution, good content uniformity and less addition amount

Inactive Publication Date: 2020-08-07
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Patent CN104095823 A discloses a preparation method of apixaban tablets, the method adopts firstly mixing and pulverizing apixaban and water-soluble materials, and then adding other auxiliary materials to the mixture and directly compressing the tablets, the apixaban prepared by this method It takes 15 minutes for Shaban tablet to achieve a dissolution rate greater than 80%, with slow dissolution rate and high impurity content

Method used

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  • Apixaban tablet and preparation method thereof
  • Apixaban tablet and preparation method thereof
  • Apixaban tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025]

[0026] Preparation Process:

[0027] Dissolve the prescribed amount of apixaban and butylated pullulan in acetone, add pure water to 3L, fill into the formed cold-formed aluminum blister, the filling volume is 3ml, and then fill the The good blisters are transferred to the freeze dryer, freeze-dried, and the freeze-dried product is transferred to the inner packaging machine, and the double aluminum packaging is ready.

Embodiment 2

[0029]

[0030] Preparation Process:

[0031] Dissolve the prescribed amount of apixaban and butylated pullulan in acetone, add pure water to 1.5L, fill it into the cold-formed aluminum blister that has been formed, and the filling volume is 1.5ml, and then put The filled blisters are transferred to the freeze dryer, freeze-dried, and the freeze-dried product is transferred to the inner packaging machine, and the double-aluminum packaging is ready.

Embodiment 3

[0033]

[0034] Preparation Process:

[0035] Dissolve the prescribed amount of apixaban and butylated pullulan in acetone, add pure water to 2L, fill into the formed cold-formed aluminum blister, the filling volume is 2ml, and then fill the The good blisters are transferred to the freeze dryer, freeze-dried, and the freeze-dried product is transferred to the inner packaging machine, and the double aluminum packaging is ready.

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PUM

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Abstract

The invention relates to an apixaban tablet and a preparation method thereof. The tablet contains butylated pullulan and is prepared by the following process: dissolving apixaban and butylated pullulan in an aqueous solution of an organic solvent, then filling the solution in a cold-formed aluminum bubble cap, freeze-drying in a freeze dryer, and encapsulating and sealing the freeze-dried product.The tablet is high in dissolution speed, good in content uniformity and low in dosage of auxiliary materials.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an apixaban tablet and a preparation method thereof. Background technique [0002] The chemical name of Apixaban is 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-piperidine- 1-yl)phenyl]-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (CAS name) or 1-(4-methoxyphenyl)-7-oxo-6- [4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (IUPAC name). [0003] Apixaban is disclosed in U.S. Patent 6,967,208 (according to U.S. Patent Application 10 / 245,122 filed September 17, 2002), which is hereby incorporated by reference in its entirety, which has the clotting factor Use of Xa inhibitors, developed as oral administration for various indications requiring the use of antithrombotic agents. The aqueous solubility of apixaban (40 μg / mL at all physiological pH) indicates that tablets with less than 10 mg of apixaba...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/36A61K31/4545A61P7/02
CPCA61K9/205A61K31/4545A61P7/02
Inventor 赵超杨蕾
Owner NANJING CHIA TAI TIANQING PHARMA
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