Ticagrelor pharmaceutical preparation

A technology for ticagrelor and pharmaceutical preparations, applied in the field of ticagrelor pharmaceutical preparations, can solve problems such as unsmooth process, increased viscosity, and reduced particle size, so as to ensure the quality and curative effect of drugs and solve the problems of poor fluidity Effect

Active Publication Date: 2021-02-05
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The present invention adopts the method of micronizing ticagrelor to increase its dissolution rate, but since the particle size of ticagrelor is reduced after micronization, the viscosity increases, which is not conducive to mixing and tableting, and the process is not good in the preparation process. smooth problem, the inventors found that the addition of calcium glycerophosphate can overcome the problem that the above-mentioned preparation process is not smooth

Method used

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  • Ticagrelor pharmaceutical preparation
  • Ticagrelor pharmaceutical preparation
  • Ticagrelor pharmaceutical preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042]

[0043] Preparation:

[0044](1) Micronize the raw material of ticagrelor to obtain a particle size d0.9 of ticagrelor of 20 μm;

[0045] (2) Mix micronized ticagrelor, mannitol, calcium glycerophosphate (d0.9 is 40um), hydroxypropyl cellulose and croscarmellose sodium to prepare a mixture;

[0046] (3) adding water to the mixture in step (2) for wet granulation, drying, and sizing to obtain drug granules;

[0047] (4) Compress the drug granules into tablets.

Embodiment 2

[0049]

[0050] Preparation:

[0051] (1) The raw material of ticagrelor is micronized, and the particle size d0.9 of ticagrelor is 18 μm;

[0052] (2) Mix micronized ticagrelor, mannitol, calcium glycerophosphate (d0.9 is 30um), hydroxypropyl cellulose and sodium carboxymethyl starch to prepare a mixture;

[0053] (3) adding water to the mixture in step (2) for wet granulation, drying, and sizing to obtain drug granules;

[0054] (4) Mix the drug granules with magnesium stearate evenly, and press into tablets.

Embodiment 3

[0056]

[0057] Preparation:

[0058] (1) The raw material of ticagrelor was micronized, and the particle size d0.9 of ticagrelor was 16 μm;

[0059] (2) Mix micronized ticagrelor, mannitol, calcium glycerophosphate (d0.9 is 25um), hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate to prepare a mixture;

[0060] (3) Dry granulate the mixture in step (2) to obtain drug granules;

[0061] (4) Compress the drug granules into tablets.

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Abstract

The invention relates to a ticagrelor medicinal preparation. The ticagrelor medicinal preparation comprises ticagrelor, mannitol, calcium glycerophosphate, an adhesive and a disintegrating agent, wherein the particle size d0.9 of ticagrelor is not more than 30 microns. According to the medicinal preparation, the dissolution rate of the ticagrelor is increased, the problems that the ticagrelor is high in viscosity after being micronized, sticking occurs in the preparation process, and obvious dents appear on a tablet surface are solved, and the process smoothness of the preparation in the preparation process is guaranteed.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of cyclopentatriazole pyrimidine novel oral anti-platelet drug, specifically ticagrelor pharmaceutical preparation, and a preparation method of the preparation. Background technique [0002] Ticagrelor belongs to the cyclopentatriazole pyrimidine compound and is the first reversible P2Y12 platelet inhibitor. It was approved by the US FDA in July 2011 for use in acute coronary syndrome (ACS) to reduce cardiovascular-related Event risk. In December 2012, ticagrelor was approved to be officially launched in China. Ticagrelor is a new type of anti-platelet aggregation drug developed by AstraZeneca. It is an active drug that does not require liver activation and has a fast effect; moreover, its binding to platelet receptors is reversible. It is very beneficial to reduce the risk of bleeding in patients with pulmonal artery syndrome; although ticagrelor treatment is accompanied by other adverse reaction...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/519A61K47/38A61K47/36A61K47/32A61K47/26A61P7/02
CPCA61K31/519A61K9/2059A61K9/2054A61K9/2027A61K9/2018A61P7/02
Inventor 邹文娟傅远鹏耿玉先产运霞
Owner BEIJING WINSUNNY PHARMA CO LTD
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