Solid preparation of ticagrelor or its pharmaceutically acceptable salt

A solid preparation, ticagrelor technology, applied in the field of medicine, can solve the problems of low degree of inhibition, unsuitable, slow onset, etc., and achieve the effects of shortened exposure time, short production cycle, and small material loss

Inactive Publication Date: 2014-06-18
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, ticagrelor also has some disadvantages: slow onset of action; low degree of inhibition, large individual differences in patient response; irreversible blocking effect on ADP receptor
The half-life of ticagrelor is 12 hours, and it needs to be taken twice a day, which is not suitable for those patients with poor compliance. If the medicine cannot be taken on time according to the doctor's advice, the trough concentration level of platelet inhibition will decrease, and the degree of platelet inhibition will decrease. also weakened
Kleiman and Berger believe that ticagrelor is more suitable for CABG patients, and it is not ideal for patients who need to take anticoagulant drugs for a long time, because immediate withdrawal of the drug may increase the risk of myocardial infarction and stroke

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Ticagrelor Tablets (45mg specification)

[0034] components 1000 pieces Ticagrelor 46.83g lactose 80.56g partially pregelatinized starch 103.13g silica 4.5g Hypromellose 16g talcum powder 10g

[0035] Preparation method:

[0036] 1. Mix ticagrelor and silicon dioxide evenly;

[0037]2. Add lactose, partially pregelatinized starch, and hydroxypropyl methylcellulose to 1 and mix well;

[0038] 3. Add talcum powder to step 2, mix well; then press into tablets.

Embodiment 2

[0040] Ticagrelor Tablets (90mg specification)

[0041] components 1000 pieces Ticagrelor 93.76g lactose 53g partially pregelatinized starch 77.54g silica 7.46g Hypromellose 7.54g talcum powder 12g

[0042] Preparation method:

[0043] 4. Mix ticagrelor and silicon dioxide evenly;

[0044] 5. Add lactose, partially pregelatinized starch, and hydroxypropyl methylcellulose to 1 and mix well;

[0045] 6. Add talcum powder to step 2, mix well; then press into tablets.

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PUM

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Abstract

The invention relates to a solid preparation of ticagrelor or its pharmaceutically acceptable salt. Ticagrelor or its pharmaceutically acceptable salt is used as a main drug, lactose, partly pregelatinized starch, hydroxypropyl methyl cellulose, silica and talcum powder are used as auxiliary materials, and powder of the above materials are directly pressed to form a tablet.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a solid preparation of a novel anticoagulant drug ticagrelor or a pharmaceutically active salt thereof and a preparation method thereof. Background technique [0002] Ticagrelor (Brilinta) is a new type of small molecule anticoagulant drug developed by AstraZeneca. It was approved by the European Union in December 2010 and approved by the US FDA in July 2011. Clinical trials have confirmed that this drug, unlike the thienopyridine anticoagulant drugs ticagrelor and prasugrel, can reversibly act on the adenosine diphosphate (ADP) receptor subtype P2Y12, and has a significant effect on ADP-induced platelet aggregation. Inhibitory effect, and rapid onset of oral administration, can effectively improve the symptoms of patients with acute coronary syndrome (ACS), especially for patients who need coronary artery bypass grafting (CABG). [0003] Platelets play an important role in the process o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/20A61K31/519A61K47/38A61K47/04A61K47/36A61K47/26A61P7/02
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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