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Composite preparation containing clopidogrel and aspirin

A technology of clopidogrel tablets and compound preparations, which is applied in the direction of medical preparations containing active ingredients, pill delivery, organic active ingredients, etc., and can solve the problems of reduced disintegration rate and reduced stability

Pending Publication Date: 2018-12-21
KOREA UNITED PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In this case, in order to solve the problems of preparations containing clopidogrel, that is, their stability decreases during their storage and distribution and the rate of disintegration decreases when the preparations of clopidogrel are tablets, the present invention The inventors have accomplished the present invention as described below

Method used

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  • Composite preparation containing clopidogrel and aspirin
  • Composite preparation containing clopidogrel and aspirin
  • Composite preparation containing clopidogrel and aspirin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Tablets were prepared according to the ingredients and contents shown in Table 2 below. Clopidogrel bisulfate and colloidal silica were mixed first, and the mixture was further mixed with PEG 6000, Mannitol 300DC, MCC 102 and L-HPC. Then, add glidants (ie talc and ) and tablet. Each content shown in Table 2 represents the amount per tablet. In particular, the tablets of Example 1 showed no sticking or capping during compression, unlike those prepared in Comparative Examples 1 and 2 (further mixing colloidal silica and using MCC 102). different. The contents of the above ingredients are shown in Table 2 below.

[0087] [Table 2]

[0088]

[0089]

Embodiment 2 to 7

[0091] To further improve sticking and capping phenomena during tableting, MCC112 with low dry weight loss (1.5 wt%) was used. After mixing clopidogrel bisulfate and colloidal silica, the mixture was further mixed with PEG6000, Mannitol 300DC, MCC112, L-HPC, CL-PVP and PVP K-30. Then, add glidant to it And tablet. The content of each ingredient is shown in Table 3 below. Each content shown in Table 3 represents the amount per tablet.

[0092] [table 3]

[0093]

Embodiment 8-10 and comparative example 3-6

[0095] In order to examine the influence of colloidal silica on formulations containing disintegrants, tablets having the compositions shown in Table 4 below were prepared by mainly changing the concentration of colloidal silica in Examples 2-7.

[0096] [Table 4]

[0097]

[0098] Experimental example 1. Disintegration test in Examples 2 to 7

[0099] Disintegration tests were performed on the tablets prepared in Examples 2-7. The disintegration test was performed according to the disintegration test method of the Korean Pharmacopoeia (test solution: water). The results are shown in Table 5 below, and Plavix Used as a control group. It was shown that the disintegration time in Examples 2 to 7 was within 11 minutes, thus showing a decrease compared to the control group. In Examples 2 to 7, tableting could be performed without tableting problems.

[0100] [table 5]

[0101]

[0102] Experimental Example 2. Disintegration tests in Examples 8 to 10 and Comparative Ex...

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PUM

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Abstract

The present invention relates to a composite preparation containing clopidogrel and aspirin and to a method for preparing the same, wherein the composite preparation has stability maintained even during storage and distribution and shows a fast clopidogrel tablet disintegration rate.

Description

technical field [0001] The invention relates to a compound preparation containing clopidogrel and aspirin and a preparation method thereof. Background technique [0002] In the present invention, clopidogrel is a platelet aggregation inhibitor, which can effectively treat peripheral and coronary artery diseases (such as stroke, thrombosis, embolism, myocardial infarction, etc.), and its chemical name is (+)-(S)- α-(2-Chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetic acid methyl ester. [0003] Clopidogrel directly inhibits the binding of adenosine diphosphate (hereinafter referred to as "ADP"), which is known to play an important role in thrombosis, to its receptor and inhibits the subsequent ADP-mediated activation of the glycoprotein GPIIb / IIa complex, thereby Specifically inhibits ADP-induced platelet aggregation. Furthermore, clopidogrel inhibits platelet aggregation induced by agonists other than ADP by blocking the expansion of platelet activation. [0004...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/20A61K9/48A61K31/4365A61K31/60
CPCA61K9/20A61K9/28A61K9/48A61K31/4365A61K31/60A61K9/2054A61K9/282A61K9/2833A61K9/4808A61K9/4816
Inventor 崔然雄河大喆宋熙用权仁浩郑来勋梁承珍柳权熙魏泰寅
Owner KOREA UNITED PHARMA
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