Composite preparation

A compound preparation and disintegrating agent technology, which is applied in the direction of pill delivery, drug combination, medical preparations of non-active ingredients, etc., can solve the problem that the compound preparation of clopidogrel and aspirin for cardiovascular diseases has not yet been developed

Active Publication Date: 2011-01-19
HANALL PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] Conventionally, the combination preparation of clopidogrel and aspirin, which is effective in the prevention and treatment of cardiovascular diseases, has not yet been developed

Method used

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Examples

Experimental program
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Effect test

preparation example 1

[0131] Preparation Example 1: Preparation of Aspirin-Containing Prior Release Compartment

[0132] According to the composition and content shown in Table 1 below, aspirin, microcrystalline cellulose (Avicel PH101, FMC Biopolymer, USA), pregelatinized starch (Starch 1500G, Colorcon, USA) and colloidal silicon dioxide (Aerosil 200, Degussa , Germany) were mixed in a double cone mixer for 20 minutes to prepare a mixture. Meanwhile, stearic acid (Whawon Pharm. Co. Ltd., South Korea) was sieved through a No. 35 sieve, and then mixed with the above mixture for 4 minutes to obtain aspirin-containing immediate-release granules. The granules were then compressed into tablets using a tablet press (MRC-30, Sejong Machinery Co., Ltd., South Korea). Meanwhile, hydroxypropylmethylcellulose (Shin-Etsu Chemical Co., Ltd., Japan), polyethylene glycol 400 (Duksan Pure Chemical Co., Ltd., South Korea), talc (Whawon Pharm.Co. Ltd., South Korea) and titanium oxide (Whawon Pharm. Co. Ltd., South...

preparation example 2

[0133] Preparation Example 2: Preparation of Aspirin-Containing Prior Release Compartment

[0134] According to the ingredients and contents shown in Table 1 below, aspirin, lactose (DMV, Germany), povidone granules (trade name: Ludipress, BASF, Germany), sodium bicarbonate (Duksan Pure Chemical Co., Ltd., South Korea) and citric acid (Duksan Pure Chemical Co., Ltd., South Korea) were mixed in a double cone mixer for 20 minutes. Meanwhile, stearic acid was sieved through a No. 35 sieve, and then mixed with the above mixture for 4 minutes to obtain aspirin-containing immediate-release granules. The granules were then compressed into tablets using a tablet press (MRC-30, Sejong Machinery Co., Ltd., South Korea). Meanwhile, hydroxypropylmethylcellulose (Shin-Etsu Chemical Co., Ltd., Japan), polyethylene glycol 400, talc, and titanium oxide were dissolved in an ethanol / methylene chloride mixture to prepare a coating solution. The compressed tablets were placed in a coating machi...

preparation example 3

[0135] Preparation Example 3: Preparation of Aspirin-Containing Prior Release Compartment

[0136] Aspirin, magnesium oxide, magnesium carbonate, calcium carbonate and pregelatinized starch were mixed in a double cone mixer for 20 minutes according to the ingredients and contents shown in Table 1 below. Meanwhile, stearic acid was sieved through a No. 35 sieve, and then mixed with the above mixture for 4 minutes to obtain aspirin-containing immediate-release granules. The granules were then compressed into tablets using a tablet press (MRC-30, Sejong Machinery Co., Ltd., South Korea). Meanwhile, hydroxypropylmethylcellulose, polyethylene glycol 400, talc, and titanium oxide were dissolved in an ethanol / dichloromethane mixture to prepare a coating solution. The compressed tablets were placed in a coating machine (SFC-30, Sejong Machinery Co., Ltd., South Korea), and the coating solution was sprayed thereon to prepare film-coated tablets.

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Abstract

The present invention provides a composite preparation which comprises: a prior-release section comprising aspirin or a pharmaceutically acceptable salt thereof as a pharmacologically active component; and a delayed-release section comprising clopidogrel, an isomer thereof or a pharmaceutically acceptable salt thereof as a pharmacologically active component. The composite preparation of the present invention exhibits a far better effect in preventing platelet aggregation than does simultaneous oral therapy or treatment with the respective single preparations, and not only can it improve the patient's drug-taking compliance by administration once a day but it can also reduce the adverse reactions which follow long-term administration of aspirin. The composite preparation of the present invention is also advantageous in that it exhibits an outstanding effect in inhibiting blood platelet aggregation despite a reduction in the amount of aspirin ingested, and in that it converts clopidogrel resistance into susceptibility and prevents serious adverse reactions caused by clopidogrel resistance and in that it can be stored over the longer term since it is stable under common storage conditions.

Description

technical field [0001] The invention relates to a compound preparation comprising clopidogrel and aspirin and a preparation method thereof. Background technique [0002] Intravascular thrombi, or embolisms, formed by platelet aggregation lead to cardiovascular disease. The term "cardiovascular disease (CVD)" refers to a class of diseases resulting from dysfunctional disorders of the heart and blood vessels. As we age, the heart muscle becomes weak, and foreign substances such as cholesterol and calcium accumulate in the coronary arteries, causing the arteries to narrow, thus making it difficult for blood to circulate smoothly. The diseases caused, including hyperlipidemia, stroke, myocardial infarction, arteriosclerosis, angina pectoris, etc. are called cardiovascular diseases. In addition, severe disease occurs, and in the rapidly increasing number of surgical patients for implantation of stents, there is a significant problem of reoperation due to the formation of thromb...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/00A61K9/20A61K9/22A61K47/00
CPCA61K9/2081A61K9/2866A61K31/60A61K9/2018A61K31/4365A61K9/2077A61K9/2027A61K9/2009A61K9/209A61K9/2059A61K9/5084A61K9/5078A61K9/2054A61K31/616A61K9/4808A61K9/2031A61P7/02A61P9/00A61K2300/00A61K9/48A61K9/28
Inventor 金圣旭田圣树曹英观具滋星宣相旭裴侦媛
Owner HANALL PHARMA CO LTD
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