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A combination formulation comprising hmg-coa reductase inhibitor and calcium channel blocker

A composite preparation and composition technology, applied in the field of oral composite preparations, can solve problems such as poor stability, undisclosed amlodipine and rosuvastatin, etc., achieve improved stability, excellent stability and dissolution, and realize manufacturing simple craftsmanship

Active Publication Date: 2019-12-06
ALVOGEN KOREA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] On the other hand, Korean Laid-Open Patent Nos. 10-2006-0054495A and 10-2009-0048023 A disclose oral compound preparations containing conventional amlodipine besylate and atorvastatin calcium, but the The oral compound preparation of Pinghe rosuvastatin has not yet been disclosed
It has been confirmed that the physicochemical properties of rosuvastatin and atorvastatin are completely different. In the dosage forms described in the above-mentioned known patents, when only atorvastatin is replaced with rosuvastatin, the stability is very poor (experimental example 6 and 7)

Method used

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  • A combination formulation comprising hmg-coa reductase inhibitor and calcium channel blocker
  • A combination formulation comprising hmg-coa reductase inhibitor and calcium channel blocker
  • A combination formulation comprising hmg-coa reductase inhibitor and calcium channel blocker

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0056] Experimental Example 1: Interaction between Rosuvastatin Calcium and Amlodipine Besylate

[0057] In order to judge whether it is easy to develop a compound preparation of rosuvastatin calcium and amlodipine besylate, a compounding test in the case where the two raw materials exist alone and in which the two drugs are mixed is carried out.

[0058] Specifically, as a raw material for rosuvastatin calcium (R), a raw material for amlodipine besylate (A) was prepared. A complex in which each raw material, rosuvastatin calcium, and amlodipine besylate was mixed at a weight ratio of 1:1 was prepared (see Table 1 below).

[0059] 【Table 1】

[0060]

[0061]

[0062] (○: no change, ●: change)

experiment example 1-1

[0063] Experimental example 1-1. Confirmation of trait changes under severe conditions

[0064] Under severe conditions, changes in properties of each raw material and complex were confirmed. Specifically, the material was stored at a temperature of 60° C. for 4 weeks, and its properties at the initial stage, after 2 weeks, and after 4 weeks were confirmed.

[0065] Such as Figures 1a to 1c As shown, it was confirmed that amlodipine besylate did not change greatly in properties, but rosuvastatin calcium was solidified and turned yellow. On the other hand, in the case of a compound of two materials, hardening and discoloration were confirmed when cured.

experiment example 1-2

[0066] Experimental example 1-2. Confirmation of content changes of raw materials under severe conditions

[0067] Under severe conditions, changes in the raw material content of each raw material and complex were confirmed. Stored under the same conditions as in Experimental Example 1-1, the change in content was calculated in % by weight and described in Table 2 below.

[0068] 【Table 2】

[0069]

[0070]

[0071] (○: the content is reduced to less than 5%, ● the content is reduced to more than 5%)

[0072] As mentioned above, in the case of amlodipine besylate, no decrease in the level occurred, whereas in the case of rosuvastatin, the level decreased by about 2% at 2 and 4 weeks. On the one hand, in the case of the complex of the two materials, the content of rosuvastatin was reduced by 28% by weight and that of amlodipine by 17% by weight at week 4. From the results, it can be seen that when rosuvastatin calcium and amlodipine contact each other, they have the prop...

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Abstract

The present invention relates to an oral combination formulation comprising a first composition comprising amlodipine or a pharmaceutically acceptable salt thereof, a disintegrant, and a sugar alcohol; and a second composition comprising rosuvastatin or a pharmaceutically acceptable salt thereof, and a stabilizer, and a preparation method thereof.

Description

technical field [0001] The present invention relates to an oral compound preparation comprising a first composition and a second composition and a preparation method thereof, wherein the first composition comprises amlodipine or a pharmaceutically acceptable salt thereof, a disintegrating agent, As well as sugar alcohol, the second composition comprises rosuvastatin or a pharmaceutically acceptable salt thereof and a stabilizer. Background technique [0002] Hypertension is the most common cardiovascular disease. When blood pressure continues to rise, it will damage the kidneys, heart and cerebrovascular, leading to an increase in the incidence of renal failure, coronary artery disease, heart failure, and stroke. Hypertension is divided into primary hypertension and secondary hypertension. Essential hypertension refers to the situation of unknown etiology, that is, high blood pressure without a specific pathogenic cause. Most people with high blood pressure (about 95%) fal...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/28A61K31/4422A61K31/505
CPCA61K9/0053A61K9/2009A61K9/2018A61K9/2059A61K9/2077A61K9/209A61K9/5084A61K31/4422A61K31/505A61P3/06A61P9/12A61K2300/00A61K9/2833
Inventor 李施范河松栮洪惠淑李允静
Owner ALVOGEN KOREA
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