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Pharmaceutical complex formulation comprising amlodipine, losartan and rosuvastatin

A technology of rosuvastatin and compound preparations, which is applied in the field of drug compound preparations containing amlodipine, losartan and rosuvastatin, can solve problems such as difficulty in commercialization, deterioration of solubility and stability, and achieve Prevention or treatment of cardiovascular diseases, the effect of excellent dissolution rate

Pending Publication Date: 2021-06-11
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been difficult to commercialize this formulation due to the complexity of its formulation design and the potential for deterioration of solubility and stability due to interactions between the active ingredients

Method used

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  • Pharmaceutical complex formulation comprising amlodipine, losartan and rosuvastatin
  • Pharmaceutical complex formulation comprising amlodipine, losartan and rosuvastatin
  • Pharmaceutical complex formulation comprising amlodipine, losartan and rosuvastatin

Examples

Experimental program
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preparation example Construction

[0051] In addition, the present invention provides a method for preparing a drug compound preparation for preventing or treating cardiovascular diseases, the method comprising the steps of: a) mixing amlodipine or a pharmaceutically acceptable salt thereof, rosuvastatin or a pharmaceutically acceptable salt and a pharmaceutically acceptable additive are mixed; and b) losartan or a pharmaceutically acceptable salt thereof is mixed with a pharmaceutically acceptable additive, wherein said rosuvastatin or its The particle size of the pharmaceutically acceptable salt (D 90 ) is 50 μm or less.

[0052] The method further comprises the step of mixing the part of the mixture comprising amlodipine, rosuvastatin and the part of the mixture comprising losartan, wherein the two parts are physically separated from each other.

[0053] In one embodiment, the present invention provides a method for preparing a double-layer tablet for preventing or treating cardiovascular diseases, the meth...

Embodiment 1

[0056] Example 1: Preparation of a pharmaceutical composition containing micronized rosuvastatin

[0057] Rosuvastatin calcium powder was pulverized by a jet mill to prepare a particle size of 22.5 μm (D 90) of micronized rosuvastatin calcium. According to the components shown in Table 1 below, mix amlodipine camphorsulfonate, micronized rosuvastatin calcium, lactose hydrate, microcrystalline cellulose, and crospovidone, pass through a 30-mesh sieve, and add hard Magnesium fatty acid is finally mixed with a mixer to obtain a mixture part containing amlodipine and rosuvastatin.

[0058] At the same time, the losartan potassium, microcrystalline cellulose, and crospovidone were mixed and passed through a 30-mesh sieve. Then, the sieved flour is compacted with a roller compactor (roller compactor wp200, alexanderwerk) with a compacting force of at least 20 kN at a roller speed of 2 to 10 rpm to form sheet-like granules. The obtained granules were pulverized with a pulverizer (...

Embodiment 2 and 3 and comparative Embodiment 1 to 3

[0063] Examples 2 and 3 and Comparative Examples 1 to 3: Preparation of Pharmaceutical Compositions Containing Rosuvastatin of Different Particle Sizes

[0064] As shown in Table 2 below, the steps of Example 1 were repeated using rosuvastatin with different particle sizes to obtain a composite bilayer tablet.

[0065] Table 2

[0066]

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Abstract

Disclosed are a pharmaceutical composition for preventing or treating a cardiovascular disorder comprising amlodipine, rosuvastatin and losartan, and a pharmaceutical complex formulation comprising afirst mixture part containing amlodipine and rosuvastatin and a second mixture part containing losartan. The composition and complex formulation comprise rosuvastatin having a particle size (D90) of 50 mum or less, and exhibit excellent dissolution rate, bioavailability, stability and content uniformity, and thus can be useful in pharmaceutical industries.

Description

[0001] This application is a divisional application of the following original application: [0002] --The filing date of the original application: June 29, 2016 [0003] --Application number of the original application: 201680031203.4 [0004] --The invention-creation name of the original application: drug compound preparation containing amlodipine, losartan and rosuvastatin technical field [0005] The present invention relates to an oral pharmaceutical composition and compound preparation containing amlodipine, losartan and rosuvastatin, which exhibit improved dissolution rate, stability and bioavailability. Background technique [0006] About 90 to 95% of high blood pressure cases are classified as essential hypertension, the cause of which is unknown. Risk factors associated with high blood pressure include psychological and environmental factors such as alcohol consumption, smoking, aging, lack of exercise, obesity, excess salt in the diet, and stress. In addition, w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/505A61K31/4422A61K31/4178A61K9/24A61K47/36A61K47/38A61K47/32A61K47/26A61P9/00A61P9/12A61P3/06
CPCA61K9/2018A61K9/2027A61K9/2054A61K9/2059A61K9/209A61K31/4178A61K31/4422A61K31/505A61P9/00A61P9/12A61P3/06A61K2300/00A61K47/38A61K9/20A61K31/44A61K9/2086A61K47/26
Inventor 金用镒林昊泽曺赫俊尹英洙朴宰贤禹钟守
Owner HANMI PHARMA