Combined preparation for the treatment of cardiovascular diseases based on chronotherapy theory

A preparation, angiotensin technology, applied in the field of designed combined preparations, can solve the problems of various pathophysiological causes of uncomfortable hypertension, difficulty in preventing the deterioration of complications, and no consideration of drug characteristics, so as to improve medication compliance, reduce Excellent blood pressure effect and the effect of saving prescription time

Inactive Publication Date: 2009-09-09
韩诺生物制约株式会社
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] 2) A single active ingredient is not suitable for multiple pathophysiological reasons of hypertension
[0010] 3) A single active ingredient is only effective in less than 50% of patients
[0012] 5) In particular, by prescribing only a single pill, it is difficult to treat hypertension with complications such as diabetes, and it is even more difficult to prevent the exacerbation of complications
[0013] 6) When the dose is increased due to unsatisfactory single pill efficacy, side effects may increase
In addition, it is clear that the above technique is not inventive because it does not take into account the characteristics of the drug

Method used

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  • Combined preparation for the treatment of cardiovascular diseases based on chronotherapy theory
  • Combined preparation for the treatment of cardiovascular diseases based on chronotherapy theory
  • Combined preparation for the treatment of cardiovascular diseases based on chronotherapy theory

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0108] A. Preparation of Tablets

[0109] Tablets of uniform weight are prepared by mixing the granules prepared in the first step, optionally coated with a release-controlling material, with the granules prepared in the second step, followed by compression. The resulting tablets may require film coatings to improve stability or shape.

[0110] B. Preparation of Multilayer Tablets

[0111] The granules prepared in the first step are optionally coated with a controlled release material and dried. The dried granules are compressed with the granules prepared in the second step by using a multi-layer tablet press machine, thereby obtaining a bi-layer tablet. Optionally, a three-layer or more-layer tablet can also be prepared by further adding a release aid layer on the bi-layer tablet. A coated multilayer tablet can be prepared by coating said multilayer tablet.

[0112] C. Preparation of Core Tablets

[0113] The coated tablets or granules prepared in the first step are opti...

Embodiment 1

[0132] Embodiment 1: the preparation of single pill

[0133] (1) Preparation of Losartan Potassium Granules

[0134] Predetermined amounts of losartan potassium, lactose and microcrystalline cellulose as shown in Table 4 were sieved through a No. 35 sieve and mixed for 5 minutes with a double cone mixer. The mixture was placed in a fluidized bed granulator (GPCG 1: Glatt), sprayed with a binder solution (aqueous solution of hydroxypropylmethylcellulose) to prepare granules, and dried. The granules are added with Carbomer 71G powder, mixed with magnesium stearate using a double cone mixer. The resulting mixture was compressed with a rotary tablet press (MRC-33: Sejong) at a speed of 30 revolutions per minute to provide tablets having a hardness of 7-9 kp, a thickness of 3.0 mm, and a diameter of 5.5 mm.

[0135] Predetermined amounts of losartan potassium, lactose and microcrystalline cellulose as shown in Table 4 were sieved through a No. 35 sieve and mixed for 5 minutes wit...

Embodiment 2

[0143] As shown in Table 4, tablets were prepared as described in Example 1, except that instead of using cellulose acetate (32% of acetal groups), only cellulose acetate (32% of acetal groups), cellulose acetate (32% of acetal groups), group 39.8%) and hydroxypropyl methylcellulose.

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Abstract

The present invention relates to a functional combination preparation comprising a dihydropyridine-based calcium channel blocker such as amlodipine and an ARB (Angiotensin-2 receptor blocker) such as losartan. In particular, the present invention relates to a chronotherapeutical combination pharmaceutical formulations with controlled-release for the prevention or treatment of cardiovascular disease, which is formulated in accordance with xenobiotics and chronotherapy for enabling the two drugs to be chronotherapeutically released, thereby improving the therapeutic activity as compared to the co-administration of each drug in the form of a single pill, while reducing side effects and maintaining the therapeutic activity as high as possible at the time of day when the risk of a complication of cardiovascular disease is highest.

Description

【Technical field】 [0001] The present invention relates to a pharmaceutical combination formulation comprising a dihydropyridine-based calcium channel blocker such as amlodipine and an ARB (angiotensin-2 receptor blocker) losartan. In particular, the present invention relates to a timing therapy-designed combination formulation for the prevention and treatment of cardiovascular diseases, formulated on the basis of xenobiotics and timing therapy for the therapeutically timed release of both drugs, thereby To improve therapeutic activity compared to the co-administration of each drug in the form of a single tablet, while reducing side effects and maintaining the highest possible therapeutic activity during the period of the day when the risk of cardiovascular disease complications is highest. 【Background technique】 [0002] Although many antihypertensive drugs with excellent efficacy have been developed and prescribed recently, there is still a 50% rule for hypertension treatme...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/12A61K31/4184A61P9/12
CPCA61K9/2081A61K9/2866A61K9/2086A61K9/209A61K31/4178A61K45/06A61K31/4422A61K9/2077A61K9/2853A61K9/5084A61K31/4184A61P9/00A61P9/10A61P9/12A61P43/00A61K2300/00A61K9/20A61K31/00
Inventor 金圣旭田圣树曺英观具滋星宣相旭
Owner 韩诺生物制约株式会社
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