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Pharmaceutical preparation

A technology for pharmaceutical preparations and renin inhibitors, applied in the field of pharmaceutical preparations, can solve the problems of not considering drug characteristics and absorption principles, and achieve the effect of improving the problem of simultaneous administration and effective curative effect

Inactive Publication Date: 2011-04-13
HANALL PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned inventions about combination therapy are based on a simple combination of drugs, therefore, they are only simple compound preparations, without considering the characteristics and absorption principles of individual drugs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0143] Example 1: Preparation of Aliskiren-atorvastatin biphasic matrix tablet

[0144] According to the ingredient composition and content shown in Table 1 below, the preparation was carried out as follows.

[0145] 1) Preparation of Aliskiren sustained-release granules

[0146] Aliskiren hemifumarate, microcrystalline cellulose, crospovidone and sodium chloride were sieved through a No. 35 sieve and mixed in a high speed mixer for 5 minutes to prepare a mixture. Meanwhile, polyvinylpyrrolidone was dissolved in purified water to prepare a binding solution, followed by kneading, granulation, and drying. Place the dried material in a fluid bed coater. Meanwhile, cellulose acetate (acetyl 32%), cellulose acetate (acetyl 39.8%), and hydroxypropylmethylcellulose were dissolved and dispersed in 220 mg of ethanol and 980 mg of dichloromethane to prepare a coating solution , which was then coated on the granules in a fluidized bed coater (GPCG-1: Glatt, Germany) to prepare ali...

Embodiment 2

[0151] Embodiment 2: Preparation of Aliskiren-simvastatin biphasic matrix tablet

[0152] According to the ingredient composition and content shown in Table 1 below, the preparation was carried out as follows.

[0153] 1) Preparation of Aliskiren sustained-release granules

[0154] Aliskiren hemifumarate and microcrystalline cellulose were sieved through a No. 35 sieve and mixed in a high-speed mixer for 5 minutes to prepare a mixture. Meanwhile, polyvinylpyrrolidone was dissolved in purified water to prepare a binding solution, which was then kneaded, granulated, and dried. Place the dried material in a fluid bed coater. At the same time, add and then, dissolve and disperse hydroxypropyl methylcellulose phthalate and hydroxypropyl methylcellulose in 220 mg of ethanol and 980 mg of dichloromethane to prepare a coating solution, and then the coating The solution was coated on the granules in a fluidized bed coater (GPCG-1: Glatt, Germany) to prepare aliskiren hemifumarate ...

Embodiment 3

[0159] Example 3: Preparation of Aliskiren-fluvastatin biphasic matrix tablet

[0160] According to the ingredient composition and content shown in Table 1 below, the preparation was carried out as follows.

[0161] 1) Preparation of Aliskiren sustained-release granules

[0162] Aliskiren hemifumarate and microcrystalline cellulose were sieved through a No. 35 sieve and mixed in a high speed mixer for 5 minutes to prepare a mixture. Meanwhile, polyvinylpyrrolidone was dissolved in purified water to prepare a binding solution, followed by kneading granulation and drying. Place the dried material in a fluid bed coater. Meanwhile, Kollicoat SR 30D was dissolved and dispersed in 220 mg of ethanol and 980 mg of dichloromethane to prepare a coating solution, which was then coated in a fluidized bed coater (GPCG-1: Glatt, Germany). Granules to prepare aliskiren hemifumarate sustained-release granules.

[0163] 2) Preparation of fluvastatin prior-release granules

[0164] F...

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Abstract

Disclosed is a pharmaceutical preparation including a compartment containing a renin inhibitor as a pharmacologically active component, and a compartment containing HMG-CoA reductase inhibitor as a pharmacologically active component, wherein one of compartments is an advance release compartment and the other of the compartments is a retard release compartment. The combination preparation of the present invention delivers the renin inhibitor and HMG-CoA reductase inhibitor with a time difference at a specific speed, reducing undesirable side-effects, improving the potentiating effect and allowing for ease in teaching dosing regimens and enhanced patient compliance. Further, the pharmaceutical preparation of the present invention has pharmacological, clinical, scientific and economical advantages in the prevention or treatment of metabolic syndrome, cardiovascular disease, renal disease and the like as compared with the complex drug regimens in which medicament ingredients are taken individually or simultaneously.

Description

technical field [0001] The present invention relates to a pharmaceutical formulation comprising a renin inhibitor and a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor. Background technique [0002] Hyperlipidemia, or elevated serum lipid levels, is associated with an increased incidence of cardiovascular disease and atherosclerosis. Examples of hyperlipidemia include hypercholesterolemia, familial blood beta lipoproteinemia, diabetic dyslipidemia, nephrotic dyslipidemia, and familial complex hyperlipidemia. Hypercholesterolemia is characterized by elevated levels of low-density lipoprotein (LDL)-cholesterol and total cholesterol in serum, and lowering serum lipid levels (especially LDL-cholesterol) can reduce the risk of cardiovascular disease and delay Progression or deterioration of arteriosclerosis (American Diabetes Association, Diabetic Care, 23 (supple.), S57-S65, 2000). [0003] That is, hypercholesterolemia and hyperlipidemia are involved in th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/22A61K9/00A61K31/165A61K31/41A61K47/00
CPCA61K31/165A61K31/41A61K9/0004A61K9/209A61P3/06A61P9/00A61K9/48A61K31/40
Inventor 金圣旭田圣树曹英观具滋星孙载云金镇昱
Owner HANALL PHARMA CO LTD
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