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Pharmaceutical preparation

A technology of pharmaceutical preparations and renin inhibitors, applied in the field of pharmaceutical preparations, can solve problems such as difficult to achieve therapeutic effects, and achieve useful therapeutic effects

Inactive Publication Date: 2012-01-11
HANALL PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0023] However, the pharmaceutical composition in the aforementioned international publication WO2003-097098 simply combines aliskiren, amlodipine, and hydrochlorothiazide as a diuretic, so it is a simple compound preparation that does not consider the characteristics and absorption principles of each drug. , it is difficult to achieve the superimposed therapeutic effect brought about by the combined administration of drugs with different therapeutic mechanisms

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0138] Example 1: Preparation of Aliskiren-Amlodipine Biphasic Matrix Tablets

[0139] Utilizing the composition and content in Table 1, biphasic matrix tablets were prepared according to the following method.

[0140] 1) Preparation of the prior release compartment containing Aliskiren

[0141] Aliskiren hemifumarate and microcrystalline cellulose (JRS, Vivapur.), lactose, corn starch, sodium starch glycolate (DMV, Primojel) as excipients were sieved with a No. 35 sieve, and a high-speed Mixer (Lab.Pharma Mixer P, Diosna, Germany) was used for mixing. Separately, a binding solution (5% W-W) was prepared by dissolving hydroxypropyl cellulose in water, and this binding solution was put into a high-speed mixer together with the main component mixture and kneaded. After the kneading was completed, granulation was performed using a shaker (Erweka, Germany) with a No. 18 sieve, and drying was performed at 60° C. using a hot water drier. After completion of the drying, the pre-...

Embodiment 2

[0146] Embodiment 2: Preparation of Aliskiren-Amlodipine Multilayer Tablet

[0147] Using the composition and content in Table 1, a multi-layer tablet was prepared according to the following method.

[0148] 1) Preparation of the prior release compartment containing Aliskiren

[0149] Aliskiren hemifumarate, microcrystalline cellulose, D-mannitol, and lactose as excipients were sieved with a No. 35 sieve, and mixed with a high-speed mixer. Separately, hydroxypropyl cellulose was dissolved in water to prepare a binding solution (5% W-W), and this binding solution was kneaded together with the main ingredient mixture. After the kneading was completed, granulation was performed using a shaker with a No. 18 sieve, and drying was performed at 60° C. using a hot water drier. Once drying is complete, sieve through a No. 20 sieve again. After mixing sodium starch glycolate and adding magnesium stearate to the sieved material, a double cone mixer was used for final mixing.

[015...

Embodiment 3

[0154] Embodiment 3: Preparation of Aliskiren-Amlodipine Capsules (Granules-Pellets)

[0155] Using the composition and content in Table 1, the capsules were prepared according to the following method.

[0156] 1) Preparation of the prior release compartment containing Aliskiren

[0157]Aliskiren hemifumarate, microcrystalline cellulose, and D-mannitol were sieved with a No. 35 sieve, and mixed with a high-speed mixer. Separately, hydroxypropyl cellulose was dissolved in water to prepare a binding solution (5% W-W), and this binding solution was kneaded together with the main ingredient mixture. After the kneading was completed, granulation was performed using a shaker with a No. 18 sieve, and drying was performed at 60° C. using a hot water drier. Once drying is complete, sieve through a No. 20 sieve again.

[0158] 2) Preparation of sustained-release compartments containing amlodipine

[0159] Amlodipine besylate, microcrystalline cellulose, and hydroxypropyl methylc...

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Abstract

The present invention relates to a pharmaceutical preparation comprising an immediate-release compartment containing a renin inhibitor as a pharmacologically active ingredient, and an extended-release compartment containing a dihydropyridine calcium channel blocker as a pharmacologically active ingredient. The pharmaceutical preparation of the present invention can avoid in vivo pharmacokinetic interaction between the renin inhibitor and the dihydropyridine calcium channel blocker, induces optimum pharmacological effects in accordance with the in vivo absorption performance of each of the active ingredients, and enables drugs to be released at the time period in which each of the active ingredients exhibits the pharmacological effects thereof, to thereby increase clinical effects, and can thus be valuably used in the prevention or treatment of metabolic syndrome, cardiovascular disease, and kidney disease.

Description

technical field [0001] The present invention relates to a pharmaceutical preparation comprising a prior-release compartment containing a renin inhibitor as a pharmacologically active ingredient, and a sustained-release compartment containing a dihydropyridine calcium channel blocker as a pharmacologically active ingredient, particularly as a The drug delivery system designed to control the release of drugs at a specific rate shows the most ideal effect when absorbed in the body. By formulating the combination of two drugs to improve the patient's drug compliance, it can also maximize the drug under external factors. Effect of pharmaceutical preparations. Background technique [0002] Hypertension is the disease with the highest incidence rate among chronic circulatory system diseases, and its incidence rate is on the rise recently. Moreover, hypertension has no external symptoms in patients with severe disease or less, but it may cause fatal complications such as stroke, he...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/165A61K31/44A61K47/48A61K47/38A61K47/30A61P3/00A61P9/00
CPCA61K31/165A61K31/44A61K9/209A61P3/00A61P9/00A61K9/20A61K47/50
Inventor 金圣旭田圣树具滋星金镇昱
Owner HANALL PHARMA CO LTD
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