Compositions comrrising amlodipine and bisoprolol

A kind of technology of amlodipine base and amlodipine besylate, applied in the field of solid pharmaceutical compositions

Active Publication Date: 2011-08-24
EGIS GYOGYSZERGYAR NYILVANOSAN MUKODO RESZVENYTARSASAG (EGIS PHARMA PLC)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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  • Compositions comrrising amlodipine and bisoprolol
  • Compositions comrrising amlodipine and bisoprolol
  • Compositions comrrising amlodipine and bisoprolol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] Composition of 1000 tablets:

[0104]

[0105] method:

[0106] The two active ingredients were sieved through a 250 μm sieve and then homogenized with microcrystalline cellulose, sodium starch glycolate and colloidal silicon dioxide in a drum mixer for 10 minutes. Magnesium stearate was then added to the mixture and the resulting mixture was further homogenized for 2 minutes.

[0107] The homogenate was compressed into tablets having a weight of 305 mg using a tablet machine.

[0108] Tablets were packed into cold-formed OPA / AL / PVC composite foil blisters with a thickness of 130 μm and covered with aluminum foil with a thickness of 20 μm.

[0109] Tablets prepared according to Example 1 were checked for contaminants on the day of manufacture and after storage for 3 months at 40°C / 75% relative humidity as follows:

[0110]

[0111] Further quality data of the product of Example 1 are as follows:

[0112]

Embodiment 2

[0114] Composition of 1000 capsules:

[0115]

[0116] method:

[0117] The two active ingredients were sieved through a 250 μm sieve and then homogenized with microcrystalline cellulose, sodium starch glycolate and colloidal silicon dioxide in a drum mixer for 10 minutes. Magnesium stearate was then added to the powder mixture and the resulting mixture was homogenized for a further 2 minutes.

[0118] The homogenate is filled into capsules with a 47 mg filling using a tablet press.

[0119] Capsules were packed into cold-formed OPA / AL / PVC composite foil blisters with a thickness of 130 μm and covered with aluminum foil with a thickness of 20 μm.

[0120] On the day of production and after storage for 3 months at 40° C. / 75% relative humidity, the results of the contaminant inspection of the capsules prepared and packaged according to Example 2 were as follows:

[0121]

[0122] Reference example:

[0123] Composition of 1000 tablets:

[0124]

[0125] method:

...

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PUM

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Abstract

Stable solid pharmaceutical composition containing amlodipine or pharmaceutical acceptable salts thereof and bisoprolol or pharmaceutical acceptable salts thereof as well as pharmaceutically accepted excipients, packaged in a damp- proof package and further comprising less than 0.5 % of the compound of the formula (3) based on the weight of the active ingredients.

Description

technical field [0001] The present invention relates to a stable solid pharmaceutical composition containing amlodipine and bisoprolol of the formula as active ingredients [0002] [0003] More particularly, the present invention relates to a composition packed in a moisture-proof package, which contains amlodipine base or a pharmaceutically acceptable salt thereof, preferably amlodipine besylate and pesofumarate of the formula Lol [0004] [0005] Further contain fillers, disintegrants, lubricants and anti-adhesion agents (anti-adhesion agent) used in the pharmaceutical industry, in addition, wherein the compound N-(2-{[4 -(2-Chlorophenyl)-3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6-methyl-1,4-dihydro-2-pyridyl]-methoxy}-ethyl )-aspartic acid in an amount not exceeding 0.5% [0006] Background technique [0007] According to "evidence-based" therapeutic practice, blood pressure values ​​required to reduce the risk of cardiovascular morbidity and mortality can be ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/138A61K31/4422
CPCA61K9/2013A61K9/4866A61K31/138A61K9/2027A61K9/2059A61K9/2054A61K31/4422A61K9/20A61K9/48A61P9/00A61P9/08A61P9/12A61K2300/00A61K31/44A61K31/422A61K9/2095
Inventor L·瓦格尼尔Z·兹格蒙德G·尤法陆斯M·莱文蒂萨尼胡萨尔P·统卡-那吉E·巴克孜L·格拉E·泽拉克基A·弗洛普
Owner EGIS GYOGYSZERGYAR NYILVANOSAN MUKODO RESZVENYTARSASAG (EGIS PHARMA PLC)
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