Atenolol and amlodipine bilayer tablet

A double-layer tablet, amlodipine technology, applied in the field of medicine, can solve the problems of unqualified dissolution rate and uneven dissolution rate of active ingredients

Active Publication Date: 2014-05-07
CHINA RESOURCES DOUBLE CRANE PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inventors have further found that designing atenolol and amlodipine into a double-layer tablet will cause new problems, that is, uneven dissolution and / or unqualified dissolution of one or even two active ingredients The problem

Method used

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  • Atenolol and amlodipine bilayer tablet
  • Atenolol and amlodipine bilayer tablet
  • Atenolol and amlodipine bilayer tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Embodiment 1: Preparation of atenolol-amlodipine bilayer tablet

[0056] Plain Tablet Prescription:

[0057] (1) Atenolol layer:

[0058] atenolol

10mg,

Calcium hydrogen phosphate

50mg,

microcrystalline cellulose

7.5 mg,

Sodium Carboxymethyl Starch

2.5 mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.35 mg;

[0059] (2) Amlodipine layer:

[0060] Amlodipine

1mg (in bases),

Calcium hydrogen phosphate

50mg,

microcrystalline cellulose

7.5 mg,

Sodium Carboxymethyl Starch

0.75mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.35 mg.

[0061] Prescription of film coating solution (according to 1000ml):

[0062] Hydroxypropyl methylcellulose 20.0 g, Tween-808.0 g, talc 15.0 g, titanium dioxide 10.0 g, and the solvent is 50% ethanol.

[0063] Preparation Process:

[0064] Take the prescription amount of at...

Embodiment 2

[0065] Embodiment 2: Preparation of atenolol-amlodipine bilayer tablet

[0066] Plain Tablet Prescription:

[0067] (1) Atenolol layer:

[0068] atenolol

15mg,

Calcium hydrogen phosphate

40mg,

microcrystalline cellulose

10mg,

Sodium Carboxymethyl Starch

2mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.3mg;

[0069] (2) Amlodipine layer:

[0070] Amlodipine

2mg (based on base),

Calcium hydrogen phosphate

40mg,

microcrystalline cellulose

10 mg,

[0071] Sodium Carboxymethyl Starch

0.5mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.3 mg.

[0072] Preparation Process:

[0073] According to the above-listed formulation, tableting was carried out basically according to the preparation process of Example 1, and the prepared bilayer tablet was coated.

Embodiment 3

[0074] Embodiment 3: Preparation of atenolol-amlodipine bilayer tablet

[0075] Plain Tablet Prescription:

[0076] (1) Atenolol layer:

[0077] atenolol

5mg,

Calcium hydrogen phosphate

60mg,

microcrystalline cellulose

5mg,

Sodium Carboxymethyl Starch

3mg,

PVP K30

Appropriate amount,

Magnesium stearate

0.4mg;

[0078] (2) Amlodipine layer:

[0079] Amlodipine

1mg (in bases),

Calcium hydrogen phosphate

60mg,

microcrystalline cellulose

5 mg,

Sodium Carboxymethyl Starch

1.0mg,

PVP K30

Appropriate amount,

Magnesium stearate

0.4mg.

[0080] Preparation Process:

[0081] According to the above-listed prescription, the tableting is basically carried out according to the preparation process of Example 1.

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PUM

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Abstract

A bilayer tablet comprising atenolol and amlodipine is disclosed. The bilayer tablet comprises: a first layer which comprises atenolol as an active ingredient and pharmaceutically acceptable excipients, and a second layer which comprises amlodipine or its pharmaceutically acceptable salt as an active ingredient and pharmaceutically acceptable excipients. The bilayer tablet has good stability and good dissolution.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a double-layer tablet comprising atenolol and amlodipine, which has better stability and can be used for treating hypertension. Background technique [0002] Cardiovascular disease is one of the most important diseases that seriously affects human health. Hypertension is the most common cardiovascular disease and a major public health problem worldwide. Combination therapy for hypertension has the following advantages over single drug therapy: (1) it is easier to control blood pressure and reduce complications by using two drugs with different mechanisms of action; (2) the combination of two low-dose drugs can avoid side effects ; (3) Fixed low-dose compound preparations can improve compliance. [0003] Chinese Patent Application Publication CN1785185A (application number: 200410096834.3, publication date: June 14, 2006) discloses a novel compound antihypertensive preparation co...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4422
CPCA61K9/2086A61K31/4422A61K31/165A61K9/209A61P9/00A61P9/12
Inventor 吴翠栓黄晶晶邱彤吴曼林营亚萍吴涛
Owner CHINA RESOURCES DOUBLE CRANE PHARMA COMPANY
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