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Felodipine pharmaceutical composition based on dry process granulation

A dry granulation technology for felodipine, which is applied in the pharmaceutical field to achieve the effects of reduced production energy consumption, enhanced quality control and cost savings, and a wide range of granulation process operations

Inactive Publication Date: 2012-05-23
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no relevant report on the dry granulation process of felodipine tablets

Method used

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  • Felodipine pharmaceutical composition based on dry process granulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation of 2.5mg Felodipine Tablets

[0034] components

[0035] Felodipine was micronized together with lactose monohydrate (premixed) and pulverized to an average particle size of 30 μm, d(0.9)=85.2 μm. Mix with other internally added materials lactose monohydrate and polyethylene glycol for 15 minutes, then add the internal lubricant glyceryl behenate and mix for 3 minutes. Dry granulation with a roller compactor. Add croscarmellose sodium and added lactose monohydrate and mix for 5 minutes, then add additional glyceryl behenate and mix for 3 minutes. Tablet to obtain the desired product.

Embodiment 2

[0037] Preparation of 2.5mg Felodipine Tablets

[0038] components

Prescription amount (mg / tablet)

percentage

Felodipine

2.5

1.25％

Lactose monohydrate (premixed)

20

10.0％

polyethylene glycol

8

4.0％

Lactose monohydrate (added)

78

39.0％

Microcrystalline Cellulose (Added)

20.3

10.15％

Glyceryl Behenate (Added)

1

0.50％

Lactose monohydrate (additional)

20

10.0％

Microcrystalline Cellulose (Extra)

40

20.0％

Croscarmellose sodium (additional)

10

5.0％

Glyceryl Behenate (additional)

0.2

0.10％

total

200

100％

[0039] Preparation Process:

[0040] Felodipine was micronized together with lactose monohydrate, and pulverized to an average particle size of 56 μm, d(0.9)=126.2 μm. Then mix with other internally added materials polyethylene glycol, microcrystalline ce...

Embodiment 3

[0041] Embodiment 3 (comparative example)

[0042] Adopt the same prescription as Example 1, but do not carry out micronization.

[0043] components

Prescription amount (mg / tablet)

percentage

Felodipine

2.5

1.25％

polyethylene glycol

10

5.0％

Lactose monohydrate (added)

90

45.0％

Lactose monohydrate (additional)

52.3

26.15％

Glyceryl Behenate (Added)

1

0.5％

Microcrystalline Cellulose (Extra)

40

20.0％

Croscarmellose sodium (additional)

4

2.0％

Glyceryl Behenate (additional)

0.2

0.1％

total

200

100％

[0044] Preparation Process:

[0045] The felodipine internal addition material lactose monohydrate and polyethylene glycol were mixed for 15 minutes, and then the internal lubricant glyceryl behenate was added and mixed for 3 minutes. Dry granulation with a roller compactor. Add additional lactose monoh...

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Abstract

The invention relates to a hypotensor felodipine pharmaceutical composition and a preparation method thereof. The composition comprises felodipine, a dispersing agent, a filling agent, a disintegrating agent, a solubilizing agent, a lubricant and a dry adhesive. The preparation method of the composition comprises the steps of: firstly, micronizing the felodipine with the dispersing agent, and then carrying out dry process granulation to prepare a felodipine pharmaceutical preparation. In the preparation method, the water and organic solvent are not used, the moist heat process and production energy consumption are reduced, and the quality control in the production process is facilitated. The felodipine pharmaceutical preparation prepared with the preparation method provided by the invention is uniform in content and good in dissolution rate.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a felodipine medicinal composition prepared by a dry granulation process and a preparation method thereof. Background technique [0002] Felodipine is a dihydropyridine calcium channel antagonist. Felodipine has strong vascular selectivity. Due to its high selectivity to small artery smooth muscle, it has no direct effect on myocardial contraction and cardiac conduction within the therapeutic dose range and does not cause orthostatic hypotension. It has a special protective effect on the kidney and has a good Tolerance, can be used in various types of hypertension. [0003] At present, the development of felodipine tablets is mainly based on wet granulation, which is related to the properties of felodipine itself. The daily routine use dose of felodipine is 5mg, takes twice, and 2.5mg is the main specification, and the proportion of the main drug in the preparation product is low, abou...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4422A61K47/26A61K47/32A61K47/34A61K47/36A61K47/38A61P9/12
Inventor 曹呈勇张荷丽
Owner YAOPHARMA CO LTD
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