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Solid preparation containing amlodipine and valsartan

A solid preparation, amlodipine technology, applied in the field of pharmacy, can solve the problems of low drug loading, complex preparation process, low bioavailability of insoluble drugs, etc.

Inactive Publication Date: 2012-09-19
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] For how to improve the dissolution of poorly soluble drugs, researchers in the field of pharmacy have been seeking various technologies to improve the solubility of drugs. However, these technologies include the synthesis of water-soluble prodrugs, the use of cyclodextrin inclusion technology, surface active Agent solubilization, solid dispersion technology, microemulsions, polymer nanoparticles, lipid systems and nanosuspensions can solve the low bioavailability problems of some insoluble drugs, all of which have low drug loading, poor stability and The complex preparation process and other problems are not suitable for large-scale industrial production

Method used

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  • Solid preparation containing amlodipine and valsartan
  • Solid preparation containing amlodipine and valsartan
  • Solid preparation containing amlodipine and valsartan

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Experimental program
Comparison scheme
Effect test

Embodiment １

[0035] Material name Weight ratio (%) Amlodipine besylate (average particle size: 10μm) 1.99 Valsartan (average particle size: 60μm) 46.11 Microcrystalline Cellulose 101 (Filler) 24.50 Croscarmellose (disintegrant) 2.88 Hypromellose (binder) 2.31 Microcrystalline Cellulose 102 (disintegrant) 15.29 Magnesium Stearate (Lubricant) 1.18 Micropowder silica gel (glidant) 0.86

[0036] Table 1

[0037] Method: Amlodipine besylate and valsartan were pulverized through a 120-mesh sieve, and the corresponding prescription amounts of microcrystalline cellulose 101, hypromellose and croscarmellose were mixed evenly, and then mixed with 5% hypromellose Soft material made of cellulose aqueous solution, pass through 18 mesh sieve, control drying temperature at 50°C, granule moisture within 3.0%, granulate with 24 mesh sieve, weigh, add microcrystalline cellulose 102, micropowder silica gel and stearin in proportion Magnesium aci...

Embodiment 2

[0043] Material name Weight ratio (%) Amlodipine besylate (average particle size: 5μm) 1.99 Valsartan (average particle size: 55μm) 46.11 Microcrystalline Cellulose 101 (Filler) 28.38 Croscarmellose (disintegrant) 2.88 Hypromellose (binder) 3.31 Crospovidone K30 (disintegrant) 15.29 Magnesium Stearate (Lubricant) 1.18 Micropowder silica gel (glidant) 0.86

[0044] table 3

[0045] Method: Amlodipine besylate and valsartan were crushed through a 120-mesh sieve, and the corresponding prescription amount of microcrystalline cellulose 101 and croscarmellose were mixed evenly, and the soft material was made with 5% hypromellose aqueous solution. , through a 18-mesh sieve, control the drying temperature at 50°C, and keep the moisture content of the granules within 3.0%, sieve the granules with a 24-mesh sieve, weigh them, add microcrystalline cellulose 102, micronized silica gel and magnesium stearate in proportion, and ...

Embodiment 3

[0051] Material name Weight ratio (%) Amlodipine besylate (average particle size: 20μm) 1.99 Valsartan (average particle size: 10μm) 46.11 Microcrystalline Cellulose 101 (Filler) 24.50 Croscarmellose (disintegrant) 2.88 Hypromellose (binder) 2.31 Microcrystalline Cellulose 102 (disintegrant) 15.29 Magnesium Stearate (Lubricant) 1.18 Micropowder silica gel (glidant) 0.86

[0052] table 5

[0053] Method: Amlodipine besylate and valsartan were pulverized through a 120-mesh sieve, and the corresponding prescription amounts of microcrystalline cellulose 101, hypromellose and croscarmellose were mixed evenly, and then mixed with 5% hypromellose Soft material made of cellulose aqueous solution, pass through 18 mesh sieve, control drying temperature at 50°C, granule moisture within 3.0%, granulate with 24 mesh sieve, weigh, add microcrystalline cellulose 102, micropowder silica gel and stearin in proportion Magnesium aci...

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Abstract

The invention provides a solid preparation containing amlodipine and valsartan, which is used as a therapeutic drug for hypertension and the like. The amlodipine and the valsartan are within a certain particle diameter ratio range. Thus, the solid preparation containing amlodipine and valsartan has excellent content uniformity, leaching property, hardness and the like.

Description

technical field [0001] The invention relates to a solid preparation containing amlodipine and valsartan antihypertensive drugs, belonging to the technical field of pharmacy. Background technique [0002] Novartis Pharmaceuticals developed the combined application of amlodipine and valsartan (trade name Exforge?), which exerted a synergistic antihypertensive effect from different perspectives and mechanisms, significantly lowering blood pressure and better protecting target organs; it is beneficial to both patients There are multiple risk factors and coexisting diseases; the combined drug can reduce the dose of a single drug, so that the side effects or adverse reactions related to the dose can be significantly reduced; the fixed compound preparation simplifies the treatment, and once a day is administered, which can improve the patient's compliance and Quality of Life. [0003] Both amlodipine and valsartan are hydrophobic drugs, and valsartan is almost insoluble in water. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/41A61K9/28A61K9/16A61P9/12
Inventor 胡畔盼郭夏宋雪梅
Owner BEIJING D VENTUREPHARM TECH DEV
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