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Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof

A technology of lercanidipine hydrochloride and lercadipine hydrochloride, applied in medical preparations containing active ingredients, pill delivery, drug combination, etc., can solve side effects and other problems, achieve the effect of reducing side effects and increasing dissolution rate

Active Publication Date: 2013-08-14
LG CHEM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, excessively increased doses may cause side effects

Method used

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  • Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof
  • Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof
  • Complex formulation comprising lercanidipine hydrochloride and valsartan and method for the preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0053] Examples 1-4: Preparation of isolated particles

[0054] [Table 1]

[0055]

[0056] The lercanidipine hydrochloride granules and valsartan granules having the above composition were wet granulated with distilled water, dried and ground into 25 meshes. The two granules are mixed and compressed into a composite tablet, which is then film-coated. Selling Colorcon as PVP II was used as a film coating material, and film coating was performed in the same manner in all of the following Examples and Comparative Examples. The mixture was mixed for 5 minutes or longer to fully wet the super-integrating agent added during wet granulation. Such intensive mixing time increases the porosity of the granules, aids disintegration time to prevent gelling. In the examples below, wet granulation was performed as described above.

Embodiment 5-8

[0057] Embodiment 5-8: Preparation of composite bilayer tablet

[0058] [Table 2]

[0059]

[0060] The lercanidipine hydrochloride granules and valsartan granules having the above composition were wet granulated with distilled water, dried and ground into 25 meshes. The two sets of granules were compressed into a bilayer solid form, whereby the bilayer solid form was film coated.

Embodiment 9-12

[0061] Embodiment 9-12: Preparation of composite three-layer tablet

[0062] [table 3]

[0063]

[0064] The lercanidipine hydrochloride granules and valsartan granules having the above composition were wet granulated with distilled water, dried and ground into 25 meshes. Valsartan granules were added to make the first tablet portion, a barrier layer was added to make the second tablet portion, and lercanidipine hydrochloride granules were added to make the third tablet portion. Composite three-layer tablets are obtained and film-coated.

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PUM

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Abstract

The present invention relates to a pharmaceutical composition comprising lercanidipine hydrochloride and valsartan as active components and a method for the preparation thereof. The pharmaceutical composition comprising lercanidipine hydrochloride and valsartan according to the present invention has a superior effect on the prevention and treatment of cardiovascular diseases and their complex diseases, and reduces the adverse effects of each component. In addition, the present composition comprises lercanidipine hydrochloride and valsartan in a separated form so as to increase the dissolution rates of both components and reduce the adverse effects.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing lercanidipine hydrochloride and valsartan as active components and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases. Persistent high blood pressure damages blood vessels in the kidneys, heart, and brain, which increases the incidence of kidney failure, coronary heart disease, heart failure, and stroke. Hypertension is divided into two types, i.e. essential or primary hypertension and secondary hypertension. The cause of essential hypertension is unknown and occurs without a specific underlying condition. Most (95%) hypertensive patients, especially those over 40 years old, belong to this type. Although no cause of essential hypertension has been found because there is no underlying disease, the problem may lie in genetics, a diet that consumes salty foods, obesity, advanced age, stress, and alcohol and tobacco us...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/41A61K9/16A61P9/00
CPCA61K9/1635A61K9/1652A61K9/2054A61K31/4422A61K31/41A61K9/2027A61K9/209A61K9/2095A61K9/5084A61P9/00A61P9/12A61K2300/00A61K9/16
Inventor 丁荣识朴秀娥金利宣金成一全宰贤金烔煃金由璘朴熙东朴圣在李承学金周铉郑珉英
Owner LG CHEM LTD
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