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Pharmaceutical composition containing fimasartan and hydrochlorothiazide

A technology of Fimasartan and Hydrochlorothiazide, which is applied in the field of pharmaceutical compositions containing Fimasartan and Hydrochlorothiazide, can solve problems such as difficulty in achieving uniform mixing and preparation of granules, and achieve prevention or treatment of cardiovascular diseases and excellent physical properties , the effect of high content uniformity

Inactive Publication Date: 2019-11-26
BORYUNG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to its agglomerating nature, it is very difficult to achieve homogeneous mixing when mixing Fimasartan in a high shear mixer
In addition, the mixing ratio of fimasartan and hydrochlorothiazide differs by more than 10 times, so it is very difficult to prepare granules in which the content of the two main components is uniform

Method used

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  • Pharmaceutical composition containing fimasartan and hydrochlorothiazide
  • Pharmaceutical composition containing fimasartan and hydrochlorothiazide
  • Pharmaceutical composition containing fimasartan and hydrochlorothiazide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Tablets comprising Fimasartan Potassium Trihydrate and Hydrochlorothiazide were prepared using the ingredients and contents shown in Table 1 below. 132.02 mg of Fimasartan potassium trihydrate, 12.50 mg of hydrochlorothiazide, 112.48 mg of lactose hydrate, 23.50 mg of microcrystalline cellulose and 22.50 mg of croscarmellose sodium were mixed with a stirrer at 100 rpm and with a chopper (chopper) was stirred at 200 rpm for 2 minutes (high shear mixer SM-5C, Sejong Pharmatech) to prepare a mixture. A binding solution prepared by dissolving 2.00 mg of low-viscosity hydroxypropylcellulose (Klucel-ELF / Ashland) in 24.0 mg of ethanol and 22.0 mg of purified water was added to the mixture, and the mixture was stirred at 200 rpm with a cutter The grinder was stirred at 2000 rpm for 2 minutes (high shear mixer SM-5C, Sejong Pharmatech) to prepare white granules. The granules were dried at 40° C. for 10 hours, and sieved with a 30-mesh sieve to prepare a sieved material. Then, ...

Embodiment 2

[0048] A tablet comprising fimasartan potassium trihydrate and hydrochlorothiazide was prepared by substantially the same method as in Example 1, except that the ingredients and contents shown in Example 2 of Table 1 below were used.

Embodiment 3

[0050] A tablet comprising fimasartan potassium trihydrate and hydrochlorothiazide was prepared by substantially the same method as in Example 1, except that the ingredients and contents shown in Example 3 of Table 1 below were used.

[0051] [Table 1]

[0052]

[0053]

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Abstract

The present invention provides: a pharmaceutical composition having a superior physical property since fimasartan and hydrochlorothiazide, which are main components of a composite, have superior content uniformity; and a preparation method thereof.

Description

[0001] This application is a divisional application of the Chinese patent application No. 201380040573.0 with the application date of April 30, 2013, entitled "Pharmaceutical Composition Containing Fimasartan and Hydrochlorothiazide". technical field [0002] The present invention relates to a pharmaceutical composition comprising fimasartan and hydrochlorothiazide, more particularly, to a pharmaceutical composition comprising angiotensin II receptor antagonist fimasartan and a diuretic hydrochlorothiazide. Background technique [0003] Fimasartan is known as an angiotensin II receptor antagonist developed for the treatment of hypertension and other medical indications (Korean Patent No. 10-1058284). Fimasartan is chemically defined as 2-n-butyl-5-dimethylaminothiocarbonylmethyl-6-methyl-3-[[2'-(1H-tetrazol-5-yl) phen-4-yl]methyl]pyrimidin-4(3H)-one, which is a chemically defined non-peptide molecule and has the empirical formula C 27 h 30 N 7 OS, molecular weight 501.65....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K9/20A61P9/12A61K31/4184
CPCA61K31/513A61K31/549A61K9/2018A61K9/2027A61K9/2054A61K9/2095A61K31/506A61P43/00A61P9/12A61K2300/00A61K9/20A61K31/4422A61K31/4184A61K9/28A61K9/0053A61K47/32A61K47/38A61K2121/00
Inventor 金济学南京完朴敍薰金周元金相烨
Owner BORYUNG PHARMA CO LTD
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