Controlled release pharmaceutical composition containing thiazides and angiotensin-ii-receptor blockers

A technology of angiotensin and receptor blockers, applied in the field of blockers or pharmaceutically acceptable drug combination preparations of thiazide compounds and angiotensin II receptor blockers, which can solve the problem of insufficiently shown Antihypertensive and preventive effects of complications, lack of creativity, increased side effects and other issues, to achieve the effect of maintaining antihypertensive effects, improving patient compliance, and reducing side effects

Inactive Publication Date: 2009-09-16
韩诺生物制约株式会社
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] 2) Clearly a single drug cannot treat multiple disease states
[0018] 3) The effect of a single drug is only effective in less than 50% of patients prescribed
[0020] 5) Especially for hypertensive patients with complications such as diabetes, a single drug not only cannot achieve the desired antihypertensive effect, but it is also difficult to prevent complications
[0021] 6) If a low dose of a single drug is ineffective, the dose sufficient to achieve the desired blood pressure level is increased, which in many cases leads to increased side effects
The above conventionally disclosed composition is considered to be an unsatisfactory combination in terms of logic or pharmacology, which cannot show sufficient antihypertensive and complication-preventing effects
Currently commercially available such combinations are simple combinations of two components because they do not take full advantage of the optimal pharmacological effects of hydrochlorothiazide and angiotensin II receptor blockers
Such a simple combination was rejected for lack of creativity

Method used

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  • Controlled release pharmaceutical composition containing thiazides and angiotensin-ii-receptor blockers
  • Controlled release pharmaceutical composition containing thiazides and angiotensin-ii-receptor blockers
  • Controlled release pharmaceutical composition containing thiazides and angiotensin-ii-receptor blockers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 to 14

[0145] Examples 1 to 14: Preparation of dry-coated tablets

[0146] 1) Preparation of losartan delayed-release tablet core

[0147] To prepare the losartan delayed-release tablet core, as shown in Table 4, losartan potassium, microcrystalline cellulose, pregelatinized starch, copovidone and micropowder silica gel 2000 (Aerosil2000) were sieved through a No. 35 sieve and mixed with each other in a high-speed mixer for 5 minutes to prepare a mixture. The magnesium stearate was mixed with the mixture for 4 minutes. The resulting mixture was compressed into core tablets using a rotary tablet press (MRC-33, Sejong Machinery Co., Korea). The thus-prepared core tablets were placed in a Hi-coater (SFC-30N, Sejong Machinery Co., Korea) to prepare delayed-release core tablet products having the composition and content shown in Table 4.

[0148] 2) Preparation of hydrochlorothiazide immediate-release layer

[0149] To prepare the hydrochlorothiazide immediate-release layer, hydrochlo...

Embodiment 15 to 22

[0152] Examples 15 to 22: Preparation of multilayer tablets

[0153] 1) Preparation of losartan delayed-release layer

[0154] In Example 15, in order to prepare losartan delayed-release tablet core, losartan potassium, microcrystalline cellulose, pregelatinized starch, copovidone and sodium starch glycolate were sieved through a No. 35 sieve and Mix with each other in a high speed mixer for 5 minutes to prepare a mixture. Meanwhile, hydroxypropyl cellulose and hydroxypropyl cellulose phthalate (HP-50) were dissolved in pure water to prepare a binder solution. A binder solution is added to the mixture, which is then kneaded, granulated and dried. The dried granules were placed in a fluid bed coater. Meanwhile, hydroxypropylcellulose phthalate (HP-55) and polyethylene glycol 6000 were dissolved in 220 mg of ethanol and 980 mg of methylene chloride to prepare a coating solution. The granules were coated with a coating solution in a fluidized bed coater (GPCG-1, Glatt, German...

Embodiment 23

[0160] Example 23: Preparation of film-coated tablets

[0161] 1) Preparation of losartan delayed-release layer

[0162] As shown in Table 5 below, losartan potassium, microcrystalline cellulose, sodium starch glycolate, and lactose were sieved through a No. 35 sieve and mixed with each other in a high-speed mixer for 5 minutes to prepare a mixture. Meanwhile, hydroxypropyl cellulose and hydroxypropyl cellulose phthalate (HP-50) were dissolved in pure water to prepare a binder solution. A binder solution is added to the mixture, which is then kneaded, granulated and dried. Place the dried granules in a fluid bed coater. Meanwhile, hydroxypropylcellulose phthalate (HP-55) and polyethylene glycol 6000 were dissolved in 220 mg of ethanol and 980 mg of methylene chloride to prepare a coating solution. The granules were coated with a coating solution in a fluidized bed coater (GPCG-1, Glatt, Germany). After the coating process was completed, micropowder silica gel 200 was mixed...

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Abstract

Disclosed herein is a pharmaceutical composition, containing a thiazide compound and an angiotensin-II-receptor blocker, and a technology for formulating the same. More particularly, disclosed is a pharmaceutical combination formulation of thiazide compound and angiotensin-II-receptor blocker, which maximizes the pharmacological and clinical antihypertensive effects and complication preventive effects of the drugs and reduces the side effects of the drugs, compared to when single-component formulations of the drugs are administered simultaneously.

Description

technical field [0001] The present invention relates to a pharmaceutical composition comprising thiazide compound and angiotensin II receptor blocker and its preparation technology. [0002] More particularly, the present invention relates to a pharmaceutical combination preparation of a thiazide compound and an angiotensin II receptor blocker, which enables all The pharmacological and clinical antihypertensive effect and complication prevention effect of the drug are maximized and side effects of the drug are reduced. [0003] In particular, the present invention relates to the release of an angiotensin II receptor blocker in a sustained-release manner to enable sustained control of blood pressure from evening to bedtime until early morning the next day, whereby said angiotensin II receptor blocker A technique for maximizing the antihypertensive effect of II receptor blockers, which is based on chronotherapy, in which dissolved drugs are absorbed in the body from the small i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/00A61K9/48
CPCA61K31/00A61K31/549A61K9/2086A61K9/209A61K45/06A61P13/12A61P43/00A61P9/00A61P9/12A61K2300/00A61K9/20A61K31/495
Inventor 金圣旭田圣树曺英观具滋星金镇昱孙载云
Owner 韩诺生物制约株式会社
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