Double-element preparation containing telmisartan and hydrochlorothiazide

A technology of telmisartan and hydrochlorothiazide, which is applied in the field of multiparticulate preparations and can solve problems such as poor solubility

Inactive Publication Date: 2011-07-20
上海中邦斯瑞生物药业技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Telmisartan is manufactured and supplied as the free acid, which is characterized by very poor solubility in aqueous systems in the physiological pH range of the gastrointestinal tract

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0029] Telmisartan pellets

[0030] 600g of blank pellet cores with a particle size of 0.6-0.8mm

[0031] Drug-containing layer

[0032] Telmisartan 180g

[0033] Sodium hydroxide 15g

[0034] Meglumine 100g

[0035] pharmacoat 60 394g

[0036] L-HPC 30g

[0037] Appropriate amount of water

[0038] The pharmacoat 603 of prescription quantity is dissolved in water, the sodium hydroxide of prescription quantity, meglumine and telmisartan are dissolved in pharmacoat 603 solution successively, L-HPC is dispersed in the above-mentioned solution, blank ball core (granule diameter 0.6 ~ 0.8mm) 600g put into the fluidized bed and apply the bottom spraying process. The material temperature is controlled at about 35 degrees.

[0039] expansion layer

[0040] pharmacoat 603 100g

[0041] L-HPC 150g

[0042] Sodium Lauryl Sulfate 15g

[0043] Appropriate amount of water

[0044] Dissolve hydroxypropyl methylcellulose in water, add L-HPC and sodium lauryl sulfate to prepar...

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Abstract

The invention provides a double-element preparation containing telmisartan and hydrochlorothiazide, comprising telmisartan containing pellets and hydrochlorothiazide containing solubilization carriers, wherein the telmisartan pellets comprise blank pellet cores, drug layers containing the active component telmisartan and expanded layers; and the hydrochlorothiazide solubilization carriers comprise solubilization carrier materials which are selected from polyethylene glycol, polyvidone, polyoxyethylene group containing surfactants, water-soluble cellulose derivatives, organic acids, saccharides and alcohols. The double-element preparation containing telmisartan and hydrochlorothiazide can be used for preparing antihypertensive medicaments, can accelerate disintegration of medicaments and promote dissolution and diffusion of active components, thereby improving the bioavailability of the medicaments.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a double-unit preparation comprising telmisartan and hydrochlorothiazide, more specifically to a multi-particle preparation in which telmisartan and hydrochlorothiazide are respectively coated on different particles. The invention also relates to its preparation method and application in the field of pharmacy. Background technique [0002] Telmisartan is a novel angiotensin II receptor (AT type I) antagonist, its chemical name is 4-{[2-n-propyl-4-methyl-6-(1-methylbenzene and imidazol-2-yl)benzimidazol-1-yl]methyl}biphenyl-2-carboxylic acid, its chemical structure is as shown in formula I. Telmisartan was originally developed by the German Boehringer Ingelheim Pharmaceutical Company. It was first approved for marketing in the United States in November 1998, and then listed in Germany, the Philippines, Australia, Belgium, the United Kingdom, China and other countries. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5415A61K31/4184A61K9/00A61K9/16A61P9/12
Inventor 黄昆鹏
Owner 上海中邦斯瑞生物药业技术有限公司
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