Compound tablet containing telmisartan and hydrochlorothiazide

A technology for hydrochlorothiazide and telmisartan, applied in the field of medicine, can solve the problems of incompleteness, slow dissolution of hydrochlorothiazide, hinder the release of hydrochlorothiazide, etc., and achieve the effects of stable quality, improved efficiency and good dissolution

Active Publication Date: 2012-06-27
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the adhesive properties of telmisartan after dissolution, it will hinder the release of hydrochlorothiazide, resulting in slow or even incomplete dissolution of hydrochlorothiazide

Method used

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  • Compound tablet containing telmisartan and hydrochlorothiazide
  • Compound tablet containing telmisartan and hydrochlorothiazide
  • Compound tablet containing telmisartan and hydrochlorothiazide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042]

[0043] Preparation of hydrochlorothiazide granules:

[0044] Mix 25.0g of hydrochlorothiazide, 58.0g of carmellose calcium, 132.8g of microcrystalline cellulose, 116.0g of cornstarch, 11.6g of povidone, and 4.6g of sodium stearyl fumarate, and use 300g of purified water as a wetting agent. One-step granulation in a fluidized bed, controlling the material temperature at 22-25°C, drying to obtain hydrochlorothiazide dry granules, and passing the dry granules through a φ1.2mm rotary sieve for granulation to obtain hydrochlorothiazide granules.

[0045] Preparation of Telmisartan Granules:

[0046] Dissolve 80g of telmisartan and 8.6g of sodium hydroxide in 200g of water to obtain a clear solution, add 20.3g of silicon dioxide to disperse evenly, place 85.4g of mannitol and 37.7g of cornstarch in a fluidized bed, and spray into the above solution , to prepare telmisartan granules, pass through a φ1.2mm rotary sieve after drying, and sieve the granules to obtain telmis...

Embodiment 2

[0050]

[0051] Preparation of hydrochlorothiazide granules:

[0052] Mix 25.0g hydrochlorothiazide, 58g carboxymethylcellulose calcium, 132.8g microcrystalline cellulose, 116.0g cornstarch, 11.6g povidone and 4.6g sodium stearyl fumarate, and use 300g purified water as a wetting agent , carry out one-step granulation in a fluidized bed, control the temperature of the material at 22-25°C, dry the granules after granulation, and use a Φ1.2mm rotary sieve to size the dry granules to obtain hydrochlorothiazide granules.

[0053] Preparation of Telmisartan Granules:

[0054] Dissolve 80g telmisartan and 8.6g sodium hydroxide in 200g water to obtain a clear solution, add 20.3g silicon dioxide and disperse evenly; place 66.8g mannitol, 37.7g cornstarch and 7.0g carboxymethylcellulose calcium In the fluidized bed, spray the above-mentioned solution, control the temperature of the material at 25-30 ° C, and make telmisartan granules; 11.6g povidone is made into an aqueous solution...

Embodiment 3

[0058]

[0059] Preparation of hydrochlorothiazide granules:

[0060] Mix 25.0g hydrochlorothiazide, 58g crospovidone, 132.8g microcrystalline cellulose, 116.0g corn starch, 11.6g povidone and 4.6g sodium stearyl fumarate, and use 300g purified water as a wetting agent, Carry out one-step granulation in a fluidized bed, control the temperature of the material at 22-25°C, dry the granules after the granulation is completed, and use a Φ1.2mm rotary sieve to size the dry granules to obtain hydrochlorothiazide granules.

[0061] Preparation of Telmisartan Granules:

[0062] Dissolve 80g telmisartan and 8.6g sodium hydroxide in 200g water to obtain a clear solution, add 20.3g silicon dioxide and disperse evenly; place 66.8g mannitol, 37.7g cornstarch and 7.0g carboxymethylcellulose calcium In the fluidized bed, spray the above-mentioned solution, control the temperature of the material at 25-30 ° C, and make telmisartan granules; 11.6g povidone is made into an aqueous solution ...

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Abstract

The invention discloses a compound tablet containing telmisartan and hydrochlorothiazide. The tablet is prepared by uniformly mixing telmisartan particles and hydrochlorothiazide particles, and tabletting the mixture. According to the weight of the hydrochlorothiazide particles, the hydrochlorothiazide particles contain 6 to 50 percent of disintegrant. The compound tablet is a single-layer tablet. The telmisartan/hydrochlorothiazide tablet is quickly dissolved and is stable in quality. The invention also provides a preparation method for the compound tablet, which is simple in process, low in cost and suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a compound tablet of telmisartan / hydrochlorothiazide. Background technique [0002] Telmisartan is an angiotensin II receptor antagonist (EP502314) developed for the treatment of hypertension and other medical conditions. Its chemical name is 4'-[2-n-propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)benzimidazol-1-ylmethyl]biphenyl-2-carboxylic acid . The CAS registry number is 144701-48-4. The molecular formula is C33H30N4O2, and the molecular weight is 514.63. has the following structure. [0003] [0004] Telmisartan is usually manufactured and supplied in the free acid form. As disclosed in WO 00 / 43370 patent, crystalline telmisartan exists in two crystalline forms with different melting points. These two crystal forms have very poor water solubility in the physiological pH range of the gastrointestinal tract between pH1 and pH7. In order to improve the solu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/549A61K31/4184A61K9/30A61P9/12
Inventor 陈浩施祥杰徐谷花李巧霞彭俊清胡功允
Owner ZHEJIANG HUAHAI PHARMA CO LTD
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