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Telmisartan oral solid preparation with stable product performance and preparation method of telmisartan oral solid preparation

A technology for telmisartan and solid preparations, applied in the field of telmisartan oral solid preparations and its preparation, can solve the problems of low tablet dissolution efficiency, unstable dissolution performance, and low bioavailability, and achieve optimized content uniformity , provide compressibility, and optimize the effect of inlet air temperature

Active Publication Date: 2022-04-15
SHANGHAI SHYNDEC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inventors found in the process of granulating telmisartan tablets using the above-mentioned process that the prepared tablets had a large difference between the tablets during dissolution, and the dissolution performance was unstable, so that the dissolution efficiency of the tablets was low and the bioavailability was low.

Method used

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  • Telmisartan oral solid preparation with stable product performance and preparation method of telmisartan oral solid preparation
  • Telmisartan oral solid preparation with stable product performance and preparation method of telmisartan oral solid preparation
  • Telmisartan oral solid preparation with stable product performance and preparation method of telmisartan oral solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The formula (based on 1000 tablets, unit g) is as follows:

[0029] Telmisartan 80 sodium hydroxide 6.72 Povidone K30 24 meglumine 24 Hypromellose 24 Mannitol core 292.08 Magnesium stearate 4.8 talcum powder 9.6 silica 4.8

[0030] Add sodium hydroxide and meglumine to a certain amount of purified water to dissolve, then add the telmisartan raw material into the solution and stir, after it is completely dissolved, continue to add povidone, stir to dissolve, and clear and transparent A slurry is prepared. Add the formula amount of mannitol ball core into the fluidized bed, set the air intake to 70°C, the air volume to 2500m3 / h, the spraying speed to 150r / min, and the material temperature to be controlled at about 42°C. The prepared granules are sized, mixed with additional auxiliary materials, and then compressed into tablets to obtain Telmisartan tablets A.

Embodiment 2

[0032] Granules were prepared according to Example 1, except that capsules were used for filling to obtain Telmisartan capsule B.

Embodiment 3

[0034] Prepare particles according to Example 1, the difference is that the air intake volume is set to 2800m 3 / h, spray speed 170r / min, made telmisartan sheet C.

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Abstract

The invention relates to a telmisartan preparation and a preparation method thereof, in particular to a telmisartan oral solid preparation with stable product performance and a preparation method thereof. The telmisartan tablet comprises the following raw material components: an active component telmisartan, a basifier, an adhesive, a filler and a lubricant, the filler is a mannitol pellet core, and the telmisartan tablet is prepared by the following method: (1) sequentially adding telmisartan, sodium hydroxide, meglumine and povidone to prepare slurry at 40 + / -5 DEG C; (2) adding the mannitol pellet cores into a fluidized bed, and spraying slurry and granulating; (3) granulating; (4) adding the external auxiliary materials including hydroxypropyl methylcellulose, silicon dioxide, magnesium stearate and talcum powder, and mixing; and (5) tabletting or filling. The mannitol pellet core is adopted, so that the pellet core is more uniform in medicine application, and the content uniformity of the medicine is ensured. And meanwhile, the process parameters are optimized, so that the smooth proceeding of the process is ensured.

Description

technical field [0001] The invention relates to a telmisartan preparation and a preparation method thereof, in particular to a telmisartan oral solid preparation with stable product performance and a preparation method thereof. Background technique [0002] Telmisartan (telmisartan), the chemical name is 4'-[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazole- 1-ylmethyl]biphenyl-2-carboxylic acid, the molecular formula is C33H30N4O2, it is white or off-white crystalline powder, odorless and tasteless. Soluble in chloroform, slightly soluble in dichloromethane or dimethylformamide, slightly soluble in methanol, very slightly soluble in ethanol, almost insoluble in water, easily soluble in 1mol / L sodium hydroxide solution, It is very slightly soluble in 0.1mol / L hydrochloric acid solution. [0003] Telmisartan is a new type of antihypertensive drug, a specific angiotensin II receptor (AT I type) antagonist, used for the treatment of essential hypertension. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4184A61K9/20A61K47/26A61K9/48A61K31/047A61P9/12
CPCA61K31/047A61K9/20A61P9/12A61K47/26A61K9/48A61K31/4184
Inventor 倪峰常艳玲钱晨陈烨岳卓陈灵楠荆双双吴圣曦王艳明
Owner SHANGHAI SHYNDEC PHARMA CO LTD
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