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Linagliptin active component-containing composition and preparation method thereof

A technology of active ingredient and composition, applied in the field of linagliptin tablet composition and preparation, can solve problems such as complex process, achieve simple operation and reduce exposure links

Inactive Publication Date: 2016-12-21
合肥远志医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Inquiring information, it can be seen from the patent prescriptions that the preparation process of linagliptin tablets is high-efficiency wet granulation. High-efficiency wet granulation technology is the most widely used method in the pharmaceutical industry, but the process is relatively complicated

Method used

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  • Linagliptin active component-containing composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

8000 tablets

[0029] Process:

[0030] Preparation of raw material suspension: Weigh 1 / 6 of the prescription amount of mannitol, dissolve it in 800 g of water, and then suspend the raw material.

[0031] Adhesive preparation: Weigh the prescription amount of povidone K90 and dissolve it in an appropriate amount of water to prepare a 6% povidone K90 aqueous solution.

[0032] First heat the fluidized bed granulator until the parameters are stable (temperature: 60℃), then put the remaining mannitol, pregelatinized starch and corn starch into the fluidized bed granulator, mix for 10 minutes, and spray the raw materials into suspension After spraying, spray the adhesive (according to the state of the particles, control the spray stop time), after drying, the particle moisture is controlled at 2-4%.

Embodiment 2

8000 tablets

[0035] Process:

[0036] Adhesive preparation: Weigh the prescription amount of povidone K90 and dissolve it in an appropriate amount of water to prepare a 3% povidone K90 aqueous solution, and suspend the raw materials in it.

[0037] First heat the fluidized bed granulator until the parameters are stable (temperature: 60℃), then put the remaining mannitol, pregelatinized starch and corn starch into the fluidized bed granulator, mix for 10 minutes, and spray the adhesive (According to the particle status, control the spray stop time), after drying, the particle moisture is controlled at 2-4%.

Embodiment 3

8000 tablets

[0040] Process:

[0041] Adhesive preparation: Weigh the prescription amount of copovidone and dissolve it in water to prepare a 15% copovidone aqueous solution, and suspend the raw materials in it.

[0042] First heat the fluidized bed granulator until the parameters are stable (temperature: 60℃), then put the remaining mannitol, pregelatinized starch and corn starch into the fluidized bed granulator, mix for 10 minutes, and spray the adhesive (According to the particle status, control the spray stop time), after drying, the particle moisture is controlled at 2-4%.

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Abstract

The invention discloses a linagliptin active component-containing composition and a preparation method thereof. The composition contains the active component linagliptin, and also comprises the following auxiliary materials, by weight, 80-150 parts of mannitol, 10-60 parts of pregelatinized starch, 1-30 parts of corn starch, 1-10 parts of polyvinylpyrrolidone and 1-5 parts of magnesium stearate. Fluidized bed granulation integrates mixing, granulation and drying, so the bare link in the granulation process is reduced, and the operation is simple and controllable. Linagliptin is added in a suspending injection manner, so uniform mixing of linagliptin is facilitated.

Description

[0001] Technical Field: The present invention belongs to the field of pharmaceutical preparations, and specifically relates to a linagliptin tablet composition and a preparation method. Background technique [0002] Linagliptin (Linagliptin, structural formula as shown in formula 1), is a dipeptidyl peptidase IV inhibitor, chemical name 1-[(4-methyl-quinazolin-2-yl) methyl] -3-Methyl-7-(2-butyne-1-yl)-8-[3-(R)-amino-piperidin-1-yl]-xanthine, developed by Boehringer Ingelheim. This product is used in combination with metformin and sulfonylureas, combined with diet control and exercise, and can be used for blood sugar control in adult patients with type 2 diabetes. [0003] [0004] Inquiry of data, it can be seen from the patent prescriptions that the preparation process of linagliptin tablets is high-efficiency wet granulation. High-efficiency wet granulation technology is the most widely used method in the pharmaceutical industry, but the process is more complicated. Fluidized b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/522A61K9/20A61K47/36A61K47/26A61K47/32
CPCA61K31/522A61K9/2018A61K9/2027A61K9/2059A61K47/26A61K47/32A61K47/36
Inventor 金慧芳王志国刘斐孙松
Owner 合肥远志医药科技开发有限公司
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