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Preparation method of succinic acid Trelagliptin tablets

A technology of troxagliptin succinate and tablets, which is applied in the field of preparation of troxagliptin succinate tablets, can solve the problems of poor granulation effect and poor fluidity of troxagliptin succinate, and achieve good in vitro Effects of dissolution behavior, stable quality, and simple production process

Active Publication Date: 2016-04-13
HONG KONG JOWA & HUAYUAN GRP CHUZHOU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Therefore, it is still necessary to provide a means, which can solve the poor granulation effect caused by the poor fluidity of trexagliptin succinate after granulation, and will not affect the stability of the product.

Method used

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  • Preparation method of succinic acid Trelagliptin tablets
  • Preparation method of succinic acid Trelagliptin tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A preparation method of trexagliptin succinate tablet, is characterized in that, comprises the following steps:

[0022] Step 1, in parts by weight, take 100 parts of trexagliptin succinate, add 10 parts of sorbitol, 5 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium, mix, and place the mixture at a temperature of 30 ℃ and a relative humidity of 80% for 200 minutes, then transferred to a vacuum kettle, heated to 40 ℃ under vacuum conditions, kept for 90 minutes, and discharged to obtain material 1;

[0023] Step 2, adding 1 part of adhesive in parts by weight to material 1, and wet granulation method to obtain pellets;

[0024] Step 3, drying the granules in a fluidized bed granulation coating machine to obtain dry granules;

[0025] Step 4: Add 0.8 parts by weight of lubricant to the dry granules, mix, compress into tablets, and coat to obtain trexagliptin succinate tablets.

[0026] Wherein, the particle diameters of troxagliptin succinate, sorb...

Embodiment 2

[0028] A preparation method of trexagliptin succinate tablet, is characterized in that, comprises the following steps:

[0029] Step 1, in parts by weight, take 105 parts of trexagliptin succinate, add 12 parts of sorbitol, 7 parts of microcrystalline cellulose, and 9 parts of croscarmellose sodium, mix, and place the mixture at a temperature of 35 ℃, relative humidity of 85% under the conditions of 250min, then transferred to a vacuum kettle, heated to 45℃ under vacuum conditions, kept for 70min, discharging, to obtain material 1;

[0030] Step 2, adding 3 parts of adhesive in parts by weight to material 1, and wet granulation method to obtain pellets;

[0031] Step 3, drying the granules in a fluidized bed granulation coating machine to obtain dry granules;

[0032] Step 4: Add 2 parts of lubricant in parts by weight to the dry granules, mix, compress into tablets, and coat to obtain troxagliptin succinate tablets.

[0033] Wherein, the particle diameters of trexagliptin s...

Embodiment 3

[0035] A preparation method of trexagliptin succinate tablet, is characterized in that, comprises the following steps:

[0036] Step 1, in parts by weight, take 110 parts of trexagliptin succinate, add 14 parts of sorbitol, 9 parts of microcrystalline cellulose, 10 parts of croscarmellose sodium, mix, and place the mixture at a temperature of 30 ℃ and a relative humidity of 90% for 300 minutes, then transferred to a vacuum kettle, heated to 45 ℃ under vacuum conditions, kept for 70 minutes, and discharged to obtain material 1;

[0037] Step 2, adding 3 parts of adhesive in parts by weight to material 1, and wet granulation method to obtain pellets;

[0038] Step 3, drying the granules in a fluidized bed granulation coating machine to obtain dry granules;

[0039] Step 4: Add 2.4 parts of lubricant in parts by weight to the dry granules, mix, compress into tablets, and coat to obtain trexagliptin succinate tablets.

[0040] Wherein, the particle diameters of trexagliptin succ...

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Abstract

The invention provides a preparation method of succinic acid Trelagliptin tablets. The method includes: taking succinic acid Trelagliptin, adding sorbitol, microcrystalline cellulose and crosslinking sodium carboxymethyl cellulose, mixing, placing mixture under a condition with certain temperature and relative humidity, moving into a vacuum kettle, rising the temperature under a vacuum condition, adding binder, performing wet granulation, drying obtained granules in a fluidized bed granulation coating machine to obtain dried granules, adding lubricant into the dry granules, mixing, tableting, and coating to obtain the succinic acid Trelagliptin tablets. The preparation method has the advantages that the succinic acid Trelagliptin tablets prepared by the method is stable in quality and good in in-vitro dissolution performance, the method is simple in production process, and large-scale industrial production can be achieved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a preparation method of trexagliptin succinate tablet. Background technique [0002] Diabetes is currently the top five leading cause of death worldwide. Especially in Asia, the number and compound growth rate of diabetic patients will rise rapidly. Although there are many types of diabetes drugs on the market, experts point out that with the progression of type 2 diabetes, the function of pancreatic beta cells gradually declines or even fails. The hypoglycemic efficacy of traditional treatments, whether it is insulin secretagogues or sensitizers, depends on the existence of pancreatic β-cell function. Therefore, more and more patients, especially those in the middle and advanced stages, have increasingly difficult to control their blood sugar levels. For such patients, insulin-independent hypoglycemic drugs may provide a more effective treatmen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/513A61P3/10A61K47/38
CPCA61K9/2018A61K9/2054A61K9/2893A61K31/513
Inventor 管悦琴肖尚志罗雪峰
Owner HONG KONG JOWA & HUAYUAN GRP CHUZHOU PHARMA CO LTD
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