Preparation method of vildagliptin and metformin hydrochloride compound preparation

A technology of metformin hydrochloride and compound preparations, which is applied in the directions of pill delivery, pharmaceutical formulations, and non-active ingredients medical preparations, etc., can solve the problems of large disparity in dose ratio, poor fluidity, and increased impurity content, and achieves production equipment. The effect of low cost, simple process operation and little impurity change

Inactive Publication Date: 2017-04-26
NANJING YOKO PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] (1) The proportion of metformin hydrochloride in the tablet is more than 80% and the fluidity is not good, so the powder direct compression process cannot be used
[0010] (2) Vildagliptin is unstable to humidity and heat, and wet granulation even with a small amount of water will lead to a significant increase in the impurity content of vildagliptin during storage
[0011] (3) The dose ratios of metformin hydrochloride and vildagliptin are very different. In the prior art, metformin hydrochloride is first granulated and then mixed with vildagliptin, and there is a problem of uneven mixing

Method used

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  • Preparation method of vildagliptin and metformin hydrochloride compound preparation
  • Preparation method of vildagliptin and metformin hydrochloride compound preparation
  • Preparation method of vildagliptin and metformin hydrochloride compound preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] 95% ethanol wet granulation

[0062]

[0063] The preparation process is as follows:

[0064] (1) Take vildagliptin, metformin hydrochloride and hydroxypropyl cellulose SL of prescription quantity and pass through 60 mesh sieves respectively, mix evenly;

[0065] (2) Use 95% ethanol solution (200 mL) to make a soft material, granulate with a 20-mesh sieve, and dry at 60°C;

[0066] (3) Mix the granules in step (2) with magnesium stearate, take a sample for testing, calculate the tablet weight, and compress the tablet.

Embodiment 2

[0068] dry granulation

[0069]

[0070] Its preparation process is as follows:

[0071] (1) Take vildagliptin, metformin hydrochloride and hydroxypropyl cellulose SL-FP of the prescribed amount by weighing and pass through a 60-mesh sieve respectively, and mix well;

[0072] (2) Put the mixture of step (1) into the dry granulator, and the granulation parameters are set as follows: the distance between the pinch wheels is 0.3 mm, the speed of the pinch wheels is 2~4 rpm, the feeding speed is 20~30 rpm, and the granulation is done through a 20-mesh sieve. , and sifted to 80 mesh fine powder;

[0073] (3) Mix the granules in step (2) with magnesium stearate, take a sample for testing, calculate the tablet weight, and compress the tablet.

Embodiment 3

[0075] dry granulation

[0076]

[0077] Its preparation process is as follows:

[0078] (1) Take vildagliptin, metformin hydrochloride and hydroxypropyl cellulose SSL-SFP of the prescribed amount by weighing and pass through a 60-mesh sieve respectively, and mix well;

[0079] (2) Put the mixture in step (1) into the dry granulator, and the granulation parameters are set as follows: pitch between pinch wheels 0.2 mm, speed of pinch wheels 3~5 rpm, speed of feeding 40~50 rpm, granulation with 20-mesh sieve , and sifted to 80 mesh fine powder;

[0080] (3) Mix the granules in step (2) with magnesium stearate, take a sample for testing, calculate the tablet weight, and compress the tablet.

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Abstract

The invention discloses a preparation method of a vildagliptin and metformin hydrochloride compound preparation. The method includes: subjecting metformin hydrochloride, an adhesive and vildagliptin to sieving mixing, performing dry granulation, adding a lubricant, conducting total blending, carrying out sampling detection, tabletting and other processes. The tablet prepared by the process solves the content uniformity problem of vildagliptin, also improves the tablet compressibility and fluidity, the friability and hardness are accord with the quality standards of Pharmacopoeia, and the stability is good. Also the method has the characteristics of simple operation and low production cost, and can realize industrialization.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of a compound preparation of vildagliptin and metformin hydrochloride. Background technique [0002] Diabetes is a chronic non-communicable disease that seriously threatens human health. It is characterized by high mortality and high medical costs, and has become a common public health problem faced by countries all over the world. According to the statistics of the International Diabetes Federation (IDF), the number of diabetic patients in the world reached 370 million in 2011, 80% of which were in developing countries. It is estimated that by 2030 there will be 550 million diabetic patients worldwide. In 2011, a total of 4.6 million people died of diabetes worldwide, and the global medical cost of diabetes reached 465 billion US dollars in that year. [0003] According to etiology, diabetes is divided into type I diabetes, type II diabetes, gesta...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/40A61K31/155A61K9/20A61K47/38A61K47/32A61P3/10
CPCA61K31/40A61K9/2027A61K9/2054A61K31/155A61K2300/00
Inventor 张烨杨勇姚运辉赵赞赞朱素华薛峪泉张峰
Owner NANJING YOKO PHARMA
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