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Composition containing vildagliptin and metformin and preparation method of composition

A technology of metformin hydrochloride and its composition, which is applied in the field of compositions containing vildagliptin and metformin and its preparation, which can solve the problems of poor compressibility of vildagliptin, increase the burden of medication for patients, and high production cost, and achieve easy operation , Improve the compressibility, the effect of cheap equipment

Inactive Publication Date: 2016-05-18
CENTAURUS BIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Metformin hydrochloride is a crystal, with poor compressibility and large dose; meanwhile, vildagliptin has poor compressibility and is sensitive to heat and humidity, so there are many difficulties in the preparation of compound tablets
This patent provides a method to improve the compressibility of metformin, but this method requires the use of an expensive hot-melt extruder, and the industrial production cost is high, which increases the drug burden of patients

Method used

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  • Composition containing vildagliptin and metformin and preparation method of composition
  • Composition containing vildagliptin and metformin and preparation method of composition
  • Composition containing vildagliptin and metformin and preparation method of composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0028] Pharmaceutical composition of the present invention, preferred formula is made up as follows: Prescription (1000 tablet amounts, unit: g)

[0029]

[0030] The composition preparation method of the present invention comprises the following steps:

[0031] a) metformin hydrochloride is pulverized through a 60-mesh sieve, and set aside;

[0032] b) Weigh the prescribed amount of metformin hydrochloride and PEG6000, mix them uniformly, put them in a fluidized bed, set the fan frequency to 45Hz, and set the material temperature to 65°C for hot-melt granulation;

[0033] c) the obtained granules are placed at room temperature, and granulated through a 30-mesh sieve;

[0034] d) Add vildagliptin and magnesium stearate, mix well, and press into tablets.

Embodiment 4-6

[0036] Pharmaceutical composition of the present invention, preferred formula is made up as follows: Prescription (1000 tablet amounts, unit: g)

[0037]

[0038] The preparation method of the composition of the present invention is the same as that of Examples 1-3.

Embodiment 7-10

[0040] Pharmaceutical composition of the present invention, preferred formula is made up as follows: Prescription (1000 tablet amounts, unit: g)

[0041]

[0042] The preparation process parameters are as follows:

[0043] parameters

Example 7

Example 8

Example 9

Example 10

Fan frequency / Hz

20

30

40

50

Material temperature / ℃

55

60

65

70

[0044] The composition preparation method of the present invention comprises the following steps:

[0045] a) metformin hydrochloride is pulverized through a 60-mesh sieve, and set aside;

[0046]b) Weigh the prescribed amount of metformin hydrochloride and PEG8000, mix them uniformly, put them in the fluidized bed, and set the parameters as shown in the table above;

[0047] c) the obtained granules are placed at room temperature, and granulated through a 30-mesh sieve;

[0048] d) Add vildagliptin and magnesium stearate, mix well, and press into tablets.

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Abstract

The invention discloses a composition containing vildagliptin and metformin and a preparation method of the composition. The composition contains more than 20% of a binding agent in terms of dry weight, wherein the metformin is prepared by virtue of a fluidized bed in a mode of hot-melting granulating. According to the composition provided by the invention, the compressibilities and the liquidities of the vildagliptin and the metformin are improved, and the method is simple and convenient to operate, low in production cost, environment-friendly and efficient. A prepared composite tablet is qualified in friability and rapid to dissolve out.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing vildagliptin and metformin as active ingredients and a preparation method thereof. Background technique [0002] Diabetes mellitus is a syndrome of glucose, protein and lipid metabolism disorders caused by insufficient insulin or defects in insulin cell metabolism. With the prolongation of diabetes mellitus, if the metabolic disorder in the body is not controlled, it can cause a series of complications. Diabetes has become the third major disease that seriously endangers human health after cardiovascular and cerebrovascular diseases and malignant tumors. According to pathological characteristics, diabetes can be divided into type I diabetes and type II diabetes. Type II diabetes is non-insulin-dependent diabetes, mostly after the age of 35-40, accounting for more than 90% of diabetic patients. Type II diabetes is characterized by insulin resistance, manifested by progressive failure of...

Claims

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Application Information

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IPC IPC(8): A61K31/40A61K9/28A61K9/20A61P3/10A61K31/155
Inventor 殷静王再全刘玲张德富马秋平杨利民张晓军韩永信
Owner CENTAURUS BIOPHARMA
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