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Medicine composition for Jardiance solid dispersion and preparation method thereof

A technology of solid dispersion and composition, applied in the field of empagliflozin oral solid preparation, empagliflozin pharmaceutical composition and its preparation, can solve the problems of cost increase, low yield, large loss, etc., and achieve low production Cost, simple and easy preparation process, simple and easy to implement effect

Inactive Publication Date: 2016-04-20
北京华禧联合科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The micronization of raw materials requires special airflow milling equipment, which leads to high loss and low yield, which leads to increased costs and is not suitable for commercial production.

Method used

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  • Medicine composition for Jardiance solid dispersion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Enpagliflozin solid dispersion preparation:

[0044] Weigh 10g of Enpagliflozin and 70g of polyethylene glycol respectively, add them to the solid dispersion machine, set the temperature to 160℃, after melting, take it out, quickly put it in the refrigerator to solidify, vacuum dry, and smash through 80 mesh sieve. .

Embodiment 2

[0046] Weigh 10g of Enpagliflozin and 80g of polyethylene glycol respectively, add them to the solid dispersion machine, set the temperature to 170℃, after melting, take it out, quickly put it in the refrigerator to solidify, vacuum dry, and smash through 80 mesh sieve. .

[0047] Determination of dissolution: Weigh 25mg of the pharmaceutical composition prepared in Examples 1 to 2 and 25mg of the raw material of Enpagliflozin in Comparative Example 1, respectively, and put them in 900ml pH1.0 medium by paddle method , 50rpm, samples were taken at 10, 15, 30, 45, and 60 minutes to detect dissolution.

[0048] The dissolution results are as follows:

[0049]

[0050] The results showed that the dissolution rate of Examples 1 to 2 made into solid dispersions was significantly faster than that of the bulk drug group of Comparative Example 1, and Example 2 with a large proportion of polyethylene glycol had a higher dissolution rate than Example 1.

Embodiment 3

[0052] For the preparation of Enpagliflozin tablets, the prescription used the composition prepared in Example 1, the prescription 2 used the composition prepared in Example 2, and the prescription 3 was a bulk drug that was not made into a solid dispersion.

[0053] See the following table for prescriptions:

[0054] Component

[0055] Determination of dissolution: Take prescription 1 to 3 samples, respectively, in 900ml pH1.0 medium, paddle method, 50rpm, and take samples at 10, 15, 30, 45, 60 minutes to detect dissolution.

[0056] The results are as follows:

[0057]

[0058] The results showed that the dissolution rate of the formulations 1 to 2 made into solid dispersions was significantly better than that of the formulation 3 made without solid dispersions.

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Abstract

The invention provides a medicine composition for Jardiance solid dispersion and a preparation method thereof. The method comprises the steps that Jardiance and polyethylene glycol are prepared into the solid dispersion in a melting mode, and the solid dispersion is mixed with other pharmaceutically acceptable excipients to form the oral solid preparation. According to the medicine composition, the main medicine solubility is improved, rapid medicine disintegration is facilitated, and therefore the composition dissolution speed is increased.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition of empagliflozin and a preparation method thereof, and an oral solid preparation of empagliflozin is obtained by this method. Background technique [0002] Type 2 diabetes is a chronic metabolic disease, and the number of diabetic patients in the world has reached 150 million. It is not only the microvascular disease and neuropathy caused by high blood sugar that endanger the health of patients with type 2 diabetes, but also more serious macrovascular disease. Epidemiological studies have shown that 60%-70% of patients with type 2 diabetes will eventually die of macrovascular disease (such as coronary heart disease, stroke, etc.). In the United States, due to people's attention to the prevention and treatment of coronary heart disease, the death rate of coronary heart disease in the non-diabetic population has dropped significantly, bu...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/20A61K31/7048A61K47/34A61P31/10A61K47/10
CPCA61K9/146A61K9/2031A61K31/7048
Inventor 刘燕平于新新代海平毕华丁继军郑丽会
Owner 北京华禧联合科技发展有限公司
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