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Preparation method of Empagliflozin and mannitol composition

A technology of mannitol and composition, which is applied in the directions of drug combination, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of cumbersome production, increased contact area between production workers and drugs, hidden dangers of production safety, etc. problems, to achieve the effect of saving cost and production time, good in vitro dissolution performance, and simple method

Active Publication Date: 2015-05-20
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To achieve this particle size, the drug needs to be micronized, which requires special mechanical pulverization or jet pulverization equipment, which is cumbersome in production and reduces production efficiency.
In addition, during the micronization process of the drug, the drug is easy to float in the air, which greatly increases the contact area between the production workers and the drug, so special protective equipment is required, otherwise it is not good for the health of the workers, and when the dust in the environment When the amount increases to a certain level, it is easy to cause an explosion, and there is also a certain safety hazard for production.

Method used

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  • Preparation method of Empagliflozin and mannitol composition
  • Preparation method of Empagliflozin and mannitol composition
  • Preparation method of Empagliflozin and mannitol composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The preparation of empagliflozin mannitol composition:

[0041]Weigh 10g of empagliflozin and 40g of mannitol and mix them into a hot-melt extruder. The temperature is set at 175°C. After extrusion, take it out and cool it down and use a mechanical pulverizer to pulverize it. Pass the pulverized material through a 40-mesh sieve That's it.

Embodiment 2

[0043] The preparation of empagliflozin mannitol composition:

[0044] Weigh 10g of empagliflozin and 60g of mannitol and mix them into a hot-melt extruder at a temperature of 185°C. After extrusion, take it out and cool it, then use a mechanical pulverizer to pulverize it, and pass the pulverized material through a 40-mesh sieve That's it.

Embodiment 3

[0046] The preparation of empagliflozin mannitol composition:

[0047] Weigh 10g of empagliflozin and 80g of mannitol and mix them into a hot-melt extruder at a temperature of 200°C. After extrusion, take it out and cool it, then use a mechanical pulverizer to pulverize it, and pass the pulverized material through a 40-mesh sieve That's it.

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Abstract

The invention provides a preparation method of an Empagliflozin and mannitol composition. The preparation method comprises the following steps: mixing Empagliflozin and mannitol, performing hot-melting granulation, and mixing with other pharmaceutically acceptable carriers to obtain an oral solid preparation. The Empagliflozin and mannitol composition prepared by using the method is stable and controllable in quality and fast to dissolve.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of an empagliflozin mannitol composition and an oral solid preparation of empagliflozin obtained by the method. Background technique [0002] Type II diabetes has become an increasingly popular disease, and its high-frequency complications (such as diabetic foot, blindness, renal failure, etc.) not only affect the quality of life of patients, but may also lead to shortened life span. [0003] Empagliflozin is an oral sodium-glucose cotransporter-2 (SGLT-2) inhibitor. SGLT-2 is the transporter mainly responsible for the reabsorption of glucose from the glomerular filtrate into the systemic circulation. By inhibiting SGLT-2, empagliflozin reduces the renal reabsorption of filtered glucose and lowers the renal threshold of glucose, Thereby increasing the excretion of urinary sugar. This product is used for Blood sugar control for adults with typ...

Claims

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Application Information

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IPC IPC(8): A61K47/48A61K47/26A61K31/7048A61P3/10
Inventor 彭俊清余慧曹宇陈浩胡功允
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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