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Empagliflozin quick-release pellet preparation and preparation method

A technology of empagliflozin and pellets, which is applied in the field of pharmaceutical preparation technology and application, and can solve the problems of inability to take oral administration, poor compliance of injections, and short half-life of drugs, etc.

Inactive Publication Date: 2017-05-31
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved in the present invention is the short half-life of the medicine that exists in the empagliflozin drug development, and the problems such as the poor compliance of the injection for clinical application (cannot be administered orally)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1 Formula 1

[0030] Empagliflozin 500mg Microcrystalline Cellulose Blank Ball Core 4000g 0.3% acetic acid solution 200ml Hypromellose (HPMC) 300g talcum powder 50g water 5500g

[0031] Preparation:

[0032] (1) Preparation of drug solution: take 500 mg of empagliflozin according to the formula, add 200 mL of 0.3% acetic acid solution to dissolve, then dissolve in an aqueous solution containing 100 g of hypromellose (HPMC) to prepare 1500 g of drug solution ;

[0033] (2) Spraying medicine at the bottom of the fluidized bed: place 4000 g of microcrystalline cellulose blank ball cores in the fluidized bed, start the fluidized bed, set the parameters of the fluidized bed medicine: fan air volume 150m3 h-1, liquid supply The pump speed is 5r·min-1, the temperature of the material is controlled at 30-40°C, the atomization pressure is 0.16MPa, and the drug is applied in a fluidized state. After the drug is applied, it is...

Embodiment 2

[0036] Example 2 Formula 2

[0037] Empagliflozin 100mg Sucrose Blank Ball Core 4000g 0.1% citrate solution 300ml Povidone (PVP) 8g Acrylic 200g water 5000g

[0038] Preparation:

[0039] (1) Preparation of drug solution: take empagliflozin 100mg by formula, add 0.1% citric acid solution 300mL to dissolve, then be dissolved in the aqueous solution that contains povidone (PVP) 8g and be mixed with 1500g drug solution ;

[0040] (2) Spray medicine at the bottom of the fluidized bed: place 4000g of sucrose blank ball cores in the fluidized bed, start the fluidized bed, set the parameters of the fluidized bed medicine: fan air volume 150m3 h-1, liquid supply pump speed 5r ·min-1, the temperature of the material is controlled at 30-40°C, the atomization pressure is 0.16MPa, and the drug is applied in a fluidized state. After the drug is applied, it is fluidized and dried for 15 minutes;

[0041] (3) Fluidized bed coating-protective fi...

Embodiment 3

[0043] Embodiment 3 Formula 3

[0044] Empagliflozin 1000mg Sucrose Blank Ball Core 4000g 0.6% hydrochloric acid solution 700ml syrup 70g Acrylic 200g water 4500g

[0045] Preparation:

[0046] (1) Preparation of drug solution: weigh 1000 mg of Empagliflozin according to the formula, add 700 mL of 0.6% hydrochloric acid solution to dissolve, then dissolve in an aqueous solution containing 70 g of syrup to prepare 1500 g of drug solution;

[0047] (2) Spray medicine at the bottom of the fluidized bed: place 4000g of sucrose blank ball cores in the fluidized bed, start the fluidized bed, set the parameters of the fluidized bed medicine: fan air volume 150m3 h-1, liquid supply pump speed 5r ·min-1, the temperature of the material is controlled at 30-40°C, the atomization pressure is 0.16MPa, and the drug is applied in a fluidized state. After the drug is applied, it is fluidized and dried for 15 minutes;

[0048] (3) Fluidized bed coat...

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Abstract

The invention discloses an empagliflozin quick-release pellet preparation and a preparation method, and relates to the field of pharmaceutic preparation techniques and applications. An administration mode of the quick-release pellet preparation is oral administration; a blank pellet core is taken as a carrier; an empagliflozin aqueous solution containing a cosolvent and an adhesive is a drug layering solution; the dosage of empagliflozin is 0.0025-0.3wt% of the dosage of the pellet core; and the oral dosage of the empagliflozin is not higher than 50mcg. The empagliflozin quick-release pellet preparation has the characteristics of high drug layering rate, good content homogeneity, quick release, rapid effect in abirritation, good clinic compliance, high safety and the like. In addition, a blank pellet core fluidized bed drug layering method is suitable for preparing a very-low-specification oral empagliflozin preparation.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparation technology and application, in particular to a preparation of empagliflozin immediate-release pellets, a preparation method and application thereof. Background technique [0002] Empagliflozin belongs to the class of SGLT2 inhibitors, which directly targets glucose, and its mechanism of action is independent of B cell function and insulin resistance. It was approved by the European Union on May 23, 2014, for the treatment of adults with type 2 diabetes who have failed to achieve adequate blood sugar control with diet and exercise, to improve blood sugar control. Trade name: Jardiance. [0003] Empagliflozin is a once-daily tablet with approved doses of 10mg and 25mg. Jardiance can be used alone or in combination with other antidiabetic drugs, including insulin and metformin. The approval of empagliflozin is based on data from a large clinical project involving more than 10 multinationa...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K47/38A61K47/32A61K47/26A61K47/22A61K31/351A61P3/10
CPCA61K9/5078A61K9/0002A61K9/5015A61K9/5026A61K9/5042A61K9/5047A61K31/351
Inventor 王雪峰
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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