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Dapagliflozin agent composition

A technology of dapagliflozin and a composition, which is applied in the field of pharmaceutical preparations, can solve the problems of increasing production cost, low dissolution rate, increasing production lines for preparing dispersion systems, etc., and achieves the effect of improving dissolution rate

Inactive Publication Date: 2018-02-02
WEIHAI GUANBIAO INFORMATION TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Daxigliflozin is a poorly soluble drug. Chinese patent application 201510687050 made it into a dispersion to solve the defect of low dissolution rate; the dispersion process is complicated, and industrial production needs to increase the production line for preparing the dispersion system. The realization of industrialization will inevitably increase production cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1, D 50 Dapagliflozin 26 microns 5g, lactose 20g, microcrystalline cellulose 65g, macrogol 6000 4g, sodium citrate 7g, povidone K30 8g, crospovidone 3g, sodium lauryl sulfate 0.8g, magnesium stearate 1g. Prepare 1000 tablets according to the preparation method described in the technical scheme.

Embodiment 2

[0018] Embodiment 2, D 50 Dapagliflozin 48 microns 10g, lactose 38g, microcrystalline cellulose 40g, polyethylene glycol 6000 10g, sodium citrate 15g, povidone K30 3g, crospovidone 8g, sodium lauryl sulfate 1.5 g, magnesium stearate 1.5g. Prepare 1000 tablets according to the preparation method described in the technical scheme.

Embodiment 3

[0019] Example 3, D 50 Dapagliflozin 42 microns 5g, lactose 30g, microcrystalline cellulose 58g, macrogol 6000 7g, sodium citrate 10g, povidone K30 6g, crospovidone 7g, sodium lauryl sulfate 1.0g, magnesium stearate 1.2g. Prepare 1000 tablets according to the preparation method described in the technical scheme.

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PUM

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Abstract

The invention relates to a dapagliflozin composition and belongs to the technical field of pharmaceutical preparations. The technical scheme of the present invention is: a kind of dapagliflozin composition, in the composition of unit dose, containing D50 is 5-10mg of dapagliflozin of 32-46 micron, lactose 26-35mg, microcrystalline cellulose 48- 60mg, Macrogol 6000 5‑8mg, Sodium Citrate 9‑12mg, Povidone K30 3‑8mg, Crospovidone 3‑8mg, Sodium Lauryl Sulfate 0.9‑1.2mg, Magnesium Stearate 1‑1.5 mg. The preparation method of the invention solves the stability problem of the content uniformity of dapagliflozin.

Description

technical field [0001] The invention relates to a dapagliflozin composition and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Diabetes is a group of metabolic diseases characterized by hyperglycemia. According to statistics from the International Diabetes Federation, there were 387 million people with diabetes worldwide in 2014, and it is expected to reach 592 million in 2035. Type 2 diabetes is the most common form of diabetes, accounting for approximately 90% of diabetic patients. [0003] Diabetes can lead to chronic damage and dysfunction of various tissues in the human body, especially the eyes, kidneys, heart, blood vessels, and nerves. Once you become a diabetic, you need to take medicine for life. Diabetes not only affects the quality of life of patients, but may also lead to shortened life expectancy. [0004] Dapagliflozin (ForxigaTM), chemical name (2S,3R ,4R ,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl] ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/351A61K47/38A61K47/32A61K47/10A61K47/12A61K47/20A61P3/10
CPCA61K9/2095A61K9/2013A61K9/2027A61K9/2031A61K9/2054A61K31/351
Inventor 孙爱梅
Owner WEIHAI GUANBIAO INFORMATION TECH
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