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Tofogliflozin composition

A technology of toggliflozin and composition, which is applied in the field of toggliflozin tablet composition, can solve the problems of high related substances, low dissolution rate of preparations, etc. Effect

Inactive Publication Date: 2018-03-20
WEIHAI GUANBIAO INFORMATION TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a topagliflozin composition, which solves the problem that the dissolution rate of the preparation is getting lower and lower and related substances are getting higher and higher during storage.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1. Togliflozin 5g, lactose 80g, sodium lauryl sulfate 8g, calcium sulfate 10g, fumed silica 8g, beta cyclodextrin 8g, povidone K30 4g, crospovidone 4g, Magnesium stearate 1g, prepare 1000 tablets according to the preparation method described in the technical scheme.

Embodiment 2

[0024] Example 2. Togliflozin 5g, lactose 65g, sodium lauryl sulfate 1.5g, calcium sulfate 20g, fumed silica 15g, β-cyclodextrin 16g, povidone K30 8g, crospovidone 8g , magnesium stearate 1.5g, prepare 1000 tablets according to the preparation method described in the technical scheme.

Embodiment 3

[0025] Example 3. Togliflozin 5g, lactose 70g, sodium lauryl sulfate 1.2g, calcium sulfate 15g, fumed silica 10g, β-cyclodextrin 12g, povidone K30 6g, crospovidone 6g , magnesium stearate 1.3g, 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 torgliflozin tablet composition and belongs to the technical field of pharmaceutical preparations. The torgliflozin tablet composition in a unit dose comprises 5 mg of torgliflozin, 65 to 80 mg of lactose, 0.8 to 1.5 mg of sodium lauryl sulfate, 10 to 20 mg of calcium sulfate, 8-15mg of fumed silica, 8-16mg of beta-cyclodextrin, 4-8mg of povidone K30, 4-8mg of cross-linked povidone and 1-1.5mg of magnesium stearate. The stable torgliflozin tablet composition has excellent dissolution rate, and the dissolution rate and the content of related substances are stable during the effective period. The problems of decline in the dissolution rate and raise of the content of the related substances in the tablet storage process in the prior art can be solved.

Description

technical field [0001] The invention relates to a topagliflozin tablet composition, which 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] Togegliflozin, the English name tofogliflozin, was developed by Chugai (acquired by Roche in 2002...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/20A61K47/02A61K47/04A61K47/40A61K31/35A61P3/10
CPCA61K9/2013A61K9/2009A61K9/205A61K31/35
Inventor 孙爱梅
Owner WEIHAI GUANBIAO INFORMATION TECH
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