Sitagliptin phosphate tablet and preparation method thereof

A technology of sitagliptin phosphate and tablet cores, which is applied in the field of medicine, can solve the problems of poor fluidity of sitagliptin phosphate, easy sticking, and lower product quality, and achieve low particle size requirements, improve easy sticking, and product quality. high quality effect

Active Publication Date: 2021-03-16
JIANGSU ALPHA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a sitagliptin phosphate tablet on the basis of the prior art, which solves the problem of poor fluidity and easy sticking of the acti...

Method used

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  • Sitagliptin phosphate tablet and preparation method thereof
  • Sitagliptin phosphate tablet and preparation method thereof
  • Sitagliptin phosphate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation methods of embodiment 1, comparative example 1, comparative example 2 and comparative example 3 are as follows:

[0033] (1) Mix sitagliptin phosphate, filler and disintegrant (croscarmellose sodium) for 15min to make it fully mixed; for Example 1, Comparative Example 1 and Comparative Example 2, the filler are microcrystalline cellulose and calcium sulfate; for comparative example 3, the filler is microcrystalline cellulose; for comparative example 4, the filler is microcrystalline cellulose and anhydrous calcium hydrogen phosphate.

[0034] (2) Add lubricant (sodium stearyl fumarate) to the mixture obtained in step (1), mix for 5min, and make it fully mixed evenly.

[0035] (3) Add lubricant (magnesium stearate) to the mixture obtained in step (2), mix for 5min, and make it fully mixed evenly.

[0036] (4) tableting and coating the mixture obtained in step (3), the coating powder used for the coating is Opadry II, the specific model is 85F17438, the c...

Embodiment 2

[0057] For embodiment 2, the lubricant is magnesium stearate, and in the mixture obtained in step (1), magnesium stearate is added, and mixed for 5min to make it evenly mixed;

Embodiment 3

[0058] For embodiment 3, lubricant is calcium stearate, in the mixture obtained in step (1), add calcium stearate, mix 5min, make it mix uniformly;

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Abstract

The invention relates to a sitagliptin phosphate tablet. The tablet or a tablet core comprises an active component sitagliptin phosphate, filling agents, a disintegrating agent and a lubricant, and apreparation process of the sitagliptin phosphate tablet comprises following steps: the active component, the filling agents and the disintegrating agent are uniformly mixed firstly, and then the mixture is mixed with the lubricant for tabletting. According to the invention, microcrystalline cellulose and calcium sulfate are used as the filling agents, the defects of poor fluidity and easy stickingof the active component can be improved, the active component and auxiliary materials do not need to be pretreated in the preparation process, the requirement on the particle size of the material islow, the active component is not easily adsorbed to containers and utensils, and the material utilization rate is high; and when batch amplification is performed to reach 500,000 tablets/batch, no sticking phenomenon is found, the preparation process is simple, the dissolution speed is high, the product quality is excellent, the stability is good, various indexes reach the ideal level of pharmaceutics, and the sitagliptin phosphate tablet is suitable for large-scale commercial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a sitagliptin phosphate tablet and a preparation method thereof. Background technique [0002] Diabetes is a group of metabolic diseases characterized by hyperglycemia. Hyperglycemia is caused by defective insulin secretion, impaired biological action, or both. Long-term hyperglycemia leads to chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves. Studies have shown that in 2015, the number of adult diabetic patients in my country reached 109.6 million, ranking first in the world. Worldwide, the prevalence and incidence of diabetes are gradually increasing. In 2040, the number of people with diabetes worldwide will reach 642 million. [0003] In 2006, Merck developed a new type of hypoglycemic drug - sitagliptin phosphate tablets, trade name JANUVIA, which can be used clinically alone or combined with othe...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/36A61K47/38A61K47/02A61K47/12A61K31/4985A61P3/10
CPCA61K9/2054A61K9/2009A61K9/2013A61K9/2866A61K31/4985A61P3/10
Inventor 陈本顺石利平叶金星徐春涛朱垒垒张维冰钱若灿郭炳华刘春河庞小召童林
Owner JIANGSU ALPHA PHARM CO LTD
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