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Empagliflozin tablet and preparation method thereof

An empagliflozin tablet, empagliflozin technology, applied in the field of medicine, can solve the problems of large loss, low yield, increased cost, etc., achieve stable release performance, high stability, and reduce adverse reactions

Inactive Publication Date: 2020-01-24
HONG KONG JOWA & HUAYUAN GRP CHUZHOU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the micronization of raw materials requires special airflow milling equipment, which leads to large losses and low yields, resulting in increased costs

Method used

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  • Empagliflozin tablet and preparation method thereof
  • Empagliflozin tablet and preparation method thereof
  • Empagliflozin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Each empagliflozin tablet includes,

[0037] The first component layer:

[0038]

[0039] The second component layer:

[0040] Sodium Croscarmellose 4.5mg;

[0041] Magnesium stearate 1.25mg;

[0042] The third component layer:

[0043] Polyvinyl alcohol 40mg.

[0044] The preparation process of Enpagliflozin tablets is as follows:

[0045] Weigh the components of the above-mentioned prescription for use.

[0046] Put the prescription amount of Enpagliflozin, calcium carbonate, microcrystalline cellulose, lactose and croscarmellose sodium (internal addition) into the granulator for premixing for 2 to 5 minutes, and add the prescription amount of hydroxypropyl cellulose Add 66.15mg of purified water and stir the hydroxypropyl cellulose aqueous solution into the granulator. High-speed granulation for 2 to 5 minutes. The soft material is granulated using a 6mm×6mm screen, and then the wet granules are placed in DPL -30 Fluidized bed multifunctional granulating dryer is boiled and drie...

Embodiment 2

[0052] Each empagliflozin tablet includes,

[0053] The first component layer:

[0054]

[0055] The second component layer:

[0056] Sodium Croscarmellose 4.5mg;

[0057] Magnesium stearate 1.25mg;

[0058] The third component layer:

[0059] Polyvinyl alcohol 40mg;

[0060] Moisture-proof coating layer:

[0061] Opadry YS-1-7040 2.5mg.

[0062] The purified water in the above formula does not appear in the final tablet product and is removed during drying or coating.

[0063] The preparation process of Enpagliflozin tablets is as follows:

[0064] Weigh the components of the above-mentioned prescription for use.

[0065] Put the prescription amount of Enpagliflozin, calcium carbonate, microcrystalline cellulose, lactose and croscarmellose sodium (internal addition) into the granulator for premixing for 2 to 5 minutes, and add the prescription amount of hydroxypropyl cellulose Add 66.15mg of purified water and stir the hydroxypropyl cellulose aqueous solution into the granulator. High-speed ...

experiment example

[0072] For the tablets of Example 1-2 and the commercially available Enpagliflozin tablets (trade name: Jardiance) (comparative example), they were placed at a temperature of 30°C ± 2°C and a humidity of RH65% ± 5% for March and June. Afterwards, the release test was carried out according to the release test method mentioned in the appendix of the Chinese Pharmacopoeia 2005 edition.

[0073] The results are shown in Table 1. The results show that the empagliflozin tablets of Example 1 and Example 2 of the present invention have good release properties, and there is basically no aging after long-term storage.

[0074] Table 1

[0075]

[0076] The test items of Examples 1 and 2 all met the requirements (shown in Table 2), and there was no significant change.

[0077] Table 2

[0078]

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PUM

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Abstract

The invention relates to an Empagliflozin tablet and its preparation method in the field of medicines. The Empagliflozin tablet successively includes a first component layer, a second component layerand a third component layer from the tablet core to the outside. The first component layer includes Empagliflozin, calcium carbonate, microcrystalline cellulose, lactose, croscarmellose sodium and hydroxypropylcellulose. The second component layer includes croscarmellose sodium and magnesium stearate. The third component layer includes polyvinyl alcohol. By adopting the first component layer, thesecond component layer and the third component layer in the Empagliflozin tablet, the medicine can be slowly and constantly released, thus prolonging the effective plasma concentration time and reducing adverse reaction. The Empagliflozin tablet has no aging phenomenon after long-term storage, has high stability, and can maintain stable release performance within the validity period of the Empagliflozin tablet.

Description

Technical field [0001] The invention relates to the field of medicine, in particular to an empagliflozin tablet and a preparation method thereof. Background technique [0002] At present, diabetes has become the world's top five leading causes of death. It is predicted that by 2020 the number of diabetes patients in China will reach 150 million, making it the country with the most diabetes patients in the world. Although there are many types of diabetes drugs on the market, with the progress of patients with type 2 diabetes, the function of pancreatic β-cells gradually declines or even fails. Traditional treatments, whether insulin secretagogues or sensitizers, depend on the existence of pancreatic β-cell function. Therefore, blood sugar levels of more and more patients, especially those in the middle and advanced stages, are becoming more and more difficult to control. For such patients, hypoglycemic drugs that do not rely on insulin will provide more effective treatment optio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K9/22A61K31/7048A61K47/38A61K47/26A61P3/10
CPCA61K9/2018A61K9/2054A61K9/284A61K9/2886A61K9/2893A61K31/7048A61P3/10
Inventor 管悦琴罗雪峰
Owner HONG KONG JOWA & HUAYUAN GRP CHUZHOU PHARMA CO LTD