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Empagliflozin tablet, and preparation method and application thereof

Empagliflozin tablets and Empagliflozin technology, applied in the field of Empagliflozin tablets and its preparation, can solve problems affecting product quality, drug safety, changing raw material crystal forms, etc., to achieve process optimization, control Product stability, increase the effect of dissolution

Inactive Publication Date: 2016-07-20
WATERSTONE PHARMA WUHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the operation of micronization or fine crystallization may have the risk of increasing related substances, or changing the crystal form of raw materials, thereby affecting product quality and potentially affecting drug safety.
[0004] Therefore, the current Empagliflozin pharmaceutical preparations still need to be improved

Method used

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  • Empagliflozin tablet, and preparation method and application thereof
  • Empagliflozin tablet, and preparation method and application thereof
  • Empagliflozin tablet, and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0039] (1) Preparation of Empagliflozin Tablets

[0040] (1) Sieve

[0041] Raw materials pass through a 20-mesh sieve to obtain uniform particles, which is beneficial to the subsequent processes of mixing, granulating, and tableting.

[0042] (2) mixed

[0043] Mix the prescribed amount of empagliflozin, filler, disintegrant and binder evenly.

[0044] (3) Granulation

[0045] Add appropriate amount of water to the mixture obtained in step (2) to make soft material, sieve and perform wet granulation.

[0046] (4) drying

[0047] Dry the granules obtained in step (3) at 50-70°C.

[0048] (5) Tablet

[0049] (2) The assay method of dissolution rate of Empagliflozin Tablets

[0050] Dissolution test conditions: 37°C, the dissolution medium is 0.1N hydrochloric acid, and the second method is the paddle method;

[0051] Sampling time is 5, 10, 20, 30, 45 minutes, filter with filter membrane, discard the initial filtrate, take the subsequent filtrate, and use ultraviolet spec...

specific Embodiment

[0081] Batch No. 1: D 90 The raw material of Empagliflozin is 9um;

[0082] Batch No. 2: D 90 Empagliflozin raw material of 200um;

[0083] Batch No. 3: D 90 Empagliflozin raw material of 400um;

[0084] The particle size was determined by a dry laser particle size analyzer.

Embodiment 1～ Embodiment 9

[0085] Embodiment 1~Example 9 investigates the impact of microcrystalline cellulose on the raw material dissolution of Empagliflozin of different particle sizes:

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Abstract

The invention relates to an empagliflozin tablet, and a preparation method and application thereof. The empagliflozin tablet comprises a first component and a second component, wherein the first component is at least one selected from a group consisting of empagliflozin, a pharmaceutical salt thereof and a solvate of empagliflozin, and the second component is microcrystalline cellulose. According to the invention, by controlling the microcrystalline cellulose in a reasonable range, empagliflozin can be better dissolved out in mediums like 0.1 N hydrochloric acid and water, so bioavailability and stability of the empagliflozin tablet are improved. A prescription and the preparation method for the empagliflozin tablet are simple and practicable, save production cost and improve the quality and treatment effect of the empagliflozin tablet.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular, the invention relates to an empagliflozin tablet and its preparation method and application. Background technique [0002] Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, was jointly developed by Boehringer Ingelheim and Eli Lilly and Company in August 2014. It was approved for marketing by the US FDA in August 2014. It is used for diet combined with exercise. Treatment of adults with adequate glycemic control of type 2 diabetes to improve glycemic control. [0003] However, Empagliflozin is an insoluble drug with a slow dissolution rate, and the dissolution rate of the drug directly affects the absorption of the drug. The low dissolution rate causes low bioavailability, affects the curative effect of the drug, and causes unsatisfactory and wasteful curative effect of the drug. Taking medicines is prone to many adverse reactions. In conventional techn...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7048A61K47/38A61P3/10A61P3/04A61P9/12
Inventor 金晶钱丽娜周晓星刘大鹏程稳项斌
Owner WATERSTONE PHARMA WUHAN
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