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Tepotinib tablet and preparation method thereof

A technology of tepotinib tablets and tablet cores, applied in the field of tepotinib tablets and its preparation, to achieve the effects of ensuring uniformity of mixing, reducing economic pressure, and stable quality

Pending Publication Date: 2020-12-29
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are no patents and documents disclosing the prescription and process related to tepotinib tablets at present.

Method used

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  • Tepotinib tablet and preparation method thereof
  • Tepotinib tablet and preparation method thereof
  • Tepotinib tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] A tepotinib tablet, the tablet specification is 250mg, consists of the following components:

[0042]

[0043] The dry granulation process is adopted, and the preparation method is as follows:

[0044] (1) 250g tepotinib hydrochloride hydrate, 329.76g mannitol, 103.57g microcrystalline cellulose, 16.57g crospovidone, 4.14g colloidal silicon dioxide and 2.07g magnesium stearate were mixed uniformly;

[0045] (2) performing dry granulation on the physical mixture obtained in step (1);

[0046] (3) Pass the granules obtained in step (2) through a 20-mesh sieve for granulation, add 103.57g microcrystalline cellulose, 16.57g crospovidone, 2.07g magnesium stearate and mix uniformly;

[0047] (4) Add the material obtained in step (3) into a tablet press to compress the tablet, and coat it with a coating solution until the weight gain is 3%, to obtain a tepotinib tablet.

Embodiment 2

[0049] A tepotinib tablet, the tablet specification is 250mg, consists of the following components:

[0050]

[0051] The dry granulation process is adopted, and the preparation method is as follows:

[0052] (1) 250g tepotinib hydrochloride hydrate, 329.76g mannitol, 103.57g microcrystalline cellulose, 16.57g crospovidone, 4.14g colloidal silicon dioxide and 2.07g magnesium stearate were mixed uniformly;

[0053] (2) performing dry granulation on the physical mixture obtained in step (1);

[0054] (3) Pass the granules obtained in step (2) through a 20-mesh sieve for granulation, add 103.57g microcrystalline cellulose, 16.57g crospovidone, 2.07g magnesium stearate and mix uniformly;

[0055] (4) Add the material obtained in step (3) into a tablet press to compress the tablet, and coat it with a coating solution until the weight gain is 5%, to obtain a tepotinib tablet.

Embodiment 3

[0057] A tepotinib tablet, the tablet specification is 250mg, consists of the following components:

[0058]

[0059] The dry granulation process is adopted, and the preparation method is as follows:

[0060] (1) Mix 250g tepotinib hydrochloride hydrate, 329.76g mannitol, 103.57g microcrystalline cellulose, 16.57g crospovidone, 4.14g colloidal silicon dioxide and 1.38g magnesium stearate;

[0061] (2) performing dry granulation on the physical mixture obtained in step (1);

[0062](3) Pass the granules obtained in step (2) through a 20-mesh sieve for granulation, add 103.57g microcrystalline cellulose, 16.57g crospovidone, 2..76g magnesium stearate and mix evenly;

[0063] (4) Add the material obtained in step (3) into a tablet press to compress the tablet, and coat it with a coating solution until the weight gain is 3%, to obtain a tepotinib tablet.

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Abstract

The present invention relates to the technical field of pharmaceutical preparations and particularly to a tepotinib tablet and a preparation method thereof. The tepotinib tablet comprises a medicine tablet core and a coating layer, and the medicine tablet core is prepared from the following components in parts by weight: 1 part of a tepotinib hydrochloride hydrate, 1.5-3 parts of a filler, 0.06-0.2 part of a disintegrating agent, 0.01-0.1 part of a flow aid and 0.01-0.1 part of a lubricating agent; wherein the filler, the disintegrating agent and the lubricating agent are added internally andexternally. The tepotinib tablet is a quick-release film-coated tablet and a detection result of an in-vitro dissolution curve of the tepotinib tablet in a medium with a pH value of 1.0-6.8 is similarto that of a reference preparation. The present invention also provides the preparation method of the tepotinib tablet.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a tepotinib tablet and a preparation method thereof. Background technique [0002] Tepmetko (Tepotinib) is an oral MET inhibitor designed to inhibit MET receptor signaling caused by MET gene mutations, including MET exon 14 skipping mutations, MET amplification, or MET protein overexpression. On March 25, 2020, Merck announced that the Japanese Ministry of Health, Labor and Welfare approved its Tepmetko (tepotinib) for the treatment of unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations patient. [0003] The molecular formula of tepotinib hydrochloride hydrate is C 29 h 28 N 6 o 2 ·HCl·H 2 O, the structural formula is as follows: [0004] [0005] Tepotinib is the world's first oral c-Met single-target inhibitor approved for marketing. However, there are no patents and documents disclosing the pr...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K47/10A61K47/38A61K47/32A61K47/04A61K47/12A61K31/513A61P35/00A61P11/00
CPCA61K9/2866A61K9/2853A61K9/2018A61K9/2054A61K9/2027A61K9/2009A61K9/2013A61K9/2095A61K31/513A61P35/00A61P11/00Y02A50/30
Inventor 苗得足胡清文李雪改王向华刘德杰
Owner REYOUNG PHARMA
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